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Binge EatingNCT03531112

Reducing Binge Eating to Prevent Weight Gain in Black Women

A study testing Appetite Awareness Treatment + Lifestyle Modification in people with Binge Eating and Weight Loss, run by University of North Carolina, Chapel Hill at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Binge Eating, Weight Loss, Weight Gain Prevention
What is being tested?
Appetite Awareness Treatment + Lifestyle Modification
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
12 Jan 2019to 13 Feb 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Nutrition Research Institute

    Kannapolis, North Carolina, 28081

Other trials in United States

About this study

Official title: Reducing Binge Eating to Prevent Weight Gain in Black Women: A Pilot Study

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.

Read the 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.

Being tested
Appetite Awareness Treatment + Lifestyle Modification
Medical subject headings
Bulimia, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Appetite Awareness Treatment + Lifestyle ModificationBehavioural

    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.

Study groups in NCT03531112
Study groupRoleWhat they receive
Appetite Awareness Treatment (AAT) + Lifestyle Modification (LM)ExperimentalParticipants 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.
Receives: Behavioral: Appetite Awareness Treatment + Lifestyle Modification
ControlNo interventionControl 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Month 6

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

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

    Measured: Month 6

  3. 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.

    Measured: Month 2

Secondary outcomes (5)

  1. Median Weight Change From Baseline to Month 4

    Measured in Kg

    Measured: Baseline, Month 4

  2. Median Weight Change From Baseline to Month 6

    Measured in Kg

    Measured: Baseline, Month 6

  3. Mean Change in Binge Eating Scale Score From Baseline to 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.

    Measured: Baseline, Month 2

  4. Mean Change in Binge Eating Scale Score From Baseline to 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.

    Measured: Baseline, Month 6

  5. Mean Objective Binge Eating Episodes

    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.

    Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2018
  2. Study start12 Jan 2019
  3. Primary completion13 Feb 2020
  4. Study completion13 Feb 2020

Why it stopped: Study terminated due to COVID-19

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03531112
Sponsor's protocol ID
18-0784
Other IDs
P30DK056350
Status last verified
Jul 2021
First submitted
8 May 2018
Last updated
17 Dec 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Appetite Awareness Treatment + Lifestyle Modification in people with Binge Eating and Weight Loss, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility (Recruitment): Total Number of Participants Who Were Eligible and Enrolled in the Study (time frame: Month 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03531112.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.

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