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

Primary Purpose

Binge-Eating Disorder, Binge Eating, Overweight and Obesity

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive-Behavioral Therapy
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge-Eating Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yale School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive-Behavioral Therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 13, 2018
Last Updated
October 9, 2019
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT03777189
Brief Title
Cognitive-Behavioral and Physical Activity Interventions for Binge Eating and Overweight
Official Title
Cognitive-Behavioral and Physical Activity Interventions for Binge Eating and Overweight
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
benefits of treatment less than expected
Study Start Date
December 5, 2018 (Actual)
Primary Completion Date
June 3, 2019 (Actual)
Study Completion Date
June 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge-Eating Disorder, Binge Eating, Overweight and Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive-Behavioral Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Binge-eating frequency
Description
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
Time Frame
Post-treatment (4 months)
Title
Body mass index
Description
BMI is calculated using measured height and weight (e.g., percent loss)
Time Frame
Post-treatment (4 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 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. Exclusion criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Grilo
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

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

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