South Asians Active Together (SAATH) Study

Physical Inactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04400253
• Other study ID #: STU00211374:
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: October 2023
• Source: Northwestern University
• Contact: Namratha Kandula, MD, MPH
• Phone: +1 312 503 6470
• Email: n-kandula[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 11 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Physical Inactivity
• South Asian

Intervention

Behavioral:
• SAATH Intervention
SAATH intervention is a physical activity intervention for South Asian mothers and daughters with group exercise classes and discussion groups.

Locations

Country	Name	City	State
United States	Northwestern University-Feinberg School of Medicine	Chicago	Illinois

Sponsors (7)

Lead Sponsor	Collaborator
Northwestern University	Ann & Robert H Lurie Children's Hospital of Chicago, Metropolitan Asian Family Services, Skokie Health Department, Skokie Park District, University of Chicago, University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)