Clinical trial NCT04708574: Lifestyle Changes Reducing Type 2 Diabetes Risk Among Arab Canadian Muslim Women.
Official title: Impact of Lifestyle Changes on Reducing Risk Factors for Type 2 Diabetes Among Arab Canadian Muslim Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lifestyle Risk Reduction
Type2 Diabetes
Keywords: type 2 diabetes
risk reduction
lifestyle intervention
Arab Canadian Muslim women
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline to post intervention for estimated fitness assessment test
timeFrame: Baseline and at the end of the 12 weeks
measure: Change in nutrition assessment from baseline to post intervention
timeFrame: Baseline and at the end of the 12 weeks
Secondary outcomes:
measure: Change in blood glucose values from baseline to post intervention
timeFrame: Baseline and at the end of the 12 weeks
measure: Change in blood pressure (systolic and diastolic) values from baseline to post intervention
timeFrame: Baseline and at the end of the 12 weeks
measure: Change in waist to hip ratio from baseline to post intervention
timeFrame: Baseline and at the end of the 12 weeks
measure: Change in steps per day from baseline to post intervention
timeFrame: baseline (7 days) and at the end of the 12 weeks (7 days)
Other outcomes:
Locations:
city: London
country: Canada
facility: Exercise and Pregnancy Lab, 2245, 3-M Centre - University of Western Ontario
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Michelle F Mottola, PhD
role: PRINCIPAL_INVESTIGATOR
References: