- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04919759
Feasibility of Technology Mediated Lifestyle Intervention for Overweight and Obese Young Adults (Rashakaty)
3 juni 2021 uppdaterad av: Habiba I. Ali, United Arab Emirates University
Development, Implementation and Evaluation of Technology Mediated Lifestyle Intervention for Promoting Weight Loss and Improving Nutrition Behaviors Among Young Adults
Rashakaty (Fitness for Me) study aimed to design a new technologies-based intervention using a website and smart phone applications and to test the feasibility of implementing a lifestyle intervention using these technologies for overweight and obese university students.
The intervention was implemented in two universities in the United Arab Emirates
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Poor eating habits and sedentary lifestyle are common among young adults and increase risk for chronic diseases in subsequent years of life.
Rashakaty (Fitness for Me) study aimed to design a new technologies-based intervention using a website and smart phone applications and to test the feasibility of implementing a lifestyle intervention using these technologies for overweight and obese university students.
The study intervention was guided by Social Cognitive Theory.
The study involved the development of a website, integrating educational material and mobile applications for monitoring diet and physical activity and a16-week feasibility trial to promote weight loss, improve food choices and increase physical activity levels.
The trial consisted of two arms: Rashakaty Basic (R-Basic) and Rashakaty Enhanced (R-Enhanced).
Studietyp
Interventionell
Inskrivning (Faktisk)
246
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Select State Or Region
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Al Ain, Select State Or Region, Förenade arabemiraten
- United Arab Emirates University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 35 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Beskrivning
Inclusion Criteria:
- Overweight or obese (BMI ≥25.0
- Adults: Female
- Age: 18-35 years
- Current user of a smart phone
- Student in one of the two target universities in the United Arab Emirates
- Living in or off the university campus
Exclusion Criteria:
- Past or planned weight loss surgery
- Pregnant or breastfeeding
- Lost 7 kg in the past 3 months
- Following any weight loss program for 3 months or more
- Taking any steroid or thyroid hormones treatment or any other medication that may affect body weight
- Enrolled in medical and nutrition programs since one of the program components was nutrition knowledge assessments
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Rashakaty Basic (R-Basic)
Participants in the R-Basic intervention arm had access to a website that contained the study questionnaires and nutrition education materials
|
Participants in the R-Basic arm received access to a static website that contained educational materials on healthier eating and physical activity and the study questionnaires.
The R-Basic intervention was implemented in the University of Sharjah.
Andra namn:
|
Experimentell: Rashakaty Enhanced (R-Enhanced)
Participants in the R-Enhanced intervention were given access to smart phones applications for monitoring diet and physical activity levels as well as an online access to a nutritionist
|
The R-Enhanced intervention was guided by the Social Cognitive Theory and employed a variety of behavior modification strategies, including self-monitoring, goal setting, self-efficacy, and social support to facilitate changes in diet and physical activity.
In addition, participants in the R-Enhanced intervention had online access to a nutritionist.
The R-Enhanced intervention was implemented in the United Arab Emirates University.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Body weight
Tidsram: 16 weeks
|
changes in body weight
|
16 weeks
|
Body composition
Tidsram: 16 weeks
|
Changes in body composition (percent body fat)
|
16 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Nutrition knowledge
Tidsram: 16 weeks
|
The General Nutrition Awareness Questionnaire (GNKQ) validated by Parmenter and Wardle in the UK. was used after local adaptation.
Four main categories containing a total of 58 items were assessed:1) Awareness of dietary recommendations (11 items); 2) Knowledge of sources of nutrients (37 items); (3) Using the information to make dietary choices (5 items); and 4) Awareness of diet-disease relationships (5 items).
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16 weeks
|
Physical activity
Tidsram: 16 weeks
|
Changes in physical activity (number of days and duration) was used using The International Physical Activity Questionnaire (IPAQ) - Short Form
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16 weeks
|
Perceived social support from family and closest friends.
Tidsram: 16 weeks
|
Perceived social support for healthier foods and physical activity scale of Health Beliefs Questionnaire which was originally developed by Anderson, E. and colleagues was used after adaptation for university students in the UAE.
The social support subscale (16 items for healthy eating and 7 items for physical activity) measures social influences on participants by their family members and closest friends.
Each question is scored 1-5 (1 - Strongly disagree, 5 - Strongly agree).
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16 weeks
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Perceived self-efficacy for healthier eating and physical activity
Tidsram: 16 weeks
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Perceived self-efficacy scale of Health Beliefs Questionnaire which was originally developed by Anderson, E. and colleagues after local adaptation was used.
It consists of 33 items for healthy eating and 24 items for physical activity.
The healthy food efficacy measure assesses the respondent's confidence in reducing fat, reducing sugar consumption and increasing fruit and vegetable intake.
The physical activity measure consists of two subscales: overcoming barriers to engaging in physical activity and integrating physical activity into the daily routine.
Each question is scored 0 to 100 (certain I cannot) to 100) all or most of the time.
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16 weeks
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Habiba I Ali, PhD, RD, CDE, United Arab Emirates University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
21 augusti 2016
Primärt slutförande (Faktisk)
31 maj 2017
Avslutad studie (Faktisk)
31 maj 2017
Studieregistreringsdatum
Först inskickad
30 maj 2021
Först inskickad som uppfyllde QC-kriterierna
3 juni 2021
Första postat (Faktisk)
9 juni 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 juni 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 juni 2021
Senast verifierad
1 juni 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 33/2014/2015
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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