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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date October 2022
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Intervention

Behavioral:
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.

Locations

Country Name City State
United States Yale School of Medicine New Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

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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