Behavioral Weight Loss Treatment for Individuals With Food Addiction

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.

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Key information

Conditions

Food Addiction Behavior Behavior, Addictive Body Weight Body Weight Changes Compulsive Behavior Feeding and Eating Disorders Impulsive Behavior Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavioral Weight Loss (BWL) counseling

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.

Primary outcomes

Weight (e.g., change in percent weight loss)

Time frame: Up to 12 weeks
Food addiction (change in food addiction scores)

Time frame: 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 outcomes

Food Craving (change in food craving scores)

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Acronym: FA Pilot

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Mar 17, 2020
Registry last updated: Oct 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed