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

NCT ID: NCT04708574

Last Updated: 2021-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-08
• Study Completion Date: 2007-05-31

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.

Conditions

Lifestyle Risk Reduction; Type2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Lifestyle intervention

Intervention Type: BEHAVIORAL

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.

Group Type: PLACEBO_COMPARATOR

Placebo - Control

Intervention Type: OTHER

Interventions

Lifestyle intervention

Intervention Type: BEHAVIORAL

Placebo - Control

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Western University, Canada

OTHER

Sponsor Role: lead

Responsible Party

Michelle Mottola

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michelle F Mottola, PhD

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Locations

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

London, Ontario, Canada

Countries

Canada

References

Hussien S, McManus R, Prapavessis H, Sopper MM, Mottola MF. Effect of Lifestyle on Reducing Risk Factors for Type 2 Diabetes among Arab Canadian Muslim Women: A Randomized Control Trial. Med Sci Sports Exerc. 2024 Feb 1;56(2):249-256. doi: 10.1249/MSS.0000000000003311. Epub 2023 Oct 11.

Reference Type: DERIVED

PMID: 38214539 (View on PubMed)

Other Identifiers

12132E

Identifier Type: -

Identifier Source: org_study_id