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

NCT03777189 | Terminated

• 1 other identifier: 2000023412
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Binge-Eating Disorder; Binge Eating; Overweight and Obesity

Outcome Measures

Primary Outcomes (2)

• 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)

• Body mass index

  BMI is calculated using measured height and weight (e.g., percent loss)

  Post-treatment (4 months)

Study Arms (1)

Cognitive-Behavioral Therapy

EXPERIMENTAL

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.

Behavioral: Cognitive-Behavioral Therapy

Interventions

Cognitive-Behavioral Therapy BEHAVIORAL

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.

Cognitive-Behavioral Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Binge-Eating Disorder; Bulimia; Overweight; Obesity

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Carlos Grilo

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 17, 2018
• Study Start: December 5, 2018
• Primary Completion: June 3, 2019
• Study Completion: June 3, 2019
• Last Updated: October 10, 2019

Record last verified: 2019-10

Locations

US (1)