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Clinical Trials/NCT04311450
NCT04311450CompletedNot Applicable

Behavioral Weight Loss Treatment for Individuals With Food Addiction

Yale University2 sites in 1 country50 target enrollmentStarted: March 1, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
2
Primary Endpoint
Weight (e.g., change in percent weight loss)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

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)(Up to 8 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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