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

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: Recruiting
• Conditions: Sedentary Behavior
• Intervention / Treatment: Behavioral: Dyad-based Zoom health coaching; Behavioral: Fitbit activity monitor; Other: Electronic newsletters

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nitha Mathew Joseph, PhD, RN, CNE; Phone Number: 713-500-2165; Email: Nitha.Mathew@uth.tmc.edu
• Study Contact Backup: Name: Maja Djukic, PhD, RN, FAAN; Phone Number: 713-500-2045; Email: Maja.Djukic@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Maja Djukic, PhD, RN, FAAN; Phone Number: 713-500-2045; Email: Maja.Djukic@uth.tmc.edu
      • Contact: Nitha M Joseph, PhD, RN, CNE; Phone Number: 713-500-2165; Email: Nitha.Mathew@uth.tmc.edu

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

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		12 weeks
Feasibility as assessed by the percentage 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	Treatment adherence will be calculated as the proportion of intervention sessions attended.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physical activity as assessed by the Godin Leisure-Time Exercise Questionnaire	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.	Baseline, 12 weeks
Change in physical activity as assessed by the values on a fitbit		Baseline, 12 weeks
Change in self-efficacy for PA as assessed by the Self-efficacy for physical activity (SEPA) scale	This is a five item questionnaire and is scored on a five point Likert-scale, ranging from not confident to extremely confident.	Baseline, 12 weeks
Change in PA-related social support as assessed by the Social Support for Physical Activity Survey	This is a 26 item questionnaire and each is scored from 1(one) to 6(very often) a higher number indicating more social support	Baseline, 12 weeks
Change in PA-related autonomy support as assessed by the Climate Questionnaire (autonomy support)	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)	Baseline, 12 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Nitha Mathew Joseph, PhD, RN, CNE, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2023
• Primary Completion (Estimated): July 30, 2024
• Study Completion (Estimated): July 30, 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): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; social support
• Other Study ID Numbers: HSC-SN-23-0576

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