Tracking Our Lives Study

Health Behavior Clinical Trial

Official title:

Impact of Using Self-monitoring Smartphone Applications on College Students' Well-being

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04052529
• Other study ID #: HUM00161687
• Status: Completed
• Phase: N/A
• Start date: March 15, 2019
• Est. completion date: November 1, 2019

Study information

• Verified date: November 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eating Disorders
• Feeding and Eating Disorders
• Health Behavior
• Mental Health Wellness 2

Intervention

Other:
• Dietary self-monitoring
Participants use a popular smartphone application to track their food and drink intake for one month.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Weight-Related Self-Monitoring	Measured via survey that includes single item measures asking about physical activity self-monitoring and self-weighing frequency.	30 days
Secondary	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.	30 days
Secondary	Weight Stigma	Measured via survey using five single item questions.	30 days
Secondary	Dietary Intake	Single item survey questions adapted from the Youth Risk Behavior Surveillance System	30 days
Secondary	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.	30 days
Secondary	Weight perception	Assessed using two questions on a survey pertaining to BMI category and weight.	30 days
Secondary	Body changing intentions	Assessed using single item question on a survey asking how, if at all, participants wanted to change their body.	30 days
Secondary	Social Media Use	Use of common social media sites assessed using five single item measures on a survey.	30 days
Secondary	Weight	Blind weights taken on research grade laboratory scale.	30 days
Secondary	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.	30 days
Secondary	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.	30 days
Secondary	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.	30 days