Evaluating Options for Non-Responders: A SMART Approach to Enhancing Weight Loss
Phase: NA
Conditions: Obesity
Sponsor: HealthPartners Institute

Official Title: Evaluating Options for Non-Responders: A SMART Approach to Enhancing Weight Loss 
NCT02368002 
Date: June 12, 2020

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PROTOCOL TITLE: BestFIT SMART weight loss trial 
PROTOCOL TITLE: 
Evaluating Options for Non-Responders: A SMART Approach to Enhancing Weight Loss 
(BestFIT Study) 
PRINCIPAL INVESTIGATOR or FACULTY ADVISOR: 
Nancy E. Sherwood, PhD 
Division of Epidemiology and Community Health 
612-600-3328
sherw005@umn.edu
 

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PROTOCOL TITLE: BestFIT SMART weight loss trial 
REVISION HISTORY 
Revision # 
Version Date Summary of Changes 
Consent Change? 

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PROTOCOL TITLE: BestFIT SMART weight loss trial 
Table of Contents 
After completing your protocol, right click on the Table of Contents below and select 
“Update Field.” If prompted, select “Update entire table.” This will automatically 
update the protocol sections and page numbers for you. Do this also each time you 
modify your protocol after initial approval. 
1.0 
Objectives ................................................................................................................ 6 
2.0 
Background .............................................................................................................. 6 
3.0 
Study Endpoints/Events/Outcomes .......................................................................... 9 
4.0 
Study Intervention(s)/Interaction(s) ......................................................................... 9 
5.0 
Procedures Involved ................................................................................................. 9 
6.0 
Data Banking ......................................................................................................... 12 
7.0 
Sharing of Results with Participants ...................................................................... 13 
8.0 
Study Duration ....................................................................................................... 13 
9.0 
Study Population .................................................................................................... 13 
10.0 Vulnerable Populations .......................................................................................... 14 
11.0 Number of Participants .......................................................................................... 15 
12.0 Recruitment Methods ............................................................................................. 15 
13.0 Withdrawal of Participants .................................................................................... 16 
14.0 Risks to Participants ............................................................................................... 16 
15.0 Incomplete Disclosure or Deception ...................................................................... 16 
16.0 Potential Benefits to Participants ........................................................................... 17 
17.0 Data Management .................................................................................................. 17 
18.0 Confidentiality ....................................................................................................... 19 
19.0 Provisions to Monitor the Data to Ensure the Safety of Participants .................... 19 
20.0 Provisions to Protect the Privacy Interests of Participants .................................... 19 
21.0 Compensation for Research-Related Injury ........................................................... 20 
22.0 Consent Process ..................................................................................................... 20 
23.0 Setting .................................................................................................................... 23 
24.0 Multi-Site Research ............................................................................................... 24 
25.0 Resources Available ............................................................................................... 24 
26.0 References .............................................................................................................. 24 

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PROTOCOL TITLE: BestFIT SMART weight loss trial 
ABBREVIATIONS/DEFINITIONS 
Include any abbreviations or definitions for key or technical terms you use in your 
protocol. 
•
SBT: Standard Behavioral Treatment
•
PCM: Portion-Controlled Meals
•
ABT: Acceptance-Based Treatment

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PROTOCOL TITLE: BestFIT SMART weight loss trial 
STUDY SUMMARY 
Study Title 
Evaluating Options for Non-Responders: A SMART 
Approach to Enhancing Weight Loss (BestFIT Study) 
Study Design 
Sequential Multiple Assignment Randomized Trial 
Primary Objective 
The primary aim is to evaluate the benefit of changing 
treatment with Portion-Controlled Meals versus 
Acceptance-Based Treatment. 
Secondary Objective(s) 
The secondary aim is to evaluate the best time to 
intervene with sub-optimal responders. 
Primary Study Intervention 
or Interaction 
Behavioral Weight Loss Treatment 
Study Population 
Adults with Obesity 
Sample Size (number of 
participants) 
500 
Study Duration for 
Individual Participants 
18 months 

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PROTOCOL TITLE: BestFIT SMART weight loss trial 
1.0 
Objectives 
1.1 Purpose: 
The BestFIT trial is a Sequential Multiple Assignment Randomized Trial 
(SMART) that is evaluating two key questions for developing an adaptive 
intervention for weight loss. The first concerns variations in therapeutic approach 
for non-responders to behavioral weight loss treatment. Therapeutic choice 
should be informed by the reasons people struggle with weight loss initiation and 
self-regulation difficulties have been identified as a major adherence barrier. Two 
attractive options to meet this challenge are: 1) augmenting behavioral treatment 
with Portion-Controlled Meals(PCM) which reduce the need for self-regulation; 
and 2) switching therapeutic approaches by providing training in acceptance and 
commitment skills (ABT) which boost capacity for self-regulation. PCM’s are 
effective, but not necessarily a “first line” of treatment.  Research suggests ABT 
outperforms standard treatment for some vulnerable individuals also making it a 
potential “second line” of treatment. Of interest, PCM and ABT may have 
differential short- and long-term efficacy given their different mechanisms of 
action. The second question concerns the timing of an augmentation or switch in 
treatment. Waiting too long may be detrimental as people may experience a sense 
of futility regarding success. Yet, augmenting or switching too early may not 
allow enough time for the initial treatment to be effective. We propose to evaluate 
two time points: 1) 3 weeks based upon empirical decision support from prior 
weight loss trials and 2) 7 weeks based upon average duration used in the extant 
stepped care literature.  
To systematically evaluate the impact of the therapeutic approach and timing for 
intervening with non-responders, we will recruit 500 adults (30 kg/m2 ≤ BMI ≤ 45 
kg/m2). Participants will be randomized to either: 1) Standard Behavioral weight 
loss (SBT) treatment with response assessment at 3weeks or 2) SBT with response 
assessment at 7 weeks. Participants identified as non-responders at Week 3 and 
Week 7 will be re-randomized to either: “Augment with PCM’s” or “Switch to 
ABT.”  Participants identified as responders at both time points continue with 
BWL. All participants receive 6 months of intervention; research assessments take 
place at baseline, 6- and 18-months (12 months post-treatment).  
Primary Aim: To evaluate, among non-responders to SBT, the benefit of 
augmenting initial treatment with PCMs versus switching to ABT. 
Hypothesis #1a & b: We hypothesize a) that non-responders randomized to 
“Augment with PCM” will weigh less at 6 months relative to those randomized to 
“Switch to ABT” (primary contrast), but that b) those randomized to “Switch to 
ABT” will weigh less at 12 months post-treatment relative to those randomized to 
“Augment with PCR” (secondary contrast). 
Secondary Aim: To evaluate the optimal timing for identifying non-responders. 
Hypothesis #2: We hypothesize participants who undergo response assessment at 
the earlier time point (3 weeks) will weigh less at 6 months and 12 months post-

