Clinical trial NCT05966506: A Culturally Adapted, Social Support-Based, Physical Activity Interventions for South Asian Indian Women in the United States
Official title: A Culturally Adapted, Social Support-Based, Physical Activity Interventions for South Asian Indian Women in the United States: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Behavior
Keywords: physical activity
social support
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2023-07-28
Enrollment: 20
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 .


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility as Assessed by the Percentage of Participants Enrolled in the Study
timeFrame: 12 weeks
measure: Feasibility as Assessed by the Number of Participants Who Complete the Study
timeFrame: 12 weeks
measure: Feasibility as Assessed by the Number of Participants Who Complete All the Assessments
timeFrame: 12 weeks
measure: Feasibility as Assessed by the Number of Participants Who Adhere to Treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: Physical Activity (PA) as Assessed by the Modified Godin Leisure-Time Exercise Questionnaire
timeFrame: Baseline, 12 weeks
measure: Physical Activity as Assessed by the Average Steps Per Day Measured Via Fitbit
timeFrame: Baseline, 12 weeks
measure: Self-efficacy for Physical Activity as Assessed by the Self-efficacy for Physical Activity (SEPA) Scale
timeFrame: Baseline, 12 weeks
measure: Physical Activity-related Social Support as Assessed by the Social Support for Physical Activity Survey (Study Partner Subscale)
timeFrame: Baseline, 12 weeks
measure: Physical Activity-related Social Support as Assessed by the Social Support for Physical Activity Survey (Self Support Subscale)
timeFrame: Baseline, 12 weeks
measure: Physical Activity Related Autonomy Support as Assessed by the Climate Questionnaire (Autonomy Support - Study Partner Subscale)
timeFrame: Baseline, 12 weeks
measure: Physical Activity Related Autonomy Support as Assessed by the Climate Questionnaire (Autonomy Support - Self Support Subscale)
timeFrame: Baseline, 12 weeks
measure: Cognitive Impairment as Measured by the Montreal Cognitive Assessment (MoCA)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Nitha Mathew Joseph, PhD, RN, CNE
role: PRINCIPAL_INVESTIGATOR
References: