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

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ClinicalTrials.gov Identifier: NCT03777189
Recruitment Status : Terminated (benefits of treatment less than expected)
First Posted : December 17, 2018
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
Binge-Eating Disorder Binge Eating Overweight and Obesity Behavioral: Cognitive-Behavioral Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cognitive-Behavioral and Physical Activity Interventions for Binge Eating and Overweight
Actual Study Start Date : December 5, 2018
Actual Primary Completion Date : June 3, 2019
Actual Study Completion Date : June 3, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. Binge-eating frequency [ Time Frame: Post-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).

  2. Body mass index [ Time Frame: Post-treatment (4 months) ]
    BMI is calculated using measured height and weight (e.g., percent loss)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03777189


Locations
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United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Carlos Grilo Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03777189     History of Changes
Other Study ID Numbers: 2000023412
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Body Weight
Signs and Symptoms
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive