Reducing Binge Eating to Prevent Weight Gain in Black Women

NCT03531112 | Terminated Results

• 2 other identifiers: 18-0784P30DK056350
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Binge Eating; Weight Loss; Weight Gain Prevention

Outcome Measures

Primary Outcomes (3)

• Feasibility (Recruitment): Total Number of Participants Who Were Eligible and Enrolled in the Study

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

  Month 6

• Feasibility (Retention): Percentage of Participants Retained in the Study

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

  Month 6

• Feasibility (Attendance): Percentage of Sessions That Were Attended

  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.

  Month 2

Secondary Outcomes (5)

• Median Weight Change From Baseline to Month 4

  Baseline, Month 4

• Median Weight Change From Baseline to Month 6

  Baseline, Month 6

• Mean Change in Binge Eating Scale Score From Baseline to Month 2

  Baseline, Month 2

• Mean Change in Binge Eating Scale Score From Baseline to Month 6

  Baseline, Month 6

• Mean Objective Binge Eating Episodes

  up to 6 months

Study Arms (2)

Appetite Awareness Treatment (AAT) + Lifestyle Modification (LM)

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Appetite Awareness Treatment + Lifestyle Modification BEHAVIORAL

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.

Appetite Awareness Treatment (AAT) + Lifestyle Modification (LM)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: self-identify as a female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Nutrition Research Institute

Kannapolis, North Carolina, 28081, United States

Location

MeSH Terms

Conditions

Bulimia; Weight Loss

Condition Hierarchy (Ancestors)

Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Body Weight

Results Point of Contact

• Title: Rachel Goode, PhD
• Organization: University of North Carolina at Chapel Hill

rwgoode@email.unc.edu

919-962-6429

Study Officials

• Rachel Goode, PhD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: May 21, 2018
• Study Start: January 12, 2019
• Primary Completion: February 13, 2020
• Study Completion: February 13, 2020
• Last Updated: December 17, 2021
• Results First Posted: December 9, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)