Physical InactivityNCT04400253
South Asians Active Together (SAATH) Study
A study testing SAATH Intervention in people with Physical Inactivity and South Asian, run by Northwestern University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 11 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, South Asian
- What is being tested?
- SAATH Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 26 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University-Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: 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.
- Conditions
- Physical Inactivity, South Asian
- Being tested
- SAATH Intervention
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAATH InterventionBehavioural
SAATH intervention is a physical activity intervention for South Asian mothers and daughters with group exercise classes and discussion groups.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: SAATH Intervention |
| Control group | No intervention | The group group will receive print materials about physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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])
Measured: The outcome will be assessed before the intervention (week 0) and after the intervention (week 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start1 Aug 2020
- Primary completion26 Mar 2024
- Study completion26 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Skokie Health Department, Skokie Park District, University of Illinois at Chicago, Metropolitan Asian Family Services, University of Chicago, Ann & Robert H Lurie Children's Hospital of Chicago
- Responsible party
- Principal investigator, Namratha Kandula, Northwestern University
- Investigators
- Namratha Kandula, MD, MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400253
- Sponsor's protocol ID
- STU00211374:
- Status last verified
- Nov 2024
- First submitted
- 11 May 2020
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kandula NR, Marquez DX, Rastogi M, Lancki N, Finch EA, Welch S, Vu M, Davis-Spells J, Liem RI, Bouris A, Kumar S, Bharucha H, Javed S, Roy R, Kwon S. Effectiveness of an online, dyadic, culturally adapted physical activity intervention for south Asian mothers and daughters (SAATH): a randomised controlled trial. Lancet Obstet Gynaecol Womens Health. 2026 Mar;2(3):e199-e208. doi: 10.1016/S3050-5038(25)00171-2. Epub 2026 Mar 9.
PubMed 42466355Kwon S, Shah NS, Tandon PS, Kandula NR. Associations of acculturation and social support with physical activity among South Asian female adolescents in the United States. BMC Pediatr. 2025 Dec 19;26(1):71. doi: 10.1186/s12887-025-06442-6.
PubMed 41413502
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multilevel Physical Activity Intervention for South Asian Women and Girls (SAATH)
- ClinicalTrials.gov ID
- NCT04400253
- Acronym / sponsor ID
- STU00211374:
- Conditions
- Physical Inactivity, South Asian
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Skokie Health Department, Skokie Park District, University of Illinois at Chicago, Metropolitan Asian Family Services, University of Chicago, Ann & Robert H Lurie Children's Hospital of Chicago
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 26 Mar 2024 (actual)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: SAATH InterventionThe 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. |
| Control group | No intervention | –The group group will receive print materials about physical activity. |
Who may qualify
- Ages
- 11 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAATH InterventionSAATH intervention is a physical activity intervention for South Asian mothers and daughters with group exercise classes and discussion groups. | Behavioural | Intervention group |
Primary outcome
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
5 secondary outcomes
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Derived from this study: PubMed 42466355Kandula NR, Marquez DX, Rastogi M, Lancki N, Finch EA, Welch S, Vu M, Davis-Spells J, Liem RI, Bouris A, Kumar S, Bharucha H, Javed S, Roy R, Kwon S. Effectiveness of an online, dyadic, culturally adapted physical activity intervention for south Asian mothers and daughters (SAATH): a randomised controlled trial. Lancet Obstet Gynaecol Womens Health. 2026 Mar;2(3):e199-e208. doi: 10.1016/S3050-5038(25)00171-2. Epub 2026 Mar 9.
- Derived from this study: PubMed 41413502Kwon S, Shah NS, Tandon PS, Kandula NR. Associations of acculturation and social support with physical activity among South Asian female adolescents in the United States. BMC Pediatr. 2025 Dec 19;26(1):71. doi: 10.1186/s12887-025-06442-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Namratha Kandula, MD, MPH principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAATH Intervention in people with Physical Inactivity and South Asian, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04400253, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.