- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04052529
Tracking Our Lives Study
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.
Studienübersicht
Status
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Michigan
-
Ann Arbor, Michigan, Vereinigte Staaten, 48109
- University of Michigan
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Intervention
Participants are instructed to use a popular dietary self-monitoring application on their smartphone for one month.
|
Participants use a popular smartphone application to track their food and drink intake for one month.
|
|
Kein Eingriff: Control
Participants are not asked to use the smartphone application.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Eating Disorder Risk
Zeitfenster: 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.
|
30 days
|
|
Eating Disorder Risk
Zeitfenster: 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.
|
30 days
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Weight-Related Self-Monitoring
Zeitfenster: 30 days
|
Measured via survey that includes single item measures asking about physical activity self-monitoring and self-weighing frequency.
|
30 days
|
|
Body Image
Zeitfenster: 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.
|
30 days
|
|
Weight Stigma
Zeitfenster: 30 days
|
Measured via survey using five single item questions.
|
30 days
|
|
Dietary Intake
Zeitfenster: 30 days
|
Single item survey questions adapted from the Youth Risk Behavior Surveillance System
|
30 days
|
|
Physical Activity
Zeitfenster: 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.
|
30 days
|
|
Weight perception
Zeitfenster: 30 days
|
Assessed using two questions on a survey pertaining to BMI category and weight.
|
30 days
|
|
Body changing intentions
Zeitfenster: 30 days
|
Assessed using single item question on a survey asking how, if at all, participants wanted to change their body.
|
30 days
|
|
Social Media Use
Zeitfenster: 30 days
|
Use of common social media sites assessed using five single item measures on a survey.
|
30 days
|
|
Weight
Zeitfenster: 30 days
|
Blind weights taken on research grade laboratory scale.
|
30 days
|
|
Subjective Quality of Life
Zeitfenster: 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.
|
30 days
|
|
Anxiety
Zeitfenster: 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.
|
30 days
|
|
Depression Symptoms
Zeitfenster: 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.
|
30 days
|
Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- HUM00161687
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .