Reducing Binge Eating to Prevent Weight Gain in Black Women

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03531112
• Collaborator: National Institutes of Health (NIH) (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 13
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

The purpose of the proposed study is to pilot a 6-month, cognitive-behavioral binge eating intervention, Appetite Awareness Training (AAT) to reduce binge eating and prevent weight gain for Black women with a BMI > 25 kg/m^2 and with weekly binge eating episodes. Intervention participants will receive a 8-week group AAT intervention, and will also receive bluetooth-connected scales for daily weighing. Participants will also receive tailored feedback on self-weighing frequency and weight change. The investigators will follow-up with participants at six months.

Condition or Disease	Intervention/Treatment	Phase
Binge Eating; Weight Loss; Weight Gain Prevention	Behavioral: Appetite Awareness Treatment + Lifestyle Modification	N/A

Detailed Description

Aim 1. Using an experimental design, examine the feasibility and acceptability of 6-month AAT (N=40) in North Carolina. Forty overweight and obese (BMI ≥ 25 kg/m^2) community-based Black women will be randomized to the AAT intervention or wait-list control (who will eventually receive the intervention). AAT participants will meet weekly for 8 weeks, followed by a 4-month period of daily weighing and weekly tailored feedback only. The study will examine the following: recruitment feasibility, attendance/retention, adherence, satisfaction, and barriers to completion.

Aim 2: At 4 and 6 months, compare changes in (a) binge eating, eating self-efficacy, and depressive symptoms and (b) weight, blood pressure, and waist circumference for participants in the intervention vs. control group.

H_1: Participants in the AAT intervention will report less binge and overeating and gain less weight than those in the control group at 2 and 6 months.

Secondary aim: Examine characteristics (e.g., baseline BMI, severity of binge eating, frequency of self-weighing) related to change in binge eating and weight.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The proposed study will use a randomized clinical trial design. A sample of 40 black women who report at least weekly binge eating episodes will be randomized to 2 arms of a 6-month AAT intervention: AAT or a wait-list control group (delayed intervention group). AAT participants will receive an 8-week AAT program using a group format, and will be provided a smart scale (with bluetooth-connection for automatic data reporting) and instructions to weigh themselves daily. Participants will also be provided with weekly tailored feedback on self-weighing frequency and weight change. Assessments will be conducted at 0, 2, and 6 months.The proposed study will use a randomized clinical trial design. A sample of 40 black women who report at least weekly binge eating episodes will be randomized to 2 arms of a 6-month AAT intervention: AAT or a wait-list control group (delayed intervention group). AAT participants will receive an 8-week AAT program using a group format, and will be provided a smart scale (with bluetooth-connection for automatic data reporting) and instructions to weigh themselves daily. Participants will also be provided with weekly tailored feedback on self-weighing frequency and weight change. Assessments will be conducted at 0, 2, and 6 months.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Reducing Binge Eating to Prevent Weight Gain in Black Women: A Pilot Study
• Actual Study Start Date: Jan 12, 2019
• Actual Primary Completion Date: Feb 13, 2020
• Actual Study Completion Date: Feb 13, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Appetite Awareness Treatment (AAT) + Lifestyle Modification (LM) Participants will receive an 8-week Appetite Awareness Training (AAT) program using a group format, will be provided a smart scale (with bluetooth connection) and instructions to weigh themselves daily. Participants will also be provided with weekly tailored feedback on self-weighing frequency and weight change. Assessment will be conducted at 0, 2, and 6 months.	Behavioral: Appetite Awareness Treatment + Lifestyle Modification; The AAT + LM intervention includes 16 60-90 minute group sessions to enable participants to be able to relearn their stomach's hunger signals and begin to obey and monitor functions of satiety. 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.
No Intervention: Control Control group participants will receive no intervention in months 1-6, but will be offered the chance to receive an abbreviated form of AAT (4 weeks) following the 6-month assessment.

Outcome Measures

Primary Outcome Measures

1. Feasibility (Recruitment): Total Number of Participants Who Were Eligible and Enrolled in the Study [Month 6]

   Recruitment is defined as the number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.

2. Feasibility (Retention): Percentage of Participants Retained in the Study [Month 6]

   Percentage of participants retained in the study following enrollment through month 6

3. Feasibility (Attendance): Percentage of Sessions That Were Attended [Month 2]

   Each session attended by participants was captured. The number of sessions attended for each participant were summed and then divided by the number of total participants and multiplied by 100.

Secondary Outcome Measures

1. Median Weight Change From Baseline to Month 4 [Baseline, Month 4]

   Measured in Kg

2. Median Weight Change From Baseline to Month 6 [Baseline, Month 6]

   Measured in Kg

3. Mean Change in Binge Eating Scale Score From Baseline to Month 2 [Baseline, Month 2]

   This measure contains 16 questions that describe both behavioral and emotional manifestations of a binge episode. This scale was specifically developed to assess binge eating severity and associated emotional distress in individuals with overweight and obesity. The total score for the measure ranges from 0-46 points with higher scores indicating greater problems with binge eating and lower scores indicating better outcome.

4. Mean Change in Binge Eating Scale Score From Baseline to Month 6 [Baseline, Month 6]

   This measure contains 16 questions that describe both behavioral and emotional manifestations of a binge episode. This scale was specifically developed to assess binge eating severity and associated emotional distress in overweight and obese individuals. The total score for the measure ranges from 0-46 points with higher scores indicating greater problems with binge eating and lower scores indicating better outcome.

5. Mean Objective Binge Eating Episodes [up to 6 months]

   Participants were administered the interviewer-based overeating section of the Eating Disorder Examination (EDE) to assess objective binge eating episodes (OBE) (i.e., consumption of an objectively large amount of food and loss of control over eating) within the 28 days prior. Assessed at Baseline, Month 4, and Month 6.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

Individuals are eligible if they are:

• non-Latino Black women,

• over 18 years of age,

• have a BMI ≥ 25kg/m^2,

• use a Bluetooth-enabled smartphone,

• report at least one binge eating episode weekly, and

• complete the screening.

Exclusion Criteria:

Individuals will be excluded if they:

• are currently pregnant,

• are in substance abuse treatment,

• are involved in another weight reduction program,

• have a history of anorexia,

• are purging,

• are currently in treatment for eating difficulties,

• are concurrent intravenous drug users or consume >4 alcoholic beverages/day.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nutrition Research Institute	Kannapolis	North Carolina	United States	28081

Sponsors and Collaborators

• University of North Carolina, Chapel Hill
• National Institutes of Health (NIH)
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Rachel Goode, PhD, MPH, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 1, 2018

More Information

Publications

None provided.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT03531112
• Other Study ID Numbers: 18-0784; P30DK056350
• First Posted: May 21, 2018
• Last Update Posted: Dec 17, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Body Weight; Weight Loss; Weight Gain; Bulimia; Binge-Eating Disorder

Study Results

Participant Flow

Pre-assignment Detail	Study terminated prior to enrollment of control participants.

Arm/Group Title	Appetite Awareness Treatment + Lifestyle Modification	Control
Arm/Group Description	Appetite Awareness Treatment (AAT) + Lifestyle Modification (LM): The AAT + LM intervention includes 16 60-90 minute group sessions to enable participants to be able to relearn their stomach's hunger signals and begin to obey and monitor functions of satiety. 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.	Control group participants will receive no intervention in months 1-6, but will be offered the chance to receive an abbreviated form of AAT (4 weeks) following the 6-month assessment.
Period Title: Overall Study
STARTED	20	0
Month 4	17	0
Month 6 (Follow-Up)	13	0
COMPLETED	13	0
NOT COMPLETED	7	0

Baseline Characteristics

Arm/Group Title	Appetite Awareness Treatment + Lifestyle Modification	Control	Total
Arm/Group Description	Appetite Awareness Treatment + Lifestyle Modification: The AAT + LM intervention includes 16 60-90 minute group sessions to enable participants to be able to relearn their stomach's hunger signals and begin to obey and monitor functions of satiety. 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.	Control group participants will receive no intervention in months 1-6, but will be offered the chance to receive an abbreviated form of AAT (4 weeks) following the 6-month assessment.	Total of all reporting groups
Overall Participants	20	0	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.4 (13.8)	46.4 (13.8)
Sex: Female, Male (Count of Participants)
Female	20 100%	20 Infinity
Male	0 0%	0 NaN
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 NaN
Not Hispanic or Latino	20 100%	20 Infinity
Unknown or Not Reported	0 0%	0 NaN
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 NaN
Asian	0 0%	0 NaN
Native Hawaiian or Other Pacific Islander	0 0%	0 NaN
Black or African American	20 100%	20 Infinity
White	0 0%	0 NaN
More than one race	0 0%	0 NaN
Unknown or Not Reported	0 0%	0 NaN
Region of Enrollment (Count of Participants)
United States	20 100%	20 Infinity

Outcome Measures

1. Primary Outcome

Title	Feasibility (Recruitment): Total Number of Participants Who Were Eligible and Enrolled in the Study
Description	Recruitment is defined as the number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

Study terminated prior to enrollment of control participants. The number of potential participants screened for study eligibility

Arm/Group Title	Appetite Awareness Treatment + Lifestyle Modification	Control
Arm/Group Description	Appetite Awareness Treatment + Lifestyle Modification: The AAT + LM intervention includes 16 60-90 minute group sessions to enable participants to be able to relearn their stomach's hunger signals and begin to obey and monitor functions of satiety. 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.	Control group participants will receive no intervention in months 1-6, but will be offered the chance to receive an abbreviated form of AAT (4 weeks) following the 6-month assessment.
Measure Participants	30	0
Count of Participants [Participants]	20 100%

2. Primary Outcome

Title	Feasibility (Retention): Percentage of Participants Retained in the Study
Description	Percentage of participants retained in the study following enrollment through month 6
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

Study terminated prior to enrollment of control participants.

Arm/Group Title	Appetite Awareness Treatment + Lifestyle Modification	Control
Arm/Group Description	Appetite Awareness Treatment + Lifestyle Modification: The AAT + LM intervention includes 16 60-90 minute group sessions to enable participants to be able to relearn their stomach's hunger signals and begin to obey and monitor functions of satiety. 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.	Control group participants will receive no intervention in months 1-6, but will be offered the chance to receive an abbreviated form of AAT (4 weeks) following the 6-month assessment.
Measure Participants	20	0
Number [percentage of participants]	85 425%

3. Primary Outcome

Title	Feasibility (Attendance): Percentage of Sessions That Were Attended
Description	Each session attended by participants was captured. The number of sessions attended for each participant were summed and then divided by the number of total participants and multiplied by 100.
Time Frame	Month 2

Outcome Measure Data

Analysis Population Description

Study terminated prior to enrollment of control participants. Data not included for three participants who discontinued.

Arm/Group Title	Appetite Awareness Treatment + Lifestyle Modification	Control
Arm/Group Description	Appetite Awareness Treatment + Lifestyle Modification: The AAT + LM intervention includes 16 60-90 minute group sessions to enable participants to be able to relearn their stomach's hunger signals and begin to obey and monitor functions of satiety. 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.	Control group participants will receive no intervention in months 1-6, but will be offered the chance to receive an abbreviated form of AAT (4 weeks) following the 6-month assessment.
Measure Participants	17	0
Number [percentage of sessions per participant]	56

4. Secondary Outcome

Title	Median Weight Change From Baseline to Month 4
Description	Measured in Kg
Time Frame	Baseline, Month 4

Outcome Measure Data

Analysis Population Description

Study terminated prior to enrollment of control participants. Data not included for three participants who discontinued.

Arm/Group Title	Appetite Awareness Treatment + Lifestyle Modification	Control
Arm/Group Description	Appetite Awareness Treatment + Lifestyle Modification: The AAT + LM intervention includes 16 60-90 minute group sessions to enable participants to be able to relearn their stomach's hunger signals and begin to obey and monitor functions of satiety. 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.	Control group participants will receive no intervention in months 1-6, but will be offered the chance to receive an abbreviated form of AAT (4 weeks) following the 6-month assessment.
Measure Participants	17	0
Median (Inter-Quartile Range) [Kg]	0

5. Secondary Outcome

Title	Median Weight Change From Baseline to Month 6
Description	Measured in Kg
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Study terminated prior to enrollment of control participants. Data not included for seven participants who discontinued.

Arm/Group Title	Appetite Awareness Treatment + Lifestyle Modification	Control
Arm/Group Description	Appetite Awareness Treatment + Lifestyle Modification: The AAT + LM intervention includes 16 60-90 minute group sessions to enable participants to be able to relearn their stomach's hunger signals and begin to obey and monitor functions of satiety. 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.	Control group participants will receive no intervention in months 1-6, but will be offered the chance to receive an abbreviated form of AAT (4 weeks) following the 6-month assessment.
Measure Participants	13	0
Median (Inter-Quartile Range) [Kg]	-0.2

6. Secondary Outcome

Title	Mean Change in Binge Eating Scale Score From Baseline to Month 2
Description	This measure contains 16 questions that describe both behavioral and emotional manifestations of a binge episode. This scale was specifically developed to assess binge eating severity and associated emotional distress in individuals with overweight and obesity. The total score for the measure ranges from 0-46 points with higher scores indicating greater problems with binge eating and lower scores indicating better outcome.
Time Frame	Baseline, Month 2

Outcome Measure Data

Analysis Population Description

Data were not collected using the Binge Eating Scale and were instead collected using the Eating Disorder Examination

Arm/Group Title	Appetite Awareness Treatment + Lifestyle Modification	Control
Arm/Group Description	Appetite Awareness Treatment + Lifestyle Modification: The AAT + LM intervention includes 16 60-90 minute group sessions to enable participants to be able to relearn their stomach's hunger signals and begin to obey and monitor functions of satiety. 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.	Control group participants will receive no intervention in months 1-6, but will be offered the chance to receive an abbreviated form of AAT (4 weeks) following the 6-month assessment.
Measure Participants	0	0

7. Secondary Outcome

Title	Mean Change in Binge Eating Scale Score From Baseline to Month 6
Description	This measure contains 16 questions that describe both behavioral and emotional manifestations of a binge episode. This scale was specifically developed to assess binge eating severity and associated emotional distress in overweight and obese individuals. The total score for the measure ranges from 0-46 points with higher scores indicating greater problems with binge eating and lower scores indicating better outcome.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Data were not collected using the Binge Eating Scale and were instead collected using the Eating Disorder Examination

Arm/Group Title	Appetite Awareness Treatment + Lifestyle Modification	Control
Arm/Group Description	Appetite Awareness Treatment + Lifestyle Modification: The AAT + LM intervention includes 16 60-90 minute group sessions to enable participants to be able to relearn their stomach's hunger signals and begin to obey and monitor functions of satiety. 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.	Control group participants will receive no intervention in months 1-6, but will be offered the chance to receive an abbreviated form of AAT (4 weeks) following the 6-month assessment.
Measure Participants	0	0

8. Secondary Outcome

Title	Mean Objective Binge Eating Episodes
Description	Participants were administered the interviewer-based overeating section of the Eating Disorder Examination (EDE) to assess objective binge eating episodes (OBE) (i.e., consumption of an objectively large amount of food and loss of control over eating) within the 28 days prior. Assessed at Baseline, Month 4, and Month 6.
Time Frame	up to 6 months

Outcome Measure Data

Analysis Population Description

Study terminated prior to enrollment of control participants.

Arm/Group Title	Appetite Awareness Treatment + Lifestyle Modification	Control
Arm/Group Description	Appetite Awareness Treatment + Lifestyle Modification: The AAT + LM intervention includes 16 60-90 minute group sessions to enable participants to be able to relearn their stomach's hunger signals and begin to obey and monitor functions of satiety. 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.	Control group participants will receive no intervention in months 1-6, but will be offered the chance to receive an abbreviated form of AAT (4 weeks) following the 6-month assessment.
Measure Participants	17	0
Baseline	6.5 (7.8)
Month 4	2.1 (5.1)
Month 6	2.6 (6.9)

Adverse Events

Time Frame	From the time of Informed Consent through Visit 3, an approximate total of up to 6 months.
Adverse Event Reporting Description	Study terminated prior to enrollment of control participants.
Arm/Group Title	Appetite Awareness Treatment + Lifestyle Modification		Control
Arm/Group Description	Appetite Awareness Treatment + Lifestyle Modification: The AAT + LM intervention includes 16 60-90 minute group sessions to enable participants to be able to relearn their stomach's hunger signals and begin to obey and monitor functions of satiety. 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.		Control group participants will receive no intervention in months 1-6, but will be offered the chance to receive an abbreviated form of AAT (4 weeks) following the 6-month assessment.
All Cause Mortality
	Appetite Awareness Treatment + Lifestyle Modification		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/0 (NaN)
Serious Adverse Events
	Appetite Awareness Treatment + Lifestyle Modification		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Appetite Awareness Treatment + Lifestyle Modification		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.