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PROTOCOL TITLE: BestFIT SMART weight loss trial 
treatment relative those who are undergo response assessment at the second time 
point (7 weeks).  
Exploratory Aim: To make further progress toward building an individually-
tailored adaptive intervention we will examine whether responsiveness to 
different sequences of treatment vary as a function of participant characteristics. 
For example, do non-responders who experience greater food-specific self-
regulation challenges respond better to “Switch to ABT”? Do non-responders 
who experience greater general self-regulation challenges respond best to re-
randomization to “Augment with PCM”?  
2.0 
Background 
2.1 
Significance of Research Question/Purpose: 
State-of-the art behavioral interventions can help people lose 8-10% of body 
weight over a 6-month period, typically the nadir for weight loss efforts. 
However, about 40-60% of participating adults do not achieve this goal. Although 
long-term weight loss maintenance is also a challenge and has received 
considerable attention in recent years by our group and others, focusing explicitly 
on initial weight loss and increasing the number of people who are able to lose 
clinically significant amounts of weight is an important building block to 
improving overall outcomes for obese adults. Despite the response heterogeneity 
observed, a “one size fits all” approach has typically been taken with the same 
treatment intensity level and modality administered regardless of treatment 
response. This is a major limitation of current treatment approaches given that 
early signs of non-response are highly predictive of end-of-treatment non-
response.  
The consistent response heterogeneity that has been observed underscores the 
importance of developing adaptive interventions. Adaptive interventions are 
sequential, tailored approaches whereby intervention strategies are adapted and 
re-adapted over time in response to the evolving status and specific needs of the 
individual. To date, a stepped care (SC) approach, a type of adaptive 
intervention, has been investigated as a strategy for improving weight loss 
outcomes among non-responders. In a SC approach to treatment, patients are 
transitioned (stepped-up) to more intensive treatment when they are unable to 
meet treatment goals with less intensive treatment. While stepped-care 
approaches are generally successful in aiding weight loss, they have produced 
mixed or null results. 
The application of a Sequential Multiple Assignment Randomized Trial (SMART) 
to behavioral weight loss intervention builds upon traditional stepped care 
designs and could lead to the development of more effective adaptive 
interventions. SMARTs have been developed explicitly for the purpose of building 
optimal adaptive interventions and use experimental design principles to obtain 
answers to challenging critical questions including the sequence of decision rules 
that specify whether, how, when, and based on which measures, to alter the 
intensity, dosage (e.g., duration, frequency or amount), type, or delivery of 
treatment(s) at critical decision points in the course of care. The application of 

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PROTOCOL TITLE: BestFIT SMART weight loss trial 
SMART designs to behavioral weight loss intervention has potential to address 
some of the limitations of traditional behavioral weight loss treatment outcome 
research, including stepped care designs, by experimentally testing competing 
interventions for non-responders. A SMART involves multiple intervention stages; 
each stage corresponds to one of the critical decisions involved in an adaptive 
intervention. Each participant moves through the multiple stages, and at each 
stage the participant is randomly (re)assigned to one of several intervention 
options. As in standard intervention trials, the randomization creates the 
opportunity to make valid causal inferences concerning the relative effectiveness 
of the intervention options without having to make unverifiable assumptions. 
Thus, utilizing a SMART design in the context of behavioral weight loss can 
provide critical empirical, experimental knowledge regarding which type of 
“stepped care” intervention strategy is most effective for a non-responder to a 
“first line” weight loss treatment and the optimal timing for offering an 
alternative treatment to such individuals.  
2.2 Preliminary Data: NA 
2.3 Existing Literature:  
In randomized controlled trials and real world clinical practice, it is widely 
recognized that there is no “one size fits all” intervention for most conditions, 
particularly chronic health issues. This treatment response heterogeneity calls for 
the development of adaptive interventions that provide the right treatment (or 
sequence of treatments), at the right time, for the right person. Sequential 
Multiple Assignment Randomized Trial designs developed explicitly to build 
optimal adaptive interventions, use experimental design principles to answer 
critical questions for adaptive interventions. SMART designs are increasingly 
being used to develop adaptive health interventions for a variety of health issues, 
primarily mental health and substance abuse. Although we are aware of one study 
utilizing a SMART design for adolescent weight management (Clinical Trials 
Identifier: NCT01350531), the proposed trial is the first we are aware of that 
applies this innovative methodological approach to the challenges of behavioral 
weight loss interventions in adults.  
The proposed SMART will systematically evaluate two theoretically- and 
empirically-driven therapeutic approaches (“Augment with PCMs” versus 
“Switch to ABT”) that address the underlying reasons people may have difficulty 
adhering to behavioral weight loss interventions.  
The proposed SMART is the first to systematically examine the role of timing of 
intervention for non-responders (3 weeks versus 7 weeks) to weight loss 
interventions. Previous stepped care trials designed to enhance outcomes among 
non-responders have not explicitly examined this issue.  
In addition to evaluating variations in timing and therapeutic approach for non-
responders, this SMART will also examine whether responsiveness to different 
sequences of treatment varies as a function of participant baseline and time 
varying characteristics that are relevant to the conceptual framework underlying 
the proposed trial and choice of options for non-responders. Specifically, our 

