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Completed

NCT Number: NCT04400253

South Asians Active Together (SAATH) Study

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.

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Key information

Age range

11 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University-Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SAATH Intervention

Behavioral

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

Primary outcomes

  1. Averaged daily minutes spent in moderate- and vigorous-intensity physical activity measured by ActiGraph accelerometers

    Time frame: The outcome will be assessed before the intervention (week 0) and after the intervention (week 18)

    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

Secondary outcomes

  1. Averaged daily minutes spent in walking or running behavior measured by ActiGraph accelerometers

    Time frame: The outcome will be assessed before the intervention (week 0) and after the intervention (week 18)

    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

  2. Averaged daily hours spent in sedentary behaviors measured by ActiGraph accelerometers

    Time frame: The outcome will be assessed before the intervention (week 0) and after the intervention (week 18)

    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

  3. Systolic and diastolic blood pressure (mmHg) measured by a sphygmomanometer

    Time frame: The outcome will be assessed before the intervention (week 0) and after the intervention (week 18)

    Blood pressure will be measured three times while sitting down and relaxing on a chair and the last two measures will be averaged

  4. Self-efficacy score measured by the Exercise Confidence Survey

    Time frame: The outcome will be assessed before the intervention (week 0) and after the intervention (week 18)

    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

  5. Self-efficacy score measured by Dishman's Barriers to Self-Efficacy questionnaire

    Time frame: The outcome will be assessed before the intervention (week 0) and after the intervention (week 18)

    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])

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
May 22, 2020
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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