South Asians Active Together (SAATH) Study

NCT04400253 | Completed DMC

• 1 other identifier: STU00211374:
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Inactivity; South Asian

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  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

  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

  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 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 outcome will be assessed before the intervention (week 0) and after the intervention (week 18)

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

The group group will receive print materials about physical activity.

Interventions

SAATH Intervention BEHAVIORAL

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

Intervention group

Eligibility Criteria

• Age: 11 Years+
• Gender Eligibility Details: South Asian girls and women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• Skokie Health Department: collaborator
• Skokie Park District: collaborator
• University of Illinois at Chicago: collaborator
• Metropolitan Asian Family Services: collaborator
• University of Chicago: collaborator
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator

Study Sites (1)

Northwestern University-Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Namratha Kandula, MD, MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 22, 2020
• Study Start: August 1, 2020
• Primary Completion: March 26, 2024
• Study Completion: March 26, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Locations

US (1)