Health TrialsbyHealthPanel

Treating Binge Eating and Obesity Digitally in Women

ConditionsBinge EatingBinge-Eating DisorderWeight Gain PreventionObesity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of North Carolina, Chapel Hill

About this trial

More than 30% of Black women with obesity binge eat. Binge eating may increase the risk for the development of metabolic syndrome and binge-eating-disorder (BED), which is associated with severe obesity. Though several effective treatments for binge eating exist, Black women have not fared well. Not only has their inclusion in treatment trials been limited, but when participating, they are more likely to drop out, and/or lose less weight, compared to their White counterparts. Furthermore, treatment for binge eating is often not available in primary care and community-based settings places where Black women are more likely to receive treatment for their eating and weight-related concerns. Currently, there is scant intervention research to treat binge eating in Black women. With the highest rates of obesity (57%) nationally, Black women are in need of culturally-relevant treatments for binge eating and weight gain prevention. Given the established relationship between frequent binge eating and subsequent weight gain, addressing binge eating among Black women with obesity is imperative.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Over 18 years of age with pre-diabetes,

Have an (A1c between 5.7%-6.4%),

BMI ≥ 30 kg/m²,

have and regularly use a Bluetooth-enabled smartphone,

Disqualifiers

currently pregnant,

Are currently taking or have taken within the prior 3 months (12 weeks) a GLP-1,

in substance abuse treatment,

involved in another weight reduction program,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Centering Appetite

    Behavioral

    A digital treatment of Appetite Awareness Treatment (AAT) and behavioral weight loss treatment (BWL) over 6 months, delivered remotely using Zoom. The goal of 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Centering Appetite Intervention, Then Attention- Control GroupExperimental treatment 1 intervention
Group B: Attention- Control Group, Then Centering Appetite InterventionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Feasibility (Recruitment): Total Number of Eligible Adults Enrolled in the Study

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

Time frame
4 month
2

Retention: Percentage of Participants Retained in the Study

Percentage of eligible participants who were enrolled and retained in the study through the 6 months.

Time frame
6 months
3

Attendance: Percentage of Intervention Sessions Attended

Percentage of intervention sessions attended for the duration of the study by each participant.

Time frame
6 months

Secondary outcomes

1

Change from Baseline to Month 4 in weight regain

Participant body weight will be measured by trained research staff using calibrated digital scales, with participants in light indoor clothing, with pockets emptied and belts and shoes removed.

Time frame
Baseline, 4 months
2

Change from Baseline to Month 6 in weight regain

Participant body weight will be measured by trained research staff using calibrated digital scales, with participants in light indoor clothing, with pockets emptied and belts and shoes removed.

Time frame
Baseline, 6 months
3

Change in number of Binge Eating Episodes from Baseline to Month 4

Participant binge eating episodes will be self-monitored via the digital health tool.

Time frame
Baseline, 4 months
4

Change in number of Binge Eating Episodes from Baseline to Month 6

Participant binge eating episodes will be self-monitored via the digital health tool.

Time frame
Baseline, 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of North Carolina, Chapel Hill

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: