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

NCT05966506 | Completed Results

• 2 other identifiers: HSC-SN-23-0576UL1TR003167-04
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 moderate-to-vigorous physical activity (MVPA), social support, and self-efficacy .

Conditions

Sedentary Behavior

Keywords

physical activity; social support

Outcome Measures

Primary Outcomes (4)

• Feasibility as Assessed by the Percentage of Participants Enrolled in the Study

  12 weeks

• Feasibility as Assessed by the Number of Participants Who Complete the Study

  12 weeks

• 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

  12 weeks

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

  12 weeks

Secondary Outcomes (8)

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

  Baseline, 12 weeks

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

  Baseline, 12 weeks

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

  Baseline, 12 weeks

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

  Baseline, 12 weeks

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

  Baseline, 12 weeks

Study Arms (1)

Health coaching

EXPERIMENTAL

Behavioral: Dyad-based Zoom health coaching; Behavioral: Fitbit activity monitor; Other: Electronic newsletters

Interventions

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

Health coaching

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.

Health coaching

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

Health coaching

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Nitha Mathew Joseph, PhD, RN, CNE, CGNC
• Organization: The University of Texas Health Science Center at Houston

Nitha.Mathew@uth.tmc.edu

713-500-2165

Study Officials

• Nitha Mathew Joseph, PhD, RN, CNE

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: July 28, 2023
• Study Start: November 14, 2023
• Primary Completion: March 19, 2024
• Study Completion: March 19, 2024
• Last Updated: June 12, 2025
• Results First Posted: June 12, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)