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PROTOCOL TITLE: BestFIT SMART weight loss trial 
measurement protocol includes measures of both food-specific self-regulation and 
general emotional- and self-regulation constructs. The novel Q learning approach 
will be utilized for these exploratory analyses that will inform the development of 
a more “deeply tailored” adaptive intervention.  
Results of this SMART trial will lead to the empirically supported construction of 
an individualized adaptive intervention for weight loss that will increase the 
number of adults who are able to lose clinically significant amounts of weight. 
The next step will be to evaluate the empirically informed adaptive intervention 
versus a standard behavioral treatment in the context of a traditional randomized 
clinical trial. 
3.0 
Study Endpoints/Events/Outcomes 
3.1 Primary Endpoint/Event/Outcome: 
The primary research outcome is change in body weight from the baseline to the 6 month 
and the 18 month measurements. Body weight and height is measured twice in light 
clothing without shoes using digital scale and a portable, calibrated stadiometer (Seca 
876 Flat Scale; Seca 217 Stable Stadiometer; SECA 437 Adapter for Flat Scale). 
Measurements differing by 0.2 kg or more for weight or 0.5 cm or more for height will be 
repeated for a third time. Data for the multiple assessments are averaged. To assess 
validity, a second trained staff member will measure the height and weight of 10% of 
participants 
3.2 Secondary Endpoint(s)/Event(s)/Outcome(s): 
NA 
4.0 
Study Intervention(s)/Interaction(s) 
4.1 Description: 
Standard Behavioral Weight Loss Treatment (SBT). This is a multi-component, in-person 
individual weight loss intervention based on state of the art behavioral weight loss 
treatment programs and emphasizes self-monitoring of eating and exercise, stimulus 
control strategies, goal setting, problem solving, addressing social situations, cognitive 
strategies, and relapse prevention. Participants meet weekly with a weight loss coach 
(master’s level training or higher) for at most 20 weekly sessions of SBT. Participants 
will be assigned a calorie intake goal of 1200, 1500, or 1800 kcal/day based on body 
weight with the goal of producing a weight loss of 2–3 lbs/wk. Participants will be 
encouraged to develop an exercise program based primarily on walking with a goal of 
increasing their physical activity level to about 1 hour of walking per day. As part of 
SBT, the weight loss coach will measure and document each participant’s weight in the 
study treatment database prior to delivering the weekly treatment session content. 
Week 3 Sub-optimal response Definition. Participants who are randomized to Week 3 
will be considered sub-optimal responders if they lose less than 2.5% of their session 1 
starting body weight by week 3. Week 3 sub-optimal responders transition to second-
stage treatment at the beginning of the 3rd SBT session. 

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PROTOCOL TITLE: BestFIT SMART weight loss trial 
Week 7 Sub-optimal response Definition. Participants who are randomized to Week 7 
will be considered sub-optimal responders if they lose less than 5.0% of their session 1 
starting body weight by week 7. Week 7 sub-optimal responders transition to second-
stage treatment at the beginning of the 7th SBT session. 
Augment with portion-controlled meals (PCM). Participants re-randomized to PCM will 
continue weekly individual sessions of SBT with their weight loss coach. Sub-optimal 
responders re-randomized at Week 3 will receive up to 17 weeks of pre-prepared fresh 
meals and those re-randomized at Week 7 will receive up to 13 weeks of portion-
controlled meals. Meals will be provided by Seattle Sutton’s Healthy Eating of 
Minnesota. Seattle Sutton’s offers meal plans at different caloric levels (e.g., 1200, 1500 
kcals/day); the meals include freshly prepared food with fruits and vegetables. The 
weight loss coach will help the participant identify the nearest location and will help the 
participant arrange for twice-weekly pick-up of the appropriate calorie level meals. 
Switch to acceptance-based behavioral treatment (ABT). Participants re-randomized to 
ABT discontinue weekly SBT sessions and begin ABT sessions. Sub-optimal responders 
re-randomized at Week 3 will receive 17 weeks of ABT and those re-randomized at Week 
7 will receive 13 weeks of ABT. ABT will primarily target the ability to tolerate 
experiential distress (i.e., increase willingness to engage in valued behavior over the 
long-term, even when it is uncomfortable). Such skills should increase adherence to 
behavioral goals and address gaps in standard behavioral strategies. Some SBT skills 
(e.g., stimulus control) will be present in ABT, but will be taught using an acceptance-
based framework. Calorie intake and physical activity goals remain identical to the SBT 
condition. 
5.0 
Procedures Involved 
5.1 Study Design: 
The study design is a two-stage sequential multiple assignment randomized 
trial (SMART). 500 adults with body mass index (BMI) between 30 kg/m2 
and 45 kg/m2 will be offered standard behavioral weight loss treatment 
(SBT) as first stage treatment (Figure 1). Participants will be randomized 
initially, with equal probability, to response assessment at Week 3 or Week 
7. Participants who are randomized to Week 3 will be considered sub-
optimal responders if they lose less than 2.5% of their session 1 starting
body weight by week 3 and/or 28 days after session 1 whichever comes first;
and those randomized to Week 7 will be considered sub-optimal responders
if they lose less than 5.0% of their session 1 starting body weight by week 7
or 63 days after session 1, whichever comes first. Participants identified as
sub-optimal responders (at either Week 3 or Week 7) will be re-randomized,
with equal probability, to one of two second-stage treatments: augmentation
of SBT with portion-controlled meals (PCM) or switching from SBT to an
acceptance-based enhanced version of SBT (Acceptance-based behavioral
treatment, ABT). Participants identified as responders continue with SBT.
5.2 Study Procedures: 

PROTOCOL TITLE: BestFIT SMART weight loss trial 
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All research outcome measures will be administered at baseline, 6 months, and 18 
months (12 months post-intervention) by independent evaluators blind to 
treatment assignment. Measures include: 
Demographic characteristics include gender, age, race/ethnicity, marital status, highest 
level of education achieved, and current employment status. 
Health Literacy. Health literacy is assessed with the validated Newest Vital Sign (NVS), a 
6-item, interviewer-administered measure assessing the ability to read, comprehend, and
use information from a nutrition label.
Physical Activity. The Paffenbarger Physical Activity Questionnaire is used to assess 
leisure-time physical activity.  
Weight loss goals. A 4-item scale adapted from Foster et al. measures participant weight 
loss goals. Participants will report their dream weight, happy weight, acceptable weight, 
and disappointed weight. 
Weight and weight-loss history. Participants will report the number of times since age 15 
that they have lost each of the following number of pounds: 5 to 9, 10 to 19, 20 to 49, 50 
to 79, 80 to 99, and ≥ 100. Six items from the Weight and Lifestyle Inventory (WALI) will 
assess participant weight history. 
Self-weighing frequency (“ranging from never” to “more than once a day”) will be 
assessed with one item. Nine items will assess weight management strategy use including 
the meal replacement use (e.g., fresh low calorie entrees or frozen low-calorie entrees), 
self-monitoring, and meal planning. 
Binge Eating Assessment. A semi-structured interview assessing the presence of binge 
eating disorder will be administered by trained interviewers. 
Binge Eating. The Binge Eating Scale (BES) is a 16-item, self-report measure designed to 
identify binge eating behaviors. This scale has moderately high internal consistency 
(alpha coefficient = 0.85) and two-week test-retest reliability (r =.87; 76).90 
The Power of Food Scale (PFS)91 is a 15-item self-report measure assessing the extent 
to which food’s availability or presence influences behavior, thinking, and feelings. 
Eating Behaviors. Cognitive restraint, uncontrolled eating, and emotional eating will be 
assessed using the Three Factor Eating Questionnaire-R18 (TFEQ-R18). Select items 
from the original Three Factor Eating Questionnaire (TFEQ) will also be used. 
Eating self-efficacy will be assessed with the Weight Efficacy Lifestyle Questionnaire 
(WEL). Individuals rate their confidence for successfully resisting opportunities to 
overeat and for self-regulating their dietary intake. 
Distress tolerance will be measured using an adapted version of the Acceptance and 
Action Questionnaire which assesses the ability to tolerate challenging eating-related 
experiences. 
Planning & Reasoning Skills. The Tower Test is part of the Delis-Kaplan Executive 
Function System (D-KEFS), a standardized set of executive functioning measures with 
well-documented test-retest reliability and validity. 

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PROTOCOL TITLE: BestFIT SMART weight loss trial 
Working Memory. Working memory is one component of executive functioning. Problems 
with working memory may contribute to difficulties holding weight-loss goals or 
nutritious eating plans “on-line”, making this domain relevant to examination in this 
study. The NIH Toolbox List Sorting Working Memory Test is a computerized test of 
working memory which has high test-retest reliability and moderate to high convergent 
validity. 
Response Inhibition. The Stop-Signal Task,102 a widely-used computerized measure of 
response inhibition, has been associated with impulsivity, restrained eating,103 and 
obesity. 
Risk Taking. The Balloon Analogue Risk Task (BART) is a computerized measure which 
assesses risk-taking behaviors which have been associated with health risk behaviors and 
impulsivity. 
Impulsive behavior will be assessed with two subscales (urgency and sensation seeking) 
of the UPPS Impulsive Behavior Scale. 
Depression symptoms will be assessed using the Patient History Questionnaire-9. 
Adverse Childhood Experiences. Four items adapted from the Revised Conflict Tactics 
Scale will assess physical and emotional adverse childhood experiences shown to be 
associated with adult obesity. 
Adverse Health Events. Participants will report any adverse health events in the 6 months 
prior to the survey. Procedures to be performed for research purposes and, if relevant, 
which procedures would be performed regardless of whether the research was 
conducted, e.g., procedures performed for diagnostic or treatment purposes. 
5.3 Follow-Up: The data to be collected, including long-term follow-up data. 
All of the above measures will be collected at 6- and 18-month follow-up 
with the exception of the cognitive testing measures which will be collected 
at baseline only. Additionally, the interviews will be conducted at baseline 
and 6-months only. 
5.4 
Individually Identifiable Health Information: If this research will involve 
the use of individually identifiable health information, either collecting or 
having access to, and including Protected Health Information complete 
and submit the University’s Privacy Office online application for data 
privacy and security review. Print and upload the application with this 
protocol in Supporting Documents in the ETHOS SmartForm. Complete 
and submit a HIPAA authorization form if applicable in Supporting 
Documents in ETHOS: UMN Privacy Office Policies and/or Fairview 
Health Services Privacy Policies, and UMN HIPAA Agreement Templates. 
For research conducted at Gillette Children’s Specialty Healthcare refer to 
Gillette Research Administration for guidance. 
NA 
6.0 
Data Banking 

