Mental Health Wellness 2NCT04052529
Tracking Our Lives Study
A study testing Dietary self-monitoring in people with Mental Health Wellness 2 and Health Behavior, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 2, Health Behavior, Eating Disorders
- What is being tested?
- Dietary self-monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2019to 1 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- University of Michigan Ann Arbor undergraduate student
- Daily access to a smartphone
- Female gender
- At least 18 years of age
- Fluent in English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Using Self-monitoring Smartphone Applications on College Students' Well-being
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.
- Conditions
- Mental Health Wellness 2, Health Behavior, Eating Disorders
- Being tested
- Dietary self-monitoring
- Medical subject headings
- Health Behavior, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary self-monitoringOther
Participants use a popular smartphone application to track their food and drink intake for one month.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants are instructed to use a popular dietary self-monitoring application on their smartphone for one month. Receives: Other: Dietary self-monitoring |
| Control | No intervention | Participants are not asked to use the smartphone application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 days
Secondary outcomes (12)
Weight-Related Self-Monitoring
Measured via survey that includes single item measures asking about physical activity self-monitoring and self-weighing frequency.
Measured: 30 days
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.
Measured: 30 days
Weight Stigma
Measured via survey using five single item questions.
Measured: 30 days
Dietary Intake
Single item survey questions adapted from the Youth Risk Behavior Surveillance System
Measured: 30 days
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.
Measured: 30 days
Weight perception
Assessed using two questions on a survey pertaining to BMI category and weight.
Measured: 30 days
Body changing intentions
Assessed using single item question on a survey asking how, if at all, participants wanted to change their body.
Measured: 30 days
Social Media Use
Use of common social media sites assessed using five single item measures on a survey.
Measured: 30 days
Weight
Blind weights taken on research grade laboratory scale.
Measured: 30 days
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.
Measured: 30 days
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.
Measured: 30 days
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start15 Mar 2019
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 2Studies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samantha Hahn, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052529
- Sponsor's protocol ID
- HUM00161687
- Status last verified
- Nov 2019
- First submitted
- 7 Aug 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34427188
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Using Self-monitoring Smartphone Applications on College Students' Well-being
- ClinicalTrials.gov ID
- NCT04052529
- Acronym / sponsor ID
- HUM00161687
- Conditions
- Mental Health Wellness 2, Health Behavior, Eating Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 9 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Dietary self-monitoringParticipants are instructed to use a popular dietary self-monitoring application on their smartphone for one month. |
| Control | No intervention | –Participants are not asked to use the smartphone application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- University of Michigan Ann Arbor undergraduate student
- Daily access to a smartphone
- Female gender
- At least 18 years of age
- Fluent in English
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary self-monitoringParticipants use a popular smartphone application to track their food and drink intake for one month. | Other | Intervention |
Primary outcome
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.
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.
12 secondary outcomes
Weight-Related Self-Monitoring
Time frame: 30 days
Body Image
Time frame: 30 days
Weight Stigma
Time frame: 30 days
Dietary Intake
Time frame: 30 days
Physical Activity
Time frame: 30 days
Weight perception
Time frame: 30 days
Body changing intentions
Time frame: 30 days
Social Media Use
Time frame: 30 days
Weight
Time frame: 30 days
Subjective Quality of Life
Time frame: 30 days
Anxiety
Time frame: 30 days
Depression Symptoms
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Derived from this study: PubMed 34427188Hahn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary self-monitoring in people with Mental Health Wellness 2 and Health Behavior, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Disorder Risk (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04052529, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.