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

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Not Applicable

Locations

United Arab Emirates

Study Type

Interventional

Intervention

Behavioral Lifestyle Intervention

Usual Care

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Emirati Adults, United Arab Emirates, Lifestyle Intervention, Type 2 Diabetes

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Ambulatory Healthcare Services, SEHA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in HbA1c

Secondary Outcome Measures

Change in Total Cholesterol, LDL, HDL and Triglycerides

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

Change in Physical Activity (total METs and total duration)

Physical Activity was assessed using International Physical Activity Questionnaire Short Form.

Change in Sitting time (minutes)

Sitting time was assessed using International Physical Activity Questionnaire Short Form.

Change in Weight

Change in BMI

Change in Nutrition Knowledge

Questionnaire was used to assess knowledge of food sources of carbohydrates and dietary fiber

Change in Diabetes Treatment Satisfaction Score

Diabetes Treatment Satisfaction Questionnaire (Bradley,C) was used

Full Information

NCT ID

NCT04264793

First Posted

February 8, 2020

Last Updated

February 8, 2020

Sponsor

United Arab Emirates University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04264793

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

November 20, 2011 (Actual)

Primary Completion Date

November 28, 2013 (Actual)

Study Completion Date

December 24, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

United Arab Emirates University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

Keywords

Emirati Adults, United Arab Emirates, Lifestyle Intervention, Type 2 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Cluster Randomized Trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

382 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Behavioral Lifestyle Intervention

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Usual Care

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in HbA1c

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Change in Total Cholesterol, LDL, HDL and Triglycerides

Time Frame

12 months

Title

Change in Dietary Intake (Total Calories, Saturated Fat, Cholesterol, Dietary Fiber and Sodium)

Description

Dietary intake was assessed using 24 hour recall with USDA Multiple Pass Method

Time Frame

12 months

Title

Change in Physical Activity (total METs and total duration)

Description

Physical Activity was assessed using International Physical Activity Questionnaire Short Form.

Time Frame

12 months

Title

Change in Sitting time (minutes)

Description

Sitting time was assessed using International Physical Activity Questionnaire Short Form.

Time Frame

12 months

Title

Change in Weight

Time Frame

12 months

Title

Change in BMI

Time Frame

12 months

Title

Change in Nutrition Knowledge

Description

Questionnaire was used to assess knowledge of food sources of carbohydrates and dietary fiber

Time Frame

12 months

Title

Change in Diabetes Treatment Satisfaction Score

Description

Diabetes Treatment Satisfaction Questionnaire (Bradley,C) was used

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Habiba I. Ali, PhD, RD,CDE

Organizational Affiliation

United Arab Emirates University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ambulatory Healthcare Services, SEHA

City

Al Ain

Country

United Arab Emirates

12. IPD Sharing Statement

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

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