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Completed

NCT Number: NCT05966506

A Culturally Adapted, Social Support-Based, Physical Activity Interventions for South Asian Indian Women in the United States

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 .

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Key information

Conditions

Sedentary Behavior Behavior Motor Activity

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dyad-based Zoom health coaching

Behavioral

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

Fitbit activity monitor

Behavioral

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.

Electronic newsletters

Other

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

Primary outcomes

  1. Feasibility as Assessed by the Percentage of Participants Enrolled in the Study

    Time frame: 12 weeks

  2. Feasibility as Assessed by the Number of Participants Who Complete the Study

    Time frame: 12 weeks

  3. 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

  4. Feasibility as Assessed by the Number of Participants Who Adhere to Treatment

    Time frame: 12 weeks

Secondary outcomes

  1. 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].

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

A Culturally Adapted, Social Support-Based, Physical Activity Interventions for South Asian Indian Women in the United States: A Feasibility Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 28, 2023
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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