Testing Intervention Strategies for Addressing Obesity and Binge Eating

• Sponsor: Northwestern University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04771455
• Collaborator: (none)
• Enrollment: 81
• Location: 1
• Arms: 8
• Anticipated Duration (Months): 22.4
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obesity; Binge Eating	Behavioral: Behavioral weight loss; Behavioral: Intervention component: Decrease overvaluation of weight and shape; Behavioral: Intervention component: Decrease unhealthy weight control practices; Behavioral: Intervention component: Decrease negative affect	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 81 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Testing Intervention Strategies for Addressing Obesity and Binge Eating
• Actual Study Start Date: Feb 16, 2021
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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 unhealthy weight control practices; Participants will receive an intervention component to decrease unhealthy weight control practices; Behavioral: Intervention component: Decrease negative affect; Participants will receive an intervention component to decrease negative affect
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 overvaluation of weight and shape; Participants will receive an intervention component to decrease overvaluation of weight and shape; Behavioral: Intervention component: Decrease negative affect; Participants will receive an intervention component to decrease negative affect
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 overvaluation of weight and shape; Participants will receive an intervention component to decrease overvaluation of weight and shape; Behavioral: Intervention component: Decrease unhealthy weight control practices; Participants will receive an intervention component to decrease unhealthy weight control practices
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 overvaluation of weight and shape; Participants will receive an intervention component to decrease overvaluation of weight and shape; Behavioral: Intervention component: Decrease unhealthy weight control practices; Participants will receive an intervention component to decrease unhealthy weight control practices; Behavioral: Intervention component: Decrease negative affect; Participants will receive an intervention component to decrease negative affect

Outcome Measures

Primary Outcome Measures

1. Weight [Measured at baseline, post-intervention (16-weeks), and 3-month follow-up]

   Changes in weight

2. Binge eating episodes [Measured at baseline, post-intervention (16-weeks), and 3-month follow-up]

   Changes in episodes of binge eating

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andrea Graham, Assistant Professor, Northwestern University
• ClinicalTrials.gov Identifier: NCT04771455
• Other Study ID Numbers: STU00208056
• First Posted: Feb 25, 2021
• Last Update Posted: Jul 7, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obesity; Bulimia; Binge-Eating Disorder

Study Results

No Results Posted as of Jul 7, 2022