NCT04711577

Brief Summary

The purpose of this study is to understand users' experiences and interests completing self-tracking in a mobile intervention for binge eating and weight management.

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 obesity

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable obesity

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

Study Start

First participant enrolled

January 8, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2021

Completed
Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

1 month

First QC Date

January 13, 2021

Last Update Submit

February 25, 2021

Conditions

ObesityBinge Eating

Outcome Measures

Primary Outcomes (2)

  • Compliance

    Number of tracking entries completed

    3 weeks

  • Satisfaction with tracking

    Self-reported satisfaction with tracking, based on the Satisfaction subscale of the Usefulness, Satisfaction, and Ease of use (USE) Questionnaire, with higher scores on the 1-7 rating scale indicating greater satisfaction

    3 weeks

Study Arms (2)

Condition 1

EXPERIMENTAL

Track clinician-determined symptoms

Behavioral: Track clinician-determined symptoms

Condition 2

EXPERIMENTAL

Track clinician-determined and self-determined symptoms

Behavioral: Track clinician-determined and self-determined symptoms

Interventions

Track clinician-determined symptomsBEHAVIORAL

Participants will track clinician-determined symptoms

Condition 1
Track clinician-determined and self-determined symptomsBEHAVIORAL

Participants will track clinician-determined symptoms and a self-determined symptom

Condition 2

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
  • Willing to practice self-monitoring
  • Has access to a scale
  • Not pregnant
  • English-speaking

You may not qualify if:

  • None

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 13, 2021

First Posted

January 15, 2021

Study Start

January 8, 2021

Primary Completion

February 11, 2021

Study Completion

February 11, 2021

Last Updated

February 26, 2021

Record last verified: 2021-02

Locations

US(1)