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

Type2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04708574
• Other study ID #: 12132E
• Status: Completed
• Phase: N/A
• Start date: March 8, 2006
• Est. completion date: May 31, 2007

Study information

• Verified date: January 2021
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 31, 2007
• Est. primary completion date: May 31, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Lifestyle Risk Reduction
• Type2 Diabetes

Intervention

Behavioral:
• Lifestyle intervention

Other:
• Placebo - Control

Locations

Country	Name	City	State
Canada	Exercise and Pregnancy Lab, 2245, 3-M Centre - University of Western Ontario	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to post intervention for estimated fitness assessment test	Step test	Baseline and at the end of the 12 weeks
Primary	Change in nutrition assessment from baseline to post intervention	From a 3-day food intake record	Baseline and at the end of the 12 weeks
Secondary	Change in blood glucose values from baseline to post intervention	Fasted	Baseline and at the end of the 12 weeks
Secondary	Change in blood pressure (systolic and diastolic) values from baseline to post intervention	Seated	Baseline and at the end of the 12 weeks
Secondary	Change in waist to hip ratio from baseline to post intervention	Waist and hip measurements to calculate waist to hip ratio	Baseline and at the end of the 12 weeks
Secondary	Change in steps per day from baseline to post intervention	pedometer	baseline (7 days) and at the end of the 12 weeks (7 days)