Diabetes Mellitus, Physical Activity
Conditions
Brief 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.
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.
Interventions
BEHAVIORALPhysical Activity
Culturally tailored physical activity intervention for South Asian women and their children.
Sponsors
Metropolitan Asian Family Services
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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. 1. Self-identified as South Asian 2. Women 3. Have children between the ages of 6 and 14 years. AND Meet either of the criteria below 4. History of gestational diabetes during any of the pregnancies Or 5. Body Mass Index between 25 and 35 kg/m2 And 6. Family history of diabetes in a first degree relative.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Activity (Minutes/Week) | 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. |
Countries
United States
Participant flow
Pre-assignment details
The total number of participants who signed up for the study were 68 and not 71.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 68 |
| Total | 68 |
Baseline characteristics
| Characteristic | Physical Activity Intervention |
|---|---|
| Age, Continuous | 40 years STANDARD_DEVIATION 5 |
| Race/Ethnicity, Customized South Asian | 68 participants |
| Region of Enrollment United States | 68 participants |
| Sex/Gender, Customized Female Child | 17 participants |
| Sex/Gender, Customized Female Parent | 30 participants |
| Sex/Gender, Customized Male Child | 21 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 68 |
| serious Total, serious adverse events | 0 / 68 |
Outcome results
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.
Time frame: Baseline and 4 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Physical Activity Intervention | Change in Physical Activity (Minutes/Week) | Baseline | 42 minute/week activity | Standard Deviation 104 |
| Physical Activity Intervention | Change in Physical Activity (Minutes/Week) | Post intervention at 4 months | 58 minute/week activity | Standard Deviation 117 |