Clinical trial NCT04400253: South Asians Active Together (SAATH) Study
Official title: A Multilevel Physical Activity Intervention for South Asian Women and Girls (SAATH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity
South Asian
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Skokie Health Department
name: Skokie Park District
name: University of Illinois at Chicago
name: Metropolitan Asian Family Services
name: University of Chicago
name: Ann & Robert H Lurie Children's Hospital of Chicago
First posted: 2020-05-22
Enrollment: 252
Sex: FEMALE
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Averaged daily minutes spent in moderate- and vigorous-intensity physical activity measured by ActiGraph accelerometers
timeFrame: The outcome will be assessed before the intervention (week 0) and after the intervention (week 18)
Secondary outcomes:
measure: Averaged daily minutes spent in walking or running behavior measured by ActiGraph accelerometers
timeFrame: The outcome will be assessed before the intervention (week 0) and after the intervention (week 18)
measure: Averaged daily hours spent in sedentary behaviors measured by ActiGraph accelerometers
timeFrame: The outcome will be assessed before the intervention (week 0) and after the intervention (week 18)
measure: Systolic and diastolic blood pressure (mmHg) measured by a sphygmomanometer
timeFrame: The outcome will be assessed before the intervention (week 0) and after the intervention (week 18)
measure: Self-efficacy score measured by the Exercise Confidence Survey
timeFrame: The outcome will be assessed before the intervention (week 0) and after the intervention (week 18)
measure: Self-efficacy score measured by Dishman's Barriers to Self-Efficacy questionnaire
timeFrame: The outcome will be assessed before the intervention (week 0) and after the intervention (week 18)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University-Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: Namratha Kandula, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: