- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04708574
Lifestyle Changes Reducing Type 2 Diabetes Risk Among Arab Canadian Muslim Women.
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
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Ontario
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London, Ontario, Canada, N6A 3K7
- Exercise and Pregnancy Lab, 2245, 3-M Centre - University of Western Ontario
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
|---|---|
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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.
|
|
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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
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Baseline and at the end of the 12 weeks
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|
Change in nutrition assessment from baseline to post intervention
Time Frame: Baseline and at the end of the 12 weeks
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From a 3-day food intake record
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Baseline and at the end of the 12 weeks
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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
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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
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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
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Waist and hip measurements to calculate waist to hip ratio
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Baseline and at the end of the 12 weeks
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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)
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pedometer
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baseline (7 days) and at the end of the 12 weeks (7 days)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michelle F Mottola, PhD, Western University, Canada
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12132E
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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