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Cognitive-Behavioral and Physical Activity Interventions for Binge Eating and Overweight

Cognitive-Behavioral and Physical Activity Interventions for Binge Eating and Overweight

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03777189
Enrollment
4
Registered
2018-12-17
Start date
2018-12-05
Completion date
2019-06-03
Last updated
2019-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Binge Eating, Binge-Eating Disorder, Overweight and Obesity

Brief summary

This study aims to perform an open-series pilot trial to examine the efficacy of cognitive-behavioral therapy delivered in a guided self-help format (CBTgsh) with added content related to physical activity (PA), for the treatment of binge-eating disorder (BED), operationalized as BED full diagnostic criteria or BED with the full criteria except for the binge episode size criterion.

Interventions

BEHAVIORALCognitive-Behavioral Therapy

Cognitive-behavioral therapy will be delivered in line with recommendations (e.g., NICE 2017). Format will be guided self help with added content related to physical activity.

Sponsors

Yale University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. 18 to 65 years old; 2. Meet DSM-5 criteria for BED or BED but without the size criterion (LOC eating); 3. BMI 25-45 kg/m2; 4. Sedentary activity pattern (\< 90 mins/week of moderate-to-vigorous intensity recreational physical activity); 5. Available for the duration of the treatment and follow-up (7 months); 6. Read, comprehend, and write English at a sufficient level to complete study-related materials.

Exclusion criteria

1. Co-existing psychiatric condition that requires hospitalization or more intensive treatment (e.g., bipolar mood disorders, psychotic illnesses, severe depression). 2. Reports active suicidal or homicidal ideation. 3. Current anorexia or bulimia nervosa. 4. Contraindications to physical activity. 5. Blood pressure \>140 systolic or \>90 diastolic. 6. Breast-feeding or pregnant, or planning to become pregnant during the study. 7. History of stroke or myocardial infarction. 8. Current or recent (within 12 months) drug or alcohol dependence 9. Currently receiving effective treatment for eating or weight loss. 10. Currently participating in another clinical study.

Design outcomes

Primary

MeasureTime frameDescription
Binge-eating frequencyPost-treatment (4 months)Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
Body mass indexPost-treatment (4 months)BMI is calculated using measured height and weight (e.g., percent loss)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026