South Asians Active Together (SAATH) Study

Study Overview
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Brief Summary
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South Asian immigrant women and girls are at increased risk for insufficient physical activity and are not being reached by current approaches to physical activity promotion. This randomized control trial study will test the effectiveness and implementation of a multi component physical activity intervention directed at the environment, family, interpersonal and individual levels to promote physical activity among South Asian immigrant mothers and daughters.

Official Title
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A Multilevel Physical Activity Intervention for South Asian Women and Girls (SAATH)

Conditions
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Physical Inactivity, South Asian

Intervention / Treatment
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* Behavioral: SAATH Intervention


Participation Criteria
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Eligibility Criteria
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The sample of this study is South Asian mothers and their daughters. The inclusion criteria for the mother include: Identifying herself as South Asian, having a sedentary lifestyle as assessed using a self-report questionnaire having ability to communicate in Hindi, Gujarati, Urdu, or English. Having a daughter aged 11-16 years Exclusion Criteria: having known medical condition that restricts ability to participate in moderate intensity Physical Activity Unable to complete study procedures (including not wearing accelerometer during run-in) Currently pregnant Unable to provide informed consent or assent.

Ages Eligible for Study
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Minimum Age: 11 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>The intervention group will receive a 18-week in-person program. The program includes the following components: multi family group counseling, group exercise classes, mother group discussion, daughter group discussion and Fitbit. | Behavioral: SAATH Intervention<br>* SAATH intervention is a physical activity intervention for South Asian mothers and daughters with group exercise classes and discussion groups.<br>|
| No Intervention: Control group<br>The group group will receive print materials about physical activity. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Averaged daily minutes spent in moderate- and vigorous-intensity physical activity measured by ActiGraph accelerometers | Moderate- and vigorous-intensity physical activity will be identified based on the accelerometer count cut-point for moderate intensity and daily minutes spent in moderate- and vigorous-intensity physical activity estimated for seven days will be averaged | The outcome will be assessed before the intervention (week 0) and after the intervention (week 18) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Averaged daily minutes spent in walking or running behavior measured by ActiGraph accelerometers | Walking and running behavior will be recognized using a machine learning activity recognition algorithm and daily minutes spent in walking or running behavior estimated for seven days will be averaged | The outcome will be assessed before the intervention (week 0) and after the intervention (week 18) | 
| Averaged daily hours spent in sedentary behaviors measured by ActiGraph accelerometers | Sedentary behaviors will be identified based on the accelerometer count cut-point for sedentary behaviors and daily minutes spent in sedentary behaviors estimated for seven days will be averaged | The outcome will be assessed before the intervention (week 0) and after the intervention (week 18) | 
| Systolic and diastolic blood pressure (mmHg) measured by a sphygmomanometer | Blood pressure will be measured three times while sitting down and relaxing on a chair and the last two measures will be averaged | The outcome will be assessed before the intervention (week 0) and after the intervention (week 18) | 
| Self-efficacy score measured by the Exercise Confidence Survey | The self-efficacy score will be calculated by averaging the responses (scored 1 to 5 point for the responses of strongly disagree to strongly agree) from each question item | The outcome will be assessed before the intervention (week 0) and after the intervention (week 18) | 
| Self-efficacy score measured by Dishman's Barriers to Self-Efficacy questionnaire | The self-efficacy score will be calculated by averaging the responses (scored 1 to 5 point; higher scores mean higher self-efficacy [a better outcome]) | The outcome will be assessed before the intervention (week 0) and after the intervention (week 18) |