- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02868853
Self-Monitoring Assessment in Real Time (2-SMART)
15. april 2019 opdateret af: Brie Turner-McGrievy, University of South Carolina
Self-Monitoring Assessment in Real Time: 2-SMART
The purpose of the study is to test the effectiveness of two different methods of mobile dietary self-monitoring for weight loss.
Both of these interventions will provide weight loss information through twice weekly audio podcasts.
In addition to the podcasts, participants will be asked to track their diet using an assigned mobile applications (for their smartphone), which will be randomly assigned.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study will include an intensive phase for 6 weeks and a follow-up phase that will occur through the final 6 months of the study.
Participants will attend one 1-hour orientation meeting at the beginning of the study and a 2-hour baseline assessment and training meeting.
A final assessment will be conducted at the end of 6 weeks with a follow-up assessment at 6 months.
Everyone in the study will be asked to listen to 2 podcasts per week.
Each of the podcasts will take about 15-20 minutes to listen to and so participants should expect to spend 30-40 minutes each week listening to podcasts.
Participants also will be randomized to track diet with one of the two mobile dietary tracking applications that will be used in the study.
Participants will be encouraged to monitor their exercise and body weight.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
44
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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South Carolina
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Columbia, South Carolina, Forenede Stater, 29208
- University of South Carolina
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Must be between 18-65 years old
- Own and use a smartphone and/or a tablet with a data plan that is apple of Android compatible
- BMI must be between 25-49.9 kg/m2
- Must be willing to reduce caloric intake and increase physical activity
- Not currently participating in a weight loss study or has been in a weight loss study that involved podcasts or diet apps
Exclusion Criteria:
- Over the age of 65 years old
- Currently participating in a weight loss program
- Has lost more than 10 pounds in the past 6 months
- Diagnosed with stroke or heart attack
- Diagnosed with diabetes that is controlled using medication
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Photo App
Participants in this group will receive podcasts twice weekly in conjunction with using a mobile dietary tracking application(Photo App).
This Photo App allows participants to track meals by taking photos.
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Use of a mobile photo app that takes pictures of foods consumed and allows users to share these pictures with other members of the study in order to receive feedback.
Listen to 2 podcasts per week about healthy eating and exercise.
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Aktiv komparator: Diet App
Participants in this group will receive podcasts twice weekly in conjunction with an app (Diet App) to track their diet by entering in foods and beverages consumed.
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Listen to 2 podcasts per week about healthy eating and exercise.
Use of a mobile diet app that allows users to track all foods and beverages consumed in order to calculate the calories consumed each day.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of days diet is self-monitored
Tidsramme: 6 months
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Assess the total number of days food is recorded via assigned app over the 6-week study and then assess follow-up at 6 months.
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6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Brie McGrievy, PhD, MS, RD, University of South Carolina
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Turner-McGrievy GM, Dunn CG, Wilcox S, Boutte AK, Hutto B, Hoover A, Muth E. Defining Adherence to Mobile Dietary Self-Monitoring and Assessing Tracking Over Time: Tracking at Least Two Eating Occasions per Day Is Best Marker of Adherence within Two Different Mobile Health Randomized Weight Loss Interventions. J Acad Nutr Diet. 2019 Sep;119(9):1516-1524. doi: 10.1016/j.jand.2019.03.012. Epub 2019 May 30.
- Dunn CG, Turner-McGrievy GM, Wilcox S, Hutto B. Dietary Self-Monitoring Through Calorie Tracking but Not Through a Digital Photography App Is Associated with Significant Weight Loss: The 2SMART Pilot Study-A 6-Month Randomized Trial. J Acad Nutr Diet. 2019 Sep;119(9):1525-1532. doi: 10.1016/j.jand.2019.03.013. Epub 2019 May 30.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. september 2016
Primær færdiggørelse (Faktiske)
1. maj 2017
Studieafslutning (Faktiske)
1. maj 2017
Datoer for studieregistrering
Først indsendt
18. juli 2016
Først indsendt, der opfyldte QC-kriterier
11. august 2016
Først opslået (Skøn)
16. august 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. april 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. april 2019
Sidst verificeret
1. april 2019
Mere information
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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