Reducing Binge Eating to Prevent Weight Gain in Black Women: A Pilot Study
Phase: NA
Conditions: Binge Eating, Weight Loss, Weight Gain Prevention
Sponsor: University of North Carolina, Chapel Hill

 
Reducing Binge Eating to Prevent Weight Gain in Black Women 
 
 
 
NCT number NCT03531112 
Document Date 12/01/2018 
 

 
 
Study Title: Reducing Binge Eating to Prevent Weight Gain in Black Women 
 
 
UNC Principal Investigator (PI): Rachel Goode, PhD 
UNC PI Department/Division: School of Social Work 
 
Number of Sites: 1 
Lead Site [If multi-site study]: UNC Department of Family Medicine 
 
Lead Site Principal Investigator: Rachel Goode  
Additional Site: N/A 
 
UNC Co-Investigator(s) and Department/Division (as applicable):  Laurel Sister; Department of Family 
Medicine, UNC-Chapel Hill 
 
Sponsor(s) : 
 
Name/Address: National Institutes of Health, National Institute of Diabetes, Digestive, and 
Kidney Diseases (NIDDK), P30DK56350 
 
I HAVE READ AND APPROVE THIS VERSION OF THE PROTOCOL.   
[electronic signature accepted]  
 
Principal Investigator:     
 
Date:  
12/1/2018 
 
 
 
 

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Summary of Changes from Previous Version [If applicable]: 
 
Previous  
Version No. 
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Table of Contents 
Statement of Compliance .................................................................................................................................... 6 
Abbreviations and Definitions of Terms .............................................................................................................. 7 
1. 
Protocol Synopsis ..................................................................................................................................... 7 
2. 
Introduction: Background and Scientific Rationale .............................................................................. 10 
2.1. 
Background Information .................................................................................................................... 10 
2.2. 
Supporting Pilot / Unpublished Data ................................................................................................. 11 
2.3. 
Scientific Rationale ............................................................................................................................. 11 
3. 
Objectives .............................................................................................................................................. 11 
3.1. 
Specific Aim 1 ..................................................................................................................................... 11 
3.2. 
Specific Aim 2 ..................................................................................................................................... 12 
5. 
Study Design .......................................................................................................................................... 12 
5.1. 
Treatment Design ............................................................................................................................... 15 
5.2. 
Experimental / Observational Design ................................................................................................ 15 
5.3. 
Measurement Design ......................................................................................................................... 15 
5.4. 
Outcome Measures ............................................................................................................................ 15 
6. 
Study Participants .................................................................................................................................. 16 
6.1. 
Number of Participants ...................................................................................................................... 16 
6.2. 
Eligibility ............................................................................................................................................. 16 
6.3. 
Strategies for Recruitment and Retention ......................................................................................... 17 
6.4. 
Consent Process ................................................................................................................................. 18 
7. 
Study Intervention ................................................................................................................................. 18 
7.1. 
Intervention – Test Article (if applicable) ........................................................................................... 18 
7.2. 
Assignment Procedures...................................................................................................................... 19 
7.3. 
Intervention – Procedural (if applicable) ........................................................................................... 19 
7.4. 
Concomitant Therapy (if applicable) .................................................................................................. 20 
7.5. 
Rescue Medications and Procedures (if applicable) .......................................................................... 20 
7.6. 
Compliance Checks ............................................................................................................................ 20 
7.7. 
Withdrawal / Discontinuation of Enrolled Participants ..................................................................... 20 
7.8. 
Voluntary Withdrawal (Drop-Out) of Enrolled Participants ............................................................... 20 
8. 
Study Procedures and Schedule ............................................................................................................ 21 
8.1. 
Table of Events ................................................................................................................................... 21 
8.2. 
Pre-Screening / Screening (Day -X to Day Y) ...................................................................................... 21 
8.3. 
Enrollment / Baseline (Day 0) ............................................................................................................ 22 
8.4. 
Study Visits (Numbered as V1, V2, etc., Day X ± Y) ............................................................................ 22 
8.5. 
Phone Contact (Day Day X ± Y) ........................................................................................................... 22 

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8.6. 
Final Visit (Day Day X ± Y) ................................................................................................................... 23 
8.7. 
Follow-Up Contact (Day Day X ± Y) .................................................................................................... 23 
8.8. 
Premature Discontinuation ................................................................................................................ 23 
8.9. 
Collection and Management of Tissue Specimens ............................................................................ 23 
9. 
Study Measurements and Evaluations ................................................................................................. 24 
9.1. 
Outcome Measures for Evaluation of Feasibility / Tolerability .......................................................... 24 
9.2. 
Outcome Measures for Evaluation of Efficacy ................................................................................... 24 
9.3. 
Outcome Measures for Evaluation of Safety ..................................................................................... 24 
9.4. 
Other Outcomes in the Causal Pathway ............................................................................................ 24 
9.5. 
Baseline Characteristics of the Participants ....................................................................................... 24 
9.6. 
Variables Representing Treatment .................................................................................................... 25 
10. 
Statistical Analysis Plans........................................................................................................................ 25 
10.1. 
Strategies that Apply to all the Specific Aims..................................................................................... 25 
10.2. 
Description of the Study Cohort......................................................................................................... 25 
10.3. 
Aim-Specific Plans .............................................................................................................................. 26 
10.4. 
Planned Interim Analyses (If Applicable) ........................................................................................... 26 
10.5. 
Plans for Coping with Withdrawals and Loss-To-Follow-Up .............................................................. 26 
10.6. 
Sample Size Rationale ........................................................................................................................ 27 
11. 
Safety Monitoring and Management .................................................................................................... 27 
11.1. 
Risk / Benefit Assessment .................................................................................................................. 27 
11.2. 
Assessment of Safety ......................................................................................................................... 27 
Range of Depression ................................................................................................................................... 28 
11.3. 
Unanticipated Problems, Adverse Events, Serious Adverse Events ................................................... 28 
11.4. 
Safety Monitoring .............................................................................................................................. 29 
11.5. 
Study Suspension / Early Termination of the Study ........................................................................... 29 
12. 
Supporting Documentation and Operational Considerations ............................................................. 29 
12.1. 
Regulatory, Ethical, and Study Oversight Considerations .................................................................. 29 
12.1.1. 
Informed Consent Process ............................................................................................................. 30 
12.1.1.1. 
Consent/Assent and Other Informational Documents Provided to Participants ...................... 30 
12.1.1.2. 
Consent Procedures and Documentation .................................................................................. 30 
12.2. 
Study Discontinuation and Closure .................................................................................................... 31 
12.3. 
Confidentiality and Privacy ................................................................................................................ 31 
12.4. 
Future Use of Stored Specimens and Data ........................................................................................ 32 
12.5. 
Key Roles and Study Governance ....................................................................................................... 32 
12.6. 
Safety Oversight ................................................................................................................................. 33 

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12.7. 
Clinical Monitoring ............................................................................................................................. 33 
12.8. 
Quality Assurance and Quality Control .............................................................................................. 33 
12.9. 
Data Handling and Record Keeping .................................................................................................... 34 
12.9.1. 
Data Collection and Management Responsibilities ....................................................................... 34 
12.9.2. 
Study Records Retention ................................................................................................................ 34 
12.10. 
Protocol Deviations ........................................................................................................................ 34 
12.11. 
Publication and Data Sharing Policy............................................................................................... 34 
12.12. 
Conflict of Interest Policy ............................................................................................................... 35 
13. 
Additional Considerations ..................................................................................................................... 35 
14. 
References ............................................................................................................................................. 35 
15. 
List of Appendices .................................................................................................................................. 37 
 
 
 
 

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Statement of Compliance 
This study will be conducted in accordance with the International Conference on Harmonisation 
guidelines for Good Clinical Practice (ICH E6) and the Code of Federal Regulations on the Protection of 
Human Subjects (45 CFR Part 46). The statistical analysis plans will be consistent with guidances such as 
the CONSORT Statement [1] or STROBE Statement [2], ICMJE recommendations [3], the 2016 and 2019 
statements of the American Statistical Association [4,5], and recommendations in Nature [6,7].1 All 
personnel involved in the conduct of this study have completed human subjects protection training. 
 
 
 
 
1 [1] www.consort-statement.org [2] www.strobe-statement.org [3] www.icmje.org [4]  Wasserstein RL, et al. 
(2016), The ASA's Statement on p-Values, The American Statistician, 70:2, 129-133 [5]  Wasserstein RL, et al. 
(2019), Moving to a World Beyond p < 0.05, The American Statistician, 73:sup1, 1-19 [6]  Amrhein, et al. (2019) 
Scientists rise up against statistical significance, Nature 567, 305-307 [7] Editorial (2019) It’s time to talk about 
ditching statistical significance: Looking beyond a much used and abused measure would make science harder, but 
better. Nature 567, 283-283. 

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Abbreviations and Definitions of Terms 
[Spell out any acronyms, abbreviations, or non-standard terminology. Delete this text and any entries 
below that are not used in your protocol.] 
Abbreviation/Acronym 
Definition 
AE 
Adverse Event/Adverse Experience 
CI 
Confidence Interval 
CIOMS 
Council for International Organizations of Medical Sciences 
CONSORT 
Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
DCC 
Data Coordinating Center 
DSMB 
Data and Safety Monitoring Board 
eCRF 
Electronic Case Report Form 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
IB 
Investigator's Brochure 
ICF 
Informed Consent Form 
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigational Device Exemption 
IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
N 
Number (typically refers to subjects) 
NDA 
New Drug Application 
PHI 
Protected Health Information 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event/Serious Adverse Experience 
SD 
Standard Deviation 
SE 
Standard Error 
SOP 
Standard Operating Procedures 
STROBE 
STrengthening Reporting of OBservational studies in Epidemiology 
UP 
Unanticipated Problem 
 
 
 
 
1. Protocol Synopsis 
 

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Study Title 
Reducing Binge Eating to Prevent Weight Gain in Black Women 
Objectives 
 
Primary: Examine the feasibility and acceptability of a 6-month AAT + NUTR (N=48) 
intervention. AA women (BMI ≥ 25 kg/m²) with weekly binge eating episodes 
will be randomized to the AAT+NUTR (n=24) or wait-list control (n=24). The 
study will examine recruitment, retention, barriers to completion, 
satisfaction, and adherence.  
Secondary: At 4 (end of treatment) and 6 months (follow-up), examine changes in (a) 
binge eating; (b) depressive symptoms; (c) dietary outcomes (e.g., overall 
energy intake, fat, fruit and vegetable intake); and (d) weight for participants 
in each group. 
 
Tertiary/Exploratory: Conduct key informant interviews (n=15-20) with UNC 
Department of Family Medicine staff and participants to determine 
acceptability of the AAT intervention in the primary care setting. 
 
 Target 
Population 
 
 
Key Inclusion Criteria Individuals are eligible if they are non-Latino Black women, 
over 18 years of age, have a BMI ≥ 25kg/m², use a Bluetooth-enabled smartphone, 
report at least one binge eating episode weekly, and 
complete the screening.  
 
Key Exclusion Criteria Individuals will be excluded if they are currently pregnant, in 
substance use treatment, involved in a weight loss program, have a history of 
anorexia nervosa, engage in purging, are currently receiving psychological or 
pharmacological treatment for disordered eating or eating disorders, or are 
concurrent intravenous drug users or consume >4 alcoholic beverages/day.  
 
Numbers of 
Participants 
 
                                                                                                                                              
Number to be recruited for screening [some will not be eligible for enrollment] 200 
 
Number of eligible participants enrolled [this is the target sample size for 
enrollment] 60 
Clinical Phase 
[I, II, III, or IV (if applicable)] 
 
Intervention 
 
Participants will participate in an 16-week combined Appetite Awareness Training 
(AAT) + Diabetes Prevention Program (NUTR) intervention. For the first 8 weeks, 
participants will attend 8 weekly AAT sessions and then transition to eight, weekly 
NUTR sessions. All sessions will be 60-90 minutes. The goal of AAT is to enable 
participants to be able to relearn their stomach's hunger signals and begin to obey 
and monitor functions of satiety. AAT has been successful in helping participants 
diagnosed with eating disorders reduce binge eating, overeating, and prevent weight 
gain. Sessions involve didactic training, review of self-monitoring of eating episodes, 
and homework assignments. NUTR includes group sessions that are based on the 
Diabetes Prevention Program curriculum, and include content on nutrition (e.g., 

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shopping, fruit and vegetable intake, eating away from home), physical activity, and 
goal setting. 
 
Study 
Description 
  
 
This study is a two-arm, randomized controlled trial to examine the feasibility and 
acceptability of 6 month AAT + NUTR compared to wait-list control. Patients will be 
recruited from the UNC Department of Family Medicine.  AAT+NUTR participants will 
spend the first 2 months receiving treatment to reduce binge eating (AAT), and the 
next 2 months engaging in group-based nutrition counseling. Participants will then 
work independently for 2 months. Data from both intervention groups will be 
collected at 3 time points: baseline, before randomization (T1), at the end of month 
4, post treatment (T2), and at the end of month 6, follow-up (T3). Descriptive 
analyses will first be performed overall, by treatment group, and time points to 
identify any data anomalies (e.g., missing data, outliers, non-normality) that may 
invalidate study findings. Remedial measures (e.g., single/multiple imputation of 
missing data, score/data transformation) will be applied as indicated based on the 
results of data screening. 
 
 
Outcome 
Measures 
[Measures that will used to assess the intervention (for feasibility, tolerability, 
efficacy, safety, comparability, pharmacokinetics/pharmacodynamics, etc.)]  
 
To assess the feasibility of recruiting adult, overweight/obese Black women to the 
proposed study, the percent of eligible overweight/obese black women who were 
enrolled and retained in the study will be examined and reasons for nonparticipation 
and attrition will be documented. Participants will also be asked to provide 
measurements for height/weight, blood pressure, binge eating, and complete several 
self-report measures. 
Study 
Duration 
2 years 
 
 
Subject 
Participation 
Duration 
30 hours 
 
 
Estimated 
Time to 
Complete 
Enrollment 
January 2019-July 2021 
 
Statistical 
Analysis 
Plans 
[Feasibility will also be determined by calculation of point and interval estimates 
(95% confidence intervals using sample size methods) of the feasibility parameters 
(proportion/percentages in terms of eligibility, participation, retention; 
means/medians for attendance at intervention sessions) and bivariate frequency 
distributions. Linear mixed effects modeling will be used to predict the association 
between treatment group assignment (AAT + NUTR or control), and binge eating, 
dietary intake, and weight scores at T2 and T3. Baseline scores will be used as 

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covariates in these analyses. Standardized mean differences (e.g., Cohen’s d with 
bias adjustment) will also be calculated as an effect size measure with 95% CI. 
 
 
2. Introduction: Background and Scientific Rationale 
2.1. Background Information 
[Do not copy the background section from a grant application. This protocol should reflect only 
information relevant to the current study, which may be smaller in scope than a grant award. The 
Background section should include a brief discussion of: the health problem the study will address 
(knowledge gaps); the name/description of the study intervention; prior research (in vitro, preclinical in 
vivo, and clinical trials) and experience that provides context and scientific justification for conducting 
the study; and the importance of the study. Include references in support of claims; in-text citations 
should be numeric in ascending order to match the reference list.]   
Binge eating Disorder (BED) is defined as recurrent binge eating while concurrently experiencing loss of 
control, marked distress, and with the absence of compensatory behaviors for weight loss. BED is the 
most common eating disorder among all racial and ethnic groups, affecting approximately 2.6% of the 
US population. Moreover, BED is associated with other co-morbid conditions, including that substance 
disorders and mood disorders.  
 
While there are several effective behavioral treatments for BED (e.g., Cognitive Behavioral Therapy 
(CBT), Interpersonal Therapy) there are racial disparities in treatment access. African-Americans (AA) 
have some of the lowest rates of access to care, and less than 8% of AA women with BED seek 
treatment compared to 20% of White women. Furthermore, BED may be more severe among AA 
women who DO not access treatment; for example, AA women receiving treatment for BED 
demonstrate less pre-treatment binge eating compared to non-treatment seeking controls with BED. 
Therefore, it is imperative that investigators develop strategies for treatments that are accessible and 
effective for AA women. 
One strategy may be to intervene with women who have not yet developed BED, but who may show 
signs of early risk factors (e.g., binge eating, rapid weight gain). A possible group for early intervention 
may be AA women, particularly since more than 30% of this population reports binge eating. Though 
treatment seeking specific to disordered eating is disparate among AA women, there is ample evidence 
to suggest their willingness to participate in nutrition counseling and weight stabilization, particularly 
when delivered in primary care. Early detection and intervention with this population may be a critical 
first step to the prevention of BED, and the increase in treatment access for disordered eating behaviors. 
Because AA women who binge eat may be at risk for BED, we hypothesize that by participating in a 
combined AAT+ nutrition counseling (NUTR) intervention, participants would increase awareness of BED 
risk, reduce binge eating, and stabilize weight. We also hypothesize this intervention will help reduce 
known co-morbidities, including depressive symptoms.  
 

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2.2. Supporting Pilot / Unpublished Data 
[Provide essential details of any as-of-yet unpublished data used to justify the proposed study, including 
any adverse event data.] 
Currently, intervention research addressing binge eating behaviors among AA women is extremely 
scarce. I am working to fill this gap. My pilot APPETITE study (n=31) examined the feasibility of Appetite 
Awareness Training (AAT), a CBT-intervention for binge eating, in a community-based sample of AA 
women (BMI=25-40 kg/m²) with moderately severe binge eating behavior. In this pilot study, retention 
was high (88%), and binge eating was significantly reduced at 8 weeks.  
2.3. Scientific Rationale 
[Describe and justify the selected intervention (including dosage, timing, schedule, method of 
administration, validity of scales, as applicable) and study population.]  
Currently, 55% of Black women are obese. Obesity is a serious health problem with numerous co-
morbidities. Recent evidence has encouraged investigators to focus their efforts on weight gain 
prevention in Black women. Consuming a healthy, energy-balanced diet and engaging in physical activity 
are important for prevention of weight gain. Black women, however, may be vulnerable to certain 
eating behaviors that may pose barriers to weight management. One particular barrier is binge eating, 
which is associated with severe obesity. By reducing binge eating episodes in black women, weight gain 
may be prevented. Based on our analysis, we determined that a sample of 60, evenly allocated between 
treated and control groups, is sufficiently powered (.80) to identify large standardized mean differences 
in binge eating (d = .74) (Aim #2). The sample, however, is underpowered to determine differences in 
weight. Because this study is exploratory, we are prioritizing feasibility, and an exploration of 
differences, rather than determining efficacy.  
 
3. Objectives 
The overarching goal of this research to examine the feasibility and acceptability of a combined AAT and 
NUTR intervention (N=48) in the primary care setting. Participants will be recruited from the UNC 
Department of Family Medicine, and will be randomized to a group-based 16-week intervention (8 
weeks AAT + 8 weeks NUTR) or wait-list control.  Following the end of the intervention, I will conduct 
semi-structured interviews with participants and primary care providers to determine the acceptability 
of the program. 
3.1. Specific Aim 1 
Examine the feasibility and acceptability of a 6-month AAT + NUTR (N=48) intervention. AA women (BMI 
≥ 25 kg/m²) with weekly binge eating episodes will be randomized to the AAT+NUTR (n=24) or wait-list 
control (n=24). The study will examine recruitment, retention, barriers to completion, satisfaction, and 
adherence.  

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3.2. Specific Aim 2 
4. At 4 (end of treatment) and 6 months (follow-up), examine changes in (a) binge eating; (b) 
depressive symptoms; (c) dietary outcomes (e.g., overall energy intake, fat, fruit and vegetable 
intake); and (d) weight for participants in each group. 
 
5. Study Design 
 
The proposed study will use a randomized controlled clinical trial design. A sample of 60 black women 
who report at least weekly binge eating episodes will be randomized to 2 arms of a 6-month AAT + BWL 
intervention: AAT+BWL or a control group. AAT+BWL participants will receive an 8-week AAT program, 
and an 8-week BWL program, both using a group format. Assessments will be conducted at 0, 4, and 6 
months. This study will be conducted at one site: UNC Department of Family Medicine.  
The goal of AAT is to enable participants to be able to relearn their stomach's hunger signals and begin 
to obey and monitor functions of satiety 11. AAT has been successful in helping participants diagnosed 
with Binge Eating Disorder (BED) and bulimia nervosa reduce binge eating, overeating, urges to eat in 
response to non-appetite stimuli, and prevent weight gain. 12-14 The AAT intervention includes eight 60-
minute group sessions. All sessions involve didactic training, review of self-monitoring of eating episodes, 
interactive activities, and homework assignments to enable participants to practice learned skills. 
Participants will be provided a workbook, which will include session content, and self-monitoring forms. 
The curriculum for BWL (behavioral weight loss) will be based on the evidenced-based curriculum from 
the Diabetes Prevention Program, or Prevent T2. Eight weekly session will review core content including 
healthy eating, increasing physical activity, and caloric balance. An outline of session curriculum is 
attached to the protocol. 
Physical measures will be taken by trained staff, who will be supervised by Dr. Rachel Goode, PI of this 
project. The following equipment will be used: 
1. Height /Weight will be measured on a digital scale and a wall-mounted stadiometer. 
2. Waist Circumference will be measured twice with a Gullick II measuring tape. 
3. Blood pressure assessment will be measured using an GE Dinamap Procare Auscultatory 400 
Multi-Parameter Patient Monitor with the subject in a sitting position after at least a minute rest 
period. 
 
 

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Questionnaires: 
1. Eating Disorder Examination (EDE-Q) is a self-reported questionnaire based on the Eating Disorder 
Examination. 
2. Beck Depression Inventory (BDI)24 is a 21-item questionnaire that measures symptoms and attitudes 
associated with depression. 
3. Weight Efficacy Life-Style Questionnaire (WEL) 25: The WEL is a 20-item questionnaire that assesses 
participants’ level of confidence in resisting eating in varied situations and in different emotional states, 
with 
higher scores indicating more confidence. 
4. Eating Disorder Examination – Overeating Section (EDE) 20 is a semi-structured interview to assess 
symptoms and DSM-IV diagnoses for Bulimia Nervosa, Anorexia Nervosa, and BED. Eating disorder 
symptoms are assessed on four subscales: restraint, eating concern, shape concern, and weight concern. 
The 
EDE has well-established validity, reliability, and has been used extensively as an established measure of 
disordered eating behavior. 
5. Modified Sociodemographic Questionnaire will be used to collect: age, marital status, education, 
neighborhood residence, employment status, household size, religious background, and income. 
Randomization will be performed by Microsoft Excel and the PI will be blinded to all randomization. A 
research assistant will be responsible for supervising randomization. Prior to randomization, potential 
participants will respond to flyers and will be screened to determine eligibility. If an individual is eligible, 
she will be given a date and time to meet with a research team member. Participants will be evaluated in 
person or by phone to determine the presence of at least one weekly binge eating episode using the 
overeating section of the Eating Disorder Examination. Participants will also complete anthropometric 
measurements, provide signed informed consent, and finish self-report measures. Once all baseline 
assessments are complete, participants will be randomized to the AAT + BWL intervention or control 
group. Participants will be assessed at 0, 4 months, and 6 months. Data on the AAT group will be 
collected at 3 time points: baseline, before randomization (T1); end of month 4, after the completion of 
intervention program (T2); and end of month 6, posttreatment follow up (T3). Data on the control group 
will be collected at: baseline (T1), 4 months (T2), and at the end of 6 months (T3). 
 
