Behavioral Weight Loss Treatment for Individuals With Food Addiction

Overweight and Obesity Clinical Trial

— FA Pilot  

Official title:

Behavioral Weight Loss Treatment for Individuals With Food Addiction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04311450
• Other study ID #: 2000027229
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Behavior, Addictive
• Body Weight
• Food Addiction
• Overweight
• Overweight and Obesity
• Weight Loss

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