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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04919759
Other study ID # 33/2014/2015
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 21, 2016
Est. completion date May 31, 2017

Study information

Verified date June 2021
Source United Arab Emirates University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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).


Recruitment information / eligibility

Status Completed
Enrollment 246
Est. completion date May 31, 2017
Est. primary completion date May 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
R-Basic
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.
R-Enhanced
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.

Locations

Country Name City State
United Arab Emirates United Arab Emirates University Al Ain Select State Or Region

Sponsors (2)

Lead Sponsor Collaborator
United Arab Emirates University University of Sharjah

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body weight changes in body weight 16 weeks
Primary Body composition Changes in body composition (percent body fat) 16 weeks
Secondary Nutrition knowledge 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). 16 weeks
Secondary Physical activity Changes in physical activity (number of days and duration) was used using The International Physical Activity Questionnaire (IPAQ) - Short Form 16 weeks
Secondary Perceived social support from family and closest friends. 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). 16 weeks
Secondary Perceived self-efficacy for healthier eating and physical activity 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. 16 weeks
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