Behavioral Weight Loss Treatment for Individuals With Food Addiction

NCT ID: NCT04311450

Last Updated: 2022-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-06-30

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.

Conditions

Food Addiction; Overweight and Obesity; Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Behavioral Weight Loss

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

Group Type: EXPERIMENTAL

Behavioral Weight Loss (BWL) counseling

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yale School of Medicine

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

2000027229

Identifier Type: -

Identifier Source: org_study_id