Behavioral Weight Loss Treatment for Individuals With Food Addiction (FA Pilot)

October 24, 2022 updated by: Yale University
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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Behavioral Weight Loss
Behavioral: Participants randomized assigned to this arm will received 12 weeks of 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.
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight (e.g., change in percent weight loss)
Time Frame: Up to 12 weeks
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)
Up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2021

Primary Completion (ACTUAL)

June 30, 2022

Study Completion (ACTUAL)

June 30, 2022

Study Registration Dates

First Submitted

March 11, 2020

First Submitted That Met QC Criteria

March 16, 2020

First Posted (ACTUAL)

March 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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