Using Partners to Enhance Long-Term Weight Loss
Phase: NA
Conditions: Obesity
Sponsor: University of Wisconsin, Madison

 
 
 
Using Partners to Enhance Long-Term Weight Loss 
(Partner2Lose) 
 
NCT03801174 
PI: Corrine Voils, PhD 
2/9/2021 

Partner2Lose 
 
 
PI: C. Voils 
 
 
 
 
 
USING PARTNERS TO ENHANCE LONG-TERM WEIGHT LOSS 
(Partner2Lose) 
 
 
A phase III, single-blind, randomized controlled trial evaluating the efficacy of partner-assisted compared to patient-only 
intervention for long-term weight loss. 
 
Protocol Number: 2018-1400 
Principal Investigator: Corrine I. Voils 
Date: 2/9/2021 
 
 
 
 
This document is confidential. 
No part of it may be transmitted, reproduced, published, or used by other persons without prior written 
authorization from the Sponsor or Principal Investigator. 
 
 
 
 
 
 
Protocol Version History 
Protocol Version 
Date 
Description of Changes 
2 
1/4/2019 
Mediators will be measured at additional time points (Month 3, 9, 15 and 21).  
Dietary fat intake has been removed as an outcome from aim 2. 
3 
2/11/2019 
Correction to the blood pressure reading at the screening visit.  Added the 
clinicaltrials.gov number. 
4 
2/28/19 
Revision to the exertional chest pain or dyspnea criterion. 
5 
4/8/19 
Clarification to data analysis procedure and storage of the audio recordings.   
6 
5/14/19 
Updated version of table 3. 
7 
6/11/19 
Correction to table 2 and 7. New eligibility criterion added. 
8 
8/14/19 
Clarification made regarding the maintenance text messages in section 9.2.2 
9 
3/11/2020 
Adding that group sessions may be delivered remotely. 
10 
4/3/2020 
Adding that self-report weight photos may be collected when classes are 
delivered remotely. 
11 
4/6/2020 
Adding the option to mail participants scales if in-person interactions aren’t 
feasible. 
12 
5/13/2020 
Adding a new inclusion eligibility criterion, the option to do the screening visit 
remotely and obtain oral consent, a COVID-19 survey, and OnceHub as an 
online scheduling platform. Removing eligibility criterion. 
13 
6/17/2020 
Editorial changes. 
14 
2/9/2021 
Adding that the COVID-19 survey will be collected at month 24. 

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Contents 
Statement of Compliance ........................................................................................................................................................ 4 
1. 
List of Abbreviations ......................................................................................................................................................... 5 
2. 
Study Summary ............................................................................................................................................................... 6 
3. 
Schematic of Study Design ............................................................................................................................................ 10 
4. 
Key Roles ....................................................................................................................................................................... 11 
5. 
Background and Introduction ......................................................................................................................................... 13 
5.1 
Background and Rationale .................................................................................................................................... 13 
5.2 
Hypothesis ............................................................................................................................................................. 14 
5.3 
Summary of Clinical Data ...................................................................................................................................... 15 
5.4 
Potential Risk and Benefits to Participants ........................................................................................................... 16 
5.4.1 
Known Potential Risks ...................................................................................................................................... 16 
5.4.2 
Alternative to Study Participation ...................................................................................................................... 16 
5.4.3 
Protection Against Risks ................................................................................................................................... 16 
5.4.4 
Potential Benefits to the Participants ................................................................................................................ 17 
5.4.5 
Risk Minimization: ............................................................................................................................................. 17 
6. 
Study Objectives and Purpose ...................................................................................................................................... 18 
7. 
Study Design and Endpoints.......................................................................................................................................... 18 
7.1 
General Design ..................................................................................................................................................... 18 
7.1.1 
Primary Study Endpoints ................................................................................................................................... 18 
7.1.2 
Secondary Study Endpoints .............................................................................................................................. 18 
8. 
Study Participants .......................................................................................................................................................... 18 
8.1 
Participant Population ........................................................................................................................................... 19 
8.2 
Inclusion Criteria .................................................................................................................................................... 19 
8.3 
Exclusion Criteria .................................................................................................................................................. 20 
8.4 
Participant Screening for Recruitment .................................................................................................................. 21 
8.4.1 
Participant Identification .................................................................................................................................... 21 
8.4.2 
Recruitment and Retention Strategies .............................................................................................................. 21 
8.5 
Vulnerable Populations ......................................................................................................................................... 22 
8.5.1 
Participant Capacity .......................................................................................................................................... 22 
8.5.2 
Participant/Representative Comprehension ..................................................................................................... 22 
8.6 
Informed Consent .................................................................................................................................................. 23 
8.6.1 
Process of Consent ........................................................................................................................................... 23 
8.6.2 
Consent to Participate in Research and Authorization to Use PHI for Research Form .................................... 23 
8.6.3 
Revoking Consent ............................................................................................................................................. 24 
8.6.4 
Costs to the Participant ..................................................................................................................................... 24 
8.6.5 
Payment for Participation .................................................................................................................................. 24 
8.7 
Early Withdrawal of Participants ........................................................................................................................... 24 
8.7.1 
Premature termination of study ......................................................................................................................... 24 

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8.7.2 
When and How to Withdraw Participants .......................................................................................................... 25 
8.7.3 
Data Collection and Follow-up for Withdrawn Participants ............................................................................... 25 
9. 
Study Procedures .......................................................................................................................................................... 25 
9.1 
Established Standard of Care: .............................................................................................................................. 25 
9.2 
Study Visits ............................................................................................................................................................ 25 
9.2.1 
Screening visit: .................................................................................................................................................. 25 
9.2.2 
Intervention ........................................................................................................................................................ 27 
9.2.3 
Follow up: .......................................................................................................................................................... 33 
9.2.4 
Unscheduled: .................................................................................................................................................... 34 
9.2.5 
Final Study Visit ................................................................................................................................................. 34 
10. 
Study Analysis ........................................................................................................................................................... 34 
10.1 
Sample Size Determination ................................................................................................................................... 34 
10.2 
Statistical Methods ................................................................................................................................................ 34 
10.3 
Participant Population(s) for Analysis ................................................................................................................... 36 
10.4 
Planned Interim Analysis: ...................................................................................................................................... 36 
11. 
Data Collection, Handling and Record Keeping ........................................................................................................ 36 
11.1 
Data Confidentiality ............................................................................................................................................... 36 
11.1.1 
Confidentiality of Participant Records ........................................................................................................... 38 
11.2 
Data Capture ......................................................................................................................................................... 38 
11.2.1 
Source Documents ........................................................................................................................................ 38 
11.2.2 
Case Report Forms ....................................................................................................................................... 39 
11.2.3 
Data Collection Tools .................................................................................................................................... 39 
11.3 
Data Management ................................................................................................................................................. 39 
11.4 
Data Monitoring ..................................................................................................................................................... 40 
11.5 
Records Retention ................................................................................................................................................. 40 
12. 
Assessment of Safety ............................................................................................................................................... 40 
12.1 
Specifications of Safety Parameters ..................................................................................................................... 40 
12.1.1 
Definition of Adverse Events (AE) ................................................................................................................. 40 
12.1.2 
Definition of Serious Adverse Events (SAE) ................................................................................................. 40 
12.1.3 
Definition of Unanticipated Problems (UP).................................................................................................... 40 
12.2 
Classification of an Adverse Event ........................................................................................................................ 41 
12.2.1 
Severity of Event ........................................................................................................................................... 41 
12.2.2 
Relationship to Study Intervention ................................................................................................................ 41 
12.2.3 
Expectedness ................................................................................................................................................ 41 
12.3 
Time period and frequency for event assessment and follow-up ......................................................................... 41 
12.4 
Reporting procedures ............................................................................................................................................ 42 
12.4.1 
Adverse Event Reporting .............................................................................................................................. 42 
12.4.2 
Serious adverse event reporting ................................................................................................................... 42 
12.4.3 
Unanticipated problem reporting ................................................................................................................... 42 
12.4.4 
Reporting of pregnancy ................................................................................................................................. 43 
12.5 
Study Halting Rules ............................................................................................................................................... 43 

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12.5.1 
Participant Stopping Rules ............................................................................................................................ 43 
12.5.2 
Study Stopping Rules .................................................................................................................................... 43 
12.6 
Safety Oversight .................................................................................................................................................... 43 
12.7 
Unblinding Procedure ............................................................................................................................................ 44 
13. 
Study Monitoring, Auditing, and Inspecting ............................................................................................................... 44 
13.1 
Medical Monitoring ................................................................................................................................................ 44 
13.1.1 
Study Monitoring Plan ................................................................................................................................... 44 
13.2 
Protocol Deviations ............................................................................................................................................... 44 
13.2.1 
Internal Data and Safety Monitoring Board ................................................................................................... 44 
13.3 
Auditing and Inspecting ......................................................................................................................................... 44 
13.4 
Participant Compliance Monitoring ....................................................................................................................... 44 
14. 
Ethical Considerations .............................................................................................................................................. 45 
15. 
Study Finances .......................................................................................................................................................... 45 
15.1 
Funding Source ..................................................................................................................................................... 45 
15.2 
Conflict of Interest ................................................................................................................................................. 45 
15.3 
Participant Stipends or Payments ........................................................................................................................ 45 
16. 
Publication Plan ......................................................................................................................................................... 45 
17. 
References ................................................................................................................................................................ 46 
18. 
Attachments .............................................................................................................................................................. 49 
 
 
 

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Statement of Compliance 
 
 
The signature below constitutes that the research will be conducted in accordance with the approved protocol, applicable 
regulations, laws and institutional policies.  
 
 
I agree to ensure that all staff members involved in the conduct of this study are informed about their obligations in meeting 
the above commitment.  
 
 
 
 
PRINTED OR TYPED NAME 
 
 
 
SIGNATURE 
 
 
 
DATE 
 
 
Corrine I. Voils 
 
 
 
 
Principal Investigator(s)  
 
 
 
 
 
 
 

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1. 
List of Abbreviations 
 
AE 
Adverse event 
ASA24 
Automated Self-Administered 24-Hour Dietary Assessment Tool 
BMI 
Body mass index 
CFR 
Code of Federal regulations 
CouPLES 
Couples Partnering to Enhance Lipid-lowering Strategies 
CRF 
Case Report Form 
DHHS 
Department of Health and Human Services 
DOS 
Department of Surgery 
DMC 
Data Monitoring Committee 
eCRF 
Electronic Case Report Forms 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
ICH E6 
International Conference on Harmonisation Guidance for Industry, Good Clinical Practice: 
Consolidated Guidance 
ICTR 
Institute for Clinical and Translational Research 
IRB 
Institutional Review Board 
LDL 
Low-density lipoprotein cholesterol 
MAINTAIN Maintenance After Initiation of Nutrition Training 
MOP 
Manual of Procedures 
MNAR 
Missing Not At Random 
MSDS 
Material Safety Data Sheet 
OHRP 
Office for Human Research Protections 
PHI 
Protected Health Information 
PI 
Principal Investigator 
REDCap 
Research Electronic Data Capture 
SAE 
Serious Adverse Event 
SMPH 
School of Medicine and Public Health 
WREN 
Wisconsin Research & Education Network 
 
 
 

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2. 
Study Summary 
 
Title 
Using Partners to Enhance Long-term Weight Loss (Partner2Lose) 
Short Title and Precis 
Partner2Lose 
Protocol Number 
2018-1400 
ClinicalTrials.gov 
number 
NCT03801174 
Phase 
Phase III equivalent 
Methodology 
Randomized controlled trial 
Study Duration 
5 years 
Study Center(s) 
University of Wisconsin (Madison, WI) 
Duke University School of Nursing and School of Medicine (Durham, NC) 
Research Triangle Institute (Seattle, WA) 
Objectives 
Aim 1: Test the hypothesis that estimated patient weight is at least 2.5 kg 
lower at 24 months in the partner-assisted arm than the patient-only arm. 
 
Aim 2: Test the hypotheses that estimated daily caloric intake are significantly 
lower and frequency of moderate intensity physical activity is greater at 24 
months in the partner-assisted arm than the patient-only arm. 
 
Aim 3: Evaluate whether weight loss is mediated by increases in 
transformation of motivation, outcome efficacy, couple efficacy, communal 
coping, and social support for diet and physical activity. 
Number of Participants 
N=230 couples (460 total) 
Diagnosis  
Obese/overweight  

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Inclusion Criteria 
Patient 
• 
aged 18-74 years 
• 
BMI 27-29.9 kg/m2 plus presence of at least one obesity-related 
comorbidity (e.g., type 2 diabetes, blood pressure >130/80, 
dyslipidemia, obstructive sleep apnea, gastroesophageal reflux 
disease, or coronary artery disease) or BMI ≥ 30 kg/m2 
• 
cohabitating and at least daily contact with a spouse/domestic partner 
(same or opposite sex) 
• 
desire to lose weight 
• 
agrees to attend visits per protocol 
• 
access to reliable transportation 
• 
score of at least 4 out of 6 on a validated cognitive screener 
• 
able to stand for weight measurements without assistance 
• 
speak and read English 
• 
individual smart phone with data and texting plan 
• 
individual e-mail address 
• 
able to complete online screener without assistance 
• 
able to use a smartphone, tablet or computer with a video camera or 
webcam and microphone to download apps and to connect to a video 
conference call without assistance 
 
Partner 
• 
aged 18 or older 
• 
willing to participate 
• 
access to reliable transportation 
• 
score of at least 4 out of 6 on a validated cognitive screener 
• 
speak and read English 
• 
smart phone with data and texting plan (not shared with index patient) 
• 
e-mail address (not shared with index patient) 
• 
able to complete online screener without assistance 
 

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Exclusion Criteria 
Patient 
• 
weight loss of at least 5 lbs in the month prior to screening 
• 
currently enrolled or enrollment in previous 3 months in a clinical or 
research program focusing on lifestyle change that could affect weight 
• 
current use of weight loss medications (prescription or over-the-
counter) 
• 
history of bariatric surgery or planning to have bariatric surgery in the 
study timeframe 
• 
residing in a nursing home or receiving home health care 
• 
impaired hearing 
• 
significant dementia, drug or alcohol abuse, or unstable psychiatric 
illness (e.g., schizophrenia or psychosis) 
• 
current treatment for cancer or being treated for cancer (beside skin 
cancer) in the last 6 months 
• 
use of Insulin, Sulfonylureas, or Meglitinides for diabetes due to 
increased risk for hypoglycemia 
• 
pregnant, breastfeeding or planning to become pregnant within the 
study timeframe  
• 
diuretic medication doses higher than hydrochlorothiazide 25 mg daily, 
furosemide 40 mg daily, Torsemide 20 mg daily, Bumetanide 1 mg 
daily or any use of Metolazone). Use of potassium-sparing diuretics is 
acceptable. 
• 
chronic or unstable illness that would limit ability to participate (e.g., 
recent hospitalization; unstable heart disease in the 6 months prior to 
screening) 
o 
having acute coronary syndrome (ACS) including STEMI (ST-
elevation myocardial infarction), NSTEMI (non-ST elevation 
myocardial infarction) and unstable angina (UA)  
o 
recent or impending coronary revascularization [recent 
coronary bypass grafting (CABG) or percutaneous coronary 
intervention (PCI) 
o 
unstable arrhythmia (e.g., hospitalized for unstable atrial 
fibrillation, supraventricular tachycardia, ventricular 
tachycardia, ventricular fibrillation and/or firing of implantable 
cardiac defibrillator [ICD]) 
o 
recent acute congestive heart failure exacerbation [requiring 
increased doses of oral or intravenous (IV) diuretics or 
hospitalization] 
o 
patient may be rescreened after sixth months 
o 
chronic kidney disease at stage 4 or higher 
• 
exertional chest pain, dizziness or lightheadedness 
• 
pain or other condition that prohibits mild-moderate exercise 
• 
history of ascites requiring paracentesis 
• 
planning to relocate in the next 2.5 years 
 
Partner 
• 
underweight BMI (i.e., BMI < 18.5 kg/ m2) 
• 
residing in a nursing home or receiving home health care 
• 
impaired hearing 
• 
any severe health issue that would impair the partner’s ability to 
provide support, including  
o 
significant dementia, drug or alcohol abuse, or unstable 
psychiatric illness (e.g., schizophrenia or psychosis) 
o 
current treatment for cancer or being treated for cancer 
(beside skin cancer) in the last 6 months 
o 
In the last 6 months prior to screening: 

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 
acute coronary syndrome (ACS) including STEMI (ST-
elevation myocardial infarction),  NSTEMI (non-ST 
elevation myocardial infarction) and unstable angina 
(UA)  
 
recent or impending coronary revascularization 
[recent coronary bypass grafting (CABG) or 
percutaneous coronary intervention (PCI) 
 
unstable arrhythmia (e.g., hospitalized for unstable 
atrial fibrillation, supraventricular tachycardia, 
ventricular tachycardia, ventricular fibrillation and/or 
firing of implantable cardiac defibrillator [ICD]) 
 
recent acute congestive heart failure exacerbation 
[requiring increased doses of oral or intravenous (IV) 
diuretics or hospitalization] 
 
Study Product, Dose, 
Route, Regimen 
Partner-assisted weight management counseling delivered in group visits 
every two weeks (months 1-6); individual telephone calls (months 7-18); and 
no further contact with the interventionist (months 19-24) 
Duration of 
administration 
6-month weight loss initiation intervention, 12-month maintenance intervention 
and 6-month no intervention contact period (24-month total follow-up) 
Reference therapy 
Patient-only weight management counseling 
Statistical 
Methodology 
Linear mixed models will be used to evaluate weight, dietary intake, and 
physical activity along with mediation analysis to evaluate the role of 
interdependence theory constructs 
 
 
 

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3. 
Schematic of Study Design 
 
 

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4. 
Key Roles 
 
 
Principal Investigator: 
 
Corrine I. Voils, PhD 
University of Wisconsin-Madison  
University of Wisconsin Department of Surgery 
600 Highland Ave 
K6/100 Clinical Science Center 
Madison, WI 53792-1690 
Office: 608-262-9636  
voils@surgery.wisc.edu 
 
Participating Sites:  
Duke University School of Nursing  
307 Trent Drive  
Durham, NC 27710 
 
Research Triangle Institute  
119 South Main Street 
Union Trust Building, Suite 220 
Seattle, WA 98104 
 
Sub-Investigator(s): 
Heather M. Johnson, MD, MS, Cardiologist 
University of Wisconsin-Madison 
University of Wisconsin (UW) School of Medicine & Public Health 
Division of Cardiovascular Medicine 
H4/512 Clinical Science Center, MC 3248 
600 Highland Avenue 
Madison, WI 53792 
Office: 608-263-0891 
hm2@medicine.wisc.edu 
 
Ryan Shaw, PhD, RN, Associate Professor 
Duke University School of Nursing  
4145 Pearson Building 
307 Trent Drive  
Durham, NC 27710 
Office: (919) 684-9434 
ryan.shaw@duke.edu 
 
Laura Porter, PhD, Clinical Psychologist 
Duke University School of Medicine 
2200 West Main St, Suite 340 
Durham, NC 27705 
Office: (919) 416-3436   
laura.porter@duke.edu 
 
Megan Lewis, PhD, Social Psychologist 
Research Triangle Institute 
119 South Main Street 
Union Trust Building, Suite 220 
Seattle, WA 98104 
Office: 206-268-3613 (3-3613) 
melewis@rti.org 
 

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Data Monitoring Committee 
Contact: 
Amy Siedschlag, MS, Protocol Review Manager 
UW Institute for Clinical and Translational Research (ICTR) Data 
Monitoring Committee (DMC)  
University of Wisconsin School of Medicine and Public Health  
2112 Health Sciences Learning Center 
750 Highland Avenue 
Madison, WI 53705 
(608) 263-3804 
 
Funding Sponsor: 
National Institute of Diabetes and Digestive and Kidney Diseases 
(NIDDK)  
9000 Rockville Pike 
Bethesda, MD 20892  
1-800-860-8747 
healthinfo@niddk.nih.gov 
 
 
NIH Point of Contact: 
Robert Kuczmarski, Program Director 
NIDDK, Division of Digestive Diseases and Nutrition 
9000 Rockville Pike 
Bethesda, MD 20892  
301-451-8354 
kuczmarskir@mail.nih.gov 
 
Biostatistician: 
Lu Mao, PhD, Assistant Professor 
University of Wisconsin-Madison 
Department of Biostatistics and Medical Informatics 
600 Highland Ave, K6/428 Clinical Science Center 
Madison, WI 53792 
(608) 263-5674 
lmao@biostat.wisc.edu 
 
 

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5. 
Background and Introduction 
 
This document is a protocol for a human research study. This study is to be conducted according to US and 
international standards of Good Clinical Practice (FDA Title 21 part 312/812 and International Conference on 
Harmonization guidelines), applicable government regulations and Institutional research policies and procedures.  
 
5.1 
Background and Rationale 
Obesity negatively affects health and is costly. Compared with normal weight peers, individuals with obesity are at 
increased risk for type 2 diabetes mellitus, gallbladder disease, hypertension, congestive heart failure, and coronary 
heart disease.(1, 2) Obesity is also associated with reduced health-related quality of life.(3, 4) People who are 
overweight with at least one obesity-related comorbidity are also at risk for adverse outcomes and thus targeted for 
treatment by the current obesity guideline.(5) The medical-care cost burden of obesity is high, with annual 
expenditures attributable to obesity estimated at $190 billion.(6) Among nationally representative cohorts, the 
average annual incremental healthcare cost associated with obesity compared to being normal weight is ~$1,308 
per person.(7, 8) Effective strategies are needed to address the individual and societal impact of the obesity 
epidemic. 
 
Weight loss improves health outcomes and reduces healthcare costs. Weight loss improves arthritis and functional 
status(9, 10) and decreases blood pressure(11) and type 2 diabetes incidence.(12) A systematic review of the 
impact of weight loss on health and economic outcomes concluded that several weight loss interventions are cost-
effective, and some interventions may even be cost-saving in targeted populations.(13) To decrease the burden of 
obesity/overweight, interventions are needed that promote long-term weight loss. 
 
Behavioral interventions that involve dietary modification and physical activity, combined with cognitive and 
behavioral strategies, are efficacious for short-term weight loss but less so for long-term weight loss. Several 
randomized trials indicate that various dietary approaches (e.g., low-carbohydrate diet, low-fat/low-calorie diet) are 
efficacious for inducing short-term weight loss.(14, 15) A systematic review indicated that supplementing dietary 
modification with physical activity improves 12-month outcomes above diet alone.(16) Incorporating behavioral 
strategies such as self-monitoring, stimulus control, action planning, and problem-solving helps promote adherence 
to these lifestyle behaviors.(14, 17) Following significant weight loss, most people tend to regain 1-2 kg per year, 
with the majority of people returning to baseline weight by 5 years.(17) Various strategies have been evaluated to 
reduce weight regain, including sequential dieting, meal replacements, medications, and behavioral 
approaches.(18) These strategies have not reduced the overall pattern of regain for most people.(17) Furthermore, 
research indicates that the best predictor of long-term weight loss is greater initial weight loss.(19) This research 
suggests that long-term weight loss will be enhanced by 1) identifying efficacious strategies to enhance 
maintenance and 2) increasing the amount of initial weight loss.  
 
One way to improve long-term weight loss is to increase the effectiveness of social support. Decades of 
observational research indicates that people with greater social support—often measured by marital status as a 
proxy--live longer and have better health.(20) Because domestic partners share eating habits, physical activity 
patterns, and other health behaviors, there are frequent opportunities for partners to provide each other with 
informational, emotional, and instrumental support.(21) Furthermore, domestic partners are the preferred source of 
support for most people.(22, 23) Despite the positive effects noted in observational research, trials of weight loss 
interventions involving spouses/partners have not yielded uniformly positive effects.(24)  
 
Scientifically rigorous research is needed to evaluate the efficacy of, and mechanisms underlying, partner-assisted 
weight management interventions. Meta-analyses comparing couples-oriented to patient-only interventions for 
weight loss, most of which were conducted in the 1970s-80s, indicated superiority of partner-assisted interventions 
immediately following treatment but not thereafter.(25, 26) These trials had significant methodological limitations. 
Most of those trials had small samples (mostly N<100, randomized to two or more arms); failed to specify a primary 
outcome, time point, or effect size; and did not include a power analysis.(27-32) Given that sample sizes were 
drastically smaller than today’s weight loss trials, which typically involve >200 participants in order to detect clinically 
significant differences in weight, these studies likely were underpowered. Some trials had suboptimal retention 
rates.(27, 28) Several trials required a monetary deposit from the index patient or the couple,(28, 30-33) which may 
have mitigated or interacted with partner support. Additionally, most trials included interventions lasting 9-16 weeks 
that focused on initial weight loss, with no emphasis on maintenance of weight loss.(28, 30, 31) In addition to issues 

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with trial design and conduct, previous interventions were not grounded in theory or empirical evidence regarding 
the provision of effective social support. Research on mechanisms of social support did not emerge until the late 
1990s; the conceptual model upon which we base our intervention was described in 2006. Furthermore, studies on 
the efficacy of cognitive-behavioral therapy for relationship distress and prevention in health contexts, which can be 
applied to weight loss, did not emerge until the 1990s. Perhaps because early trials of partner-assisted weight loss 
interventions were not uniformly positive, few trials have been conducted in the past 20 years. More recent 
investigations of the possible benefits of partner support have been limited to secondary analyses of the subset of 
married patients in trials that did not compare patient-only to partner-assisted weight loss interventions and did not 
train partners in skills for providing effective support.(34-36)  
 
Taken together, previous research indicates a possible benefit to including partners in weight loss efforts but 
underscores the need for rigorous research on efficacy that builds on modern theoretical frameworks. Trials are 
needed that (1) are rigorous in design and implementation; (2) address weight loss initiation and maintenance; (3) 
systematically train couples to communicate about health and train partners in strategies for providing effective 
support for health behavior change; (4) isolate the partner intervention to provide a stringent test; and (5) evaluate 
theoretically specified mediators. This study accomplishes each of these. 
 
Framing a health problem as “our” problem can initiate 
communal coping responses to promote health behavior 
change. The domestic partnership can be leveraged to help 
initiate and maintain behavior change. According to Lewis’ 
interdependence model of communal coping and behavior 
change,(37) couples who approach behavior change as a 
problem to be tackled together versus independently 
(referred to as ‘transformation of motivation’) are more likely 
to utilize effective communal coping processes, including 
higher levels of (1) outcome efficacy (i.e., a couple’s beliefs 
about the utility of communal coping for improving health), 
(2) couple efficacy (i.e., a couple’s confidence that they can 
engage in communal coping efforts), and (3) use of 
communal coping strategies (i.e., communicating about and 
coordinating actions relevant to the health problem, such as 
joint decision making and planning regarding health 
behavior and identifying and practicing methods of providing 
informational, emotional, and instrumental support). Our 
intervention is designed to affect these interdependence 
constructs to improve long-term weight loss and associated 
health behaviors (Figure 1). We will measure these 
constructs so that we can empirically assess the extent to which they mediate the effect of our partner-assisted 
intervention on long-term weight loss. 
5.2 
Hypothesis 
 
H1: Average patient weight is at least 2.5 kg lower in the partner-assisted arm than the patient-only arm at 24 months. 
 
H2: Average daily caloric intake are significantly lower, and frequency of moderate intensity physical activity is 
significantly greater, in the partner-assisted arm than the patient-only arm at 24 months. 
 
H3: Interdependence constructs (transformation of motivation, couple efficacy, outcome efficacy, use of communal 
coping) mediate the effect of the partner-assisted weight management intervention on weight loss. 
 
 
 

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5.3 
Summary of Clinical Data 
 
Previous research has shown evidence of the efficacy of patient weight loss initiation and maintenance interventions.  
The MAINTAIN trial involved randomization of patients who lost at least 4 kg in a 16-week program to usual care or a 
weight loss maintenance program.(38) To participants in the latter arm, maintenance-specific skills were delivered in 3 
group meetings and 8 individual telephone calls, which decreased in frequency from every 2 weeks to every 2 months. 
Over 56 weeks, the maintenance group regained only 0.75 kg, whereas the usual care group regained 2.36 kg (p <.04). 
Retention was 80%.(39) This study shows that an intervention can be used to induce clinically significant weight loss 
and reduce subsequent weight regain among patients. The weight loss initiation and maintenance interventions 
implemented in MAINTAIN will be delivered to patients in both arms of this trial.  
 
The results of the CouPLES trial showed evidence for the efficacy of training partners by telephone to provide support 
for the initiation of dietary change and physical activity.  This trial compared usual care to a partner-assisted intervention 
to reduce patient LDL. This intervention comprised 9 monthly telephone calls to patients and their spouses. Patients 
generated behavioral goals and action plans, and spouses were taught support principles and created plans to support 
patient goal achievement.(40) At 11 months, there was no difference in the primary outcome of patient LDL, perhaps 
due to a facility-level co-intervention that increased statin prescribing and reduced LDL(41) (statins are more potent 
than lifestyle change for reducing LDL). Compared to usual care patients, intervention patients had lower 11-month 
caloric, total fat, and saturated fat intake and 20% greater frequency of moderate intensity physical activity.(42) 
Furthermore, social support for physical activity and dietary change increased in the intervention but not in the control 
group.(43) Retention was 88%. The CouPLES study demonstrates the ability to recruit and retain couples in a 
telephone-delivered, partner-assisted lifestyle intervention and to increase and measure social support for physical 
activity and eating. The partner-assisted arm of the proposed study will utilize the protocol for sharing patients’ action 
plans with their partners and having partners develop a support plan. In CouPLES, we did not focus on maintenance, 
nor did we teach couples communication skills. In this study, the aim is to increase the efficacy of the CouPLES 
approach by addressing maintenance and incorporating communication skills training from Dr. Porter’s research. 
 
There is evidence of the efficacy of partner-assisted interventions to enhance communication and support and change 
behavior. Dr. Porter has developed and tested multiple interventions to enhance communication and support among 
dyads coping with cancer. These interventions systematically train patients and partners in communication skills to 
provide each other with effective informational, emotional, and instrumental support, which are central components of 
the partner-assisted intervention in the proposed study. Dr. Porter’s studies have also included joint training in 
behavioral skills for pain and symptom management(44) and increasing physical activity,(45) including joint goal setting 
and monitoring of these behaviors. Findings indicate that these interventions led to significant improvements in couples’ 
relationship quality and communication;(46-48) in patient outcomes regarding pain, psychological distress, quality of 
life, and self-efficacy;(46) and in partner outcomes of psychological distress and self-efficacy.(46) Findings have not 
differed by sex. Findings from a recent pilot study of a couple-based intervention for physical activity among cancer 
survivors (which included components similar to those in the proposed study) suggested that the intervention led to 
increases in physical activity among both patients and partners, as well as increases in partner support for physical 
activity (Porter et al under review). In a recent trial involving 14 telephone-based intervention sessions delivered at a 
tapered frequency (biweekly to monthly to bimonthly) to lung cancer patients and their family caregivers, retention rates 
were >80% despite the fact that patients were suffering from an illness associated with high rates of morbidity and 
mortality.(44, 49) These studies demonstrate expertise in designing effective partner support protocols and in retaining 
couples, which will be applied in this study. 
 
The investigator and collaborators of this trial have expertise in collecting data from wireless devices. Drs. Voils and 
Shaw were PIs on an R34 that involved transmission of patient weight from cellular scales and dietary intake from 
MyFitnessPal to the study team to enable provision of financial incentives for weekly weight loss and dietary self-
monitoring. Data were transmitted to Prompt, a web-based software application that obtains data from remote devices 
and sensors and can “push” multiple types of data—in this case, text messages. This study demonstrates the 
experience of using the Prompt system to collect data from cellular scales and mobile telephone apps and to send 
automated text messages to participants, which will be done in the current study. 
 

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5.4 
Potential Risk and Benefits to Participants 
5.4.1 
Known Potential Risks 
 
• 
Physical activity: There are small risks of injury or heart problems due to increased participation in physical 
activity.  The risks associated with physical activity will be minimized by screening for contraindications to 
physical activity participation.  The study physician will be available to answer patients’ questions during their 
participation. Participants will also be instructed to consult with their physician/health care team if they have 
any new health problems or symptoms.   
 
• 
Low blood pressure: In patients taking blood pressure medications, dietary changes and/or weight loss can 
result in low blood pressure.  
 
• 
Disclosure of data: There is a small risk of inadvertent disclosure of participant data.  As our standing 
operating procedure, we have policies and procedures in place to protect the confidentiality and security of 
participant data, see below in “Protection Against Risks”.   
 
• 
Questionnaires, interactions with interventionist: Sensitive questions about personal issues (e.g., quality 
of marital relationship, positive and negative interactions) may make participants uncomfortable.   Participants 
do not have to answer any question that they do not wish to answer, as will be explained during the consent 
process and during subsequent visits.  Participants could become psychologically distressed during group 
visits or telephone calls.  If necessary, any individual or couple experiencing notable psychological distress 
will be discussed with Dr. Porter (psychologist at Duke). 
 
• 
Reproductive risks: No reproductive risks are expected from this trial. This study does not start, change, or 
alter medications in any way. Patients are excluded if pregnant and if planning to become pregnant.   
5.4.2 
Alternative to Study Participation 
The alternative to study participation for all participants is not to participate in the study.  Participants may also 
choose to discontinue their participation in the study at any time.   
 
Rationale for the necessity of exposing human participants to such risks: It is expected that this study will pose 
minimal risks to participants.  
Why the value of the information to be gained outweighs the risks involved: Obesity has become increasingly 
prevalent in the US and is associated with myriad health problems that are alleviated by weight loss. Many of these 
problems (e.g., elevated cholesterol, blood pressure, and blood glucose) are major risk factors for coronary heart 
disease and increase in prevalence as age increases. Despite the known risk of obesity, many Americans have 
difficulty losing weight and even more difficulty maintaining their new weight after losing. There is a dire need for 
effective weight loss and maintenance interventions that can be incorporated into primary care where clinician 
supervision is available. Therefore, the value of the information gained from this study far outweighs the risks 
involved. 
5.4.3 
Protection Against Risks 
 
Sensitive questions about personal issues may make participants uncomfortable. Participants do not have to 
answer any question that they do not wish to answer, as will be explained during the consent process and during 
subsequent visits. Regarding partner interactions, our team includes a clinical psychologist and cardiologist, who 
will be able to recommend appropriate intervention as necessary.   
 
There are small risks of injury or heart problems due to increased participation in physical activity. We will 
minimize the risks associated with physical activity by screening for contraindications to physical activity 
participation (e.g., unstable heart disease in the past 6 months), by providing proper instruction regarding 
methods for engaging in physical activity safely during the group sessions, by providing handouts regarding 
physical activity, and by educating patients to recognize symptoms consistent with overexertion. Several aspects 
of our active intervention will help reduce risks associated with physical activity: 1) All patient materials promoting 
physical activity endorse moderate intensity physical activity during initiation phases of physical activity; 2) 

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Patients are encouraged to establish goals and action plans they feel capable of performing in partnership with 
the interventionist who will assess the feasibility of such goals and expectations; 3) Our interventionists assess 
barriers, which include health problems that may preclude safe physical activity, using American College for 
Sports Medicine (ACSM) guidelines; 4) Our written materials emphasize the need to monitor for symptoms of 
overexertion and other acute health problems (e.g., chest pain, excessive shortness of breath) and recommend 
that patients contact their physician or emergency care (for heart attack or stroke symptoms) if they experience 
any difficulties; and 5) The study physician will be available to answer patients’ questions, and the staff exercise 
physiologist will be available to answer questions as well. Current guidelines from the ACSM and the Department 
of Health and Human Services (DHHS) do not require physician approval for initiation of moderate physical 
activity. In accordance with these guidelines, we will not require participants to check with their personal physician 
upon enrollment in our study.  However, as described above, participants will be instructed about when they 
should consult with their physician, in accordance with ACSM and DHHS guidelines, about new health problems 
or symptoms that require a review of physical activity.  
 
In patients taking blood pressure medications, dietary changes and/or weight loss can result in low blood 
pressure. Participants will be counseled on how to recognize and respond to symptoms of low blood pressure. 
Study personnel will also be trained how to respond when participants report symptoms of low blood pressure. 
The study physician will provide recommendations to the interventionists regarding any issues that arise with 
specific participants and will be available to answer patients’ questions. Participants may also be referred to 
his/her own primary care provider for additional work up. 
 
There is a small risk of inadvertent disclosure of participant data. Research personnel will use only those parts of 
the medical record necessary to determine eligibility and follow the research protocol, and measures will be taken 
to maintain privacy during in-person sessions. We will establish ground rules at the group sessions, advising 
participants that they should only communicate information they feel comfortable communicating in public and that 
any information learned about other participants should be kept confidential. The procedures that will be followed 
in order to prevent the exposure of personal identifying information or protection health information are listed in 
detail in section 11, Data Collection, Handling and Record Keeping of this protocol. 
 
Some participants could become distressed during group visits or telephone calls. The risk that some participants 
could become distressed during the telephone calls is quite unlikely given the previous research literature and our 
experience in our prior studies. Dr. Porter is a licensed clinical psychologist with expertise in working with both 
couples and individuals.  Any couples or individuals who experience notable psychological distress from the 
intervention will be discussed with Dr. Porter (psychologist at Duke)who will make a recommendation about 
intervention that cannot be addressed within the context of the ongoing intervention (e.g., recommend follow up 
with primary care provider, provide contact information for social work service).Study personnel may consult the 
study physician and the study team will attempt to determine whether the study is exacerbating a distressing 
condition; if so, the participant may be withdrawn from the study for his/her safety. 
 
A Certificate of Confidentiality will automatically be granted by the NIH that will protect participants' sensitive 
information. 
 
5.4.4 
Potential Benefits to the Participants 
All participants will receive some level of intervention, as participants in both arms will receive weight loss initiation 
and maintenance instruction; thus, we expect all to derive some benefit from participation. This instruction exceeds 
the available standard of outpatient care that is available to people in the community and involves no direct cost to 
participants. Patients in both arms may learn skills that help them reduce weight by adhering to dietary 
recommendations and participating in regular physical activity.  
 
Participants may experience a positive change in their domestic partnership as a result of participating in the study. 
Although the participants themselves might not derive direct benefit, knowledge gained from the study will assist in 
the treatment of others with weight problems. 
 
5.4.5 
Risk Minimization: 
 
No procedures, situations, or materials are expected to be hazardous.  

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6. 
Study Objectives and Purpose 
• 
Primary objective:  To assess 24-month long-term weight loss in a patient-only vs. partner-assisted intervention.   
• 
Secondary objective:  To assess 24-month long-term self-reported patient caloric intake and physical activity in a 
patient-only vs. partner-assisted intervention.   
• 
Exploratory objective: The role of theoretically hypothesized mediators of intervention effects will be examined, 
including transformation of motivation, couple efficacy, outcome efficacy, use of communal coping, and social 
support for physical activity and dietary intake at 24 months. 
7. 
Study Design and Endpoints 
7.1 
General Design  
 
In this two-arm RCT, 230 couples (460 total) will be randomized to patient-only or partner-assisted intervention. In 
both arms, intervention will be delivered for 18 months followed by 6 months of no intervention contact in order to 
evaluate sustainability of effects. The primary endpoint is weight measured at 24 months (Figure 2). 
 
 
  
This design addresses long-term weight loss, which results from both initial weight loss and weight loss maintenance. 
Because social support is important for initiation and maintenance, incorporating partners in both phases is likely to 
have greater impact on long-term weight loss than incorporating partners in either phase alone. The patient 
intervention is identical between arms. The partner-assisted arm involves additional content, which increases the 
amount of each intervention contact. This is by design, as the partner-assisted intervention involves teaching couples 
to communicate about health and engage in cooperative action. Equalizing dose in both arms would require removing 
portions of the efficacious patient intervention in the partner-assisted arm or adding unrelated content to the patient-
only arm, neither of which would provide a stringent test of the partner intervention. 
 
7.1.1 
Primary Study Endpoints 
 
The primary outcome is long-term weight loss, defined as patient weight at 24 months.  
 
7.1.2 
Secondary Study Endpoints 
 
Secondary outcomes include self-reported patient caloric intake and physical activity at 24 months.  
 
 
 
 
 
8. 
Study Participants 
 
Our target sample size is n=230 patients (115 per arm), randomized to receive the partner-assisted or patient-only 
intervention, to detect a 2.5 kg difference in mean 24-month net weight loss between arms. The sample size estimate 
is based on the primary hypothesis that estimated patient weight will be at least 2.5 kg lower at 24 months in the partner-

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assisted than patient-only arm. This effect size was chosen because smaller differences are unlikely to be considered 
meaningful to researchers, providers, or patients. The sample size was determined by multiplying the number of 
participants required for a t-test of post scores by 2(1-ρ) and adding one extra participant per arm. Based on our previous 
MAINTAIN trial, we anticipate a common standard deviation of 19.9 kg and a correlation (ρ) between the month0 and 
month24 time points of 0.96. Thus, we need 160 participants total (80 in each arm) to detect a 2.5 kg difference with 
80% power and a type-I error rate of 5%. We further inflate the sample size to 1) incorporate the intra-class correlation 
(ICC) of small group members into consideration and 2) compensate for attrition using procedures for group-randomized 
designs.  Let m=15 (conservative upper limit) be the number of patients in each of the small groups, and let ICC=0.01 
represent the intra-class correlation between patients in the same group. The updated sample size is n = 160* [1 + (m-
1)ICC], or 180. We then conservatively inflate the sample size for an attrition rate of 20% through month24. To achieve 
the target sample, we estimate that we will screen up to 500 patients as some couples may provide consent and screen 
as eligible but never show for the first intervention session and thus provide a baseline weight (not counted in ITT 
analyses). 
 
Eligibility will be determined via online screening. Patients who screen as eligible will provide their partner’s information 
(name and email) so that their partner can complete a separate online screening. Couples passing the online screening 
will be scheduled for an in-person (or remote) screening/enrollment visit.  The in-person (or remote) 
screening/enrollment visit will be divided up into two parts. The first part of the in-person screening visit will determine 
the patient’s final eligibility by collecting the following measurements: weight, cognitive screen, and reconfirmation that 
they are not pregnant (females).  For the partners, height, weight and cognitive screening measurements will be 
completed to determine their final eligibility.  Once the patient and partner meet the final eligibility measurements, they 
will be asked to provide written consent (or oral consent if the screening/enrollment visit is done remotely) and complete 
the rest of the baseline measurements.    
 
8.1 
Participant Population  
The age range of participants is 18-74 years. A key inclusion criterion is that participants need to be cohabiting with a 
significant other and have daily contact. As most children aged 17 or under are not emancipated, few children would be 
eligible for this study. The upper age range is 74 as weight loss is often contraindicated in adults aged 75 and older and 
more extensive health screening, in addition to consultation with their primary care physician, may be needed. 
  
No participant will be excluded on the basis of race ethnic origins.  The planned distribution of patient and partner 
participants by racial/ethnic group and sex is shown in the Inclusion Enrollment Report. The race and ethnicity 
distributions 
are 
based 
on 
the 
2015 
estimated 
Dane 
County 
Census 
accessed 
on-line 
at 
https://www.census.gov/quickfacts: ethnicity is approximately 94% non-Hispanic/Latino, 6% Hispanic/Latino; the racial 
make-up is 86% White, 6% Black, 6% Asian, and <1% American Indian or Alaska Native, and <1% Hawaiian/Pacific 
islander.  
8.2 
Inclusion Criteria  
Patient 
• 
aged 18-74 years 
• 
BMI 27-29.9 kg/m2 plus presence of at least one obesity-related comorbidity (e.g., type 2 diabetes, blood pressure 
>130/80, dyslipidemia, obstructive sleep apnea, gastroesophageal reflux disease, or coronary artery disease) or 
BMI ≥ 30 kg/m2 
• 
cohabitating and at least daily contact with a spouse/domestic partner (same or opposite sex) 
• 
desire to lose weight 
• 
agrees to attend visits per protocol 
• 
access to reliable transportation 
• 
score of at least 4 out of 6 on a validated cognitive screener 
• 
able to stand for weight measurements without assistance 
• 
speak and read English 
• 
individual smart phone with data and texting plan 
• 
individual e-mail address 
• 
able to complete online screener without assistance 
 
Partner 
• 
aged 18 or older 

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• 
willing to participate 
• 
access to reliable transportation 
• 
score of at least 4 out of 6 on a validated cognitive screener 
• 
speak and read English 
• 
smart phone with data and texting plan (not shared with index patient) 
• 
e-mail address (not shared with index patient) 
• 
able to complete online screener without assistance 
• 
able to use a smartphone, tablet or computer with a video camera or webcam and microphone to download apps 
and to connect to a video conference call without assistance 
8.3 
Exclusion Criteria 
Patient 
• 
weight loss of at least 5 lbs in the month prior to screening 
• 
currently enrolled or enrollment in previous 3 months in a clinical or research program focusing on lifestyle change 
that could affect weight 
• 
current use of weight loss medications (prescription or over-the-counter) 
• 
history of bariatric surgery or planning to have bariatric surgery in the study timeframe 
• 
residing in a nursing home or receiving home health care 
• 
impaired hearing 
• 
significant dementia, drug or alcohol abuse, or unstable psychiatric illness (e.g., schizophrenia or psychosis) 
• 
current treatment for cancer or being treated for cancer (beside skin cancer) in the last 6 months 
• 
use of Insulin, Sulfonylureas, or Meglitinides for diabetes due to increased risk for hypoglycemia 
• 
pregnant, breastfeeding or planning to become pregnant within the study timeframe  
• 
diuretic medication doses higher than hydrochlorothiazide 25 mg daily, furosemide 40 mg daily, Torsemide 20 mg 
daily, Bumetanide 1 mg daily or any use of Metolazone). Use of potassium-sparing diuretics is acceptable. 
• 
chronic or unstable illness that would limit ability to participate (e.g., recent hospitalization; unstable heart disease 
in the 6 months prior to screening) 
o 
having acute coronary syndrome (ACS) including STEMI (ST-elevation myocardial infarction), NSTEMI 
(non-ST elevation myocardial infarction) and unstable angina (UA)  
o 
recent or impending coronary revascularization [recent coronary bypass grafting (CABG) or percutaneous 
coronary intervention (PCI) 
o 
unstable arrhythmia (e.g., hospitalized for unstable atrial fibrillation, supraventricular tachycardia, 
ventricular tachycardia, ventricular fibrillation and/or firing of implantable cardiac defibrillator [ICD]) 
o 
recent acute congestive heart failure exacerbation [requiring increased doses of oral or intravenous (IV) 
diuretics or hospitalization] 
o 
patient may be rescreened after sixth months 
o 
chronic kidney disease at stage 4 or higher 
• 
exertional chest pain, dizziness or lightheadedness 
• 
pain or other condition that prohibits mild-moderate exercise 
• 
history of ascites requiring paracentesis 
• 
planning to relocate in the next 2.5 years 
 
