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CompletedNCT04400253Updated Nov 22, 2024

South Asians Active Together (SAATH) Study

An interventional study of SAATH Intervention in Physical Inactivity and South Asian, sponsored by Northwestern University. Completed at 1 site in United States. Open to female participants aged 11 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-22.

Sponsored by Northwestern University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
252
Allocation
Randomized
Ages
11 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Physical Inactivity
  • South Asian

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In context

Sedentary Behavior

368 studies on the registry are indexed under Sedentary Behavior; 165 are open to participants now.

This study's enrollment of 252 is above the median of 70 across 314 interventional studies indexed under Sedentary Behavior.

Browse Sedentary Behavior studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,420 studies on the registry; 199 are open to participants now.

Of its 103 completed or terminated interventional studies of FDA-regulated products, 75 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
11 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
252 participants (actual)

Study arms

  • 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

  • No intervention
    Control group

    The group group will receive print materials about physical activity.

Interventions

  • BehavioralSAATH Intervention

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

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What researchers measure

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

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

Secondary outcomes

  1. 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

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

  2. 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

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

  3. 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

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

  4. 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

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

  5. 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 \[a better outcome\])

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

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Study locations

1 site
  • Northwestern University-Feinberg School of Medicine
    Chicago, Illinois 60611, United States
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References and documents

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 42466355 ↗
  • Kwon 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 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2020 to primary completion in Mar 2024, 43 months.

Of 243 non-industry interventional studies with no phase under Sedentary Behavior, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's 43 months is above that.

Counting every sponsor, half of 246 studies reached it within 22 months; a quarter within 9 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
May 11, 2020
First posted
May 22, 2020
StartActual
Aug 1, 2020
Primary completionActual
Mar 26, 2024
CompletionActual
Mar 26, 2024
Last update
Nov 22, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04400253
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
Namratha Kandula (Prinicipal Investigator, Northwestern University) — Principal investigator
First posted
May 22, 2020
Start date
Aug 1, 2020
Primary completion
Mar 26, 2024
Completion
Mar 26, 2024
Last update
Nov 22, 2024

Study contacts

Namratha Kandula, MD, MPH
principal investigator · Northwestern University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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