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Sedentary BehaviorNCT05966506

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

A study testing Dyad-based Zoom health coaching, Fitbit activity monitor and Electronic newsletters in people with Sedentary Behavior, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 40 to 65 years, women only
Conditions the study is for
Sedentary Behavior
What is being tested?
Dyad-based Zoom health coaching, Fitbit activity monitor and Electronic newsletters
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
14 Nov 2023to 19 Mar 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 40 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: 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 .

Being tested
Dyad-based Zoom health coaching, Fitbit activity monitor, Electronic newsletters
Keywords
physical activity, social support
Medical subject headings
Sedentary Behavior, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dyad-based Zoom health coachingBehavioural

    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 monitorBehavioural

    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 newslettersOther

    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

Study groups in NCT05966506
Study groupRoleWhat they receive
Health coachingExperimentalNot described
Receives: Behavioral: Dyad-based Zoom health coaching; Behavioral: Fitbit activity monitor; Other: Electronic newsletters

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 weeks

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

    Measured: 12 weeks

  3. Feasibility as Assessed by the Number of Participants Who Complete All the Assessments

    Assessments include counseling calls ,use of Fitbit, receipt and review of newsletters

    Measured: 12 weeks

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

    Measured: 12 weeks

Secondary outcomes (8)

  1. Physical Activity (PA) as Assessed by the Modified Godin Leisure-Time Exercise Questionnaire

    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].

    Measured: Baseline, 12 weeks

  2. Physical Activity as Assessed by the Average Steps Per Day Measured Via Fitbit

    The average steps per day will be reported.

    Measured: Baseline, 12 weeks

  3. Self-efficacy for Physical Activity as Assessed by the Self-efficacy for Physical Activity (SEPA) Scale

    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

    Measured: Baseline, 12 weeks

  4. Physical Activity-related Social Support as Assessed by the Social Support for Physical Activity Survey (Study Partner Subscale)

    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.

    Measured: Baseline, 12 weeks

  5. Physical Activity-related Social Support as Assessed by the Social Support for Physical Activity Survey (Self Support Subscale)

    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.

    Measured: Baseline, 12 weeks

  6. Physical Activity Related Autonomy Support as Assessed by the Climate Questionnaire (Autonomy Support - Study Partner Subscale)

    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.

    Measured: Baseline, 12 weeks

  7. Physical Activity Related Autonomy Support as Assessed by the Climate Questionnaire (Autonomy Support - Self Support Subscale)

    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.

    Measured: Baseline, 12 weeks

  8. Cognitive Impairment as Measured by the Montreal Cognitive Assessment (MoCA)

    Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2023
  2. Study start14 Nov 2023
  3. Primary completion19 Mar 2024
  4. Study completion19 Mar 2024

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05966506
Sponsor's protocol ID
HSC-SN-23-0576
Other IDs
UL1TR003167-04
Status last verified
May 2025
First submitted
21 Jul 2023
Last updated
12 Jun 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Dyad-based Zoom health coaching, Fitbit activity monitor and Electronic newsletters in people with Sedentary Behavior, run by The University of Texas Health Science Center, Houston 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 7 inclusion and 5 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 12 Jun 2025. 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?

Yes. Results are posted in the registry (first posted 12 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Feasibility as Assessed by the Percentage of Participants Enrolled in the Study (time frame: 12 weeks). The study lists 4 primary outcomes in all. 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 NCT05966506.

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 12 Jun 2025; AzTrials last refreshed its copy on 30 Oct 2026.

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