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Overweight and ObesityRashakatyNCT04919759

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

A study testing R-Basic and R-Enhanced in people with Overweight and Obesity, run by United Arab Emirates University at 1 site in United Arab Emirates.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Overweight and Obesity
What is being tested?
R-Basic and R-Enhanced
Could I receive a placebo?
No, everyone receives an active treatment
How many people
246 participants
Where
1 siteUnited Arab Emirates
Study dates
21 Aug 2016to 31 May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Arab Emirates1 site

  • United Arab Emirates University

    Al Ain City, Select State Or Region

Other trials in United Arab Emirates

About this study

Official title: 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

Read the 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).

Being tested
R-Basic, R-Enhanced
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • R-BasicBehavioural

    Also called Rashakaty Basic intervention

    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-EnhancedBehavioural

    Also called Rashakaty Enhanced intervention

    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.

Study groups in NCT04919759
Study groupRoleWhat they receive
Rashakaty Basic (R-Basic)Active comparatorParticipants in the R-Basic intervention arm had access to a website that contained the study questionnaires and nutrition education materials
Receives: Behavioral: R-Basic
Rashakaty Enhanced (R-Enhanced)ExperimentalParticipants 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
Receives: Behavioral: R-Enhanced

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body weight

    changes in body weight

    Measured: 16 weeks

  2. Body composition

    Changes in body composition (percent body fat)

    Measured: 16 weeks

Secondary outcomes (4)

  1. 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).

    Measured: 16 weeks

  2. Physical activity

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

    Measured: 16 weeks

  3. 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).

    Measured: 16 weeks

  4. 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.

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2021
  2. Study start21 Aug 2016
  3. Primary completion31 May 2017
  4. Study completion31 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Two arms, non-randomized
Masking
None (open label)
Enrolment
246 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04919759
Sponsor's protocol ID
33/2014/2015
Acronym
Rashakaty
Status last verified
Jun 2021
First submitted
30 May 2021
Last updated
9 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing R-Basic and R-Enhanced in people with Overweight and Obesity, run by United Arab Emirates University at 1 site in United Arab Emirates.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body weight (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04919759.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.

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