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Completed

NCT Number: NCT04708574

Lifestyle Changes Reducing Type 2 Diabetes Risk 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.

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Key information

Age range

20 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Exercise and Pregnancy Lab, 2245, 3-M Centre - University of Western Ontario

London, Ontario, N6A 3K7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Intervention

Behavioral

Placebo - Control

Other

Primary outcomes

  1. Change from baseline to post intervention for estimated fitness assessment test

    Time frame: Baseline and at the end of the 12 weeks

    Step test

  2. 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

Secondary outcomes

  1. Change in blood glucose values from baseline to post intervention

    Time frame: Baseline and at the end of the 12 weeks

    Fasted

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jan 14, 2021
Registry last updated
Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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