Partner 
• 
underweight BMI (i.e., BMI < 18.5 kg/ m2) 
• 
residing in a nursing home or receiving home health care 
• 
impaired hearing 
• 
any severe health issue that would impair the partner’s ability to provide support, including  
o 
significant dementia, drug or alcohol abuse, or unstable psychiatric illness (e.g., schizophrenia or 
psychosis) 
o 
current treatment for cancer or being treated for cancer (beside skin cancer) in the last 6 months 
o 
In the last 6 months prior to screening: 
 
acute coronary syndrome (ACS) including STEMI (ST-elevation myocardial infarction),  NSTEMI 
(non-ST elevation myocardial infarction) and unstable angina (UA)  
 
recent or impending coronary revascularization [recent coronary bypass grafting (CABG) or 
percutaneous coronary intervention (PCI) 

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 
unstable arrhythmia (e.g., hospitalized for unstable atrial fibrillation, supraventricular tachycardia, 
ventricular tachycardia, ventricular fibrillation and/or firing of implantable cardiac defibrillator 
[ICD]) 
 
recent acute congestive heart failure exacerbation [requiring increased doses of oral or 
intravenous (IV) diuretics or hospitalization] 
 
Given population rates of overweight/obesity and the fact that weight and health behaviors are highly correlated 
within couples, it is possible that both members of a couple will be eligible to be index patients. If both partners 
in a household desire and are eligible for the patient intervention, then we will ask them to decide which one 
will be the index patient.  Partners may choose to make similar behavior changes as patients; however, partner 
behavior change is not the focus, and partners in the patient-only arm will receive no intervention. Because 
partner outcomes are of potential interest to society and to payers, and because previous studies targeting 
patients have observed “ripple” effects,(36) we will analyze partner outcomes. 
8.4 
Participant Screening for Recruitment  
8.5 
Participant Identification 
 
We will take a two-pronged approach to recruitment. First, we will coordinate with WREN, a voluntary network of 
primary care clinical practices across the state of WI that participate in practice-based research, to access electronic 
medical records of UW Health patients from the Department of Family Medicine and Community Health and General 
Internal Medicine clinics. Second, we will recruit from the community. To recruit from the community, we may place 
advertisements in public meeting places (e.g., churches, community centers, grocery stores), websites (e.g., UW, 
Facebook), and local print publications (e.g., Isthmus).  
8.5.1 
 
Recruitment and Retention Strategies 
Patients identified through the electronic medical record will receive a recruitment letter in the mail that will contain 
a url address link to an online screening website if they are interested in participating and a different url address 
link to a website where they can opt-out of the study.  After sufficient time has elapsed allowing people to opt-out 
(≥1 week), the study team may begin calling people who have received recruitment letters to ascertain interest in 
the study. To meet our study recruitment goals, we will consent up to 500 potential index patients and partners. 
 
For both recruitment paths (i.e., electronic medical record review and posted advertisements), eligibility will be 
determined via online screening. Patients who screen as eligible will provide their partner’s information so that their 
partner can complete a separate online screening. Couples passing the online screening will be scheduled for in-
person (or remote) screening/enrollment visit.  The in-person (or remote) screening/enrollment visit will be divided 
up into two parts. The first part of the visit will determine the patient’s final eligibility by collecting the following 
measurements: weight, height, cognitive screen, and reconfirmation that they are not pregnant (females).  For the 
partners, height, weight and cognitive screen measurements will be completed to determine their final eligibility.  If 
the visit is done remotely, then height and weight will not be collected.  Once the patient and partner meet the final 
eligibility measurements, they will be asked to provide consent and complete the rest of the screening visit 
measurements. This study will be conducted in 5 cohorts of ~46 couples each. Each new cohort will begin as the 
previous cohort transitions to maintenance (in month 7 of 24). As in our previous studies, we will recruit each cohort 
over 4-6 weeks and will not begin group sessions until we have achieved our recruitment target for that cohort.     
 
To enhance recruitment, we will do the following: discuss the study directly with partners to address any 
questions/concerns; frame weight loss as a couples’ issue in recruitment materials; emphasize potential benefits of 
the intervention and outcome assessments to partners; offer sessions at different times of day; and offer two 
sessions that address communication to couples in the patient-only arm following the 24-month assessment. If 
partners no longer wish to receive intervention, then we will retain patients in the intervention (intent-to-treat 
analyses). If patients no longer wish to receive the intervention, then partners will no longer receive the intervention 
either. In such cases, we will ask patients (and partners) to return for outcome assessments, as we have done in 
our previous trials. Other efforts to maximize retention for outcome assessments include: administer the ASA24 
online; e-mail/text reminders one week prior to the beginning of each window; place telephone calls and mail letters 
if participants are non-responsive to electronic reminders; compensate patients and partners $40 each for 
completed interim assessments; and increase payments for the final assessment ($60 each), as we did in the 

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MAINTAIN trial. In the MAINTAIN trial, 85% of patients returned for final assessments; in the CouPLES trial, 88% 
of patients and 70% of spouses did.(42, 50) 
 
No participant will be excluded on the basis of race or sex. There have been mixed findings regarding the 
moderating role of sex in couples-based weight loss interventions. Failure to balance arms with respect to sex 
could, therefore, affect outcomes. Sex is explicitly accounted for in the study design in that it is a stratification 
variable. This variable, along with the other stratification variables of patient BMI and partner BMI, will be included 
in the statistical models for the primary outcome of weight, secondary outcomes of diet and physical activity, and 
mediation analyses.  
 
The study is being conducted in Dane County, Wisconsin. Although the Dane County female population is 50%, 
there is selection bias into weight loss intervention studies, such that, typically, ~70% of patient participants are 
female. McLean’s (2003) systematic review of previous social support interventions for weight loss indicated a 
similar proportion of females as index patients. Therefore, we estimate that 70% of index patients will be female. 
Given a sample size of 230 and 70% female index patients, we may be able to detect a large moderation effect 
but unable to detect a small effect. Any sex differences are likely to reflect societal gender roles because many 
support behaviors for weight management reflect cultural gender norms, such as having primary responsibility for 
the household’s food shopping and cooking. We will therefore measure differences according to gender and sex, 
but with such a small sample, we are unlikely to be able to capture or make meaningful distinctions between sex 
as a biological variable and the distinct variable of gender. 
 
Both same-sex and heterosexual couples are eligible for the study. We require that couples be cohabitating so as 
not to discriminate based on legal marital status. We expect that 5-10% of couples will be same-sex.  
 
The planned distribution of patient and partner participants by racial/ethnic group and sex is shown in the 
Inclusion Enrollment Report. The race and ethnicity distributions are based on the 2015 estimated Dane County 
Census accessed on-line at https://www.census.gov/quickfacts: ethnicity is approximately 94% non-
Hispanic/Latino, 6% Hispanic/Latino; the racial make-up is 86% White, 6% Black, 6% Asian, and <1% American 
Indian or Alaska Native, and <1% Hawaiian/Pacific islander.  
 
8.6 
Vulnerable Populations 
 
TABLE 1: Vulnerable populations included and excluded from this study: 
 
Include 
Exclude 
Vulnerable Population Type 
 
x 
Adults unable to consent 
 
x 
Individuals who are not yet adults (e.g. infants, children, teenagers) 
 
x 
Wards of the State (e.g. foster children) 
 
x 
Pregnant women 
 
x 
Prisoners 
 
 
No vulnerable populations will be enrolled. A key inclusion criterion is that participants need to be cohabiting with a 
significant other and have daily contact. As most children aged 17 or under are not emancipated, few children would 
be eligible for this study.  Pregnant women will be excluded since the primary outcome of this study is long-term 
weight loss, and weight loss is contraindicated during pregnancy.  Prisoners will be excluded as per the OHRP 
guidelines.  Prisoners would not have daily contact with their study partner or the flexibility in dietary and exercise 
choices comparted to the general population.   
8.6.1 
Participant Capacity 
All participants will have the capacity to give informed consent.   
 
8.6.2 
Participant/Representative Comprehension 
To ensure comprehension, after hearing and reading about the study, the participant will be asked to summarize 
the study and the requested activities for participation in the study. The investigator or research staff will then ask 
the participant if anything could be clarified before consent is obtained.  

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Decisionally impaired adults are excluded from this study. 
8.7 
Informed Consent 
 
The PI will be responsible for ensuring that valid consent is obtained in person and documented for all 
participants.  
 
The activities involved to review the EMR for potentially eligible participants are considered “preparatory to 
research” and will be conducted by the Clinical Research Data Service or the Department of Surgery Data 
Analysis & Reporting Team. The Department of Surgery Data Analysis & Reporting Team will pull the data once 
they have the necessary approvals.  Individuals will be directed to go to an online screening website or they 
might be contacted directly by phone by the study team if individuals do not opt-in or opt-out on their own.   
 
Individuals and their partners who are interested in participating will be instructed to go to an online screening 
website which will determine their initial eligibility.  For those who are potentially eligible, an in-person (or 
remote) screening/enrollment visit will be scheduled.  The screening/enrollment visit will be divided up into two 
parts. The first part of the visit will determine the patient’s final eligibility by collecting the following 
measurements: height, weight, cognitive screen, and reconfirmation that they are not pregnant (females).  For 
the partners, height, weight and cognitive screening measurements will be completed to determine their final 
eligibility. If the visit is done remotely, height and weight will not be collected. Once the patient and partner meet 
the final eligibility measurements, they will be asked to provide written consent (or oral consent if the 
screening/enrollment visit is done remotely) and complete the rest of the baseline measurements.  The consent 
process will consist of a detailed verbal description of the study including its risks, potential benefits, and 
requirements. Potentially eligible participants and their partner will be given an IRB-approved/stamped informed 
consent form with all required elements and factual correctness to read, then ample time to read and reflect on 
participating. If the individual and/or partner requests, they will be given additional time to consider participation, 
including re-scheduling the screening visit. Before obtaining  consent, each individual and their partner will be 
allowed to ask questions until a decision can be made by either party. When ready, participants and their partner 
will be required to sign the consent form (or oral consent will be obtained if the screening/enrollment visit is 
done remotely). Study audits by the PI will include review of consent documents for signatures and use of the 
IRB date-stamped form to ensure compliance. 
8.7.1 
Process of Consent 
 
Members of the WREN staff will be responsible for obtaining consent. The written/signed consent (original copy) 
will be stored in a locked file cabinet, in a locked office with the research team. 
 
The process of informed consent will be structured to be conducive to rational and thoughtful decision making by 
the patient and their partner – including time for discussion, questions, and the ability to reschedule if additional 
time for consideration is needed. Legally authorized representatives will not be allowed to sign the consent; patients 
who require legally authorized representatives are excluded from the study.  
 
Auditors, witnesses, and translators will not be part of the consent process. Non-English speakers are excluded 
from the study. Additionally, patients who are unable to read or write in English (i.e., illiterate) are excluded.  
8.7.2 
Consent to Participate in Research and Authorization to Use Protected Health 
Information for Research Form  
 
See Attachment for Consent to Participate in Research and Authorization to Use Protected Health 
Information for Research Form  
 
Signed consent and HIPAA authorization (or oral consent if the screening/enrollment visit is done remotely) will be 
obtained from the patients and their partners arriving for the screening visit once their final eligibility requirements 
have been met.  Patients and partners will be given adequate time to review the document and ask any questions 
they have.  A copy will be given to the patient and their partner that signed the form, on the same day they each 
sign the form. 
 

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Information about study participants will be kept confidential and managed according to the requirements of the 
Health Insurance Portability and Accountability Act of 1996 (HIPAA). PHI that will be collected from participants 
includes name, address, telephone numbers, Medical Record Number, e-mail, date of birth, web addresses and 
internet protocol addresses. 
8.7.3 
Revoking Consent 
In the event that a participant revokes authorization to collect or use PHI, the investigator, by regulation, retains the 
ability to use all information collected prior to the revocation of participant authorization.  For participants that have 
revoked authorization to collect or use PHI, attempts will be made to obtain permission to collect at least vital status 
(i.e. that the participant is alive) at the end of their scheduled study period. 
8.7.4 
Costs to the Participant 
 
 
Participants will not have to pay for any study procedures or materials including the FitbitTM watch that will be used.  
The patient will not be billed by their healthcare system or their health insurance company for any costs related to 
a study procedure.  
Participants will be responsible for any costs if they require any follow-up procedures with their primary care 
physician, including all out-of-pocket costs.   
8.7.5 
Payment for Participation 
 
Payments to patients and partners will be provided as the study progresses; participants do not have to complete 
the entire study to receive a payment.       
 
All patients and their partners can receive a remuneration up to $180/each ($360 for the couple) for completing all 
outcome assessments. For each of the Month 6, 12 and 18 month completed assessments, patients and their 
partners will receive $40/each ($80 for the couple). The payment will increase to $60 for completion of the final 
assessment ($120 for the couple) due to the importance of collecting the primary outcome data at this visit. 
     
Month 6: $40 each/$80 per couple 
Month 12: $40 each/$80 per couple 
Month 18: $40 each/$80 per couple 
Month 24: $60 each/$120 per couple 
 
The remuneration will acknowledge their time and study participation, not behavior change.  Additional payment will 
not be available to participants for travel or other costs (example: childcare) that are incurred.  
8.8 
Early Withdrawal of Participants 
8.8.1 
Premature termination of study 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable cause. Written 
notification, documenting the reason for study suspension or termination, will be provided by the suspending or 
terminating party to all site investigators, funding agency, DSMB (i.e., ICTR DMC), and IRB. If the study is 
prematurely terminated or suspended, the PI will promptly inform the IRB and will provide the reason(s) for the 
termination or suspension.  
 
Circumstances that may warrant termination or suspension include, but are not limited to:  
• 
Determination of unexpected, significant, or unacceptable risk to participants  
• 
Insufficient compliance to protocol requirements  
• 
Data that are not sufficiently complete and/or evaluable  
 
Study may resume once concerns about safety, protocol compliance, data quality are addressed and satisfy the 
funder, IRB and/or DMC. All participant data that were collected prior to study termination will be analyzed and 
continue to be handled/stored per this protocol. 

