- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04264793
Skills for Change: Nutrition Education Program for Emirati Adults With Type 2 Diabetes
February 8, 2020 updated by: Habiba I. Ali, United Arab Emirates University
Skills for Change: Implementation of a Community-based Diabetes Nutrition Education Program for Emirati Adults With Type 2 Diabetes
The "Skills for Change" Diabetes Nutrition Education Program was a one-year, community-based conducted in Ambulatory Health Care Services health centers in Al Ain.
The project involved nutrition education to improve blood glucose control, diet and physical activity levels of Emirati adults with type 2 diabetes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Despite the high prevalence of diabetes and its complications in the UAE, very few diabetes education intervention studies have been conducted in a representative population in the country.
The Skills for Change Program was a one-year, community-based, cluster randomized study involving Emirati adults with type 2 diabetes.
We implemented a behavioral lifestyle intervention to improve glycemic control, food choices, and physical activity levels and to decrease sedentarity.
The project was culturally adapted to Emirati adults with type 2 diabetes and was driven by theoretical principles of behavior change and education to enhance intervention effectiveness.
Study Type
Interventional
Enrollment (Actual)
382
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Al Ain, United Arab Emirates
- Ambulatory Healthcare Services, SEHA
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- United Arab Emirates national
- Type 2 diabetes
- Adults: Male and female
- Age: 20-70 years
- Attending one of the 7 health centers in Al Ain managed by the Ambulatory Healthcare Services.
Exclusion Criteria:
- Type 1 diabetes
- Age >70 Years
- Medical conditions that prevent active participation in the program, based on recommendation of the attending physicians
- Participating in other nutrition intervention programs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Behavioral Lifestyle Intervention (3 health centers): In addition to usual care in the health center, the intervention included individual counseling and group education on nutrition and physical activity.
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In addition to usual care in the health center, the intervention included 7 visits with the health center dietitian for individual nutrition counseling, invitation for group nutrition education (5 sessions), individual counseling for physical activity, invitation for a 6-weekly structured group physical activity, DVD on physical activity to perform physical activity at home.
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Active Comparator: Control
Control (4 health centers): Patients received usual care including education as part of the diabetes management from their healthcare professionals (physicians and nurses), normally every 2-3 months.
Visits with the health center dietitian were arranged as per physician referral.
|
Patients received usual care including education as part of the diabetes management from their healthcare professionals (physicians and nurses), normally every 2-3 months.
Visits with the health center dietitian were arranged as per physician referral.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in HbA1c
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Total Cholesterol, LDL, HDL and Triglycerides
Time Frame: 12 months
|
12 months
|
|
Change in Dietary Intake (Total Calories, Saturated Fat, Cholesterol, Dietary Fiber and Sodium)
Time Frame: 12 months
|
Dietary intake was assessed using 24 hour recall with USDA Multiple Pass Method
|
12 months
|
Change in Physical Activity (total METs and total duration)
Time Frame: 12 months
|
Physical Activity was assessed using International Physical Activity Questionnaire Short Form.
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12 months
|
Change in Sitting time (minutes)
Time Frame: 12 months
|
Sitting time was assessed using International Physical Activity Questionnaire Short Form.
|
12 months
|
Change in Weight
Time Frame: 12 months
|
12 months
|
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Change in BMI
Time Frame: 12 months
|
12 months
|
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Change in Nutrition Knowledge
Time Frame: 12 months
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Questionnaire was used to assess knowledge of food sources of carbohydrates and dietary fiber
|
12 months
|
Change in Diabetes Treatment Satisfaction Score
Time Frame: 12 months
|
Diabetes Treatment Satisfaction Questionnaire (Bradley,C) was used
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Habiba I. Ali, PhD, RD,CDE, United Arab Emirates University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 20, 2011
Primary Completion (Actual)
November 28, 2013
Study Completion (Actual)
December 24, 2013
Study Registration Dates
First Submitted
February 8, 2020
First Submitted That Met QC Criteria
February 8, 2020
First Posted (Actual)
February 11, 2020
Study Record Updates
Last Update Posted (Actual)
February 11, 2020
Last Update Submitted That Met QC Criteria
February 8, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10/48
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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