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Trial record 89 of 592 for:    binge eating disorder

Reducing Binge Eating to Prevent Weight Gain in Black Women

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ClinicalTrials.gov Identifier: NCT03531112
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : February 28, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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/m² 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. We 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 Not Applicable

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/m²) 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 2 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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.
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 : January 12, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Appetite Awareness Treatment
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
The goal of Appetite Awareness Treatment (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 Binge Eating Disorder (BED) and bulimia nervosa reduce binge eating, overeating, urges to eat in response to non-appetite stimuli, and prevent weight gain. 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.

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.



Primary Outcome Measures :
  1. Feasibility (Recruitment): Total number of participants who were eligible and enrolled in the study [ Time Frame: Month 6 ]
    Total number of participants who were eligible and enrolled in the study

  2. Feasibility (Retention): Percentage of participants retained in the study [ Time Frame: Month 6 ]
    Percentage of participants retained in the study following enrollment through month 6

  3. Feasibility (Attendance): Percentage of sessions that were attended [ Time Frame: Month 2 ]
    Percentage of sessions that were attended


Secondary Outcome Measures :
  1. Percent weight change from Baseline to Month 2 [ Time Frame: Baseline, Month 2 ]
    Measured in Kg

  2. Percent weight change from Baseline to Month 6 [ Time Frame: Baseline, Month 6 ]
    Measured in Kg

  3. Mean Change in Binge Eating Scale Score from Baseline to Month 2 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   self-identify as a female
Accepts Healthy Volunteers:   Yes
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531112


Contacts
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Contact: Rachel W. Goode, PhD, MPH 919-962-6429 rwgoode@email.unc.edu

Locations
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United States, North Carolina
Nutrition Research Institute Recruiting
Kannapolis, North Carolina, United States, 28081
Contact: Jomari Torres, MD    704-250-5062      
Principal Investigator: Rachel W. Goode, PhD, MPH         
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
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Principal Investigator: Rachel Goode, PhD, MPH University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03531112     History of Changes
Other Study ID Numbers: 18-0784
P30DK056350 ( U.S. NIH Grant/Contract )
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Bulimia
Binge-Eating Disorder
Feeding and Eating Disorders
Mental Disorders
Body Weight
Weight Loss
Weight Gain
Signs and Symptoms
Body Weight Changes
Hyperphagia
Signs and Symptoms, Digestive