NCT04264793

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
382

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable type-2-diabetes

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2013

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2013

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

February 8, 2020

Last Update Submit

February 8, 2020

Conditions

Type 2 Diabetes

Keywords

Emirati AdultsUnited Arab EmiratesLifestyle InterventionType 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c

    12 months

Secondary Outcomes (8)

  • 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

  • Change in Physical Activity (total METs and total duration)

    12 months

  • Change in Sitting time (minutes)

    12 months

  • Change in Weight

    12 months

  • +3 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

Behavioral Lifestyle InterventionBEHAVIORAL

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
Usual CareBEHAVIORAL

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.

Control

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ambulatory Healthcare Services, SEHA

Al Ain City, United Arab Emirates

Location

Related Publications (1)

  • Ali HI, Al Ketbi LB, Platat C, Abdl El Baki H, Elmi F, Ibrahim W, Zoubeidi T, Al Dhaheri AS, Cheikh Ismail L, Tariq MNM, Souka U, Yasin J, Stojanovska L. Impact of Skills for Change Program on metabolic control, diet and physical activity levels in adults with type 2 diabetes: A cluster randomized trial. PLoS One. 2024 May 31;19(5):e0304639. doi: 10.1371/journal.pone.0304639. eCollection 2024.

    PMID: 38820345DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Habiba I. Ali, PhD, RD,CDE

    United Arab Emirates University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Cluster Randomized Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 8, 2020

First Posted

February 11, 2020

Study Start

November 20, 2011

Primary Completion

November 28, 2013

Study Completion

December 24, 2013

Last Updated

February 11, 2020

Record last verified: 2020-02

Locations

AE(1)