 

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Example #1 Flow diagram (e.g., randomized controlled trial). Customize to your study flow.] 
 
Prior to  
Enrollment 
 
 
 
 
 
 
 
 
 
 
Visit 1 
Baseline 
 
 
 
Visit 2 
4-months 
 
 
Visit 3 
6- months 
 
 
 
 
 
 
 
Total N:  Obtain informed consent. Screen potential participants by inclusion and 
exclusion criteria; obtain history, document. 
Perform baseline assessments: Sociodemographic survey, height, weight, blood 
pressure, waist circumference, Eating Disorder Examination, Eating Disorder 
Examination-Questionnaire, Weight Efficacy Lifestyle Questionnaire 
  
Final Assessments: Anthropometric 
measures, blood pressure, Eating 
Disorder Examination, Eating Disorder 
Examination-Questionnaire, Weight 
Efficacy Lifestyle Questionnaire 
Arm 2 
Waitlist 
Arm 1 
AAT + NUTR 
Conduct 4-month Assessment: weight, blood pressure, waist circumference, Eating 
Disorder Examination, Eating Disorder Examination-Questionnaire, Weight Efficacy 
Lifestyle Questionnaire  
Randomize 

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5.1. Treatment Design 
The proposed study will use a randomized clinical trial design. A sample of 48 Non-Latino, AA women 
(BMI > 25 kg/m2; rationale:  prior clinical and research experience suggests that AA women within this 
BMI range are most likely to identify their eating as problematic and engage in a clinical intervention26) 
who report at least weekly binge eating episodes will be randomized to 2 arms of a 6-month 
intervention: AAT + NUTR or wait-list control. AAT + NUTR participants (n=24) will first receive a weekly, 
group-based AAT program for the first two months, and then will begin NUTR and receive weekly, group 
sessions for the next 2 months.  Wait-list control group (n=24) participants will receive an abbreviated 
AAT treatment at the end of 6 months.  Following the intervention, UNC WMP providers (e.g., social 
workers, preventive medicine residents), and participants will be asked to participate in a 30-60 minute 
interview on the acceptability of the AAT +NUTR program, and to explore factors that will increase 
dissemination and uptake in the primary care setting.  
 
5.2. Experimental / Observational Design 
The proposed study will use a randomized clinical trial design. A sample of 60 black women who report 
at least weekly binge eating episodes will be randomized to 2 arms of a 6-month AAT + BWL 
intervention: AAT+BWL or a control group. AAT+BWL participants will receive an 8-week AAT program, 
and an 8-week BWL program, both using a group format. Assessments will be conducted at 0, 4, and 6 
months. 
5.3. Measurement Design 
 
 
5.4. Outcome Measures 
 

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Primary Outcome(s):  
 
 
 
 
 
 
 
Secondary Outcome(s):  Linear mixed effects modeling will be used to examine the association between 
treatment group assignment (AAT + BWL or wait-list control group coded as a (0,1)-indicator) and binge 
eating, eating self-efficacy, depressive symptoms, weight, blood pressure, and waist circumference 
scores at 2 and 6 months. 
 
6. Study Participants 
6.1. Number of Participants 
Number to be recruited for screening: 160 
Number of eligible participants enrolled: 60 
Eligibility criteria includes Non-Latino Black women individuals over 18 years of age, have a BMI ≥ 25 
kg/m², use a Bluetooth-enabled smartphone, and report at least one binge eating episode weekly. We 
will recruit participants in two ways: 1) We will request an IRB-waiver to allow Laurel Sisler, the director 
of the Weight Management Program and co-investigator on this study to a list of eligible participants 
(e.g., Non-Hispanic, AA & White women, BMI > 30 kg/m2) at UNC Family Medicine. The names will be 
randomly ordered, and women will be sent an introductory letter via email and/or postal mail describing 
the project and inviting them to contact the research team if no further contact is desired. If no such 
contact is received, the letter will be followed by a telephone call from the project coordinator, who will 
discuss all components of informed consent and participation. 2) Potential participants will respond to 
flyers, email announcements in community centers, doctor's offices, churches, and university listservs. 
Participants will also be approached in local community agencies by community center staff members 
and lay health counselors to request their consent to be approached by a member of the research team. 
IRB-approved flyers will be posted in the lobbies and recreation halls of the community facilities. 
Potential participants may self-refer to the study after reading the flyer. 
 
 
6.2. Eligibility 
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the 
following criteria: 

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• 
Non-Latino Black women 
• 
Over 18 years of age, 
• 
Have a BMI ≥ 25 kg/m² 
• 
Use a Bluetooth-enabled smartphone 
• 
Report at least one binge eating episode weekly 
 
Exclusion Criteria: Any individual who meets one or more of the following criteria will be excluded 
from participation: 
• 
Individuals who are currently pregnant, 
• 
In substance use treatment, 
• 
Currently receiving psychological or pharmacological treatment for disordered eating or 
eating disorders, 
• 
Children (under the age of majority for their location), 
• 
Nonviable neonates or neonates of uncertain viability, 
• 
Prisoners, other involuntarily detained or incarcerated (this includes parolees help in 
treatment centers as a condition of their parole), 
• 
Decisionally impaired individuals,  
• 
Children who are wards of the State (Foster children), 
• 
Non-English-speaking individuals, 
• 
People, including children, who are likely to be involved in abusive relationships, either as 
perpetrator or victim 
 
6.3. Strategies for Recruitment and Retention 
Recruitment Strategy:  
Using an IRB-approved waiver, a list of eligible participants (e.g., Non-Hispanic, AA women, BMI ≥ 25 
kg/m2) at UNC Family Medicine will be generated from examining the electronic health record.  We will 
then send an introductory letter via postal mail to all eligible participants.  This letter will describe the 
study, and then provide information on opting out.  Study staff will contact those who do not opt out 
and conduct an eligibility screen. If an individual is eligible, they will be given a date and time to meet 
with a research team member. Participants will be evaluated in person to determine the presence of at 
least one weekly binge eating episode using the overeating section of the Eating Disorder Examination. 
Participants will also complete height/weight measurements, provide signed informed consent, and 
finish self-report measures (See Table 1). Once all baseline assessments are complete, participants will 
be randomized to the AAT + NUTR intervention or wait-list control.   
 
Retention Strategy:  
Participants will receive $25 for completing the assessment at 0, 4, and 6 months, for a total of $75.00. 
Participants will be provided the incentive after participating in each assessment. If a participant 
withdraws prior to the completion of a particular assessment, the participant will only have access to 
incentives based on what assessments were previously completed. Because we wanted to prevent 

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coercion, we have purposely kept study incentives at a reasonable cost, and only at a level to offset the 
burden of participating in the study. 
 
6.4. Consent Process 
If participants are eligible for the study, the applicant will be given a date and time to meet with the PI 
and will be provided an email link to access the self-report measures associated with this study. At 
appointment, participants will provide signed informed consent, finish self-report measures, and be 
evaluated in person to determine the presence of at least one weekly binge eating episode using the 
overeating section of the Eating Disorder Examination. Participants will also have their height, weight, 
blood pressure, and waist circumference measured at this time. Baseline appointment will take place in 
a private room at the UNC Department of Family Medicine. If all inclusion criteria are met, participants 
will be randomly assigned to one of the two treatment conditions. There will be a brief waiting period 
between the initial consent discussion and obtaining consent for this study. In addition, consent will be 
obtained by research assistants affiliated with this study, other than the study PI. 
 
7. Study Intervention 
[An interventional study may involve a drug, device, biologic agent, or a medical, surgical, dental, 
radiological, nutritional, neurological, or behavioral intervention. The study may use an experimental 
design (e.g. a randomized trial) or it may use an observational design (e.g., a single-arm study or study in 
which the physician and patient choose from among available treatment regimens). Complete only the 
sections below that are relevant to your study; enter N/A otherwise.] 
 
7.1. Intervention – Test Article (if applicable) 
Description:  
The Appetite Awareness Treatment (AAT) intervention includes eight 60-minute group sessions. All 
sessions involve didactic training, review of self-monitoring of eating episodes, interactive activities, and 
homework assignments to enable participants to practice learned skills. Participants will be provided a 
workbook, which will include session content, and self-monitoring forms. 
The Behavioral Weight Loss (BWL) intervention us based on the curriculum for the Diabetes Prevention 
Program, and offers training in healthy eating, increasing physical activity, and achieving caloric balance. 
 
Acquisition: [State how test article will be acquired, e.g., from manufacturer, IND/IDE Sponsor, UNC 
Investigational Drug Services, or internal, e.g., device developed by a UNC faculty or laboratory.]  
N/A 
 

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Formulation/Packaging/Labeling:  
N/A 
 
Storage and Stability:  
N/A 
 
Preparation and Administration:  
N/A 
 
Modification:  
N/A 
 
Accountability: [ 
N/A 
 
7.2. Assignment Procedures 
[If applicable to the study design, specify complete details of the plan for assigning enrolled participants 
to the treatment regimens.] 
Matching and Stratification: (if applicable) [If applicable, specify exactly how matching and/or 
stratification of subjects will be accomplished] 
N/A 
 
Randomization, Concealment, and Blinding:  
Randomization will be performed by Microsoft Excel and the PI will be blinded to all randomization. A 
research assistant will be responsible for supervising randomization. 
 
Masking (Blinding):  
Randomization will be performed by Microsoft Excel and the PI will be blinded to all randomization. 
 
7.3. Intervention – Procedural (if applicable) 
Description:  

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The training manual for this intervention is based on the Appetite Awareness Training Workbook by 
Linda Craighead. 
 
Training on Procedural Intervention:  
MSW-trained social work clinicians will be responsible for conducting both interventions, and will have 
weekly supervision with the PI (Dr. Goode). Due to their training in the social determinants of health and 
in providing behavioral health interventions, social workers with graduate training are well-equipped to 
apply a person-in-environment perspective, and treat the biopsychosocial factors that influence the 
health and eating behaviors of study participants. Moreover, using social workers may reduce burden in 
a busy, primary care setting, and increase treatment access and uptake.   
 
7.4. Concomitant Therapy (if applicable) 
[Describe what is prohibited, what is recommended and/or allowed, and what information about this 
topic will be collected as part of the study.] 
N/A 
 
7.5. Rescue Medications and Procedures (if applicable) 
[Describe rescue procedures or medications that are permissible or required for adverse events.]   
N/A 
 
7.6. Compliance Checks 
[Discuss measures and procedures to assess participant compliance.] 
N/A 
 
7.7. Withdrawal / Discontinuation of Enrolled Participants 
Participants may be withdrawn if participant develops a condition that is an exclusion criterion (e.g. 
participants who become pregnant will be asked to withdraw from the study).  
 
7.8. Voluntary Withdrawal (Drop-Out) of Enrolled Participants 
Participants may voluntarily withdraw participation at any time, for any reason, with no penalty or loss 
of rights. If a participant withdraws prior to the completion of a particular assessment, the participant 
will only have access to incentives based on what assessments were previously completed. 

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8. Study Procedures and Schedule 
[Information presented in this section should be consistent with the Synopsis (MPD Section 1) and the 
Table of Events (example below) 
8.1. Table of Events 
 
 
 
 
 
[In the following sections 7.2 – 
7.8, fully describe:  
 
• All contact with subjects (study 
visits, telephone/electronic 
contact) 
• Permissible time windows for 
study procedures, lab tests, etc. 
While a treatment visit may have 
a small window (such as ± 1 day), 
a 6-month follow-up call may have larger window (such as ± 1 week) 
• 
Clearly distinguish activities and procedures that participants will complete in the course of clinical 
care from those that participants will complete solely for research purposes] 
 
8.2. Pre-Screening / Screening (Day -X to Day Y) 
 

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During recruitment, participants will not be directly contacted identified from privately held sources 
without the participant's permission. Methods that are the "least intrusive" will be used, and 
participants will be encouraged to contact the research team if they are interested in receiving more 
information about the study. Participants will self-refer to the study, and provided the link to participate 
in the survey. Participants will be contacted by email or telephone to after determining preliminary 
eligibility via a Qualtrics web survey. Recruitment will be managed by study investigators and research 
assistants. Potential participants will respond to notices by calling number on flyer or filling out the 
screening link, and will be screened to determine eligibility. If an individual is eligible, she will be given a 
date and time to meet with a research team member.  
 
8.3. Enrollment / Baseline (Day 0) 
 
If participants are eligible for the study, the applicant will be given a date and time to meet with the PI 
and will be provided an email link to access the self-report measures associated with this study. At 
appointment, participants will provide signed informed consent, finish self-report measures, and be 
evaluated in person to determine the presence of at least one weekly binge eating episode using the 
overeating section of the Eating Disorder Examination. Participants will also have their height, weight, 
blood pressure, and waist circumference measured at this time. Baseline appointment will take place in 
a private room at the UNC Department of Family Medicine. If all inclusion criteria are met, participants 
will be randomly assigned to one of the two treatment conditions. 
 
8.4. Study Visits (Numbered as V1, V2, etc., Day X ± Y) 
Participants will attend 8 weekly AAT sessions and then transition to eight, weekly NUTR sessions. All 
sessions will be 60-90 minutes.  
V1: Data on AAT group and control group collected at baseline, before randomization (T1) 
V2: Data on AAT group and control group collected at end of month 4, after completion of intervention 
program (T2) 
V3: Data on AAT group and control group collected data end of month 6, posttreatment follow-up (T3) 
Data collected includes height, weight, blood pressure, and waist circumference.  
8.5. Phone Contact (Day Day X ± Y) 
[Describe information/data to be collected, e.g., activities of daily living, symptom rating.]  
 
 
<Insert text> 
 

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8.6. Final Visit (Day Day X ± Y) 
[List all interventions/evaluations/procedures in the sequence they will occur, e.g., record adverse 
events as reported by subject or observed by investigator, record subject's compliance with 
intervention, provide final instruction to subject.] 
 
 
<Insert text> 
Data collected at end of month 4, after the completion of intervention program, includes: height, 
weight, blood pressure, and waist circumference. Participants will also be asked to complete the Eating 
Disorder Examination, Eating Disorder Examination-Questionnaire, Weight Efficacy Lifestyle 
Questionnaire, and the Beck Depression Inventory.  
 
8.7. Follow-Up Contact (Day Day X ± Y) 
[Describe information/data to be collected, e.g., adverse events, disease progression/recurrence.] 
 
 
<Insert text> 
Data collected at end of month 6, posttreatment follow up, includes: height, weight, blood pressure, and 
waist circumference. Participants will also be asked to complete the Eating Disorder Examination, Eating 
Disorder Examination-Questionnaire, Weight Efficacy Lifestyle Questionnaire, and the Beck Depression 
Inventory.  
 
 
8.8. Premature Discontinuation 
[If a subject withdraws or the investigator discontinues subject participation, specify evaluations that 
should be performed and data that should be collected. Indicate if you plan to collect medical record 
data for the duration of the study for follow-up purposes, even if the study intervention is discontinued.] 
<If a participant withdraws or study participation is discontinued by the principal investigator, 
participants will be asked to complete the Eating Disorder Examination-Questionnaire Survey.  
 
8.9. Collection and Management of Tissue Specimens 
Sample Preparation: [As applicable, describe measures to prevent sample loss and degradation, cooling 
and freezing procedures, sample labeling, etc.] 
Record Keeping and Monitoring: [As applicable, describe procedures for maintaining sample 
accountability and traceability and for ensuring regulatory compliance.] 
Sample Storage and Security: [As applicable, describe the location, facility, and storage 
method/equipment; sample chain of custody; the remote monitoring and maintenance procedures; 
data security system, encryption, and access restrictions for study personnel. 

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9. Study Measurements and Evaluations 
 
 
9.1. Outcome Measures for Evaluation of Feasibility / Tolerability 
To assess the feasibility of recruiting adult, AA women to the proposed study, the percent of eligible 
women who were enrolled and retained in the study will be examined and reasons for nonparticipation 
and attrition will be documented.  Feasibility will also be determined by calculation of point and interval 
estimates (95% confidence intervals using sample size methods) of the feasibility parameters 
(proportion/percentages in terms of eligibility, participation, retention; means/medians for attendance 
at intervention sessions) and bivariate frequency distributions.  
 
 
 
 
 
 
 
 
 
 
 
9.2. Outcome Measures for Evaluation of Efficacy 
Linear mixed effects modeling will be used to examine the association between treatment group 
assignment (AAT + BWL or wait-list control group coded as a (0,1)-indicator) and binge eating, eating 
self-efficacy, depressive symptoms, weight, blood pressure, and waist circumference scores at 2 and 6 
months. Baseline scores will be used as covariates in these analyses with interactions between 
treatment group assignments with baseline values of outcome scores. Standardized mean differences 
(e.g., Cohen’s d with bias adjustment) will also be calculated as an effect size measure with 95% CI. 
Standardized residuals will be examined to assure no assumptions are violated. 
 
9.3. Outcome Measures for Evaluation of Safety 
[e.g., rate of hospitalization, rate of safety events, rate of drop-outs due to adverse events] 
 
N/A 
 
9.4. Other Outcomes in the Causal Pathway 
N/A 
 
9.5. Baseline Characteristics of the Participants 
 

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Non-Latino Black women, over 18 years of age, have a BMI ≥ 25kg/m², and report at least one binge 
eating episode weekly.  
 
9.6. Variables Representing Treatment 
N/A 
10. Statistical Analysis Plans 
 
10.1. Strategies that Apply to all the Specific Aims 
To help ensure replicability of the research, the analysis plans will be reviewed and finalized prior to 
collection of data (a priori). For each specific aim, the analysis plans specify detailed steps for obtaining 
estimates of population parameters (e.g., treatment effects) and for making inferences.   
Sensitivity analyses will be performed to assess the robustness of the major results as indicated by their 
sensitivity to reasonable perturbations of the choices of the methods and assumptions used. Any 
question about the optimal choice of methods and assumptions are best handled by relegating 
competing approaches to roles in the domain of sensitivity analyses. Results of the sensitivity analyses 
will be used to guide our level of trust in the main results. Best practices for dealing with incomplete 
data will depend on the documented causes of missing, censored, and coarsened values. The reasons for 
missing data values, drop-out, and protocol departures will have been documented in/with the 
database.  
All hypothesis tests yielding p-values that are deemed to be not statistically significant will be reported 
as being inconclusive. The proposed statistical analysis strategy acknowledges that no p-value can reveal 
the plausibility, presence, truth, or importance of an association or effect--which is consistent with the 
statements of the American Statistical Association [4,5], the recommendations in Nature [6,7], and 
guidances, such as the CONSORT Statement [1], STROBE Statement [2], and ICMJE guidance [3].2]    
 
10.2. Description of the Study Cohort 
Descriptive analyses will first be performed overall, by treatment group, and time points to identify any 
data anomalies (e.g., missing data, outliers, non-normality) that may invalidate study findings. Remedial 
measures (e.g., single/multiple imputation of missing data, score/data transformation) will be applied as 
indicated based on the results of data screening.   
 
2 [1] www.consort-statement.org; [2] www.strobe-statement.org; [3] www.icmje.org; [4]  Wasserstein RL, et al. 
(2016), The ASA's Statement on p-Values, The American Statistician, 70:2, 129-133. [5] Wasserstein RL, et al. 
(2019), Moving to a World Beyond p < 0.05, The American Statistician, 73:sup1, 1-19. [6] Amrhein, et al. (2019) 
Scientists rise up against statistical significance, Nature 567, 305-307. [7] Editorial (2019) It’s time to talk about 
ditching statistical significance:  Looking beyond a much used and abused measure would make science harder, but 
better. Nature 567, 283-283. 
 

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10.3. Aim-Specific Plans 
 
 
Plans for Aim 1: [e.g., to evaluate Efficacy, characterize and compare two treatment regimens] 
To evaluate the feasibility and acceptability of 6-month AAT + NUTR, we will examine several feasibility 
outcomes. To assess the feasibility of recruiting adult, AA women to the proposed study, the percent of 
eligible women who were enrolled and retained in the study will be examined and reasons for 
nonparticipation and attrition will be documented.  Feasibility will also be determined by calculation of 
point and interval estimates (95% confidence intervals using sample size methods) of the feasibility 
parameters (proportion/percentages in terms of eligibility, participation, retention; means/medians for 
attendance at intervention sessions) and bivariate frequency distributions.  
 
 
Plans for Aim 2: [e.g., to evaluate Safety, characterize and compare two treatment regimens] 
At 4 and 6 months, compare changes in (a) binge eating, eating self-efficacy, and depressive symptoms 
and (b) weight for participants in the AAT vs. control group. Linear mixed effects modeling will be used 
to examine the association between treatment group assignment (AAT + BWL or wait-list control group 
coded as a (0,1)-indicator) and binge eating, eating self-efficacy, depressive symptoms, weight, blood 
pressure, and waist circumference scores at 2 and 6 months. Baseline scores will be used as covariates 
in these analyses with interactions between treatment group assignments with baseline values of 
outcome scores. Standardized mean differences (e.g., Cohen’s d with bias adjustment) will also be 
calculated as an effect size measure with 95% CI. Standardized residuals will be examined to assure no 
assumptions are violated. 
 
 
 
Plans for Aim 3: N/A 
 
 
Plans for Aim 4: N/A 
 
10.4. Planned Interim Analyses (If Applicable) 
 
N/A 
 
10.5. Plans for Coping with Withdrawals and Loss-To-Follow-Up 
 
Enrolled participants who discontinue/are withdrawn will not be replaced. The initial target number of 
enrolled participants is large enough to cope with loss of participants’ data due to discontinuation, 
withdrawal, or insufficiently complete data (missing values).  
 
 

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10.6. Sample Size Rationale 
 
Because this is a feasibility study, we are not prioritizing powering the sample to determine the 
efficacy of the AAT intervention. However, we ran conservative tests for statistical power incorporating 
parameters from our preliminary study using G*Power. Based on our analysis, we determined that a 
sample of 60, evenly allocated between treated and control groups, is sufficiently powered (.80) to 
identify large standardized mean differences in binge eating (d = .74) (Aim #2). The sample, however, is 
underpowered to determine differences in weight. Because this study is exploratory, we are prioritizing 
feasibility, and an exploration of differences, rather than determining efficacy. This is a pilot study, If this 
pilot study is successful, we will conduct a larger study with a greater sample of participants and test the 
AAT intervention for a longer duration. 
 
11. Safety Monitoring and Management 
 
11.1. Risk / Benefit Assessment 
 
Potential Risks:  
 
The major risks are likely to be fatigue, distress from revealing personal information and possibly during 
the intervention trial if the participant is not feeling like she is making progress. If participants complain 
about fatigue or distress, they will be given an opportunity to complete the questionnaire later.  
 
Potential Benefits: [State anticipated direct benefit(s) for individual subjects, if any, or to 
society] 
 
Participants may benefit from the tools learned within the intervention, and healthy non-eating coping 
skills. Study participants will also have the opportunity to receive support from sharing of their 
experiences and may receive further insight regarding tools to manage their binge eating behaviors and 
gain awareness for future weight loss attempts. They may also experience pride in knowing that they 
are contributing to a study that may make a significant contribution to the field in the future.  
 
11.2. Assessment of Safety 
To minimize emotional distress, if participants cite this concern, they will be provided the option to a) 
pause 
and regroup; and/or b) finish the survey at a later time. If the previous is not sufficient, and participants 
report experiencing significant distress, participants will be provided the number to Hopeline 
(https://www.hopeline-nc.org; 919-231-4525), a North Carolina crisis line and to the local emergency 
room. 
Participants who experience significant distress will also be asked permission to provide their contact 
information to the PI (Dr. Goode). Dr. Goode, who is a licensed clinical social worker, will contact those 

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participants on the next day. Dr. Goode will also be updated immediately on all participants who 
experience 
significant distress.  
Depression – Beck Depression Inventory 
Using the total score (from all added scores on the BDI), the following interpretation applies: 
Potential participants who on initial 
assessment (or is there a screening assessment) 
have a BDI-II score of 29 or greater (“severe” 
depression) are excluded from the study 
(please see below). 
If a participant’s total score is  20 or greater, this 
will be reported to the Principal Investigator (PI) 
or Project Director (PD) who will discuss their 
results, inquire about current status and 
treatment, will provide information on community resources for the treatment of depression, and 
document the conversation and actions taken.  
For question #9 “Suicidal Thoughts or Wishes”: If a participant chooses response option 1, 2 or 3, this 
will be reported to the PI or PD who will discuss the results, inquire about current status and treatment 
and document the conversation and actions taken (providing a detailed note of the discussion that will 
be maintained using the participant’s ID number). The participant will also be referred to their PCP, 
given a list of mental health providers in the community, and urged to seek treatment if they are not 
already receiving treatment.  
If a participant endorses suicidality or imminent fear of self-harm, the PD will contact and inform the PI 
(who is a licensed mental health professional), and also make telephone contact with the local suicide 
crisis network while in the presence of the participant; if a significant other is with the participant, that 
individual will be provided with instructions to accompany the person to the nearest Emergency Room. 
In either of these situations, the individual will be asked for permission to contact and inform their PCP 
of their condition.  
 
11.3. Unanticipated Problems, Adverse Events, Serious Adverse Events 
 
Unanticipated Problems: An unanticipated problem is any incident, experience or outcome that 
meets all three OHRP criteria (1) unexpected (in severity, specificity, frequency, or nature), (2) 
related or possibly related to the research, and (3) suggests the research places subjects or 
others at greater risk than previously known or recognized.  
 
 
Adverse Event (AE) Definitions: An adverse event is one that occurs during the course of a 
 
research protocol that either causes physical or psychological harm, or increases the risk of 
 
physical or psychological harm, or results in a loss of privacy and/or confidentiality to a 
 
research participant or others (such as family members). 
  
 
Total Score 
Range of Depression 
0 – 13 
Minimal 
14 – 19 
Mild 
20 – 28 
Moderate 
29 – 63 
Severe 

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Serious Adverse Events (SAE) Definition: A serious adverse event means any event temporally 
associated with the subject’s participation in research that meets any of the following criteria: 
results in death; is life threatening (places the subject at immediate risk of death from the event 
it occurred); requires inpatient hospitalization or prolongation of existing hospitalization; results 
in a persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; or 
any other adverse event that, based upon appropriate medical judgement, may jeopardize the 
subject’s health and may require medical or surgical intervention to prevent one of the 
outcomes listed .  
 
Reporting and Documentation Procedures:  
Data and safety monitoring will be conducted during meetings with the PI and research 
assistants during which recruitment, data acquisition, management and any adverse events 
arising from the study will be reviewed. Any unanticipated and adverse events will be reported 
immediately to the IRB, a serious event will be reported to the IRB and funding agency. 
 
Participant Notification of New Information: All participants will be aware of new safety 
information within 7 days of the event preceding the development of new information. 
 
11.4. Safety Monitoring 
Data and safety monitoring will be conducted during meetings with the PI and research assistants during 
which recruitment, data acquisition, management and any adverse events arising from the study will be 
reviewed. Any unanticipated and adverse events will be reported immediately to the IRB, a serious 
event will be reported to the IRB and funding agency. 
 
11.5. Study Suspension / Early Termination of the Study 
 
Given that this is such a minimal risk intervention, we do not expect that serious AEs will occur and 
require stopping the trial. Though extremely unlikely, difficulties with compliance and/or attrition would 
be far more likely to result in trial stoppage. However, as previously noted, we, along with our safety 
officer, will closely monitor any injury rates and notify the UNC Chapel Hill IRB and the UNC NORC if a 
larger than expected SAE rate is observed. 
 
12. Supporting Documentation and Operational Considerations 
 
12.1. Regulatory, Ethical, and Study Oversight Considerations 
 
The following subsections should include a description of the regulatory and ethical considerations, and 
context for the conduct of the trial. Of note, the guiding ethical principles being followed by this study 
are included in the Statement of Compliance at the beginning of this protocol. For NIH Intramural 
Research Program studies only:  A statement referencing compliance with NIH Human Research 

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Protections Program policies and procedures is adequate for Subsection 10.1.1, Informed Consent 
Process.   
 
12.1.1. Informed Consent Process 
 
12.1.1.1. 
Consent/Assent and Other Informational Documents Provided to Participants 
In obtaining and documenting informed consent, the investigator must comply with applicable 
regulatory requirements (e.g., 45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56) and should adhere to ICH 
GCP. Prior to the beginning of the trial, the investigator should have the IRB’s written approval for the 
protocol and the written informed consent form(s) and any other written information to be provided to 
the participants.  
 
This section should demonstrate that the consent form contains all required regulatory elements. List all 
consent and/or assent documents and materials submitted with this protocol.  Include consent and/or 
assent forms, printed or web-based materials, phone scripts and any other related material. 
 
If needed, describe special documents or materials (e.g., Braille, another language, audio recording) 
 
Example text provided as a guide, customize as needed:  
 
 
[Consent forms describing in detail the study intervention, study procedures, and risks are given to the 
participant and written documentation of informed consent is required prior to starting 
intervention/administering study intervention.  The following consent materials are submitted with this 
protocol <insert list>.] 
 
<Insert text> 
 
12.1.1.2. 
Consent Procedures and Documentation 
 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the 
study and continues throughout the individual’s study participation. Consent forms will be Institutional 
Review Board (IRB)-approved and the participant will be asked to read and review the document. The 
investigator will explain the research study to the participant and answer any questions that may arise. 
A verbal explanation will be provided in terms suited to the participant’s comprehension of the 
purposes, procedures, and potential risks of the study and of their rights as research participants.  
Participants will have the opportunity to carefully review the written consent form and ask questions 
prior to signing. The participants should have the opportunity to discuss the study with their family or 
surrogates or think about it prior to agreeing to participate. The participant will sign the informed 
consent document prior to any procedures being done specifically for the study. Participants must be 
informed that participation is voluntary and that they may withdraw from the study at any time, without 
prejudice. A copy of the informed consent document will be given to the participants for their records. 
The informed consent process will be conducted and documented in the source document (including the 

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date), and the form signed, before the participant undergoes any study-specific procedures. The rights 
and welfare of the participants will be protected by emphasizing to them that the quality of their 
medical care will not be adversely affected if they decline to participate in this study. 
 
12.2. Study Discontinuation and Closure 
 
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 study participants, investigator, funding agency, and 
UNC-Chapel Hill.  If the study is prematurely terminated or suspended, the Principal Investigator (PI) will 
promptly inform study participants, the Institutional Review Board (IRB), and sponsor and will provide 
the reason(s) for the termination or suspension.  Study participants will be contacted, as applicable, and 
be informed of changes to study visit schedule. 
  
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Demonstration of efficacy that would warrant stopping    
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination that the primary endpoint has been met 
• 
Determination of futility 
 
Study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the sponsor, IRB and/or NIH. 
 
