NCT04771455

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Feb 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

February 16, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

February 16, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.8 years

First QC Date

February 16, 2021

Results QC Date

December 20, 2023

Last Update Submit

September 16, 2024

Conditions

ObesityBinge Eating

Outcome Measures

Primary Outcomes (2)

  • Weight

    Changes in weight

    Measured at baseline, post-intervention (16-weeks)

  • Binge Eating Episodes

    Changes in episodes of binge eating (past 28 days)

    Measured at baseline, post-intervention (16-weeks)

Study Arms (8)

Condition 1

EXPERIMENTAL

Behavioral weight loss intervention

Behavioral: Behavioral weight loss

Condition 2

EXPERIMENTAL

Behavioral weight loss intervention and decrease negative affect

Behavioral: Behavioral weight lossBehavioral: Intervention component: Decrease negative affect

Condition 3

EXPERIMENTAL

Behavioral weight loss intervention and decrease unhealthy weight control practices

Behavioral: Behavioral weight lossBehavioral: Intervention component: Decrease unhealthy weight control practices

Condition 4

EXPERIMENTAL

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

Behavioral: Behavioral weight lossBehavioral: Intervention component: Decrease unhealthy weight control practicesBehavioral: Intervention component: Decrease negative affect

Condition 5

EXPERIMENTAL

Behavioral weight loss intervention and decrease overvaluation of weight and shape

Behavioral: Behavioral weight lossBehavioral: Intervention component: Decrease overvaluation of weight and shape

Condition 6

EXPERIMENTAL

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

Behavioral: Behavioral weight lossBehavioral: Intervention component: Decrease overvaluation of weight and shapeBehavioral: Intervention component: Decrease negative affect

Condition 7

EXPERIMENTAL

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

Behavioral: Behavioral weight lossBehavioral: Intervention component: Decrease overvaluation of weight and shapeBehavioral: Intervention component: Decrease unhealthy weight control practices

Condition 8

EXPERIMENTAL

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

Behavioral: Behavioral weight lossBehavioral: Intervention component: Decrease overvaluation of weight and shapeBehavioral: Intervention component: Decrease unhealthy weight control practicesBehavioral: Intervention component: Decrease negative affect

Interventions

Behavioral weight lossBEHAVIORAL

Participants will receive behavioral weight loss intervention

Condition 1Condition 2Condition 3Condition 4Condition 5Condition 6Condition 7Condition 8
Intervention component: Decrease overvaluation of weight and shapeBEHAVIORAL

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

Condition 5Condition 6Condition 7Condition 8
Intervention component: Decrease unhealthy weight control practicesBEHAVIORAL

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

Condition 3Condition 4Condition 7Condition 8
Intervention component: Decrease negative affectBEHAVIORAL

Participants will receive an intervention component to decrease negative affect

Condition 2Condition 4Condition 6Condition 8

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

ObesityBulimia

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperphagiaSigns and Symptoms, Digestive

Results Point of Contact

Title
Dr. Andrea Graham
Organization
Northwestern University
andrea.graham@northwestern.edu
312-503-5266

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 16, 2021

First Posted

February 25, 2021

Study Start

February 16, 2021

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

September 19, 2024

Results First Posted

September 19, 2024

Record last verified: 2024-09

Locations

US(1)