Diabetes MellitusNCT02342535
Community-Clinic Partnership to Promote Physical Activity in South Asian Women
A study testing Physical Activity in people with Diabetes Mellitus and Physical Activity, run by Northwestern University at 2 sites in United States.
Trial summary
The goal of this study is to pilot-test a culturally-salient physical activity intervention, using a randomized design, among under served, overweight/obese South Asian women at high risk for developing Diabetes. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Diabetes Mellitus, Physical Activity
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Should meet all the 3 criteria below and meet the criteria for option 4 below or should meet the criteria for 5 as well as 6.
- Self-identified as South Asian
- Women
- Have children between the ages of 6 and 14 years. AND Meet either of the criteria below
- History of gestational diabetes during any of the pregnancies Or
- Body Mass Index between 25 and 35 kg/m2 And
- Family history of diabetes in a first degree relative.
Who cannot join
- Blood pressure of over 160/100 mm Hg
- History of diabetes
- Saying Yes to any question on the Exercise Assessment and Screening for You (EASY) exercise screening tool
- Currently pregnant or trying to get pregnant in the next year
- Planning to move out of Illinois in the next 6 months.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University-Feinberg School of Medicine
Chicago, Illinois, 60611
Metropolitan Asian Family Services
Chicago, Illinois, 60645
About this study
The goal of this study is to pilot-test a culturally-salient physical activity intervention, using a randomized design, among under served, overweight/obese South Asian women at high risk for developing Diabetes.
Read the detailed description
Regular physical activity prevents type 2 diabetes mellitus (DM). Although physical inactivity and DM are common in the United States (US), the investigators data, and others,have shown that Asian Indian and Pakistani (South Asian) women are at even greater risk. South Asians (SA) are one of the fastest growing segments of the US population.Studies show that SA women have a markedly higher DM prevalence and are less physically active than women from other racial/ethnic groups.SA also have greater insulin resistance and visceral adiposity at a lower body mass index (BMI). A combination of regular, moderate intensity physical activity (PA) and resistance exercises has been shown to decrease visceral adiposity and improve insulin sensitivity, even without weight loss; thus, PA may be especially important for DM prevention among SA women. Despite being at increased risk, very few evidence-based DM prevention and PA interventions exist for SA women in the US.
This proposal builds on a successful academic-community partnership between Northwestern University and Metropolitan Asian Family Services, an organization that provides health care and social services to lower-income SA immigrant families. The partnership has focused on translating and implementing evidence-based lifestyle interventions for SA immigrants in real-world, clinic and community settings. The investigators formative research found that SA women, in particular, were not being reached by current efforts to promote PA. Importantly, however, the main reasons for the reduced effectiveness of traditional strategies for PA promotion related more to socio-cultural perceptions and beliefs than simply to language barriers. SA women reported little PA and had difficulty even defining exercise. Although 75% of women were sedentary and overweight, they did not recognize these as risk factors for DM. Lack of knowledge about benefits of PA, cultural and linguistic isolation, concerns about modesty, and rigid gender roles strongly influenced SA women's proclivity for physical inactivity. In this context, much more work will be needed to address SA women's physical inactivity than simple language translation of proven lifestyle interventions.
- Conditions
- Diabetes Mellitus, Physical Activity
- Being tested
- Physical Activity
- Medical subject headings
- Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
Culturally tailored physical activity intervention for South Asian women and their children.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity intervention | Other | Participants will attend bi weekly exercise classes for a total of 16 weeks, led by certified, and trained instructors.
The participant's children between the ages of 6 and 14 years will participate in the martial arts class with the mothers. Receives: Behavioral: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Activity (Minutes/Week)
To test for differences in physical activity, we used mixed-effects models for pre- and post-intervention accelerometer data. In these models, the outcome was daily minutes of bout corrected moderate-vigourous physical activity. Time (pre/post-intervention) was treated as a binary variable in order to measure changes in physical activity. Models controlled for accelerometer wear time and weekend day.
