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| Name | Class |
|---|---|
| Metropolitan Asian Family Services | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Activity | Behavioral | Culturally tailored physical activity intervention for South Asian women and their children. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 4 months |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Namratha Kandula, MD,MPH | Assistant Professor, Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University-Feinberg School of Medicine | Chicago | Illinois | 60611 | United States | ||
| Metropolitan Asian Family Services |
The total number of participants who signed up for the study were 68 and not 71.
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| ID | Title | Description |
|---|---|---|
| FG000 | Physical Activity Intervention | 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. Physical Activity: Culturally tailored physical activity intervention for South Asian women and their children. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
30 South Asian adult women were the participants whose data is being analyzed. No research data was obtained from the children. The children have only assented to be in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Physical Activity Intervention | 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 and yoga class with their mothers. Physical Activity: Culturally tailored physical activity intervention for South Asian women and their children. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Participants were enrolled into the study from November 2014 to February 2015. The average age of mothers was 40 (SD±5) years. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | We did not collect any data from the children, so all the data analysis is from the data obtained from the 30 mothers. 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. | Posted | Mean | Standard Deviation | minute/week activity | Baseline and 4 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Physical Activity Intervention | 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 kids exercise class with their mothers. Physical Activity: Culturally tailored physical activity intervention for South Asian women and their children. |
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Limitations of this pilot study are inclusion of a single site in Chicago, lack of a control arm, and that we were only able to recruit and enroll 20% of the individuals we approached.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Namratha Kandula | Northwestern University | 312-503-6470 | nkandula@nm.org |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Chicago |
| Illinois |
| 60645 |
| United States |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Majority participants from the Rogers Park neighborhood of Chicago and the neighboring suburbs in Illinois. | Number | participants |
|
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 kids exercise class with their mothers.
Physical Activity: Culturally tailored physical activity intervention for South Asian women and their children.
|
|
| 0 |
| 68 |
| 0 |
| 68 |
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| D001519 | Behavior |