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

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
R-Basic
R-Enhanced
Sponsored by
United Arab Emirates University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • United Arab Emirates University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Rashakaty Basic (R-Basic)

Rashakaty Enhanced (R-Enhanced)

Arm Description

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-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

Outcomes

Primary Outcome Measures

Body weight
changes in body weight
Body composition
Changes in body composition (percent body fat)

Secondary Outcome Measures

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).
Physical activity
Changes in physical activity (number of days and duration) was used using The International Physical Activity Questionnaire (IPAQ) - Short Form
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).
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.

Full Information

First Posted
May 30, 2021
Last Updated
June 3, 2021
Sponsor
United Arab Emirates University
Collaborators
University of Sharjah
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1. Study Identification

Unique Protocol Identification Number
NCT04919759
Brief Title
Feasibility of Technology Mediated Lifestyle Intervention for Overweight and Obese Young Adults
Acronym
Rashakaty
Official Title
Development, Implementation and Evaluation of Technology Mediated Lifestyle Intervention for Promoting Weight Loss and Improving Nutrition Behaviors Among Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
August 21, 2016 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
May 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United Arab Emirates University
Collaborators
University of Sharjah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two arms, non-randomized
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
246 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rashakaty Basic (R-Basic)
Arm Type
Active Comparator
Arm Description
Participants in the R-Basic intervention arm had access to a website that contained the study questionnaires and nutrition education materials
Arm Title
Rashakaty Enhanced (R-Enhanced)
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
R-Basic
Other Intervention Name(s)
Rashakaty Basic intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
R-Enhanced
Other Intervention Name(s)
Rashakaty Enhanced intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body weight
Description
changes in body weight
Time Frame
16 weeks
Title
Body composition
Description
Changes in body composition (percent body fat)
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Nutrition knowledge
Description
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).
Time Frame
16 weeks
Title
Physical activity
Description
Changes in physical activity (number of days and duration) was used using The International Physical Activity Questionnaire (IPAQ) - Short Form
Time Frame
16 weeks
Title
Perceived social support from family and closest friends.
Description
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).
Time Frame
16 weeks
Title
Perceived self-efficacy for healthier eating and physical activity
Description
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.
Time Frame
16 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Habiba I Ali, PhD, RD, CDE
Organizational Affiliation
United Arab Emirates University
Official's Role
Principal Investigator
Facility Information:
Facility Name
United Arab Emirates University
City
Al Ain
State/Province
Select State Or Region
Country
United Arab Emirates

12. IPD Sharing Statement

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

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