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8.8.2 
When and How to Withdraw Participants 
Participants will be educated on the consent form that they are able to withdraw at any time without adverse effects. 
Participants may withdraw by alerting study staff in person, by telephone, or by email. If participants withdraw from 
the study, then their status will be updated in the tracking database, and no further contact will be made. Participants 
may be withdrawn at the discretion of the PI for safety reasons (e.g., self-report of pregnancy) or because they 
cannot participate meaningfully in the intervention (e.g., cannot communicate well by telephone). These individuals 
will be informed by study staff in person or by telephone that their participation has ended and the reason for ending 
their study participation. Their status will then be updated in the tracking database, and no further contact will be 
made.  
8.8.3 
Data Collection and Follow-up for Withdrawn Participants 
If partners no longer wish to receive intervention, then we will retain patients in the intervention. If patients no longer 
wish to receive the intervention, then partners will no longer receive the intervention either. Regardless of whether 
partners or patients request not to receive further intervention, we will ask patients and partners to return for 
outcome assessments. Patients who attend the first group session (i.e., provide a baseline weight) will be 
considered randomized and will be analyzed according to intent-to-treat principles, regardless of further intervention 
adherence; these individuals will not be replaced if they drop out subsequent to the first session. Consented 
participants who do not attend the first session (i.e., do not provide a baseline weight measurement) will not be 
considered randomized and thus will be replaced.  
9. 
Study Procedures 
9.1 
Established Standard of Care:  
 
Current standards of care include consultation by primary care physician or specialist; referral to dietician; and 
commercial weight loss programs. 
9.2 
Study Visits 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9.2.1 
Screening visit:  
 
Table 2. Patient Measurement Schedule 
Baseline medical history, demographics* 
Screening Visit – Month 0 –   
(0-8 weeks) 
 
Measure  
Month 
0 
3 
6 
9 
12 
15 
18 
21 
24 
Baseline weight 
X 
 
 
 
 
 
 
 
 
Primary outcome: Weight* 
X 
 
X 
 
X 
 
X 
 
X 
Secondary outcomes 
   Caloric intake* 
X 
 
X 
 
X 
 
X 
 
X 
   Physical activity 
X 
 
X 
 
X 
 
X 
 
X 
Mediators 
   Transformation of motivation* 
X 
X 
X 
X 
X 
X 
X 
X 
 
   Couples’ efficacy* 
X 
X 
X 
X 
X 
X 
X 
X 
 
   Outcome efficacy* 
X 
X 
X 
X 
X 
X 
X 
X 
 
   Use of communal coping* 
X 
X 
X 
X 
X 
X 
X 
X 
 
   Social support for diet* 
X 
X 
X 
X 
X 
X 
X 
X 
 
   Social support for physical activity* 
X 
X 
X 
X 
X 
X 
X 
X 
 
   Brief pain inventory-short form * 
X 
 
X 
 
X 
 
X 
 
 
   Weight loss methods* 
 
 
X 
 
X 
 
X 
 
X 
   COVID-19* 
X 
X 
X 
X 
X 
X 
X 
X 
X 
*Assessed from partners as well 

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The screening visit will occur up to 8 weeks prior to the first group intervention visit. The following measurements 
will be obtained at screening by the WREN Research Coordinators: 
 
• 
Medical history and demographics: age, race, ethnicity, gender and birth sex, insurance status, 
financial stress, education, smoking status, alcohol use, illicit drug use, employment status, previous 
weight loss attempts, history of heart disease, diabetes, cancer, liver disease, and hypertension.  
 
• 
Body weight will be obtained using a calibrated digital scale in light clothing, with shoes removed.  
 
• 
Height will be determined without shoes using a portable or wall-mounted stadiometer. 
 
• 
BMI. The weight and height measures will be used to calculate BMI (weight in kilograms divided by height 
in meter squared; kg/m2). 
 
• 
Dietary intake will be assessed using the Automated Self-Administered 24-hour dietary recall 
(ASA24).(51, 52) Patients will receive training to use the website during the screening visit and may call 
study staff to ask for assistance. Electronic messages via text and/or e-mail will be sent to notify 
participants on one randomly determined weekend day and one weekday during the measurement 
window to complete an unscheduled 24-hour recall. Patients who do not comply within 24 hours will be 
sent notifications to complete recalls on other dates within the window. 
 
• 
Physical activity will be assessed with FitbitTM watches. Patients will be given their FitbitTM and download 
the FitbitTM application at their screening visit, along with instructions on how to use and wear it. They will 
be sent a text and/or e-mail reminder about when to start wearing it continuously for 7 days.  Patients will 
be instructed to return the FitbitTM to the study team if they do not attend the first group session. 
 
• 
Transformation of motivation will be assessed with both Aron’s Inclusion of Other in Self (IOS) scale(56) 
and the Unidimensional Relationship Closeness Scale (URCS).(57) The IOS comprises 7 Venn-like 
diagrams representing different degrees of overlap between the partner and self. IOS scores range from 1 
(completely separate, non-overlapping circles) to 7 (completely overlapping circles). The IOS has produced 
test-retest correlations >.80 and has been associated with relationship longevity. The theoretical basis 
supports the transformation of motivation concept in that self-expansion occurs when the interests and 
experiences of one’s partner are integrated into one’s self definition. The 12-item URCS has produced 
highly reliable scores (>.90) across different relationship types, demonstrates measurement invariance 
across relationship types, and is associated with relational satisfaction. 
 
• 
Couple efficacy, outcome efficacy, and use of communal coping measures have been be adapted 
from previous studies. As with self-efficacy, there is no standardized measure of couple efficacy or outcome 
efficacy that applies across behaviors; instead, a measurement approach must be tailored to each health 
behavior. Dr. Lewis and others have developed items to measure these constructs in the context of smoking 
cessation,(58) HIV,(59, 60) vasculitis,(61) and colon cancer prevention.(62) We have adapted these items 
for the current study. Following Dr. Lewis’ previous research, we will assess communal coping in three 
domains (use, confidence, and effectiveness) related to dietary and physical activity changes for both 
patient and partner. We focus on these three domains because of evidence showing: a) the 
interdependence of coping behaviors in chronic illness within couples (use)(63); b) the importance of 
efficacy perceptions in predicting a wide range of health outcomes (confidence); and c) the relevance of 
behavioral expectations (effectiveness).(64) Use of communal coping for diet and physical activity will be 
measured with 10 items (e.g., “How often do you and your spouse talk about ways to eat less fat?” 1 never 
to 5 very often). Confidence in communal coping for diet and physical activity will be measured with 10 
items (e.g., “How confident are you that, as a couple, you can talk about ways to eat less fat?” 0 = not at all 
confident to 10 = extremely confident). Effectiveness of communal coping for diet and physical activity will 
be measured with 10 items (e.g., “How effective would it be to talk as a couple about ways to eat less fat in 
getting you to eat less fat?” 0 = not at all effective to 10 = extremely effective). Reliabilities for the all 
measures have been >.75. 
 
• 
Social support for diet and physical activity will be measured by two additional measures of communal 
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Habits Survey, respectively (65). These surveys will be modified to address partners. The measures have 
produced reliable scores and demonstrated validity in women with overweight/obesity.(66) 
 
• 
Brief pain inventory-short form will ask participants’ questions about their pain intensity and its 
interference in their lives in the last 24 hours.   
 
• 
COVID-19 will asks participants’ questions about COVID-19 and possible effects of COVID-19 their own 
life and their family’s lives. 
 
When possible, the partner screening visit will occur at the same time as the patient’s screening visit; when 
impossible, we will allow partners to schedule their screening visit any time before the first patient group session. 
From the partner, we will obtain medical history/demographics, weight, dietary intake, transformation of motivation, 
couples’ efficacy, outcome efficacy, use of communal coping, social support for diet and physical activity, brief pain 
inventory-short form, and COVID-19 using the previously described methods. 
 
At the end of the screening visit, once both members of a couple have been deemed eligible, they will be 
randomized. Patients will be informed of which group date and time they need to attend (which corresponds to 
their randomization assignment), but they will not be told whether they have been assigned to the partner-
assisted vs. patient-only intervention until the first group session. Only patients will attend the first group session, 
where they will learn of their randomization assignment and be instructed about whether to bring their partner to 
the next session (depending on arm assignment). Couples will be considered randomized only when their 
randomization assignment has been disclosed in the first group session. We have done this in previous studies so 
that patients who do not attend the first group session, where the month 0 “baseline” weight is obtained, do not 
take a slot in the randomization scheme. To address possible dissatisfaction with randomization in the patient-
alone arm, we will emphasize the importance of the patient-only comparator arm during consent and the first 
group session; emphasize that partners in both arms will be able to participate in assessments; and offer two 
group sessions to couples in the patient-only arm after final assessments. We have not observed differential 
dropout in prior studies. 
 
Patients and their partners will return for outcome assessment visits at month 6, 12, 18 and 24 (Table 2).  These 
outcome assessment visits may occur remotely via a video conference if necessary due to public health safety 
measures.  For the patients, at months 6, 12 and 18: weight, dietary intake, physical activity, transformation of 
motivation, couples’ efficacy, outcome efficacy, use of communal coping, social support for diet and physical activity, 
brief pain inventory-short form and COVID-19 will be measured by using the previously described methods.  
Additionally, at months 6, 12, 18 and 24, patients will complete a weight loss methods survey to see if there are any 
other ways they attempted to lose weight other than being in the study.  For the transformation of motivation, 
couples’ efficacy, outcome efficacy, use of communal coping, social support for diet and physical activity, brief pain 
inventory-short form, weight loss methods, and COVID-19 surveys, these will be sent ahead of their visits as a 
REDCap link via text and/or e-mail.  The surveys will be completed at the outcome assessment visit if patients and 
partners do not complete them ahead of time, on their own. At month 24: weight, surveys (weight loss methods and 
COVID-19), dietary intake and physical activity assessments will be obtained.  For the partners, all of the same 
measurements will be obtained at the same time-points except for physical activity.  All outcome assessment visits 
will be completed by the WREN Research Coordinators.  If patients or partners are unable to attend an in-person 
outcome assessment visit due to illness or public health safety measures, then we will collect their self-reported 
weight photos via a DOS REDCap link. 
 
At months 3, 9, 15 and 21, transformation of motivation, couples’ efficacy, outcome efficacy, use of communal 
coping, social support for diet and physical activity, and COVID-19 will be measured for both patients and partners.  
Patients and partner will be sent the surveys as a REDCap link via text and/or e-mail.   
9.2.2 
Intervention 
 
Patient intervention overview (both arms) 
 
We will use a low-calorie approach from our previous studies.(39, 67) The diet will consist mainly of whole-grain, 
complex starches, vegetables, fruits, lean meats, and low-fat dairy products.(68, 69) The goal for total caloric intake, 
which will be personalized for each patient, will be calculated by subtracting 500-1000 kcal from the maintenance 
energy requirement determined by a sex and overweight/obesity-specific outpatient formula.(70) The range is 

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provided to encourage participants to stay under the 500 kcal deficit level in order to lose weight at an adequate 
rate but above the 1000 kcal deficit level, which may require closer medical monitoring. If a participant experiences 
a prolonged plateau after a previous downward weight trajectory, then energy intake may be reduced further by 
300-500 kcal per day. If a participant achieves goal weight before the end of the 6-month initiation period, then 
energy intake will be adjusted to maintenance-level calories. At the end of the initiation period, all patients will be 
provided with a personalized maintenance-level calorie budget. 
 
Patients will be guided to achieve the current recommendations for physical activity The 2018 current Guideline 
recommends at least 150 minutes per week of moderate-intensity aerobic physical activity such as brisk 
walking.(71)  We acknowledge that some individuals will not meet recommended guidelines.  Consistent with 
national recommendations, they will be encouraged to do as much as they can since bouts of moderate to 
vigorous exercise of any duration have been found to beneficial. (71)  Additionally, in accordance with the 
American College of Sports Medicine guidelines, we will recommend 2-3 days per week of muscle strengthening 
activities and stretching. (72)  We will emphasize that between 150-250 minutes per week of moderate intensity 
exercise is recommended for weight loss, with greater weight loss achieved with more minutes of exercise and 
>250 minutes needed to maintain weight loss and prevent regain.(73) One group session (in month 5) will be 
devoted entirely to physical activity. Additionally, 15 minutes of each of the other sessions will be devoted to 
educating, demonstrating, and performing exercises, such as a walk, a muscle strengthening routine that can be 
done in the home without equipment (e.g., chair stands), and a stretching routine. The content of physical activity 
education, which can occur during didactic session or during the 15-minute exercise demonstrations, will 
encourage increased self-efficacy, awareness of health benefits, reduction of barriers, increased enjoyment, 
identification of strategies to overcome relapse, and development of personally meaningful incentives and 
reinforcements for successful physical activity engagement. Collectively, these are associated with initiation and 
maintenance of physical activity.(74) An overview of patient weight loss initiation and maintenance interventions is 
provided in Table 3. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table 3 
  
 
 
 
Patient weight loss initiation intervention (months 1-6, both arms) 
 
Groups of ~11-12 patients will meet every 2 weeks and will be led by an interventionist. Meetings will begin with 
weigh-ins by research staff (self-report weight photos may be collected via a DOS REDCap link if group classes 
are delivered remotely and participants will be mailed a scale in this situation) and will involve dietary education, 
physical activity demonstration, and goal setting.   Partners in the partner-assisted arm will attend a subset of these 
sessions, whereas partners in the patient-only arm will not be permitted to attend group sessions. The group 
sessions may be delivered via a video call if necessary due to public health measures that would prevent classes 
from happening in-person. Patients will download the MyFitnessPal application to their mobile phones, to promote 

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self-monitoring of diet.  Although patients will be recruited in Madison, WI, where the PI is located, data from the 
FitbitTM will be transmitted to Prompt, a mobile health platform developed by the Duke Digital Health Institute. Using 
Prompt will save time and money that would be needed to develop a similar resource at UW. Study staff will assist 
patients during the first group meeting with installing the apps and will be available for ongoing support throughout 
the trial.  
 
We have reported the theoretical orientation of the initiation and maintenance interventions.(75) The constructs and 
way they are operationalized are summarize in Table 4. Although the didactic content varies across contacts, the 
same initiation behavioral strategies are taught and practiced in each group session in months 1-6, and the same 
maintenance strategies are taught and practiced in each contact in months 7-18. Our model addresses social 
support during initiation and maintenance.(75) During initiation, patients in a group-based weight loss intervention 
may receive support from two sources: (1) the intervention setting (interventionist, group members) and (2) their 
existing social network (friends, family, coworkers). Regarding (1), patients in both arms may derive support from 
the intervention setting.  Regarding (2), in the patient-only arm, patients will not receive instruction on how to solicit 
social support and partners will not receive intervention.  In the partner-assisted arm, couples will receive training 
in how to engage in communal coping.  All the in-person group sessions will be audio recorded.   
 
 
 
Table 4 
 
 
 
Patient weight loss maintenance intervention (months 7-18, both arms) 
 
Patients will transition to the behavioral maintenance intervention in month 7 regardless of whether they achieved 
their 6-month weight loss goal for 3 reasons: 1) It is not feasible for some patients to continue the group-based 
initial protocol while others transition to the individual maintenance protocol; 2) Based on previous studies, most 
patients achieve maximum weight loss at 6 months; 3) Our maintenance protocol allows for patients to continue 
pursuing weight loss during the maintenance phase if desired. The protocol also stipulates that patients who 
relapse (gain > 3lb.) should revert to creating dietary and physical activity goals and monitoring these behaviors, 
thus re-focusing on weight loss. In months 19-24, patients will not receive intervention but will be encouraged to 
continue self-monitoring using the provided devices. This transition mimics real-world practice in which patients 
would be expected to apply the maintenance skills they have learned once intervention contacts cease. The 6-
month period without intervention contact will allow examination of the sustainability of intervention effects.  
 
 

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The maintenance intervention was designed to help patients transition from the intensity that characterizes most 
weigh loss interventions to the real world in which patients rarely have further intervention-related contact. This 
intervention involves a shift from diet initiation content to maintenance-oriented skills training, then switches mode 
from in-person to telephone, and finally decreases contact frequency. The interventionist will place all telephone 
calls using a semi-structured script programmed into a custom intervention program that records participant 
responses for reference in subsequent calls. There will be a 2-week window around the target call date. If the 
educator is unable to contact a patient in the call window, then that telephone call will be skipped. Continuity will 
be maintained because each call involves a review of data from the previous call and a review of the same 
behavioral skills. All maintenance telephone calls will be audio recorded. Dr. Voils will meet with Dr. Porter and 
the interventionists weekly to review a random subset of recorded calls and provide feedback using a checklist. 
 
Partner intervention overview (partner-assisted arm)  
 
The theoretical basis for the partner intervention is Lewis’ interdependence model (Table 5), along with principles 
of cognitive-behavioral couples therapy.(76) Cognitive-behavioral couple therapy (CBCT) is an empirically 
supported, efficacious intervention for both preventing and treating relationship distress. A central feature of 
CBCT is communication skills training, which focuses on teaching couples skills for effectively sharing their 
thoughts and feelings, listening supportively to each other, and making decisions together. Our intervention 
incorporates treatment components of evidence-based, couples interventions for medical problems specified by 
Baucom, Porter, et al.(46) to target key processes in the interdependence model (Table 5). We will train couples 
in communication and support skills and help them apply these to 1) increase their perception of weight loss as 
“our problem” (transformation of motivation”) and 2) enhance partners’ efficacy and abilities to engage in 
communal coping and support patients’ weight loss efforts in a way that is mutually acceptable and satisfying 
(communal coping processes). 
 
Table 5 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Partner involvement in weight loss initiation intervention (months 1-6)  
 
The partner intervention will be delivered by the interventionist and, as explained in C.9, will be supplemented with 
text messages to reinforce support principles and support commitment. There is no literature to suggest the optimal 
dose of a partner intervention. We are using our experience in dyadic interventions to strike the balance between 
efficacy and burden, which will be achieved by a combination of partners participating in a subset of group and 
telephone patient intervention contacts and receiving supplemental text messages. Partners are not requested to 
attend all 12 biweekly patient sessions, as burden may lead to attrition. Instead, they will attend 6 monthly meetings. 
Monthly contacts led to meaningful patient behavior change in our previous trials. The month 1 partner meeting will 
be conducted at the same time as the patient meeting with the goals of orienting partners to the intervention, 
introducing social support principles, and providing example behaviors that are likely to be perceived as bilateral 
and supportive versus unilateral and unsupportive. For example, partners will be taught to provide empathy and 
avoid making comments that can be perceived as critical; comment on positive rather than negative patient 
behaviors; make the same lifestyle changes when possible; offer praise; and help patients reward themselves for 
goal achievement.  
 

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In months 2-6, partners will attend monthly sessions along with the patients; they will receive the same dietary and 
physical activity education as patients, which can provide the basis for instrumental support and may benefit 
partners who are attempting weight loss themselves. These sessions will also include continued training in 
communication skills and social support principles with a focus on applying skills to the educational topic presented 
that month. Sessions will involve group discussion and role-plays around common challenges. Participants will be 
encouraged to share successes and challenges if they are comfortable doing so. There will also be breakout 
sessions so that couples can engage in guided exercises to identify individual challenges and preferred supportive 
behaviors and practice providing support (partner) and reinforcing this support (patients). During these meetings, 
couples will work together to generate a partner support plan to enhance support commitment. The interventionist 
and attending co-investigator will assist couples in this task. 
 
Partner involvement in weight loss maintenance intervention (months 7-18) 
 
Month 7 will involve partner attendance at the three patient group sessions led by the interventionist, which includes 
an overview of the patient maintenance program and a discussion of the partner’s role in weight maintenance. 
Partners will co-participate in the three monthly calls in months 7-9 because it is important for partners to learn to 
work together effectively to promote patient behaviors that maintain weight loss and to receive coaching from the 
interventionist if challenges are encountered. Partners will also participate in calls in months 12 and 18. During all 
joint telephone calls, partners and patients will co-develop patient relapse plans and partner support plans. They 
will be encouraged to communicate regularly about the identified plans, assess progress, and work together to 
overcome barriers. Calls to couples will be ~10 minutes longer than patient-only calls. In the CouPLES trial, patients 
and spouses participated on >75% of calls together even though the protocol did not require it; thus, we expect high 
compliance in this study.  
 
The content from the group sessions and maintenance telephone calls will be revised iteratively until the team feels 
that patients understand and can engage with the content. Changes may be made to enhance comprehension of 
intervention material or the ability to engage in the recommended behavioral skills. 
 
Text messages to reinforce intervention principles and reduce burden (months 1-18) 
 
Timing, frequency and development of message content are consistent with Dr. Shaw’s previous successful 
research that is now being translated into clinical practice.(77) To recapture intervention principles, we will use text 
messages that we have developed and are currently implementing in our ongoing R34 (to patients in both arms) 
and support principles that were included in handouts from the CouPLES study (to partners in partner-assisted 
arm). These will be supplemented with patients’ personalized goals and relapse prevention plans (to patients both 
arms) and partners’ support plans (to partners in partner-assisted arm).  In the maintenance period, the partner text 
messages with be the same as the patient text messages.  Research staff will schedule the messages to be 
delivered over 18 months by Prompt. Table 6 shows the schedule and content by arm. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table 6   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Couples’ communication sessions (patient-only arm) 
 
Following the 24-month outcome assessment, we will offer sessions 1 and 2 from the partner-assisted intervention 
to couples in the patient-only arm. 
 
9.2.3 
Follow up: 
 
Table 7. Acceptable Window for Study Visits (including weekends) 
 
Visit 
Window 
Activities 
Screening visit 
Up to 8 weeks prior to 
first group session  
Informed consent, medical history/demographics, weight, dietary 
intake, physical activity, transformation of motivation, couples’ 
efficacy, outcome efficacy, use of communal coping, social support 
for diet and physical activity, brief pain inventory-short form, 
COVID-19 
Month 0  
1st group session (0-8 
weeks post screening 
visit) 
Baseline weight is recorded, randomization status is revealed to 
participant. 
Month 3  
+/- 14 days from target 
assessment date 
Transformation of motivation, couples’ efficacy, outcome efficacy, 
use of communal coping, social support for diet and physical 
activity, COVID-19 
Month 6  
+/- 14 days from target 
assessment date 
Weight, dietary intake, physical activity, transformation of 
motivation, couples’ efficacy, outcome efficacy, use of communal 
coping, social support for diet and physical activity, brief pain 
inventory-short form, weight loss methods, COVID-19 
Month 9  
+/- 14 days from target 
assessment date 
Transformation of motivation, couples’ efficacy, outcome efficacy, 
use of communal coping, social support for diet and physical 
activity, COVID-19 
Month 12 
+/- 14 days from target 
assessment date 
Weight, dietary intake, physical activity, transformation of 
motivation, couples’ efficacy, outcome efficacy, use of communal 
coping, social support for diet and physical, activity brief pain 
inventory-short form, weight loss methods, COVID-19 

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Month 15  
+/- 14 days from target 
assessment date 
Transformation of motivation, couples’ efficacy, outcome efficacy, 
use of communal coping, social support for diet and physical 
activity, COVID-19 
Month 18  
+/- 14 days from target 
assessment date 
Weight, dietary intake, physical activity, transformation of 
motivation, couples’ efficacy, outcome efficacy, use of communal 
coping, social support for diet and physical activity, brief pain 
inventory-short form, weight loss methods, COVID-19 
Month 21  
+/- 14 days from target 
assessment date 
Transformation of motivation, couples’ efficacy, outcome efficacy, 
use of communal coping, social support for diet and physical 
activity, COVID-19 
Month 24  
+/- 14 days from target 
assessment date 
Weight, dietary intake and physical activity, weight loss methods 
 
9.2.4 
Unscheduled: 
 
• 
Unscheduled visits will not be included in this study. 
• 
No concomitant therapies will be advised or suggested in this study. 
 
9.2.5 
Final Study Visit 
 
The final study visit will occur 24 months after enrollment.  At the 24 month visit, the patient’s weight, dietary 
intake and physical activity will be assessed via the methods described previously. We will have a two-week 
window on either side of the target assessment date. 
 
No additional follow-up for AEs/SAEs will occur after the final outcome measurement visit due to minimal risk. 
Newsletters will be sent to all participants with study results summarized across participants. Patients will be 
aware of their weight measurements that occur at study visits, so individual disclosure of data is not necessary.  
10. 
Study Analysis 
10.1 Sample Size Determination 
 
The sample size estimate is based on the primary hypothesis that estimated patient weight will be at least 2.5 kg 
lower at 24 months in the partner-assisted than patient-only arm. This effect size was chosen because smaller 
differences are unlikely to be considered meaningful to researchers, providers, or patients.(78) The sample size was 
determined by multiplying the number of participants required for a t-test of post scores by 2(1-ρ) and adding one 
extra participant per arm.(79)  Based on MAINTAIN, we anticipate a common standard deviation of 19.9 kg and a 
correlation (ρ) between the month0 and month24 time points of 0.96. Thus, we need 160 participants total (80 in each 
arm) to detect a 2.5 kg difference with 80% power and a type-I error rate of 5%. We further inflate the sample size to 
1) incorporate the intra-class correlation (ICC) of small group members into consideration and 2) compensate for 
attrition using procedures for group-randomized designs.(66) Let m=15 (conservative upper limit) be the number of 
patients in each of the small groups, and let ICC=0.01 represent the intra-class correlation between patients in the 
same group. The updated sample size is n = 160* [1 + (m-1)ICC], or 180. We then conservatively inflate the sample 
size for an attrition rate of 20% through month24.  Therefore, we will enroll n=230 patients (115 per arm), randomized 
to receive the partner-assisted or patient-only intervention, to detect a 2.5 kg difference in mean 24-month net weight 
loss between arms.  
10.2 Statistical Methods 
 
Descriptive statistics, including graphical displays, will be used to summarize all study variables. Distributional 
assumptions of the continuous outcome variables will be carefully examined and transformations made, if 
necessary. We will construct individual and mean trajectory plots of the longitudinal outcome variables to understand 
their general trends over the study period. In addition, we will explore the variability and correlation structure of the 
longitudinal outcome variables.   

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Aim 1: Test the hypothesis that average patient weight is at least 2.5 kg lower in the partner-assisted arm than 
the patient-only arm at 24 months. The unit of time will be months relative to randomization. The outcome is weight 
measured at each in-person study visit. Therefore, month0 represents the weight at the point of randomization (i.e., the 
first group visit), and month24 represents the primary study endpoint.  The between-arm comparison in net weight loss 
from month0 to month24 will be examined with a multilevel longitudinal model(80) of the general form: Yijt = Xijtβ + cj + 
Zijbij+ εijt, where Yijt is weight in kg for patient i in small group j at t=month0, 6, 12, 18, 24.  The predictors in the model 
will (Xijt) include a time main effect, the intervention main effect, and the intervention arm by time interaction, and Zijt will 
include an intercept and a time effect. We will use a flexible polynomial model for the main effect of time and keep the 
treatment by time interaction linear in time. We will first explore cubic time effects. If it is inadequate for the complexity 
in the temporal trend, higher order polynomials will be explored. We will formally check for the adequacy of a particular 
form for time effects using Wald or likelihood ratio tests for higher-order terms. The effect cj is an additional random 
intercept for small group j, capturing common effects at the small group level. The predictor vector Xijt will also include 
indicator variables for each of the eight strata defined by the cross-classification of the stratification variables of patient 
sex, patient BMI, and partner BMI. As a first step, the correlation of patients’ repeated measures over time will be 
modeled and accounted for via the patient-level random intercept and time slope, bij. However, as is advised by good 
modeling practice,(80) various covariance structures for time will be explored, including unstructured and differential 
correlation structures by arm, via graphics such as the variogram and estimation with ReML,(81) all while being blinded 
to treatment effects. The AIC and BIC fit indices will be used to choose the best correlation structure. We will estimate 
the parameters in the model using the SAS procedure MIXED (Cary, NC). To test the null hypothesis that the average 
weight is equal in the two intervention arms, we will test if the coefficient for the time by treatment interaction is zero.  
Specifically, if 𝑋𝑋𝑖𝑖𝑖𝑖𝑖𝑖𝛽𝛽 takes the following form𝛽𝛽0 + 𝛽𝛽1𝑡𝑡𝑡𝑡𝑡𝑡+ 𝛽𝛽2𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡+ 𝛽𝛽3𝑡𝑡𝑡𝑡𝑡𝑡∗𝑡𝑡+ 𝛽𝛽4𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐, 
 
where 𝑡𝑡𝑡𝑡𝑡𝑡 is the treatment indicator and 𝑡𝑡 is linear time, then the null hypothesis is 𝐻𝐻0: 𝛽𝛽3 = 0. In addition, we will 
tabulate the analysis results for the (fixed) effects of the baseline covariates such as patient sex, patient BMI, and 
partner BMI. 
 
Aim 2: Test the hypotheses that average daily caloric intake is significantly lower, and frequency of moderate 
intensity physical activity is significantly greater, in the partner-assisted arm than the patient-only arm at 24 
months. Dietary adherence will be operationalized as daily intake of calories at months 0, 6, 12, 18, and 24. For each 
of these same assessment times, physical activity will be summarized as the total and mean minutes of moderate 
levels per week. Changes in dietary adherence and physical activity will be analyzed using the same methods and 
models as presented for the Aim 1 analyses of weight loss. Previous experience with these outcomes has shown they 
are often non-normally distributed; therefore, outcomes may be analyzed as generalized linear mixed models, 
estimated with adaptive Gaussian quadrature, as needed.  As exploratory analyses, we will use the models described 
for Aims 1 and 2 to examine “spillover” effects(34) of the partner-assisted intervention on partner weight and dietary 
adherence.(50)  
 
Aim 3: Assess the extent to which interdependence constructs (transformation of motivation, couple efficacy, 
outcome efficacy, use of communal coping) mediate the effect of the partner-assisted weight management 
intervention on weight loss.   We will estimate the extent to which the effect of the partner intervention, Ti on 
participants’ weight at 6 months, Yi, is jointly mediated by a vector of five mediating constructs, Mi = (Mi1,…,Mi5) 
measured at 3 months: transformation of motivation, couples’ efficacy, outcome efficacy, use of communal coping, 
and social support. Each mediating construct is measured by the summary scale of associated items. We will assess 
mediation twice: separately for the diet and physical activity domains of the mediators.  
 
Mediation analysis requires additional assumptions beyond treatment randomization, most importantly: (i) no 
unobserved mediator-outcome confounders; and (ii) no observed mediator-outcome confounder is affected by the 
intervention. In order to render assumption (i) more plausible, we will make statistical control for a vector of baseline 
values, Bi of the blocking variables, weight, and the mediating constructs, and we will assume that the block of 
mediators referring to diet and the block referring to physical activity do not affect each other (we do, however, permit 
that the elements of each Mi affect each other). 
 
We will follow VanderWeele and Vansteelandt’s9 approach to estimate the natural direct effect (NDE) and the natural 
indirect effect (NIE) of the intervention relative to a set of mediators, M, by estimating a set of regression equations.  
E[Yi| T, M, B] = a0 + a1Ti + a21Mi1 + ⋯+ a25Mi5 + a3Bi 
 
E[Mik| T, B] = b0k + b1kTi + b2kBi for k = 1, … ,5. 

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We write Yi(t, Mi൫t′൯) for the potential outcome of i if i received intervention t and the value the mediators if i received 
intervention t′. Under assumptions (i), (ii), successful randomization of the intervention (all condition on B), and 
correct functional form, we will then estimate the average natural direct effect of the intervention (versus not) on 
weight at 6 months as 
E[Yi൫1, Mi(0)൯−Yi(0, Mi(0)|B) = a1 
 
and the natural indirect (mediation) effect as 
 
E[Yi൫0, Mi(0)൯−Yi(0, Mi(1)|B) = b11a21 + ⋯+ b15a25. 
 
We will bootstrap the standard errors for the direct and indirect effects.  
 
10.3 Participant Population(s) for Analysis 
 
All participants’ data will be analyzed, using an intent-to-treat approach. The sample size justification appears in Section 
8 Study Participants. 
10.4 Planned Interim Analysis:  
There is no interim analysis planned. However, we are prepared, if requested by the Data Monitoring Committee at any 
point, to calculate interim statistical power for its review. Projections of interim power can be made under several 
scenarios for future data, including assumptions that current trends continue or that the future data reflect the relative 
effects used in the design of the trial. Safety reports will tally adverse events by intervention assignment and postulated 
relationship to the trial interventions; event rates will be reported per person year of follow-up. Should excessive risk to 
study participants be determined during the DMC review, the study will be stopped and all participants notified in a 
manner appropriate to the nature of the risk as defined by the IRB and DMC. 
11. 
Data Collection, Handling and Record Keeping 
11.1 Data Confidentiality 
Every effort will be made to protect participant confidentiality. Research personnel will use only those parts of the 
medical record necessary to determine eligibility and follow the research protocol, and measures will be taken to 
maintain privacy during in-person sessions. We will establish ground rules at the group sessions, advising 
participants that they should only communicate information they feel comfortable communicating in public and that 
any information learned about other participants should be kept confidential.  
 
Data from the mobile device (FitbitTM) will be automatically transferred to the FitbitTM smartphone app.  The data are 
then automatically transferred to the FitbitTM company servers. These data are not identifiable since we are providing 
participants with a FitbitTM login ID that is created by the study team. Data will be maintained on the FitbitTM servers 
indefinitely. Data from the FitbitTM servers will be automatically transmitted to Dr. Shaw’s team’s mobile health 
platform (Prompt) at Duke University. The platform compiles and analyzes biological, environmental and behavioral 
data from mobile devices and sensors. Using these data, algorithms are developed to perform analytics and, in a 
feedback loop, intervene with patients or their social network, or transmit their data to providers. This software is 
currently used in NIH-funded trials, including another with Drs. Voils’ and Shaw, and approved by the Duke IRB and 
security office for clinical trial use. 
 
In this study, participants will sign a consent and HIPAA Authorization (or oral consent will be obtained if the 
screening/enrollment visit is done remotely) to allow data from the mobile devices to be transmitted to the platform, 
where it will be aggregated. Interventionists will have access to a dashboard in the software system, where they 
can view physical activity data from study participants. This will allow the interventionists to provide tailored 
feedback. All data from the platform will be transferred (with identifiers: phone number and study ID) using IRB-
approved methods to the University of Wisconsin-Madison during the data analysis phase of the grant. The data 
can be used for ancillary analyses to examine patterns of self-monitoring and engagement with the intervention.  
 
In order to prevent the exposure of personal identifying information or PHI, we will use the following procedures: 

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1. During the screening process, each potential patient and partner will be assigned a study participant number 
for tracking purposes.  
2. Participant identifying information that is recorded on paper will be kept in a locked file cabinet in the research 
offices at UW-Madison of the PI or WREN.  
3. Potential participants who decline participation or are ruled ineligible during the screening process will have all 
their identifying information destroyed.  
4. Case report forms will be identified by study participant number only.  
5. No results will be reported in a personally identifiable manner. 
6. The recruitment tracking system will be firewalled behind the SMPH firewall, only accessible from SMPH 
workstations, not the internet in general.  SSL (secure socket layer) encryption will be employed to access the 
site, guaranteeing end to end security.  The server physically resides on Surgery’s Virtual Infrastructure 
located in the data center in MFCB behind a locked, keycarded, and PIN required door.  The same security 
measures will be in place for the online screening website except that the website will be accessible from the 
general internet. 
7. All tracking system data will be password-protected with several levels of protection.  
a. The first password will allow access to the operating system of the computer.  
b. The second password will allow access to the basic menus of the integrated system.  Administrative 
functions are restricted to only certain ID’s.  Our prior research employing similar precautions has 
demonstrated that these techniques are very successful in assuring the protection of participants.  
8. Data from the mobile device (FitbitTM) will be aggregated using a software engine designed by Duke software 
engineers, called Prompt. Prompt is used in many NIH-funded studies at Duke University and has received 
approval to be used by the Duke IRB. Prompt uses Twilio and Amazon S3. Prompt will receive physical 
activity data from FitbitTM. We will not collect names in this database, only phone number and study ID of each 
participant, as well as data from FitbitTM (physical activity). Study staff will login to a password-protected 
database to view study ID and see if participants are using the devices. We will use Amazon S3 to store data; 
data will be encrypted when it is stored. These are companies outside of Duke that will have access to 
participants’ personal information (phone number and data from the devices). If these data are further 
disclosed by them or their business partners, it may no longer be covered under the privacy protections.  
Stefan Wahe, UW-Madison HIPAA Security Officer, has vetted and approved these Duke platforms.      
a. The mobile health platform, Prompt, is password-protected and only the necessary investigators (with 
Duke IRB approval) will have access to the software and participant data. All data that are exported 
from the platform will be coded with only the participant study ID linked (not their phone number). 
b. Data exported from the mobile health platform will sit on a firewall-protected Duke School of Nursing 
Server in a secure electronic folder (S:\SED\Partner2Lose). Only necessary investigators will have 
access to this folder. 
c. This data will be transferred approximately every 6 months to the University of Wisconsin-Madison via 
a Duke managed Box folder.  Once the data are uploaded, the UW will download and store the data 
to the Department of Surgery (DOS) Instance of REDCap.  DOS REDCap will only accessible by 
members of the UW research team.  Each user in DOS REDCap has their own ID and can only see 
their projects or projects that have been shared with them.  The UW Department of Surgery and 
School of Medicine and Public Health scan for vulnerabilities on a regular basis. 
9. We will register all participants with the mobile devices using their coded study ID and a coded e-mail address. 
For example, for participant ‘P1234’ we will create a Gmail account ‘P1234@gmail.com’. This coded e-mail 
address will be used as the registration for the FitbitTM and will only be linked to the participant using the secured 
study key.  The participant ‘name’ in the Fitbit App and at Duke will be the Study ID. 
10. We will ensure that all sharing options with third party services such as online social networks or other fitness 
apps are disabled. Participants will be encouraged not to share information with third party services such as 
online social networks or other fitness apps. However, some participants may opt to do this. Thus, all 
participants will be encouraged to read the privacy statement for the mobile devices and to decide for 
themselves what information they would like to share.  
11. The group sessions and maintenance telephone calls will be audio recorded. The recordings will be stored and 
shared with Dr. Porter via a secure Duke box folder.  Only members of the research team will have access to 
these recordings.  The audio recordings will not contain identifiers and the study team will discourage the use 
of identifiers at the beginning of each group session (e.g. ask the participants not to use full names).  The 
recordings will be stored for up to 7 years after the study is completed. 
12. DOS REDCap, an approved electronic database that is only accessible by members of the research team, will 
be used for randomization, enrollment, and questionnaire/survey completion.  Each user in DOS REDCap has 

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their own ID and can only see their projects or projects that have been shared with them.  The Department of 
Surgery and School of Medicine and Public Health scan for vulnerabilities on a regular basis.  Particpants will 
be assigned a unique identifier number in this database once they are scheduled for their in-person screening 
visit.  At that time, some of their identifiable information will be entered and stored in DOS REDCap. This unique 
identifier will be linked to a separately maintained master list that contains participant identifiers, which will be 
located in the tracking system. This linkage will allow research staff to track the enrollment process.  Any 
additional identifiable information will be coded prior to entry into the final dataset. Consequently, the final 
dataset that will be retained will not include any participant identifiers.   
13. We will use Duke’s instance of REDCap to send text messages to participants to encourage them to self-
monitor and use the devices. This software interfaces with Twilio to send text messages. We will store 
participant phone numbers and study IDs in Duke’s REDCap, no other information is needed. 
a. Text messaging does not provide a completely secure and confidential means of communication. No 
PHI will be sent via text message.  All of this information is included in the consent form.  
b. Duke’s REDCap, is password-protected and only the necessary investigators will have access to the 
software and participant data. All data in Duke’s REDCap will be coded with only the participant ID. 
c. Duke’s REDCap will only store phone numbers and study ID codes while the UW-Madison DOS 
REDCap will store all other study data.  
14. For data analysis and safety monitoring, the data will be downloaded from DOS REDCap to the UW secure 
Biostatistic servers.  Data analysis will occur on the secure Biostatistic servers.   
15. Access to study data will be removed for all study personnel when they are no longer part of the research team. 
16. If it's necessary to have the group classes via a Webex video call, participants will be provided a link to join the 
call via their desktop or cell phone.  Webex is approved for use by UW HIPAA.  
17. The OnceHub online scheduling program is a secure and HIPAA compliant website. Participants will only use 
their name and email to schedule their 6, 12, 18 and 24 month in-person measurements. Only members of the 
study team will be able to view participant information. Participants cannot see any other participants' 
information. 
 
11.1.1 
Confidentiality of Participant Records 
By signing the protocol, the Investigator agrees that the NIH or IRB representative may consult and/or copy study 
documents in order to verify CRF data. By signing the consent form (or providing oral consent if the 
screening/enrollment visit is done remotely), the participant agrees to this process. If study documents will be 
photocopied during the process of verifying CRF information, the participant will be identified by unique code only 
and full names and similar identifying information (such as medical record number) will be masked. 
 
The Clinical Site Investigators will ensure that the identity of participants will be protected. All study records will be 
maintained in a secure fashion with access limited to essential study personnel only. All study documents submitted 
to the Coordinating Center will have identifiers removed other than dates of birth and service and participants will 
be identified with a site-specific identification number only. The Clinical Site Investigators will maintain, in a secure 
location, an enrollment log that includes participant identifying information and links participants to their study-
specific identification number.  
 
11.2 Data Capture  
11.2.1 
Source Documents 
All source data will be kept and merged and/or entered into the electronic clinical trial software (DOS REDCap). 
Source data is all information, original records of clinical findings, observations, or other activities in a clinical trial 
necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents. 
Examples of these original documents and data records include: surveys recorded on hard copy or in DOS 
REDCap; ASA24 data; participant files.  
Data will be collected during the screening visit, Month 0 (first group session: weight only), Month 6 visit, Month 12 
visit, Month 18 visit, Month 24 visit.  Data will also be collected during the in-person group visits and telephone calls 
for the intervention portion of the study.   
 
Data will also be pulled from the mobile device FitbitTM using our mobile health platform, known as Prompt. The 
data will be used for research purposes only. 

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11.2.2 
Case Report Forms 
 
The study case report form (CRF) is a data-reporting instrument for the study. All data requested on the CRF must 
be recorded. All missing data must be explained.  
• 
All entries should be printed legibly in black ink.  
• 
If any entry error has been made, to correct such an error, draw a single straight line through the incorrect 
entry and enter the correct data above it.  
• 
All such changes must be initialed and dated. 
 
NOTE: 
• 
If a space on the CRF is left blank because the procedure was not done or the question was not asked, write 
“N/D”.  
• 
If the item is not applicable to the individual case, write “N/A”.  
• 
DO NOT ERASE OR WHITE OUT ERRORS.  
• 
For clarification of illegible or uncertain entries, print the clarification above the item, then initial and date it. 
11.2.2.1 
Missing Data 
 
Our plans for preventing and dealing with missing data follow the guidelines set forth by the National 
Research Council’s Panel on Handling Missing Data in Clinical Trials. First, we will employ numerous 
strategies to achieve < 20% patient attrition. Second, as recommended by the panel, we will conduct two 
general types of sensitivity analyses for our primary analysis. Because we are using full likelihood methods, 
the primary analysis model above (as well as the exploratory aim analysis model discussed below) is valid 
under the MAR (missing at random) framework, where missing values may depend on treatment arm, any 
observed weight measurement, patient sex, and patient and partner month0 weight. If missing values are 
related to other measured factors, such as physical activity measurements, then multiple imputation provides 
a framework for incorporating information from these auxiliary variables while still preserving a parsimonious 
main treatment effect model.(86) As a first sensitivity analysis, a general, multivariate imputation model will be 
constructed using all observed weights, treatment arm, and any covariates predictive of missingness. The 
primary model, specified above, will then be fit to the multiply imputed data, and the estimates and standard 
errors will be combined using appropriate combining rules. We acknowledge the possibility that data may be 
MNAR and propose as a second sensitivity analysis to explore MNAR methods, including pattern-mixture 
models and the toolkit of methods presented in O’Kelly & Ratitch.(87)   
 
11.2.3 
Data Collection Tools 
 
This study will use the Department of Surgery instance of REDCap, which provides data management 
functionality by allowing the development of eCRFs and surveys to support data capture. DOS REDCap is a 
secure, web-based, flexible system with an intuitive interface to enter data and has real time validation rules 
with automated data type and range checks at the time of data entry.  
 
 
11.3 Data Management 
 
UW-Madison will serve as the data coordinating center, overseeing timely and accurate data collection. The data 
coordinating center agrees to be responsible for implementing and maintaining quality control and quality assurance 
systems with written standard operation procedures (SOPs) to ensure that trial is conducted and data are generated, 
documented, and reported in compliance with the protocol, accepted standards of Good Clinical Practice (International 
Conference on Harmonization E6), and all applicable federal, state, provincial, and local laws, rules, and regulations 
relating to the conduct of the clinical trial in an ongoing and auditable manner. The DOS instance of REDCap, a web 
application for managing surveys will be used for data collection of survey instruments and to randomize participants.  

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11.4 Data Monitoring  
 
DOS REDCap reports will be used to provide up-to-the-minute access to all entered data. This will allow verification of 
completeness, timeliness, reliability, and accuracy of collection and coding of data. Consistency checks and range 
checks have been built into the DOS REDCap System.  
 
In preparation for and during ICTR DMC reviews, the DMC staff will notify the study team if any questions regarding 
data arise.  This may include, but is not limited to, missing data elements, outliers, and/or conflicting data points. 
 
