South Asians Active Together (SAATH) Study

November 19, 2024 updated by: Namratha Kandula, Northwestern University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
252

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University-Feinberg School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
The outcome will be assessed before the intervention (week 0) and after the intervention (week 18)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
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
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])
The outcome will be assessed before the intervention (week 0) and after the intervention (week 18)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Namratha Kandula, MD, MPH, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 26, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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