Clinical trial NCT03531112: Reducing Binge Eating to Prevent Weight Gain in Black Women
Official title: Reducing Binge Eating to Prevent Weight Gain in Black Women: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Binge Eating
Weight Loss
Weight Gain Prevention
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-05-21
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility (Recruitment): Total Number of Participants Who Were Eligible and Enrolled in the Study
timeFrame: Month 6
measure: Feasibility (Retention): Percentage of Participants Retained in the Study
timeFrame: Month 6
measure: Feasibility (Attendance): Percentage of Sessions That Were Attended
timeFrame: Month 2
Secondary outcomes:
measure: Median Weight Change From Baseline to Month 4
timeFrame: Baseline, Month 4
measure: Median Weight Change From Baseline to Month 6
timeFrame: Baseline, Month 6
measure: Mean Change in Binge Eating Scale Score From Baseline to Month 2
timeFrame: Baseline, Month 2
measure: Mean Change in Binge Eating Scale Score From Baseline to Month 6
timeFrame: Baseline, Month 6
measure: Mean Objective Binge Eating Episodes
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Kannapolis
country: United States
facility: Nutrition Research Institute
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Rachel Goode, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: