NCT04919759

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
246

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 21, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 9, 2021

Completed
Last Updated

June 9, 2021

Status Verified

June 1, 2021

Enrollment Period

9 months

First QC Date

May 30, 2021

Last Update Submit

June 3, 2021

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (2)

  • Body weight

    changes in body weight

    16 weeks

  • Body composition

    Changes in body composition (percent body fat)

    16 weeks

Secondary Outcomes (4)

  • Nutrition knowledge

    16 weeks

  • Physical activity

    16 weeks

  • Perceived social support from family and closest friends.

    16 weeks

  • Perceived self-efficacy for healthier eating and physical activity

    16 weeks

Study Arms (2)

Rashakaty Basic (R-Basic)

ACTIVE COMPARATOR

Participants in the R-Basic intervention arm had access to a website that contained the study questionnaires and nutrition education materials

Behavioral: R-Basic

Rashakaty Enhanced (R-Enhanced)

EXPERIMENTAL

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

Behavioral: R-Enhanced

Interventions

R-BasicBEHAVIORAL

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.

Also known as: Rashakaty Basic intervention
Rashakaty Basic (R-Basic)
R-EnhancedBEHAVIORAL

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.

Also known as: Rashakaty Enhanced intervention
Rashakaty Enhanced (R-Enhanced)

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

United Arab Emirates University

Al Ain City, Select State Or Region, United Arab Emirates

Location

MeSH Terms

Conditions

OverweightObesity

Interventions

Basic Blue K

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Habiba I Ali, PhD, RD, CDE

    United Arab Emirates University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two arms, non-randomized
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 30, 2021

First Posted

June 9, 2021

Study Start

August 21, 2016

Primary Completion

May 31, 2017

Study Completion

May 31, 2017

Last Updated

June 9, 2021

Record last verified: 2021-06

Locations

AE(1)