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

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03777189
• Other study ID #: 2000023412
• Status: Terminated
• Phase: N/A
• Start date: December 5, 2018
• Est. completion date: June 3, 2019

Study information

• Verified date: October 2019
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 3, 2019
• Est. primary completion date: June 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Binge Eating
• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Cognitive-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.

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binge-eating frequency	Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).	Post-treatment (4 months)
Primary	Body mass index	BMI is calculated using measured height and weight (e.g., percent loss)	Post-treatment (4 months)