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ClinicalTrials.gov Identifier: NCT04052529
Recruitment Status : Recruiting
First Posted : August 9, 2019
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Samantha Hahn, University of Michigan

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.


Condition or disease Intervention/treatment Phase
Mental Health Wellness 2 Health Behavior Eating Disorders Other: Dietary self-monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of Using Self-monitoring Smartphone Applications on College Students' Well-being
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Experimental: Intervention
Participants are instructed to use a popular dietary self-monitoring application on their smartphone for one month.
Other: Dietary self-monitoring
Participants use a popular smartphone application to track their food and drink intake for one month.

No Intervention: Control
Participants are not asked to use the smartphone application.



Primary Outcome Measures :
  1. Eating Disorder Risk [ Time Frame: 30 days ]
    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.

  2. Eating Disorder Risk [ Time Frame: 30 days ]
    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.


Secondary Outcome Measures :
  1. Weight-Related Self-Monitoring [ Time Frame: 30 days ]
    Measured via survey that includes single item measures asking about physical activity self-monitoring and self-weighing frequency.

  2. Body Image [ Time Frame: 30 days ]
    Assessed via survey using the validated 6 question Body Image States Scale (BISS). Scores are the mean of the six items, three of which are reverse coded. Higher scores mean better body image states.

  3. Weight Stigma [ Time Frame: 30 days ]
    Measured via survey using five single item questions.

  4. Dietary Intake [ Time Frame: 30 days ]
    Single item survey questions adapted from the Youth Risk Behavior Surveillance System

  5. Physical Activity [ Time Frame: 30 days ]
    Single item survey questions adapted from the Youth Risk Behavior Surveillance System and an open ended question for amount of time physically active.

  6. Weight perception [ Time Frame: 30 days ]
    Assessed using two questions on a survey pertaining to BMI category and weight.

  7. Body changing intentions [ Time Frame: 30 days ]
    Assessed using single item question on a survey asking how, if at all, participants wanted to change their body.

  8. Social Media Use [ Time Frame: 30 days ]
    Use of common social media sites assessed using five single item measures on a survey.

  9. Weight [ Time Frame: 30 days ]
    Blind weights taken on research grade laboratory scale.

  10. Subjective Quality of Life [ Time Frame: 30 days ]
    Assessed using the Brunnsviken Brief Quality of Life Scale (BBQ) on a survey. The BBQ has 12 questions, each ranging from 0-4. Higher scores indicate higher subjective quality of life.

  11. Anxiety [ Time Frame: 30 days ]
    State anxiety as measured via survey using the short-form of the state scale of the Spielberger State-Trait Anxiety Inventory. The scale consists of 6 questions with a range of scores 1-4 for each question. Three positive questions are reverse coded and scores are added together with higher scores indicating higher state anxiety.

  12. Depression Symptoms [ Time Frame: 30 days ]
    Measured via survey using the Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10). The CESD-R-10 is a 10 item scale with each question having the possibility of a score 0-3. Two questions are reverse coded, then scores from each question are added to give an overall score. Higher scores indicate more depressive symptoms.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Identify as female.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04052529


Contacts
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Contact: Samantha L Hahn, MPH, RD 5178984129 hahnsam@umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Samantha L Hahn, MPH, RD    517-898-4129    hahnsam@umich.edu   
Principal Investigator: Samantha L Hahn, MPH, RD         
Sub-Investigator: Kendrin R Sonneville, PhD, RD         
Sub-Investigator: Katherine W Bauer, PhD         
Sub-Investigator: Niko Kaciroti, PhD         
Sub-Investigator: Daniel Eisenberg, PhD         
Sponsors and Collaborators
University of Michigan

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Responsible Party: Samantha Hahn, PhD Candidate, University of Michigan
ClinicalTrials.gov Identifier: NCT04052529     History of Changes
Other Study ID Numbers: HUM00161687
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Feeding and Eating Disorders
Mental Disorders