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Tracking Our Lives Study

Primary Purpose

Mental Health Wellness 2, Health Behavior, Eating Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary self-monitoring
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mental Health Wellness 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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

Participants are not asked to use the smartphone application.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Weight-Related Self-Monitoring
Measured via survey that includes single item measures asking about physical activity self-monitoring and self-weighing frequency.
Body Image
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.
Weight Stigma
Measured via survey using five single item questions.
Dietary Intake
Single item survey questions adapted from the Youth Risk Behavior Surveillance System
Physical Activity
Single item survey questions adapted from the Youth Risk Behavior Surveillance System and an open ended question for amount of time physically active.
Weight perception
Assessed using two questions on a survey pertaining to BMI category and weight.
Body changing intentions
Assessed using single item question on a survey asking how, if at all, participants wanted to change their body.
Social Media Use
Use of common social media sites assessed using five single item measures on a survey.
Weight
Blind weights taken on research grade laboratory scale.
Subjective Quality of Life
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.
Anxiety
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.
Depression Symptoms
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.

Full Information

First Posted
August 7, 2019
Last Updated
November 4, 2019
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT04052529
Brief Title
Tracking Our Lives Study
Official Title
Impact of Using Self-monitoring Smartphone Applications on College Students' Well-being
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Wellness 2, Health Behavior, Eating Disorders

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants are instructed to use a popular dietary self-monitoring application on their smartphone for one month.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants are not asked to use the smartphone application.
Intervention Type
Other
Intervention Name(s)
Dietary self-monitoring
Intervention Description
Participants use a popular smartphone application to track their food and drink intake for one month.
Primary Outcome Measure Information:
Title
Eating Disorder Risk
Description
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.
Time Frame
30 days
Title
Eating Disorder Risk
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Weight-Related Self-Monitoring
Description
Measured via survey that includes single item measures asking about physical activity self-monitoring and self-weighing frequency.
Time Frame
30 days
Title
Body Image
Description
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.
Time Frame
30 days
Title
Weight Stigma
Description
Measured via survey using five single item questions.
Time Frame
30 days
Title
Dietary Intake
Description
Single item survey questions adapted from the Youth Risk Behavior Surveillance System
Time Frame
30 days
Title
Physical Activity
Description
Single item survey questions adapted from the Youth Risk Behavior Surveillance System and an open ended question for amount of time physically active.
Time Frame
30 days
Title
Weight perception
Description
Assessed using two questions on a survey pertaining to BMI category and weight.
Time Frame
30 days
Title
Body changing intentions
Description
Assessed using single item question on a survey asking how, if at all, participants wanted to change their body.
Time Frame
30 days
Title
Social Media Use
Description
Use of common social media sites assessed using five single item measures on a survey.
Time Frame
30 days
Title
Weight
Description
Blind weights taken on research grade laboratory scale.
Time Frame
30 days
Title
Subjective Quality of Life
Description
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.
Time Frame
30 days
Title
Anxiety
Description
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.
Time Frame
30 days
Title
Depression Symptoms
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Identify as female.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34427188
Citation
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.
Results Reference
derived

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Tracking Our Lives Study

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