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

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05966506
Collaborator
M.D. Anderson Cancer Center (Other)
20
1
1
9
2.2

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Dyad-based Zoom health coaching
  • Behavioral: Fitbit activity monitor
  • Other: Electronic newsletters
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Culturally Adapted, Social Support-Based, Physical Activity Interventions for South Asian Indian Women in the United States: A Feasibility Study
Anticipated Study Start Date :
Oct 31, 2023
Anticipated Primary Completion Date :
Jul 30, 2024
Anticipated Study Completion Date :
Jul 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Health coaching

Behavioral: Dyad-based Zoom 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

Behavioral: Fitbit activity monitor
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.

Other: Electronic newsletters
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

Outcome Measures

Primary Outcome Measures

  1. Feasibility as assessed by the percentage of participants enrolled in the study [12 weeks]

  2. Feasibility as assessed by the percentage of participants who complete the study [12 weeks]

  3. Feasibility as assessed by the number of participants who complete all the assessments [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 [12 weeks]

    Treatment adherence will be calculated as the proportion of intervention sessions attended.

Secondary Outcome Measures

  1. Change in physical activity as assessed by the Godin Leisure-Time Exercise Questionnaire [Baseline, 12 weeks]

    This is a self reported questionnaire with 3 questions. A score of 24 units or more indicates participant is active and score of less than 14 units show participant is insufficiently active or sedentary.

  2. Change in physical activity as assessed by the values on a fitbit [Baseline, 12 weeks]

  3. Change in self-efficacy for PA as assessed by the Self-efficacy for physical activity (SEPA) scale [Baseline, 12 weeks]

    This is a five item questionnaire and is scored on a five point Likert-scale, ranging from not confident to extremely confident.

  4. Change in PA-related social support as assessed by the Social Support for Physical Activity Survey [Baseline, 12 weeks]

    This is a 26 item questionnaire and each is scored from 1(one) to 6(very often) a higher number indicating more social support

  5. Change in PA-related autonomy support as assessed by the Climate Questionnaire (autonomy support) [Baseline, 12 weeks]

    This is a 12 item questionnaire (first 6 about partner and the next 6 about participant ) Response options are on a 7-point scale (1=not at all true, 4=somewhat true, 7=very true)

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Texas Health Science Center at Houston Houston Texas United States 77030

Sponsors and Collaborators

  • The University of Texas Health Science Center, Houston
  • M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Nitha Mathew Joseph, PhD, RN, CNE, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nitha Mathew Joseph, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT05966506
Other Study ID Numbers:
  • HSC-SN-23-0576
First Posted:
Jul 28, 2023
Last Update Posted:
Jul 28, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nitha Mathew Joseph, Associate Professor, The University of Texas Health Science Center, Houston

Study Results

No Results Posted as of Jul 28, 2023