NCT04311450

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

1.3 years

First QC Date

March 11, 2020

Last Update Submit

October 24, 2022

Conditions

Food AddictionOverweight and ObesityWeight Loss

Outcome Measures

Primary Outcomes (2)

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

    Up to 12 weeks

  • 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)

    Up to 12 weeks

Secondary Outcomes (1)

  • Food Craving (change in food craving scores)

    Up to 8 weeks

Study Arms (2)

Behavioral Weight Loss

EXPERIMENTAL

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

Behavioral: Behavioral Weight Loss (BWL) counseling

Waitlist Control

NO INTERVENTION

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.

Interventions

Behavioral Weight Loss (BWL) counselingBEHAVIORAL

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.

Behavioral Weight Loss

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Food AddictionOverweightObesityWeight Loss

Interventions

Counseling

Condition Hierarchy (Ancestors)

Behavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehaviorFeeding and Eating DisordersMental DisordersOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2020

First Posted

March 17, 2020

Study Start

March 1, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

October 26, 2022

Record last verified: 2022-10

Locations

US(1)