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

Sedentary Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05966506
• Other study ID #: HSC-SN-23-0576
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: Nitha Mathew Joseph, PhD, RN, CNE
• Phone: 713-500-2165
• Email: Nitha.Mathew[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Sedentary Behavior

Intervention

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
• 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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as assessed by the percentage of participants enrolled in the study		12 weeks
Primary	Feasibility as assessed by the percentage of participants who complete the study		12 weeks
Primary	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
Primary	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	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
Secondary	Change in physical activity as assessed by the values on a fitbit		Baseline, 12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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.	12 weeks