Measured: Baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study startSep 2014
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Metropolitan Asian Family Services
- Responsible party
- Principal investigator, Namratha Kandula, Northwestern University
- Investigators
- Namratha Kandula, MD,MPH, Principal investigator, Assistant Professor, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342535
- Sponsor's protocol ID
- STU00101433
- Status last verified
- Apr 2023
- First submitted
- 15 Jan 2015
- Last updated
- 6 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Clinic Partnership to Promote Physical Activity in South Asian Women
- ClinicalTrials.gov ID
- NCT02342535
- Acronym / sponsor ID
- STU00101433
- Conditions
- Diabetes Mellitus, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Metropolitan Asian Family Services
- Study start
- Sep 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 21 Jan 2015 (estimated)
- Results
- Posted 26 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to pilot-test a culturally-salient physical activity intervention, using a randomized design, among under served, overweight/obese South Asian women at high risk for developing Diabetes.
Detailed description
Regular physical activity prevents type 2 diabetes mellitus (DM). Although physical inactivity and DM are common in the United States (US), the investigators data, and others,have shown that Asian Indian and Pakistani (South Asian) women are at even greater risk. South Asians (SA) are one of the fastest growing segments of the US population.Studies show that SA women have a markedly higher DM prevalence and are less physically active than women from other racial/ethnic groups.SA also have greater insulin resistance and visceral adiposity at a lower body mass index (BMI). A combination of regular, moderate intensity physical activity (PA) and resistance exercises has been shown to decrease visceral adiposity and improve insulin sensitivity, even without weight loss; thus, PA may be especially important for DM prevention among SA women. Despite being at increased risk, very few evidence-based DM prevention and PA interventions exist for SA women in the US.
This proposal builds on a successful academic-community partnership between Northwestern University and Metropolitan Asian Family Services, an organization that provides health care and social services to lower-income SA immigrant families. The partnership has focused on translating and implementing evidence-based lifestyle interventions for SA immigrants in real-world, clinic and community settings. The investigators formative research found that SA women, in particular, were not being reached by current efforts to promote PA. Importantly, however, the main reasons for the reduced effectiveness of traditional strategies for PA promotion related more to socio-cultural perceptions and beliefs than simply to language barriers. SA women reported little PA and had difficulty even defining exercise. Although 75% of women were sedentary and overweight, they did not recognize these as risk factors for DM. Lack of knowledge about benefits of PA, cultural and linguistic isolation, concerns about modesty, and rigid gender roles strongly influenced SA women's proclivity for physical inactivity. In this context, much more work will be needed to address SA women's physical inactivity than simple language translation of proven lifestyle interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical activity intervention | Other | Behavioral: Physical ActivityParticipants will attend bi weekly exercise classes for a total of 16 weeks, led by certified, and trained instructors. The participant's children between the ages of 6 and 14 years will participate in the martial arts class with the mothers. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Should meet all the 3 criteria below and meet the criteria for option 4 below or should meet the criteria for 5 as well as 6.
Key exclusion criteria (5 listed)
- Blood pressure of over 160/100 mm Hg
- History of diabetes
- Saying Yes to any question on the Exercise Assessment and Screening for You (EASY) exercise screening tool
- Currently pregnant or trying to get pregnant in the next year
- Planning to move out of Illinois in the next 6 months.
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 |
|---|---|---|
| Physical ActivityCulturally tailored physical activity intervention for South Asian women and their children. | Behavioural | Physical activity intervention |
Primary outcome
Change in Physical Activity (Minutes/Week)
Time frame: Baseline and 4 months
To test for differences in physical activity, we used mixed-effects models for pre- and post-intervention accelerometer data. In these models, the outcome was daily minutes of bout corrected moderate-vigourous physical activity. Time (pre/post-intervention) was treated as a binary variable in order to measure changes in physical activity. Models controlled for accelerometer wear time and weekend day.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Namratha Kandula, MD,MPH principal investigator
Assistant Professor, Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Diabetes Mellitus and Physical Activity, run by Northwestern University at 2 sites in United States.
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 7 inclusion and 5 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 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. 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?
Yes. Results are posted in the registry (first posted 26 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Physical Activity (Minutes/Week) (time frame: Baseline and 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2023.