South Asians Active Together (SAATH) Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Physical Inactivity; South Asian
• Intervention / Treatment: Behavioral: SAATH Intervention

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Namratha Kandula, MD, MPH; Phone Number: +1 312 503 6470; Email: n-kandula@northwestern.edu
• Study Contact Backup: Name: Emily Anderson; Phone Number: 312 503 6995; Email: emily.anderson1@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University-Feinberg School of Medicine
      • Principal Investigator: Namratha Kandula
      • Contact: Emily Anderson; Phone Number: 312-503-6995; Email: emily.anderson1@northwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; SAATH intervention is a physical activity intervention for South Asian mothers and daughters with group exercise classes and discussion groups.
No Intervention: Control group; The group group will receive print materials about physical activity.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: University of Chicago; University of Illinois at Chicago; Ann & Robert H Lurie Children's Hospital of Chicago; Skokie Health Department; Skokie Park District; Metropolitan Asian Family Services
• Investigators: Principal Investigator: Namratha Kandula, MD, MPH, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (Actual): May 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: STU00211374:

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No