PROTOCOL TITLE: BestFIT SMART weight loss trial 
VERSION DATE: May 16, 2017 
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If this study does not involve data banking for future use, type “N/A” and delete 
the sub-headings below. Otherwise, complete all items below. 
N/A 
7.0 
Sharing of Results with Participants 
7.1 Describe whether results (study results or individual participant results, 
such as survey results) will be shared with participants or others (e.g., 
participants’ parent or school administrators) and, if so, describe how the 
results will be shared. 
Please see the Investigator Manual (HRP-103) for additional information 
about language that should be included in the consent form related to 
sharing of results. 
We plan on sending a newsletter summarizing the study findings to participants when the 
study is complete. 
8.0 
Study Duration 
8.1 Describe: 
The anticipated duration of participation for each individual participant is 18 months. 
Enrollment began at the HealthPartners Institute in June 2015 and it is anticipated that 
enrollment will be complete in September 2017. The last 18-month data collection will be 
March 2019. 
9.0 
Study Population 
9.1 Inclusion Criteria: 
Study participants recruited through the community, will meet the following inclusion 
criteria: 1) aged 21 – 70 years; 2) initial BMI ≥ 30.0 and ≤ 45 kg/m2; 3) willing and able 
to participate in study activities for 18 months. 
9.2 Exclusion Criteria: 
Exclusion criteria include: 1) inability to participate in physical activity; 2) pregnancy or 
breastfeeding or planning a pregnancy within the next 18 months; 3) involvement in 
another diet intervention study or organized weight loss program; 4) dietary restrictions 
(e.g., gluten-free); 5) insulin-dependent diabetes, and 6) and presence of a significant 
psychiatric disorder (e.g., schizophrenia) that could interfere with trial participation. 
9.3 Screening: Describe how individuals will be screened or assessed for 
eligibility. 
Participants will be recruited through several methods that we have used successfully in 
prior weight loss trials including radio, print, web-based advertisements, and direct 
mailings. The study phone number and email address will be included in the 
advertisements and those interested will be directed to contact the study team using their 
preferred communication mode to indicate their interest. These potential participants will 
be asked screening questions over the phone to assess their eligibility. Respondents who 
confirm eligibility and interest will be invited to an orientation session during which they 

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PROTOCOL TITLE: BestFIT SMART weight loss trial 
will learn more about the study and requirements of participation. BMI eligibility will 
also be determined at this visit based on staff-measured height and weight. Interested and 
eligible respondents will then schedule a phone call to discuss and confirm that the 
respondent understands and is willing and able to complete the study recruitments. Next, 
a baseline intake measurement visit is scheduled which takes place at the Institute, a 
convenient location for metropolitan area residents. At the intake visit, informed consent 
will be obtained and the baseline measures will be collected. 
10.0 Vulnerable Populations 
10.1 Vulnerable Populations: Identify which of the following populations will be 
involved in this study. (You may not include members of the populations 
below as participants in your research unless you indicate this in your 
inclusion criteria above.) 
☐Children
☐Pregnant women/Fetuses/Neonates
☐Prisoners
☐Adults lacking capacity to consent and/or adults with diminished
capacity to consent, including, but not limited to, those with acute
medical conditions, psychiatric disorders, neurologic disorders,
developmental disorders, and behavioral disorders
☐Approached for participation in research during a stressful situation such
as emergency room setting, childbirth (labor), etc.
☐Disadvantaged in the distribution of social goods and services such as
income, housing, or healthcare
☐Serious health condition for which there are no satisfactory standard
treatments
☐Fear of negative consequences for not participating in the research (e.g.
institutionalization, deportation, disclosure of stigmatizing behavior)
☐ Any other circumstance/dynamic that could increase vulnerability to
coercion or exploitation that might influence consent to research or
decision to continue in research
☐Undervalued or disenfranchised social group
☐Members of the military
☐Non-English speakers
☐Those unable to read (illiterate)
☐Employees of the researcher
☐Students of the researcher
☒None of the above
10.2 Adults lacking capacity to consent and/or adults with diminished capacity to 
consent: 
N/A 

PROTOCOL TITLE: BestFIT SMART weight loss trial 
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10.3 Additional Safeguards: If the research involves individuals Checked in 
Section 10.1 above, provide justification for their inclusion and describe 
additional safeguards included to protect their rights and welfare. 
N/A. 
11.0 Number of Participants 
11.1 Number of Participants to be Consented: 
500 
11.2 Recruitment Methods 
11.3 Recruitment Process:  
All recruitment activities take place at the HealthPartners Institute and are 
conducted by HealthPartner Institute BestFIT study staff. 
Potential participants are asked screening questions over the phone to assess 
their eligibility. Respondents who confirm eligibility and interest are invited 
to an orientation session during which they will learn more about the study 
and requirements of participation. BMI eligibility is determined at this visit 
based on staff-measured height and weight. Interested and eligible 
respondents then schedule a phone call to discuss and confirm that the 
respondent understands and is willing and able to complete the study 
recruitments. Next, a baseline intake measurement visit is scheduled which 
takes place at the Institute. At the intake visit, informed is obtained and the 
baseline measures are collected. 
11.4 Source of Participants: 
Participants are recruited through several methods including radio 
advertisements, web-based advertisements, HealthPartners employee e-
newsletters and website, and direct mailings to adults with a BMI > 30 
kg/m2 who attended a HealthPartners clinic during that past year that is 
located within several miles of the Institute. The study phone number and 
email address is included in the advertisements and those interested are 
directed to contact the study team using their preferred communication 
mode to indicate their interest.  
11.5 Identification of Potential Participants: 
As stated previously, participants are recruited through several methods that 
we have used successfully in prior weight loss trials including radio, print, 
web-based advertisements, and direct mailings. The study phone number 
and email address is included in the advertisements and those interested are 
directed to contact the study team using their preferred communication 
mode to indicate their interest. 
11.6 Recruitment Materials: 

PROTOCOL TITLE: BestFIT SMART weight loss trial 
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Recruitment materials include basic information about the study including 
that it is a weight loss study for adults and that the focus is on “finding the 
right weight loss treatment for the right person at the right time”.  
11.7 Payment: 
Participants receive a $25 gift card at the 6-month measurement visit and a 
$50 gift card at the 18-month measurement visit. They also receive a $10 
gift card for completing a 5-minute online survey at 12 months.  
12.0 Withdrawal of Participants 
12.1 Withdrawal Circumstances: 
If there is any evidence that the participant is experiencing any adverse 
consequences we would communicate with the study participant and 
encourage him/her to discontinue participating. 
12.2 Withdrawal Procedures: 
If a participant is withdrawn we would not continue to collect any data on 
that participant.  
12.3 Termination Procedures: 
Study staff and/or the PI would have a conversation with the participant if 
termination was deemed to be the best solution. We would provide the study 
participant with any referral information as appropriate (e.g., other weight 
loss counseling resources). 
13.0 Risks to Participants 
For each risk or set of risks below, include the procedures to be performed to 
lessen the probability, magnitude, duration, or reversibility of those risks. 
13.1 Foreseeable Risks: 
Participants may feel embarrassed answering questions about their eating 
habits, mood, etc. We let participants know that they do not have to answer 
any questions that they do not want to answer. Participants also may 
experience disappointment if they do not lose as much weight as they would 
like to. We work very hard to help participants overcome barriers to their 
weight loss effort. This study is specifically designed to help “suboptimal 
responders” lose more weight by identifying them early and testing two 
different options to increase the likelihood that they will lose weight. 
13.2 Reproduction Risks: 
If a participant becomes pregnant during the course of the study we would 
discontinue intervention activities.  
13.3 Risks to Others: 
N/A 
14.0 Incomplete Disclosure or Deception 

PROTOCOL TITLE: BestFIT SMART weight loss trial 
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14.1 Incomplete Disclosure or Deception: 
N/A 
15.0 Potential Benefits to Participants 
15.1 Potential Benefits: 
Participants may experience weight loss and associated health benefits. 
16.0 Data Management 
16.1 Data Analysis Plan: Describe the data analysis plan, including any 
statistical procedures. 
The primary aim is a comparison of average weight loss among sub-optimal responders 
re-randomized to “Augment with portion-controlled meals” (PCM) relative to sub-
optimal responders re-randomized to “Switch to acceptance-based behavioral therapy” 
(ABT) at months 6 and 18. As stated above, we hypothesize the effect to be different at 6 
months, favoring PCM, and at 18 months (12 months post-treatment), favoring ABT. To 
address this aim, we will fit, among sub-optimal responders, the following linear mixed 
model for the repeated weight loss measures at months 6 and 18 (t) nested within each 
participant (i): 
•
weight lossit = γ00 + γ10 PCM + γ0118m + γ11PCM*18m + γ*0(covariates) + [u0i +
eit],
where PCM indicates re-randomization to portion-controlled meals, 18m indicates the 
18-month measurement, a series of parameters, γ*0, will estimate relationships between
pre-stage 2 covariates (e.g., sex, baseline BMI, timing of transition to second stage) and
weight loss, with u0ij and eit estimating random between- and within-participant variances.
Parameter γ10 estimates weight loss at 6 months among sub-optimal responders who
augment with PCM relative to those who switch to ABT; whereas, γ11estimates whether
the difference in weight loss among PCM versus ABT sub-optimal responders is different
at 18 months compared to at 6 months. The interaction parameter γ11 must be statistically
significant for the primary hypothesis to be supported. Conclusions as to whether the
shape of the interaction is consistent with predictions will be informed by two contrasts
comparing weight loss at 6 and at 18 months between sub-optimal responders re-
randomized to PCM or to ABT. The contrast with the smaller p-value will be tested
α2=0.025, and the second tested at α2=0.05 to ensure a family-wise Type I error rate of
0.05.116–118
The secondary aim analysis compares the two sub-optimal response definitions (timing of 
transition to second stage). The hypothesis is that participants randomized to the 3 week 
response assessment will lose more weight at 6 and 18 months relative to participants 
assessed at 7 weeks. The secondary analysis will also rely on a mixed model approach 
using 6 and 18 month weight loss measures from all randomized participants, such as, 
•
weight lossit = γ00 + γ203weeks + γ*0(covariates) + [u0i + eit].

PROTOCOL TITLE: BestFIT SMART weight loss trial 
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In this model, weight loss will be predicted from fixed timing (γ20) and person level 
covariate parameters and a random participant intercept (u0i). A significant parameter 
γ02 will support the prediction that earlier response assessment results in more short- and 
long-term weight loss. 
The exploratory third aim analyses explore moderators of the effect of sequences of 
treatment. We will use Q-Learning regression, an extension of moderated regression 
analysis for developing individualized sequences of treatment using data arising from a 
SMART. The overarching goal of this analysis is to empirically generate a candidate 
adaptive intervention that deeply tailors the decision to augment with PCMs or switch to 
ABT as a function of what type of sub-optimal responder the individual is. This analysis 
aims to take advantage of residual heterogeneity in the data among sub-optimal 
responders to SBT and generate an adaptive intervention that further optimizes weight 
loss. It is hypothesized that sub-optimal responders will vary in terms of their general and 
food-specific regulation, which can be used to tailor ABT or PCM. Specifically, it is 
hypothesized that sub-optimal responders (i) who are higher in general, but lower in 
food-specific, self-regulation will attain maximum weight loss under ABT, whereas (ii) 
those lower in general self-regulation will respond best to PCM. To implement Q-
Learning, we will follow the approach in Nahum-Shani et al., for example using the qlaci 
package in R or the PROC QLEARN add-on for SAS.1 
16.2 Power Analysis: Provide a power analysis, if applicable. 
Participants will be randomized equally to be assessed for response to SBT at Week 3 
(n=250) or Week 7 (n=250). Analysis of weekly weight data from previous trials 
informed our expectation that 2.5% and 5.0% weight loss thresholds at weeks 3 and 7, 
respectively, would identify about 60% of participants as sub-optimal responders. Data 
from an estimated N=500 randomized * .60 sub-optimal response rate = 300 sub-optimal 
responders, equally re-randomized to second stage PCM (n=150) and ABT (n=150) 
treatment approaches, are expected to be available to test the primary hypothesis. The 
anticipated 90% retention rate at each measurement translates into N ≈ 300 sub-optimal 
responders * 1.8 observations per person = 540 weight loss observations. Accounting for 
the design effect resulting from repeated within-person weight measures and anticipated 
ICCnon-resp=.70, the effective sample size for testing the significance of interaction 
parameter γ11 is approximately 346, or 346/4 ≈ 86 per group (PCM vs ABT). The 
minimum detectable standardized effect for γ11 at this sample size is Cohen’s d ≈ .43 
(power=.80, α2=.05). Any combination of the difference in weight loss between PCM and 
ABT at 18 months that is about .43 standard deviations larger (or smaller) than the same 
difference at 6 months should be statistically significant (e.g., d(PCM-ABT)=.24 at 6m, 
d(PCM-ABT)=−.20 at 18m). The between groups contrasts at 6 and 18 months are 
powered to detect differences of d=.38 when α2 = 0.025 and d=.34 when α2 = 0.05. 
Participants in the preliminary analyses lost M=21.5 pounds (SD=12.5) at 6 months. A 
5.4 pound difference in re-randomized treatment group differences at 6 and 18 months 
should be detectable as well as 4.3 and 4.8 pound differences at the 6 and 18 month 
measurements. 

PROTOCOL TITLE: BestFIT SMART weight loss trial 
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16.3 Data Integrity: Describe any procedures that will be used for quality control 
of collected data. 
Data quality are routinely reviewed and cleaned by the study Project Manager. 
17.0 Confidentiality 
17.1 Data Security: Describe the steps that will be taken to secure the data (e.g., 
training, authorization of access, password protection, encryption, physical 
controls, certificates of confidentiality, and separation of identifiers and 
data) for storage, use, and transmission of data. Include also whether a 
copy of the consent form or other research study information will be 
placed in the participants’ medical, employment, or educational records, 
and why that is appropriate (if so, this information must be included in the 
confidentiality section of the consent form). Review the University’s 
Privacy Office guidance on securing and de-identification of data. 
Data are housed on a secure, password-protected server at the 
HealthPartners Institute. 
18.0 Provisions to Monitor the Data to Ensure the Safety of 
Participants 
This section is required when research involves more than Minimal Risk to 
participants. If you believe that the study is not greater than Minimal Risk, type 
“N/A” and delete the sub-headings below. Otherwise, complete all items below. 
The IRB ultimately determines the risk level of the study. 
18.1 Data Integrity Monitoring. This is a minimal risk study. However, we do 
have a Data Safety Monitor who annually reviews progress with respect to 
recruitment, retention, and adverse events. 
18.2 Data Safety Monitoring 
See 18.1 
19.0 Provisions to Protect the Privacy Interests of Participants 
19.1 Protecting Privacy: Describe the steps that will be taken to protect 
participants’ privacy interest. “Privacy interest” refers to a person’s desire 
to place limits on with whom they interact or to whom they provide personal 
or sensitive information. 
Describe any privacy concerns and what steps you will take to make the 
participants feel more comfortable with the research situation in terms of 
the questions being asked and the procedures being performed. 
“Comfortable” does not refer to physical discomfort only, but to the sense 
of intrusiveness a participant might experience in response to questions, 
procedures, or interactions with researchers or in certain settings. 
The following language is included in the consent form: 

PROTOCOL TITLE: BestFIT SMART weight loss trial 
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“The records of this study will be kept private.  In any report that might be 
published or presented, only group data will be shown and no information 
will be included that will make it possible to identify a specific individual.  
Data about you will be identified only by a study number or code. We will 
keep all paper records in a locked filing cabinet in a locked office. 
Electronic records, including audio recordings, will be password-protected 
and available only to study personnel.” 
19.2 Access to Participants: Explain why the research team is permitted to access 
medical records, student records, or any other sources of private 
information about the participants. (Note that you were asked a similar 
question above about access to information about potential participants. 
This item refers to information about participants who have consented to 
participate and about whom you are collecting research data.) 
NA 
20.0 Compensation for Research-Related Injury 
20.1 Compensation for Research-Related Injury: If the research involves greater 
than Minimal Risk to participants, describe the available compensation in 
the event of research-related injury. 
NA 
20.2 Contract Language: Provide a copy of the contract language, if any, 
relevant to compensation for research-related injury. 
NA 
21.0 Consent Process 
Note: You must follow “SOP: Informed Consent Process for Research (HRP-
090)” and “SOP: Written Documentation of Consent (HRP-091).” 
21.1 Consent Process (when consent will be obtained): Describe the consent 
process, including: 
•
Where the consent process will take place.
o
The consent process takes place at the HealthPartners
Institute
•
Any waiting period available between informing the prospective
participants and obtaining the consent.
o
Participants first learn details about the study during a
phone call with BestFIT study staff. Then they are invited to
an orientation during which they learn more about the
study and have a chance to ask questions. A post-
orientation phone call takes place which provides another
opportunity to ask questions. The consent is signed online
at the beginning of their baseline measurement visit.
•
Any process to ensure ongoing consent.

PROTOCOL TITLE: BestFIT SMART weight loss trial 
Page 21 of 32
o
Participants attend weekly sessions and then are invited to
participate in the measurement visits. Staff always make
sure to emphasize that their continued participation is
voluntary.
•
If you will document consent in writing, submit a consent document in
ETHOS. If you will obtain consent, but not document consent in
writing, submit a consent script in ETHOS. Review “CHECKLIST:
Waiver of Written Documentation of Consent (HRP-411)” to ensure
that you have provided sufficient information.
21.2 Waiver or Alteration of Consent Process (when consent will not be 
obtained, required information will not be disclosed, or the research 
involves deception): If you are not requesting a consent alteration or 
waiver, type “N/A” and delete the bullets below. Otherwise, complete all 
items below: 
•
NA
21.3 Non-English Speaking Participants: Indicate what language(s) other than 
English is/are understood by prospective participants or their 
representatives. 
NA 
•
As identified in Section 10.1, if participants who do not speak English
will be enrolled, describe the process to ensure that the oral or written
information provided to those participants will be in their own
language. Indicate the language that will be used by those obtaining
consent.
•
If you will be using a translator during recruitment, consent, data
collection, or data analysis, specify how you will identify an
appropriate translator and what the provisions will be for protecting
the confidentiality of participants.
•
Translated short forms are available on the UMN IRB website:
https://www.research.umn.edu/irb/guidance/short-forms.html.
21.4 Participants Who Are Not Yet Adults (infants, children, teenagers under 18 
years of age): 
NA 
•
Describe the criteria that will be used to determine whether a
prospective participant has not attained the legal age for consent to
treatments or procedures involved in the research under the
applicable law of the jurisdiction in which the research will be
conducted. (E.g., in Minnesota, individuals under the age of 18 years.)
o
For research conducted in Minnesota, review “SOP: Legally
Authorized Representatives, Children, and Guardians (HRP-
013)” to be aware of which individuals in the state meet the
definition of “children.”

PROTOCOL TITLE: BestFIT SMART weight loss trial 
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o
For research conducted outside of Minnesota, provide
information that describes which persons have not attained the
legal age for consent to treatments or procedures involved the
research, under the applicable law of the jurisdiction in which
research will be conducted. One method of obtaining this
information is to have a legal counsel or authority review your
protocol along with the definition of “children” in “SOP:
Legally Authorized Representatives, Children, and Guardians
(HRP-013).”
•
Describe whether parental permission will be obtained from:
o
Both parents, unless one parent is deceased, unknown,
incompetent, or not reasonably available, or when only one
parent has legal responsibility for the care and custody of the
child.
o
One parent, even if the other parent is alive, known, competent,
reasonably available, and shares legal responsibility for the care
and custody of the child.
•
Describe whether permission will be obtained from individuals other
than parents, and if so, who will be allowed to provide permission.
Describe the process used to determine these individuals’ authority to
consent to each child’s general medical care.
•
Indicate whether assent will be obtained from all, some, or none of the
children. If assent will be obtained from some children, indicate which
children will be required to assent.
•
When assent of children is obtained describe whether and how it will
be documented.
21.5 Cognitively Impaired Adults, or adults with fluctuating or diminished 
capacity to consent: 
NA 
•
Describe the process to determine whether an individual is capable of
consent. Review “POLICY: Capacity to Consent (HRP-110)” and
“POLICY: Research Involving Adults Under Court Jurisdiction (HRP-
111)” for additional information. Reference “CHECKLIST:
Cognitively Impaired Adults (HRP-417).”
•
Confirm use of one of the approved validated instruments to assess
capacity to consent appropriate for the level of risk associated with
the research (i.e., the MacArthur Competence Assessment Tool for
Clinical Research for greater than Minimal Risk research or the
UCSD Brief Assessment of Capacity to Consent for Minimal Risk
research). If you will not be using one of these tools, describe the
alternative validated tool(s) you propose to use instead. If available in
electronic format, submit the alternative tool(s) for review by the IRB
in ETHOS.
•
Document plans, if any, to avoid seeking consent during periods of
greater than normal impairment.

PROTOCOL TITLE: BestFIT SMART weight loss trial 
Page 23 of 32
21.6 Adults Unable to Consent: 
NA 
•
Permission: List the individuals from whom permission will be
obtained in order of priority (e.g., durable power of attorney for
health care, court appointed guardian for health care decisions,
spouse, and adult child.)
o
For research conducted in Minnesota, review “SOP: Legally
Authorized Representatives, Children, and Guardians (HRP-
013)” to be aware of which individuals in the state meet the
definition of “legally authorized representative.” Additionally,
be aware of special restrictions regarding recruiting or enrolling
persons under a stay of commitment.
o
For research conducted outside of Minnesota, provide
information that describes which individuals are authorized
under applicable law to consent on behalf of a prospective
participant to their participation in the procedure(s) involved in
this research. One method of obtaining this information is to
have a legal counsel or authority review your protocol along
with the definition of “legally authorized representative” in
“SOP: Legally Authorized Representatives, Children, and
Guardians (HRP-013).”
•
Assent: Describe the process for assent of the participants. Indicate
whether:
o
Assent will be required of all, some, or none of the participants.
If some, indicate which participants will be required to assent
and which will not.
o
If assent will not be obtained from some or all participants, an
explanation of why not.
o
Describe whether assent of the participants will be documented
and the process to document assent.
22.0 Setting 
22.1 International Research: If the research will take place in more than one 
international location, include information below for each location. 
NA 
22.2 Community Based Participatory Research: If the research will be based in 
or in partnership with more than one community, include information below 
for each community. 
NA 
22.3 Research Sites: Describe the sites or locations where your research team 
will conduct the research. 
All research activities with study participants take place at the 
HealthPartners Institute. I oversee all aspects of study implementation along 

PROTOCOL TITLE: BestFIT SMART weight loss trial 
Page 24 of 32
with Dr. Lauren Crain who is Co-PI on the study, including providing 
supervision to intervention and measurement staff, however, BestFIT study 
team members are directly supervised by HealthPartners Institute 
employees. I will also be working on manuscripts and presentations once the 
baseline data collection is complete and then after all of the data is collected 
after the last participant’s 18-month data collection visit. Data sent to the U 
will be a limited data set.  
23.0 Multi-Site Research 
NA 
24.0 Resources Available 
24.1 Resources Available: Describe other resources available to conduct the 
research. For example, as appropriate: 
NA 
25.0 References 
Include references to any scholarly articles or other materials used to discuss the 
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