Overweight and Obesity Clinical Trial
— FA PilotOfficial title:
Behavioral Weight Loss Treatment for Individuals With Food Addiction
NCT number | NCT04311450 |
Other study ID # | 2000027229 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2021 |
Est. completion date | June 30, 2022 |
Verified date | October 2022 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | June 30, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Yale School of Medicine | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight (e.g., change in percent weight loss) | Up to 12 weeks | ||
Primary | Food addiction (change in food addiction scores) | 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 | Food Craving (change in food craving scores) | 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 |
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