- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04311450
Behavioral Weight Loss Treatment for Individuals With Food Addiction (FA Pilot)
October 24, 2022 updated by: Yale University
The purpose of this research study is to examine how well an existing weight loss treatment works for individuals with food addiction.
Treatment will consist of a preliminary 12-week RCT pilot of the feasibility and effectiveness of behavioral weight loss (BWL) compared to a waitlist control.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06520
- Yale School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI 25-50 kg/m2
- Meets criteria for Food Addiction (based on the self-report score from the Yale Food Addiction Scale)
- Available for the duration of the treatment (3 months)
- Read, comprehend, and write English at a sufficient level to complete study-related materials.
- Availability of internet to participate in study interventions (i.e., electronic SMART scales)
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
- Endorsing current or history of heart trouble/chest pain.
- 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, including individual who received bariatric surgery within the past five years
- Currently participating in another clinical study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Behavioral Weight Loss
Behavioral: Participants randomized assigned to this arm will received 12 weeks of Behavioral Weight Loss (BWL) counseling.
|
This therapy is a weekly treatment which focuses on making gradual and modest lifestyle changes with goals of establishing regular patterns of eating, setting weekly goals, decreasing caloric intake, developing coping skills, and increasing physical activity.
|
NO_INTERVENTION: Waitlist Control
Waitlist Control: Participants assigned to this arm will attend follow-up visits to control for the effect of time.
Following completion of post-treatment assessment participants in the waitlist control group will be offered an abbreviated BWL treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight (e.g., change in percent weight loss)
Time Frame: Up to 12 weeks
|
Up to 12 weeks
|
|
Food addiction (change in food addiction scores)
Time Frame: Up to 12 weeks
|
Yale Food Addiction Scale scores will be assessed by self-report (range of scores 0-7, higher score reflect greater food addiction symptoms)
|
Up to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Food Craving (change in food craving scores)
Time Frame: Up to 8 weeks
|
Food Craving Inventory scores will be assessed by self-report (range of score 0-185, higher scores reflect greater food cravings).
|
Up to 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 1, 2021
Primary Completion (ACTUAL)
June 30, 2022
Study Completion (ACTUAL)
June 30, 2022
Study Registration Dates
First Submitted
March 11, 2020
First Submitted That Met QC Criteria
March 16, 2020
First Posted (ACTUAL)
March 17, 2020
Study Record Updates
Last Update Posted (ACTUAL)
October 26, 2022
Last Update Submitted That Met QC Criteria
October 24, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000027229
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Weight Loss
-
United States Army Research Institute of Environmental...USDA Grand Forks Human Nutrition Research Center; Eastern Michigan UniversityCompletedWeight Loss | Bone Loss | Muscle LossUnited States
-
Case Comprehensive Cancer CenterUniversity Hospitals Seidman Cancer CenterRecruitingUnintentional Weight Loss and Cancer: A Prospective Trial of Patient-centered Weight Tracking CombinUnintended Weight LossUnited States
-
Zhen Jun WangUnknownSleeve Gastrectomy | Excessive Weight Loss | Total Weight Loss | Jejunojejunal Bypass | UncutChina
-
HealthPartners InstituteNational Cancer Institute (NCI)Completed
-
Dana-Farber Cancer InstituteCompletedWeight Loss Program After Cancer DiagnosisUnited States
-
Medical University of ViennaCompleted
-
Power Life Sciences Inc.Not yet recruitingGastric Bypass | Weight Loss Surgery
-
University at BuffaloHarvard Medical School (HMS and HSDM)TerminatedWeight Loss | Appetite LossUnited States
-
Duke UniversityNational Institute on Aging (NIA)Suspended
-
Drexel UniversityUniversity of PennsylvaniaCompletedObesity | Overweight | Weight Loss MaintenanceUnited States
Clinical Trials on Behavioral Weight Loss (BWL) counseling
-
University of PennsylvaniaNational Institute of Nursing Research (NINR)Recruiting
-
University of California, San DiegoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National... and other collaboratorsActive, not recruitingOverweight and ObesityUnited States
-
Virginia Commonwealth UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Virginia Commonwealth UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
University of California, San DiegoCompletedObesity | OverweightUnited States
-
University of PennsylvaniaNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
University of California, San DiegoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Stanford UniversityNational Institute of Mental Health (NIMH)Completed
-
Yale UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
University of California, San DiegoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National...CompletedObesity | OverweightUnited States