Feasibility of Technology Mediated Lifestyle Intervention for Overweight and Obese Young Adults

Overweight and Obesity Clinical Trial

— Rashakaty  

Official title:

Development, Implementation and Evaluation of Technology Mediated Lifestyle Intervention for Promoting Weight Loss and Improving Nutrition Behaviors Among Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04919759
• Other study ID #: 33/2014/2015
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

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