NCT04052529

Brief Summary

College women are at risk for eating disorders, which have profound health impacts. Cross-sectional studies have shown that the use of dietary self-monitoring is associated with eating disorder risk among college students. However, causality cannot be established with cross-sectional studies. This study utilizes a randomized controlled trial design to examine how the use of a popular dietary self-monitoring smartphone application impacts college females' well-being, including eating disorder risk. We hypothesize those who are randomized to dietary self-monitoring will have a greater increase in eating disorder risk compared to the control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

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

March 15, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

November 5, 2019

Status Verified

November 1, 2019

Enrollment Period

8 months

First QC Date

August 7, 2019

Last Update Submit

November 4, 2019

Conditions

Mental Health Wellness 2Health BehaviorEating Disorders

Outcome Measures

Primary Outcomes (2)

  • Eating Disorder Risk

    Eating disorder risk will be measured on a survey via the Eating Disorder Examination Questionnaire Short Form (EDE-QS). The EDE-QS is a validated 12 question scale. Each question has a score range 0-3, and the average of all scores is the overall score. A higher score indicates higher risk.

    30 days

  • Eating Disorder Risk

    Measured via survey using the validated SCOFF questionnaire which consists of five questions. Each question is a yes/no and a yes receives one point with a total score ranging from 0-5. Higher scores indicate higher risk. Modified to ask about pounds instead of stone as a measure of weight.

    30 days

Secondary Outcomes (12)

  • Weight-Related Self-Monitoring

    30 days

  • Body Image

    30 days

  • Weight Stigma

    30 days

  • Dietary Intake

    30 days

  • Physical Activity

    30 days

  • +7 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Participants are instructed to use a popular dietary self-monitoring application on their smartphone for one month.

Other: Dietary self-monitoring

Control

NO INTERVENTION

Participants are not asked to use the smartphone application.

Interventions

Dietary self-monitoringOTHER

Participants use a popular smartphone application to track their food and drink intake for one month.

Intervention

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsIdentify as female.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • University of Michigan Ann Arbor undergraduate student
  • Daily access to a smartphone
  • Female gender
  • At least 18 years of age
  • Fluent in English

You may not qualify if:

  • Self-reported history of any medical condition that impacts the types or amount of food eaten
  • Self-reported recent use of dietary self-monitoring
  • Self-reported history of an active or past eating disorder
  • Eating Disorder Examination Questionnaire Short Form (EDE-QS) score ≥ 2, indicating high eating disorder risk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • Hahn SL, Kaciroti N, Eisenberg D, Weeks HM, Bauer KW, Sonneville KR. Introducing Dietary Self-Monitoring to Undergraduate Women via a Calorie Counting App Has No Effect on Mental Health or Health Behaviors: Results From a Randomized Controlled Trial. J Acad Nutr Diet. 2021 Dec;121(12):2377-2388. doi: 10.1016/j.jand.2021.06.311. Epub 2021 Aug 20.

    PMID: 34427188DERIVED

MeSH Terms

Conditions

Health BehaviorFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

BehaviorSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

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
PhD Candidate

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 9, 2019

Study Start

March 15, 2019

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

November 5, 2019

Record last verified: 2019-11

Locations

US(1)