Lifestyle Changes Reducing Type 2 Diabetes Risk Among Arab Canadian Muslim Women.

January 13, 2021 updated by: Michelle Mottola, Western University, Canada

Impact of Lifestyle Changes on Reducing Risk Factors for Type 2 Diabetes Among Arab Canadian Muslim Women.

Aim: The purpose was to investigate whether modifiable risk factors for type 2 diabetes can be reduced by an intensive healthy lifestyle intervention designed for Arab Muslim women.

Methods: Women were assigned randomly to either an Exercise and Nutrition Group (ENG) or a Control Group (CG). The ENG attended a women-only supervised exercise program that presented Arabic music and traditional Lebanese Dabka steps three times/week in the Mosque Gym for 12 weeks. A nutritionist was available one hour/week for nutrition education. The CG followed their typical day.

Study Overview

Detailed Description

Women were assigned randomly using a computer-generated random numbers table to either an Exercise and Nutrition Group (ENG) or a Control Group (CG). The women received step-by-step instructions on how to complete a consecutive 3-day food record (including two week-days and one weekend day) and an exercise log for 7 days using a pedometer (YAMAX SW-200 Digi-Walker) to determine steps/day. The information and instruction were delivered to the women in English or Arabic. Body weight and height were measured to the nearest 0.1 kg and 0.1 cm, respectively. Women came to the lab after a 12 hour fast and a blood sample was drawn. Waist and hip measurements were taken along with resting blood pressure. Estimated fitness levels was measured by a trained kinesiologist using a Step Test (Siconolfi et al. 1985). All baseline measurements, including the 3-day food intake record and the 7-day pedometer step count log were repeated at the end of the 12-week intervention in both groups. The ENG group attended a supervised women-only exercise program that presented Arabic music and traditional dance steps (the Lebanese Dabka) three times a week in the London Muslim Mosque Gym and received nutrition education over the 12 weeks, one session per week.

Study Type

Interventional

Enrollment (Actual)

60

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

    • Ontario
      • London, Ontario, Canada, N6A 3K7
        • Exercise and Pregnancy Lab, 2245, 3-M Centre - University of Western Ontario

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 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • family history of type 2 diabetes (at least one parent),
  • overweight or obese,
  • been in Canada more than 10 years,
  • mild hypertension,
  • impaired glucose tolerance, or previous gestational diabetes (including giving birth to babies 4.0 kg or more),
  • a sedentary lifestyle

Exclusion Criteria:

  • uncontrolled hypertension,
  • unstable angina,
  • pulmonary and metabolic disease,
  • severe arthritis or rheumatologic problems,
  • already engaged in regular exercise training,
  • pregnancy,
  • menopause,
  • already enrolled in a clinical research trial

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
The intervention group attended a supervised exercise program for women only that presented Arabic music and traditional dance steps (the Lebanese Dabka) three times a week in the London Muslim Mosque Gym. The intervention lasted 12 weeks. There was also a nutrition education component that occurred once per week for the duration of the intervention. The lifestyle intervention group was instructed to walk 10,000 steps per day for the 12 weeks of the program. They were given instructions to take a 30-min walk on days when no formal exercise sessions were offered.
Placebo Comparator: Control
The control group participants followed their typical work and leisure routines during the weeks of investigation. The women in the control group were offered the same intervention at the end of the 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to post intervention for estimated fitness assessment test
Time Frame: Baseline and at the end of the 12 weeks
Step test
Baseline and at the end of the 12 weeks
Change in nutrition assessment from baseline to post intervention
Time Frame: Baseline and at the end of the 12 weeks
From a 3-day food intake record
Baseline and at the end of the 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in blood glucose values from baseline to post intervention
Time Frame: Baseline and at the end of the 12 weeks
Fasted
Baseline and at the end of the 12 weeks
Change in blood pressure (systolic and diastolic) values from baseline to post intervention
Time Frame: Baseline and at the end of the 12 weeks
Seated
Baseline and at the end of the 12 weeks
Change in waist to hip ratio from baseline to post intervention
Time Frame: Baseline and at the end of the 12 weeks
Waist and hip measurements to calculate waist to hip ratio
Baseline and at the end of the 12 weeks
Change in steps per day from baseline to post intervention
Time Frame: baseline (7 days) and at the end of the 12 weeks (7 days)
pedometer
baseline (7 days) and at the end of the 12 weeks (7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michelle F Mottola, PhD, Western University, Canada

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)

March 8, 2006

Primary Completion (Actual)

May 31, 2007

Study Completion (Actual)

May 31, 2007

Study Registration Dates

First Submitted

January 8, 2021

First Submitted That Met QC Criteria

January 11, 2021

First Posted (Actual)

January 14, 2021

Study Record Updates

Last Update Posted (Actual)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

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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