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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04264793
Other study ID # 10/48
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 20, 2011
Est. completion date December 24, 2013

Study information

Verified date February 2020
Source United Arab Emirates University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 382
Est. completion date December 24, 2013
Est. primary completion date November 28, 2013
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility 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 Design


Intervention

Behavioral:
Behavioral Lifestyle Intervention
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.
Usual Care
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.

Locations

Country Name City State
United Arab Emirates Ambulatory Healthcare Services, SEHA Al Ain

Sponsors (3)

Lead Sponsor Collaborator
United Arab Emirates University Ambulatory Healthcare Services, Al Ain, UAE, Sheikh Hamdan bin Rashid Al Maktoum Award for Medical Sciences

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in HbA1c 12 months
Secondary Change in Total Cholesterol, LDL, HDL and Triglycerides 12 months
Secondary Change in Dietary Intake (Total Calories, Saturated Fat, Cholesterol, Dietary Fiber and Sodium) Dietary intake was assessed using 24 hour recall with USDA Multiple Pass Method 12 months
Secondary Change in Physical Activity (total METs and total duration) Physical Activity was assessed using International Physical Activity Questionnaire Short Form. 12 months
Secondary Change in Sitting time (minutes) Sitting time was assessed using International Physical Activity Questionnaire Short Form. 12 months
Secondary Change in Weight 12 months
Secondary Change in BMI 12 months
Secondary Change in Nutrition Knowledge Questionnaire was used to assess knowledge of food sources of carbohydrates and dietary fiber 12 months
Secondary Change in Diabetes Treatment Satisfaction Score Diabetes Treatment Satisfaction Questionnaire (Bradley,C) was used 12 months
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