Skills for Change: Nutrition Education Program for Emirati Adults With Type 2 Diabetes

Sponsor

United Arab Emirates University (Other)

Overall Status

Completed

CT.gov ID

NCT04264793

Collaborator

Ambulatory Healthcare Services, Al Ain, UAE (Other), Sheikh Hamdan bin Rashid Al Maktoum Award for Medical Sciences (Other)

382

Enrollment

Location

Arms

25.1

Actual Duration (Months)

15.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Behavioral: Behavioral Lifestyle Intervention Behavioral: Usual Care	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

382 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Cluster Randomized TrialCluster Randomized Trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Skills for Change: Implementation of a Community-based Diabetes Nutrition Education Program for Emirati Adults With Type 2 Diabetes

Actual Study Start Date :

Nov 20, 2011

Actual Primary Completion Date :

Nov 28, 2013

Actual Study Completion Date :

Dec 24, 2013

Arms and Interventions

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.	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.
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.	Behavioral: 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.

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.

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.

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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

Change in HbA1c [12 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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