NCT04708574

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2007

Completed
13.6 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

1.2 years

First QC Date

January 8, 2021

Last Update Submit

January 13, 2021

Conditions

Lifestyle Risk ReductionType2 Diabetes

Keywords

type 2 diabetesrisk reductionlifestyle interventionArab Canadian Muslim women

Outcome Measures

Primary Outcomes (2)

  • Change from baseline to post intervention for estimated fitness assessment test

    Step test

    Baseline and at the end of the 12 weeks

  • 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 Outcomes (4)

  • Change in blood glucose values from baseline to post intervention

    Baseline and at the end of the 12 weeks

  • Change in blood pressure (systolic and diastolic) values from baseline to post intervention

    Baseline and at the end of the 12 weeks

  • Change in waist to hip ratio from baseline to post intervention

    Baseline and at the end of the 12 weeks

  • Change in steps per day from baseline to post intervention

    baseline (7 days) and at the end of the 12 weeks (7 days)

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Lifestyle intervention

Control

PLACEBO COMPARATOR

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.

Other: Placebo - Control

Interventions

Lifestyle interventionBEHAVIORAL
Intervention
Placebo - ControlOTHER
Control

Eligibility Criteria

Age20 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

London, Ontario, N6A 3K7, Canada

Location

Related Publications (1)

  • 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.

    PMID: 38214539DERIVED

MeSH Terms

Conditions

Risk Reduction BehaviorDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

BehaviorDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Michelle F Mottola, PhD

    Western University, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 8, 2021

First Posted

January 14, 2021

Study Start

March 8, 2006

Primary Completion

May 31, 2007

Study Completion

May 31, 2007

Last Updated

January 19, 2021

Record last verified: 2021-01

Locations

CA(1)