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

Primary Purpose

Food Addiction, Overweight and Obesity, Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Weight Loss (BWL) counseling
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Food Addiction

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yale School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Behavioral Weight Loss

Waitlist Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

Full Information

First Posted
March 11, 2020
Last Updated
October 24, 2022
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT04311450
Brief Title
Behavioral Weight Loss Treatment for Individuals With Food Addiction
Acronym
FA Pilot
Official Title
Behavioral Weight Loss Treatment for Individuals With Food Addiction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Addiction, Overweight and Obesity, Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Weight Loss
Arm Type
Experimental
Arm Description
Behavioral: Participants randomized assigned to this arm will received 12 weeks of Behavioral Weight Loss (BWL) counseling.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Weight Loss (BWL) counseling
Intervention Description
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 Outcome Measure Information:
Title
Weight (e.g., change in percent weight loss)
Time Frame
Up to 12 weeks
Title
Food addiction (change in food addiction scores)
Description
Yale Food Addiction Scale scores will be assessed by self-report (range of scores 0-7, higher score reflect greater food addiction symptoms)
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Food Craving (change in food craving scores)
Description
Food Craving Inventory scores will be assessed by self-report (range of score 0-185, higher scores reflect greater food cravings).
Time Frame
Up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States

12. IPD Sharing Statement

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Behavioral Weight Loss Treatment for Individuals With Food Addiction

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