<Insert text> 
 
12.3. Confidentiality and Privacy 
Confidentiality of information will be maintained and assured by use of a unique numerical code that 
will be used for managing data. Only trained and certified staff will obtain data according to detailed 
research protocols. All research staff is required to have human subjects training.  All gathered data will 
be used only for research purposes.   
 
A master list of participant names and code numbers will be kept in a locked file maintained by the PI. 
Study results will be reported in the aggregate. The PI will monitor all data management and security 
procedures and report any adverse events to the IRB as soon as they occur. In addition, all of the 
samples and the databases will contain anonymous information only, each sample/entry associated with 
only a unique code. In addition, every precaution will be taken to minimize exposure of the data to 
persons outside of this project by using passwords for all computer files and keeping all hard copies of 
data within locked files. All results generated from this project will be reported in aggregate only. To 
decrease the likelihood of a breach of confidentiality, questionnaire data will be assigned a code number 
and stored in a locked file cabinet. This file will be separate from the file with the participants’ 
identifying information. 

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Certificate of Confidentiality (if applicable) 
 
To further protect the privacy of study participants, a Certificate of Confidentiality will be issued by the 
National Institutes of Health (NIH).  This certificate protects identifiable research information from 
forced disclosure. It allows the investigator and others who have access to research records to refuse to 
disclose identifying information on research participation in any civil, criminal, administrative, legislative, 
or other proceeding, whether at the federal, state, or local level. By protecting researchers and 
institutions from being compelled to disclose information that would identify research participants, 
Certificates of Confidentiality help achieve the research objectives and promote participation in studies 
by helping assure confidentiality and privacy to participants. 
 
 
12.4. Future Use of Stored Specimens and Data 
Once the study has ended, data will be kept for at least 7 years to keep with federal regulations, and to 
ensure there is no reasonable probability left to defend against allegations of scientific misconduct . If, 
after the seven years have passed, and it is deemed appropriate, paper records containing identifiable 
data will be shredded and recycled. Records stored on the computer will be erased with commercial 
erasing applications designed to move all data from the storage device.  
 
12.5. Key Roles and Study Governance 
Provide the name and contact information of the Principal Investigator and the Medical Monitor. 
 
Principal Investigator 
Medical Monitor 
Rachel Goode, PhD, MPH, 
Principal Investigator  
Deborah Tate, PhD 
University of North Carolina 
at Chapel Hill, School of 
Social Work 
Department of Health Behavior and 
Nutrition  
Address: 325 Pittsboro 
Street; Chapel Hill, NC 
27599 
Address: CB #7440 
Chapel Hill, NC 
Phone Number: 919-962-
6429 
Phone Number: 919-966-7546 
rwgoode@email.unc.edu 
dtate@unc.edu 
 
 
 

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12.6. Safety Oversight 
12.7. Clinical Monitoring 
Clinical site monitoring is conducted to ensure that the rights and well-being of trial participants are 
protected, that the reported trial data are accurate, complete, and verifiable, and that the conduct of 
the trial is in compliance with the currently approved protocol/amendment(s), with International 
Conference on Harmonisation Good Clinical Practice (ICH GCP), and with applicable regulatory 
requirement(s).  
 
The intervention and evaluation protocols pose minimal risk to participants. Because of this low 
risk status, the data safety monitoring plan (DSMP) for this trial focuses on close monitoring by the 
principal investigator (PI) as safety officer, along with prompt reporting of excessive adverse events 
and any serious adverse events that are possibly related to the intervention to the NIH and to the 
IRB at the University of North Carolina at Chapel Hill. 
 
Our project director will oversee the creation of several additional safety reports that will be shared 
regularly with the PI/safety officer. The frequency of data review for this study differs according to 
the type of data and can be summarized in the following table: 
 
Data type 
Frequency of Review 
Subject accrual (adherence to protocol 
regarding demographics, inclusion/exclusion) 
 
Adverse event rates (injuries) 
 
Intervention Engagement 
Monthly during the 3-month recruitment 
period 
 
As they occur 
 
Quarterly 
Stopping rules report regarding statistical 
power implications of drop outs and missing 
data 
 
Annually 
 
The safety officer for this trial will be Rachel W. Goode, PhD, MPH. Dr. Goode has been PI on several 
obesity treatment clinical trials and has a high degree of understanding about the types of injuries 
potentially experienced when individuals engage in weight management interventions. As principal 
investigator and safety officer for this study, Dr. Goode will review the reports sent by the project 
director (at the frequency outlined above) to determine whether there is any corrective action, 
trigger of an ad hoc review, or stopping rule violation that should be communicated to the study 
investigator, the UNC-Chapel Hill IRB, UNC NORC, and the NIH IC. In addition, Dr. Goode will consult 
with senior consultants on this pilot/feasibility study, Dr. Deborah Tate and Dr. Anna Bardone-Cone.  
 
12.8. Quality Assurance and Quality Control  
The principal investigator will guide the creation of all study protocol, and have involvement with 
trainings and supervision of study staff. Quality control will be conducted in all phases of the project. 
Intervention sessions will be supervised by the principal investigator. All staff will be trained on the 

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intervention and will be required to attend weekly supervision to assure integrity to the intervention 
protocol. Quality assurance and control concerns will be addressed by the principal investigator.  
 
 
12.9. Data Handling and Record Keeping 
 
Each participating site will maintain appropriate medical and research records for this trial, in 
compliance with ICH GCP and regulatory and institutional requirements for the protection of 
confidentiality of participants.  As part of participating in a NIH-sponsored or NIH-affiliated study, each 
site will permit authorized representatives of the NIH, sponsor, and regulatory agencies to examine (and 
when permitted by applicable law, to copy) clinical records for the purposes of quality assurance 
reviews, audits, and evaluation of the study safety, progress, and data validity. Describe in this section 
who will have access to records.   
 
12.9.1. Data Collection and Management Responsibilities 
Study data will be collected and managed using REDCap electronic data capture tools hosted at the 
University of North Carolina at Chapel Hill. REDCap (Research Electronic Data Capture) is a secure, web-
based application designed to support data capture for research studies, providing: 1) an intuitive 
interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 
3) automated export procedures for seamless data downloads to common statistical packages; and 4) 
procedures for importing data from external sources. 
 
12.9.2. Study Records Retention 
Once the study has ended, data will be kept for at least 7 years to keep with federal regulations, and to 
ensure there is no reasonable probability left to defend against allegations of scientific misconduct . If, 
after the seven years have passed, and it is deemed appropriate, paper records containing identifiable 
data will be shredded and recycled. Records stored on the computer will be erased with commercial 
erasing applications designed to move all data from the storage device.  
12.10. 
Protocol Deviations 
 A protocol deviation is any noncompliance with the clinical trial protocol. 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 investigator will 
use continuous vigilance to identify and report deviations in a timely manner. The site investigator is 
responsible for knowing and adhering to the reviewing IRB requirements.  
 
12.11. 
Publication and Data Sharing Policy  
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As 

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such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be 
submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-
reviewed journals.  Data from this study may be requested from other researchers x years after the 
completion of the primary endpoint by contacting <specify person or awardee institution, or name of 
data repository>.  
 
12.12. 
Conflict of Interest Policy 
 
The independence of this study from any actual or perceived influence, such as by the pharmaceutical 
industry, is critical.  Therefore, any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. Furthermore, 
persons who have a perceived conflict of interest will be required to have such conflicts managed in a 
way that is appropriate to their participation in the design and conduct of this trial.  The study 
leadership in conjunction with the NIDDK has established policies and procedures for all study group 
members to disclose all conflicts of interest and will establish a mechanism for the management of all 
reported dualities of interest 
 
13. Additional Considerations 
This section should include a description of any additional considerations not currently covered in this 
protocol template, such as particular institutional or IRB-related requirements.  
 
N/A 
 
14. References 
 
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15. List of Appendices 
N/A 

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