11.5 Records Retention 
For this non-FDA regulated study, all study data will be retained for at least 5 years after the last manuscript published 
under this clinical trials protocol number. If the analysis data will be retained beyond this window (example: for another 
study), a separate protocol and IRB approval will be obtained. 
12. 
  Assessment of Safety 
 
This is a minimal risk study. The PI will be notified of any AEs/SAEs and ensure that all notifications (IRB, DSMB, etc.) 
occur according to protocol. 
12.1 Specifications of Safety Parameters 
12.1.1 
Definition of Adverse Events (AE)  
 
Adverse event means any untoward medical occurrence associated with the use of an intervention in humans, 
whether or not considered intervention-related (21 CFR 312.32 (a)). 
12.1.2 
 Definition of Serious Adverse Events (SAE)  
 
An AE or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it 
results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or 
prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability 
to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result 
in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate 
medical judgment, they may jeopardize the patient or participant and may require medical or surgical intervention 
to prevent one of the outcomes listed in this definition. 
 
12.1.3 
Definition of Unanticipated Problems (UP)  
 
OHRP considers unanticipated problems involving risks to participants or others to include, in general, any incident, 
experience, or outcome that meets all of the following criteria:  
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are described in 
the protocol-related documents, such as the IRB-approved research protocol and informed consent document; 
and (b) the characteristics of the participant population being studied;  
• 
Related or possibly related to participation in the research (“possibly related” means there is a reasonable 
possibility that the incident, experience, or outcome may have been caused by the procedures involved in the 
research); and  
• 
Suggests that the research places participants or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized.  
 
This study will use the OHRP definition of UP. 
 
Corrective actions or changes that will be considered in response to an UP will include:  

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• 
Modification of inclusion or exclusion criteria to mitigate the newly identified risks  
• 
Implementation of additional safety monitoring procedures  
• 
Suspension of enrollment of new participants or halting of study procedures for enrolled participants  
• 
Modification of informed consent documents to include a description of newly recognized risks  
• 
Provision of additional information about newly recognized risks to previously enrolled participants. 
 
12.2 Classification of an Adverse Event 
12.2.1 
Severity of Event 
 
The following guideline will be used to describe severity: 
 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily activities.  
Moderate – Events result in a low level of inconvenience or concern with the therapeutic measures. Moderate 
events may cause some interference with functioning.  
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug therapy or other 
treatment. Severe events are usually potentially life-threatening or incapacitating. 
 
12.2.2 
Relationship to Study Intervention 
For all collected AEs, the clinician who examines and evaluates the participant will determine the AE’s causality 
based on temporal relationship and his/her clinical judgment. The degree of certainty about causality will be graded 
using the categories below. 
 
Definitely Related – There is clear evidence to suggest a causal relationship, and other possible contributing 
factors can be ruled out. The clinical event occurs in a plausible time relationship to intervention and cannot be 
explained by other factors.  
Probably Related – There is evidence to suggest a causal relationship, and the influence of other factors is unlikely. 
The clinical event occurs within a reasonable time after administration of the intervention and is unlikely to be 
attributed to other factors.  
Possibly Related – There is some evidence to suggest a causal relationship (e.g., the event occurred within a 
reasonable time after administration of the intervention). However, other factors may have contributed to the event 
(e.g., the participant’s clinical condition, other concomitant events). Although an AE may rate only as “possibly 
related” soon after discovery, it can be flagged as requiring more information and later be upgraded to “probably 
related” or “definitely related,” as appropriate. 
Unlikely to be related – A clinical event whose temporal relationship to drug administration makes a causal 
relationship improbable (e.g., the event did not occur within a reasonable time after administration of the trial 
medication) and in which other behaviors or underlying disease provides plausible explanations (e.g., the 
participant’s clinical condition, other concomitant treatments). 
Not Related – The AE is completely independent of intervention and/or evidence exists that the event is definitely 
related to another etiology. There must be an alternative, definitive etiology documented by the clinician. 
12.2.3 
Expectedness 
 
The study clinician will be responsible for determining whether an AE is expected or unexpected. An AE will be 
considered unexpected if the nature, severity, or frequency of the event is not consistent with the risk information 
previously described for the intervention. 
12.3 Time period and frequency for event assessment and follow-up 
 
The occurrence of an AE or SAE may come to the attention of study personnel during study visits and interviews of 
a study participant presenting for medical care. All AEs, including local and systemic reactions not meeting the 
criteria for SAEs, will be captured on the appropriate CRF. Information to be collected includes event description, 
time of onset, clinician’s assessment of severity, relationship to study intervention, and time of 

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resolution/stabilization of the event. All AEs occurring while on study must be documented appropriately regardless 
of relationship. All AEs will be followed to adequate resolution.  
 
Any medical condition that is present at the time that the participant is screened will be considered as baseline and 
not reported as an AE. However, if the study participant’s condition deteriorates at any time during the study, it will 
be recorded as an AE. UPs will be recorded in the data collection system throughout the study.  
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event at each 
level of severity to be performed. AEs characterized as intermittent require documentation of onset and duration of 
each episode.  
 
12.4 Reporting procedures 
 
This study will follow the HS-IRB reporting and submission timeframes: 
https://kb.wisc.edu/images/group78/18324/ReportingTimeframesJanuary2013.pdf  
  
Reporting time frames are in the Attachment. 
 
This document will take priority for timeframes. The PI is responsible for reporting to the IRB, DMC, and NIH. 
 
12.4.1 
Adverse Event Reporting  
 
Adverse events must be reported once the participant undergoes any study procedures and adverse events must 
be reported during the entire active study period. The IRB, DMC, and NIH will receive notifications about AEs.  
 
12.4.2 
Serious adverse event reporting  
 
Any SAE (including death, irrespective of the cause) occurring during the study will be immediately reviewed by the 
PI/study physician(s).  Only SAEs meeting the Health Sciences IRB’s reporting requirements will be submitted for 
IRB review. These SAEs will be submitted within the timeframe that is required by the HS-IRB and will also be 
reported to the DMC within the same timeframe.  
 
The DMC will review all SAEs, regardless of reporting requirements to the IRB, every 12 months or ad hoc 
depending on the clinical case at the discretion of the PI/study physician(s). Each SAE will be followed until it is 
resolved or can be explained satisfactorily. 
 
12.4.3 
Unanticipated problem reporting  
 
The site investigator will be responsible for creating and completing a UP report form. Incidents that meet the OHRP 
criteria for UPs will be reported promptly per the HS IRB timeline (See Attachment). 
• 
All UPs should be reported to appropriate institutional officials as required by the HS-IRB, the NIH, DSMB, and 
OHRP upon receipt of the report of the problem from the investigator per the HS IRB policy: 
https://kb.wisc.edu/images/group78/18324/ReportingTimeframesJanuary2013.pdf  
 
The UP report will include the following information:  
• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project number; 
• 
A detailed description of the event, incident, experience, or outcome; 
• 
An explanation of the basis for determining that the event, incident, experience, or outcome represents 
an UP; 
• 
A description of any changes to the protocol or other corrective actions that have been taken or are 
proposed in response to the UP. 
 

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12.4.4 
Reporting of pregnancy  
 
Participants will also be immediately withdrawn from the study if they report being pregnant or planning to become 
pregnant. Study data acquired up to the withdrawal date will be analyzed. No additional routine pregnancy reporting 
is indicated for this study. 
 
12.5 Study Halting Rules 
12.5.1 
Participant Stopping Rules 
 
 Participants will be informed that they have the right to withdraw from the study at any time for any reason, 
without prejudice to their medical care.  The investigator also has the right to withdraw participants from the 
study for any of the following reasons: 
 
• 
If study intervention is discontinued due to AE  
• 
Protocol violation 
• 
Study terminated  
 
Participants may be withdrawn at the discretion of the PI for safety reasons. Women that are currently pregnant or 
plan to become pregnant during enrollment screening will be excluded from study participation. If a participant 
becomes pregnant during the study, she will be excluded immediately from further participation in all study activities. 
Pregnancy testing is not part of the study protocol. Once enrolled in the study, individuals in either the usual care 
or intervention group who become ineligible during the study (e.g., self-report of pregnancy) will be informed that 
their participation has ended and will be provided the reason for ending their study participation. 
 
12.5.2 
Study Stopping Rules 
 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable cause. Written 
notification, documenting the reason for study suspension or termination, will be provided by the suspending or 
terminating party to investigator, funding agency and the regulatory authorities. If the study is prematurely 
terminated or suspended, the PI will promptly inform the IRB and DMC and will provide the reason(s) for the 
termination or suspension.  
 
 Circumstances that may warrant termination or suspension include, but are not limited to the following:  
• 
Determination of unexpected, significant, or unacceptable risk to participants  
• 
Insufficient compliance to protocol requirements  
• 
Data that are not sufficiently complete and/or evaluable  
12.6 Safety Oversight 
Independent safety oversight will be provided by The UW ICTR Data Monitoring Committee (DMC). The UW ICTR 
DMC is comprised of experienced members (core plus ad hoc) with expertise required to oversee this study. The 
DMC members will review protocol-specific reports created by statisticians using data pulled from DOS REDCap 
data management tool. These standard reports will include an overview of study objectives, a review of actual and 
projected accrual rates, an evaluation of patient demographics for balance of randomization, and a summary of the 
number and seriousness of adverse events. Source documents may be reviewed to allow the DMC to independently 
judge whether the overall integrity and conduct of the protocol remain acceptable based on data provided and 
reported by the PI. The DMC will make recommendations to the PI that could include actions of continuation, 
modification, suspension, or termination. 
 

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12.7 Unblinding Procedure 
 
Blinding of participants is not possible in behavioral interventions. Only WREN outcome assessors will be blinded.  
 
13. 
Study Monitoring, Auditing, and Inspecting 
13.1 Medical Monitoring 
13.1.1 
Study Monitoring Plan 
No independent study monitoring will be conducted.  
 
13.2 Protocol Deviations 
A protocol deviation is any noncompliance with the clinical trial protocol, GCP, or MOP requirements. The 
noncompliance may be either on the part of the participant, the investigator, or the study site staff. As a result 
of deviations, corrective actions are to be developed by the site and implemented promptly.  
 
The site PI/staff will be responsible for continuous vigilance to identify and report deviations to the protocol. 
These will be reported per the HS IRB requirements (see attachment). All deviations must be addressed in 
study source documents, reported to NIH Program Official, DMC, and IRB.  Protocol deviations will be sent to 
the local IRB per their guidelines. The site PI/study staff is responsible for knowing and adhering to their IRB 
requirements. 
  
 
13.2.1 
Internal Data and Safety Monitoring Board 
 
We plan to utilize the UW ICTR Data Monitoring Committee (DMC) to oversee the study. The UW ICTR DMC 
is comprised of experienced members with expertise required to oversee this study. The DMC members will 
review protocol-specific reports created by statisticians using data pulled from the DOS REDCap data 
management tool. These standard reports will include an overview of study objectives, a review of actual and 
projected accrual rates, an evaluation of patient demographics for balance of randomization, and a summary 
of the number and seriousness of adverse events. An interim analysis of study results may be performed and 
source documents may be reviewed to allow the DMC to independently judge whether the overall integrity and 
conduct of the protocol remain acceptable based on data provided and reported by the Principal Investigator. 
The DMC will make recommendations to the Principal Investigator that could include actions of continuation, 
modification, suspension, or termination. 
 
In providing oversight for the conduct of this study, the ICTR DMC will meet annually during the 5-year study to 
review all adverse events. Additional meetings may be scheduled as determined by the DMC or as requested 
by the PI. Additional information about the ICTR DMC can be found in the ICTR DMC Charter and Composition, 
located in the Attachment section of this protocol.  
13.3 Auditing and Inspecting 
The investigator will permit study-related monitoring, audits, and inspections by the EC/IRB (or their 
representatives), the sponsor, government regulatory bodies, of all study related documents (e.g. source 
documents, regulatory documents, data collection instruments, study data etc.).  The investigator will ensure 
the capability for inspections of applicable study-related facilities (e.g. pharmacy, diagnostic laboratory, etc.). 
13.4 Participant Compliance Monitoring 
 
Adherence to the behavioral interventions will be tracked by the study team. At each group visit, an attendance 
sheet will be kept. All missed group visits and telephone calls will be recorded in the tracking database. No 

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participant will be excluded from the study or analyses for noncompliance. Compliance with study treatment 
may be used in secondary analyses (e.g., dose-response relationship).  
14. 
Ethical Considerations 
This study is to be conducted according to US and international standards of Good Clinical Practice (FDA Title 21 
part 312 and International Conference on Harmonization guidelines), applicable government regulations, applicable 
local and state laws, and Institutional research policies and procedures. 
 
This protocol and any amendments will be submitted to a properly constituted independent Ethics Committee (EC) 
or Institutional Review Board (IRB), in agreement with local legal prescriptions, for formal approval of the study 
conduct.  The decision of the EC/IRB concerning the conduct of the study will be made in writing to the investigator 
and a copy of this decision will be provided to the sponsor before commencement of this study.  The investigator 
should provide a list of EC/IRB members and their affiliate to the sponsor. 
 
All participants for this study will be provided a consent form describing this study and providing sufficient 
information for participants to make an informed decision about their participation in this study.  See Attachment for 
a copy of the Participant Informed Consent Form.  This consent form will be submitted with the protocol for review 
and approval by the EC/IRB for the study.  The formal consent of a participant, using the EC/IRB-approved consent 
form, must be obtained before that participant undergoes any study procedure.  The consent form must be signed 
by the participant, and the investigator-designated research professional obtaining the consent. If it’s necessary to 
do the screening/enrollment visit remotely, participant’s oral consent will be obtained by the investigator-designated 
research professional. 
 
 
 
 
15. 
 Study Finances 
15.1 Funding Source 
This study is funded by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases.  
15.2 Conflict of Interest 
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or financial gain 
greater than the minimum allowable by their institution, etc.) must have the conflict reviewed by a properly 
constituted Conflict of Interest Committee with a Committee-sanctioned conflict management plan that has been 
reviewed and approved by the study sponsor prior to participation in this study.  All UW investigators will follow 
the UW conflict of interest policy. 
15.3 Participant Stipends or Payments 
All participants and their partners can receive a remuneration up to $180 each/$360 per couple for study 
completion. For each of the Months 6, 12 and 18 month in-person assessments, patients and their partners will 
receive $40 each/$80 per couple.  The payment will increase to $60 each/$120 per couple for completion of 
the final assessment. Payments will be made by check to the participant at each visit. 
     
Month 6: $40 each/$80 per couple 
Month 12: $40 each/$80 per couple 
Month 18: $40 each/$80 per couple 
Month 24: $60 each/$120 per couple 
16. 
 Publication Plan 
 
Neither the complete nor any part of the results of the study carried out under this protocol will be published or 
passed on to any third party without the consent of the PI. The PI has primary responsibility for publication. All 
publications resulting from the study will be uploaded to PubMed per NIH policy. 

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procedures. Psychological Methods. 2001;6(4):330-51. 
87. 
O'Kelly M, Ratitich B. Clinical trials with missing data: A guide for practitioners. West Sussex, United Kingdom: 
John Wiley & Sons; 2014. 
 
 
18. 
Attachments 
 
• Consent to Participate in Research and Authorization to Use Protected Health Information for Research Form 
• ICTR DMC Charter and Composition  
• H-S IRB Reporting Time Frames 
• Inclusion Enrollment Report 
• Self-report surveys 
• Statistical Analysis Plan