- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05966506
A Culturally Adapted, Social Support-Based, Physical Activity Interventions for South Asian Indian Women in the United States
May 23, 2025 updated by: Nitha Mathew Joseph, The University of Texas Health Science Center, Houston
A Culturally Adapted, Social Support-Based, Physical Activity Interventions for South Asian Indian Women in the United States: A Feasibility Study
The purpose of this study is to assess the feasibility and acceptability of a peer-based dyadic social support health coaching physical activity (PA) intervention in inactive South Asian Indian (SAI) and to explore preliminary effects of the intervention on intermediate outcomes: self-reported and objective moderate-to-vigorous physical activity (MVPA), social support, and self-efficacy .
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- 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 Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
-
-
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- inactive SAI (Physical activity (PA) <150 minutes/week)
- physically able to engage in moderate PA
- speak and read English; able to enroll with an eligible adult female partner who does not live in the same household
- willing to use the Fitbit app/device
- own a smartphone that is compatible with Fitbit software (up to 223.3 MB on iPhone or 165 MB on Android) 9)
- able and willing to send and receive text messages
- Blood pressure reading <160/100 mm Hg, or with medical clearance.
Exclusion Criteria:
- SAI women with a current/planned pregnancy
- cannot speak and read English
- those participating in a PA or weight loss program
- those diagnosed with a physical disability that interferes with their ability to be physically active.
- not living in Houston, Texas
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Health coaching
|
This will be delivered by a certified nurse coach, certified in holistic nursing who will provide 6 sessions of Zoom health coaching over 12 weeks to dyads, biweekly (weeks 1, 3, 5,7, 9 &11) for 45 minutes
Participants will be instructed to use the Fitbit to monitor their partners' PA in addition to their own.
All participants will be instructed to "friend" their health coach to enable real-time monitoring of PA to inform coaching zoom calls.
The Fitbit will provide feedback on steps, active minutes, and calories burned.
Participants will be asked to wear the device on most days and while they sleep.
Newsletters will be sent twice monthly during months 1-3 via email or text with an online link.
Newsletters will be designed to share educational PA-related information from publicly available resources.
Newsletters will also contain tips for overcoming barriers to PA ,finding time to exercise, low-cost ways to be active and being active with kids.Newsletters will also contain links to brief exercise routines that participants can do in their homes and information on low cost/free exercise classes in the community, which may help to overcome perceived access barriers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility as Assessed by the Percentage of Participants Enrolled in the Study
Time Frame: 12 weeks
|
12 weeks
|
|
|
Feasibility as Assessed by the Number of Participants Who Complete the Study
Time Frame: 12 weeks
|
12 weeks
|
|
|
Feasibility as Assessed by the Number of Participants Who Complete All the Assessments
Time Frame: 12 weeks
|
Assessments include counseling calls ,use of Fitbit, receipt and review of newsletters
|
12 weeks
|
|
Feasibility as Assessed by the Number of Participants Who Adhere to Treatment
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Activity (PA) as Assessed by the Modified Godin Leisure-Time Exercise Questionnaire
Time Frame: Baseline, 12 weeks
|
A modified version of the validated Leisure Score Index from the Godin Leisure-Time Exercise Questionnaire (GLTEQ) was used to assess episodes, intensity, and duration of PA during a typical 7-day period within the past month.
The modified GLTEQ asked the participants to recall the amount of time spent in strenuous, moderate, and mild physical activity for each day over seven days.
Time spent in moderate and strenuous physical activity was summed to calculate minutes of moderate-to-vigorous activity from the modified GLTEQ.
Responses to the GLTEQ at each of the study assessments were converted to estimated weekly metabolic equivalent (METS).
Responses on the LTEQ were converted into estimated weekly METS using a slightly modified version of the formula used by the developers of the GLTEQ: [(total METS = minutes of strenuous exercise / 15) × 9] + [(total minutes of moderate exercise / 15) × 5] + [(total minutes of light exercise / 15) × 3].
|
Baseline, 12 weeks
|
|
Physical Activity as Assessed by the Average Steps Per Day Measured Via Fitbit
Time Frame: Baseline, 12 weeks
|
The average steps per day will be reported.
|
Baseline, 12 weeks
|
|
Self-efficacy for Physical Activity as Assessed by the Self-efficacy for Physical Activity (SEPA) Scale
Time Frame: Baseline, 12 weeks
|
The Self-efficacy for physical activity scale total score ranges from 5 to 25, a higher score indicating more confidence in one's ability to engage in physical activity
|
Baseline, 12 weeks
|
|
Physical Activity-related Social Support as Assessed by the Social Support for Physical Activity Survey (Study Partner Subscale)
Time Frame: Baseline, 12 weeks
|
The Social Support for Physical Activity survey assess the level of support for exercising from both the individual (self) and their study partner.
All participants completed both subscales: self-support subscale and study partner support subscale.
Each subscale total score ranges from 13 to 104, with higher scores indicating greater social support.
The study partner support subscale is reported.
|
Baseline, 12 weeks
|
|
Physical Activity-related Social Support as Assessed by the Social Support for Physical Activity Survey (Self Support Subscale)
Time Frame: Baseline, 12 weeks
|
The Social Support for Physical Activity survey assess the level of support for exercising from both the individual (self) and their study partner.
All participants completed both subscales: self-support subscale and study partner support subscale.
The survey consists of two subscales: self-support and study partner support.
Each subscale total score ranges from 13 to 104, with higher scores indicating greater social support.
The self support subscale is reported.
|
Baseline, 12 weeks
|
|
Physical Activity Related Autonomy Support as Assessed by the Climate Questionnaire (Autonomy Support - Study Partner Subscale)
Time Frame: Baseline, 12 weeks
|
The Climate questionnaire (autonomy support) asses the level of autonomy support provided by both the individual (self) and their study partner.
All participants completed both subscales: self-support and study partner support.
The study partner subscale is a 6 item questionnaire and each is scored from 1 (strongly disagree) to 7 (strongly agree).
The sum of the 6 items were divided by 6, to generate a scale from 1 to 7, with higher scores indicating greater autonomy support.
The study partner subscale is reported.
|
Baseline, 12 weeks
|
|
Physical Activity Related Autonomy Support as Assessed by the Climate Questionnaire (Autonomy Support - Self Support Subscale)
Time Frame: Baseline, 12 weeks
|
The Climate questionnaire (autonomy support) asses the level of autonomy support provided by both the individual (self) and their study partner.
All participants completed both subscales: self-support and study partner support.
The self support subscale is a 6 item questionnaire and each is scored from 1 (strongly disagree) to 7 (strongly agree).
The sum of the 6 items were divided by 6, to generate a scale from 1 to 7, with higher scores indicating greater autonomy support.
The self support subscale reported.
|
Baseline, 12 weeks
|
|
Cognitive Impairment as Measured by the Montreal Cognitive Assessment (MoCA)
Time Frame: 12 weeks
|
Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nitha Mathew Joseph, PhD, RN, CNE, The University of Texas Health Science Center, Houston
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)
November 14, 2023
Primary Completion (Actual)
March 19, 2024
Study Completion (Actual)
March 19, 2024
Study Registration Dates
First Submitted
July 21, 2023
First Submitted That Met QC Criteria
July 21, 2023
First Posted (Actual)
July 28, 2023
Study Record Updates
Last Update Posted (Actual)
June 12, 2025
Last Update Submitted That Met QC Criteria
May 23, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HSC-SN-23-0576
- UL1TR003167-04 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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