Lifestyle Risk ReductionNCT04708574
Lifestyle Changes Reducing Type 2 Diabetes Risk Among Arab Canadian Muslim Women.
A study testing Lifestyle intervention in people with Lifestyle Risk Reduction and Type2 Diabetes, run by Western University, Canada at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 20 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lifestyle Risk Reduction, Type2 Diabetes
- What is being tested?
- Lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 8 Mar 2006to 31 May 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise and Pregnancy Lab, 2245, 3-M Centre - University of Western Ontario
London, Ontario, N6A 3K7
About this study
Official title: Impact of Lifestyle Changes on Reducing Risk Factors for Type 2 Diabetes 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.
Read the 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
- Being tested
- Lifestyle intervention, Placebo - Control
- Keywords
- type 2 diabetes, risk reduction, lifestyle intervention, Arab Canadian Muslim women
- Medical subject headings
- Risk Reduction Behavior, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionBehavioural
Placebo - ControlOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo - Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to post intervention for estimated fitness assessment test
Step test
Measured: 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
Measured: Baseline and at the end of the 12 weeks
Secondary outcomes (4)
Change in blood glucose values from baseline to post intervention
Fasted
Measured: Baseline and at the end of the 12 weeks
Change in blood pressure (systolic and diastolic) values from baseline to post intervention
Seated
Measured: Baseline and at the end of the 12 weeks
Change in waist to hip ratio from baseline to post intervention
Waist and hip measurements to calculate waist to hip ratio
Measured: Baseline and at the end of the 12 weeks
Change in steps per day from baseline to post intervention
pedometer
Measured: baseline (7 days) and at the end of the 12 weeks (7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start8 Mar 2006
- Primary completion31 May 2007
- Study completion31 May 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lifestyle Risk ReductionStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Mottola, Western University, Canada
- Investigators
- Michelle F Mottola, PhD, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708574
- Sponsor's protocol ID
- 12132E
- Status last verified
- Jan 2021
- First submitted
- 8 Jan 2021
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38214539
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Lifestyle Changes on Reducing Risk Factors for Type 2 Diabetes Among Arab Canadian Muslim Women.
- ClinicalTrials.gov ID
- NCT04708574
- Acronym / sponsor ID
- 12132E
- Conditions
- Lifestyle Risk Reduction, Type2 Diabetes
- Keywords
- type 2 diabetes, risk reduction, lifestyle intervention, Arab Canadian Muslim women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 8 Mar 2006 (actual)
- Primary completion
- 31 May 2007 (actual)
- Study completion
- 31 May 2007 (actual)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Lifestyle interventionThe 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. |
| Control | Placebo comparator | Other: Placebo - ControlThe 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. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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),
Key exclusion criteria (8 listed)
- uncontrolled hypertension,
- unstable angina,
- pulmonary and metabolic disease,
- severe arthritis or rheumatologic problems,
- already engaged in regular exercise training,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle intervention | Behavioural | Intervention |
| Placebo - Control | Other | Control |
Primary outcome
Change from baseline to post intervention for estimated fitness assessment test
Time frame: Baseline and at the end of the 12 weeks
Step test
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
4 secondary outcomes
Change in blood glucose values from baseline to post intervention
Time frame: Baseline and at the end of the 12 weeks
Change in blood pressure (systolic and diastolic) values from baseline to post intervention
Time frame: Baseline and at the end of the 12 weeks
Change in waist to hip ratio from baseline to post intervention
Time frame: Baseline and at the end of the 12 weeks
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Derived from this study: PubMed 38214539Hussien 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle F Mottola, PhD principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention in people with Lifestyle Risk Reduction and Type2 Diabetes, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to post intervention for estimated fitness assessment test (time frame: Baseline and at the end of the 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04708574, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.