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Testing Intervention Strategies for Addressing Obesity and Binge Eating

Primary Purpose

Obesity, Binge Eating

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Behavioral weight loss

Intervention component: Decrease overvaluation of weight and shape

Intervention component: Decrease unhealthy weight control practices

Intervention component: Decrease negative affect

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

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

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

Sites / Locations

Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Arm Label

Condition 1

Condition 2

Condition 3

Condition 4

Condition 5

Condition 6

Condition 7

Condition 8

Arm Description

Behavioral weight loss intervention

Behavioral weight loss intervention and decrease negative affect

Behavioral weight loss intervention and decrease unhealthy weight control practices

Behavioral weight loss intervention, decrease unhealthy weight control practices, and decrease negative affect

Behavioral weight loss intervention and decrease overvaluation of weight and shape

Behavioral weight loss intervention, decrease overvaluation of weight and shape, and decrease negative affect

Behavioral weight loss intervention, decrease overvaluation of weight and shape, and decrease unhealthy weight control practices

Behavioral weight loss intervention, decrease overvaluation of weight and shape, decrease unhealthy weight control practices, and decrease negative affect

Outcomes

Primary Outcome Measures

Weight

Changes in weight

Binge eating episodes

Changes in episodes of binge eating

Secondary Outcome Measures

Full Information

NCT ID

NCT04771455

First Posted

February 16, 2021

Last Updated

March 28, 2023

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT04771455

Brief Title

Testing Intervention Strategies for Addressing Obesity and Binge Eating

Official Title

Testing Intervention Strategies for Addressing Obesity and Binge Eating

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

February 16, 2021 (Actual)

Primary Completion Date

November 30, 2022 (Actual)

Study Completion Date

November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Binge Eating

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

Participant

Allocation

Randomized

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Condition 1

Arm Type

Experimental

Arm Description

Behavioral weight loss intervention

Arm Title

Condition 2

Arm Type

Experimental

Arm Description

Behavioral weight loss intervention and decrease negative affect

Arm Title

Condition 3

Arm Type

Experimental

Arm Description

Behavioral weight loss intervention and decrease unhealthy weight control practices

Arm Title

Condition 4

Arm Type

Experimental

Arm Description

Behavioral weight loss intervention, decrease unhealthy weight control practices, and decrease negative affect

Arm Title

Condition 5

Arm Type

Experimental

Arm Description

Behavioral weight loss intervention and decrease overvaluation of weight and shape

Arm Title

Condition 6

Arm Type

Experimental

Arm Description

Behavioral weight loss intervention, decrease overvaluation of weight and shape, and decrease negative affect

Arm Title

Condition 7

Arm Type

Experimental

Arm Description

Behavioral weight loss intervention, decrease overvaluation of weight and shape, and decrease unhealthy weight control practices

Arm Title

Condition 8

Arm Type

Experimental

Arm Description

Behavioral weight loss intervention, decrease overvaluation of weight and shape, decrease unhealthy weight control practices, and decrease negative affect

Intervention Type

Behavioral

Intervention Name(s)

Behavioral weight loss

Intervention Description

Participants will receive behavioral weight loss intervention

Intervention Type

Behavioral

Intervention Name(s)

Intervention component: Decrease overvaluation of weight and shape

Intervention Description

Participants will receive an intervention component to decrease overvaluation of weight and shape

Intervention Type

Behavioral

Intervention Name(s)

Intervention component: Decrease unhealthy weight control practices

Intervention Description

Participants will receive an intervention component to decrease unhealthy weight control practices

Intervention Type

Behavioral

Intervention Name(s)

Intervention component: Decrease negative affect

Intervention Description

Participants will receive an intervention component to decrease negative affect

Primary Outcome Measure Information:

Title

Weight

Description

Changes in weight

Time Frame

Measured at baseline, post-intervention (16-weeks), and 3-month follow-up

Title

Binge eating episodes

Description

Changes in episodes of binge eating

Time Frame

Measured at baseline, post-intervention (16-weeks), and 3-month follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Testing Intervention Strategies for Addressing Obesity and Binge Eating

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