Behavioral Weight Loss Treatment for Individuals With Food Addiction

Not Applicable

Completed

• Conditions: Food Addiction; Weight Loss; Overweight and Obesity
• Interventions: Behavioral: Behavioral Weight Loss (BWL) counseling

• Registration Number: NCT04311450
• Lead Sponsor: Yale University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-11
• Study First Submitted QC: 2020-03-16
• Study First Posted: 2020-03-17
• Study Start: 2021-03-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Behavioral Weight Loss	Behavioral Weight Loss (BWL) counseling	Behavioral: Participants randomized assigned to this arm will received 12 weeks of Behavioral Weight Loss (BWL) counseling.

Primary Outcome Measures

Name	Time	Method
Weight (e.g., change in percent weight loss)	Up to 12 weeks
Food addiction (change in food addiction scores)	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)

Secondary Outcome Measures

Name	Time	Method
Food Craving (change in food craving scores)	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).

Trial Locations

Locations (1)

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States