Testing Intervention Strategies for Addressing Obesity and Binge Eating

March 28, 2023 updated by: Andrea Graham, Northwestern University

The purpose of this study is to conduct a randomized pilot trial of a mobile intervention that targets obesity and binge eating.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

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

United States
- Illinois
  - Chicago, Illinois, United States, 60611
    - Northwestern University

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Adults age 18 years or older
Obesity (BMI ≥30)
Recurrent binge eating (≥12 episodes in the past 3 months)
Interested in losing weight and reducing binge eating
Willing to use a mobile application
Has a smartphone with Internet access and capacity for calls and text messaging
Has a valid email address
Has access to a scale
Not pregnant
English-speaking

Exclusion Criteria:

Diagnosis for which the study/intervention is not clinically indicated
Not currently receiving clinical services for weight management or binge eating

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: Factorial Assignment
Masking: Single

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Condition 1 Behavioral weight loss intervention	Behavioral: Behavioral weight loss Participants will receive behavioral weight loss intervention
Experimental: Condition 2 Behavioral weight loss intervention and decrease negative affect	Behavioral: Behavioral weight loss Participants will receive behavioral weight loss intervention Behavioral: Intervention component: Decrease negative affect Participants will receive an intervention component to decrease negative affect
Experimental: Condition 3 Behavioral weight loss intervention and decrease unhealthy weight control practices	Behavioral: Behavioral weight loss Participants will receive behavioral weight loss intervention Behavioral: Intervention component: Decrease unhealthy weight control practices Participants will receive an intervention component to decrease unhealthy weight control practices
Experimental: Condition 4 Behavioral weight loss intervention, decrease unhealthy weight control practices, and decrease negative affect	Behavioral: Behavioral weight loss Participants will receive behavioral weight loss intervention Behavioral: Intervention component: Decrease negative affect Participants will receive an intervention component to decrease negative affect Behavioral: Intervention component: Decrease unhealthy weight control practices Participants will receive an intervention component to decrease unhealthy weight control practices
Experimental: Condition 5 Behavioral weight loss intervention and decrease overvaluation of weight and shape	Behavioral: Behavioral weight loss Participants will receive behavioral weight loss intervention Behavioral: Intervention component: Decrease overvaluation of weight and shape Participants will receive an intervention component to decrease overvaluation of weight and shape
Experimental: Condition 6 Behavioral weight loss intervention, decrease overvaluation of weight and shape, and decrease negative affect	Behavioral: Behavioral weight loss Participants will receive behavioral weight loss intervention Behavioral: Intervention component: Decrease negative affect Participants will receive an intervention component to decrease negative affect Behavioral: Intervention component: Decrease overvaluation of weight and shape Participants will receive an intervention component to decrease overvaluation of weight and shape
Experimental: Condition 7 Behavioral weight loss intervention, decrease overvaluation of weight and shape, and decrease unhealthy weight control practices	Behavioral: Behavioral weight loss Participants will receive behavioral weight loss intervention Behavioral: Intervention component: Decrease unhealthy weight control practices Participants will receive an intervention component to decrease unhealthy weight control practices Behavioral: Intervention component: Decrease overvaluation of weight and shape Participants will receive an intervention component to decrease overvaluation of weight and shape
Experimental: Condition 8 Behavioral weight loss intervention, decrease overvaluation of weight and shape, decrease unhealthy weight control practices, and decrease negative affect	Behavioral: Behavioral weight loss Participants will receive behavioral weight loss intervention Behavioral: Intervention component: Decrease negative affect Participants will receive an intervention component to decrease negative affect Behavioral: Intervention component: Decrease unhealthy weight control practices Participants will receive an intervention component to decrease unhealthy weight control practices Behavioral: Intervention component: Decrease overvaluation of weight and shape Participants will receive an intervention component to decrease overvaluation of weight and shape

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Time Frame: Measured at baseline, post-intervention (16-weeks), and 3-month follow-up	Changes in weight	Measured at baseline, post-intervention (16-weeks), and 3-month follow-up
Binge eating episodes Time Frame: Measured at baseline, post-intervention (16-weeks), and 3-month follow-up	Changes in episodes of binge eating	Measured at baseline, post-intervention (16-weeks), and 3-month follow-up

Collaborators and Investigators

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

Sponsor

Northwestern University

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)

February 16, 2021

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

February 16, 2021

First Submitted That Met QC Criteria

February 24, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Actual)

March 30, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

STU00208056

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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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Testing Intervention Strategies for Addressing Obesity and Binge Eating

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Obesity

Clinical Trials on Behavioral weight loss

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