Trial Outcomes & Findings for A Culturally Adapted, Social Support-Based, Physical Activity Interventions for South Asian Indian Women in the United States (NCT NCT05966506)
NCT ID: NCT05966506
Last Updated: 2025-06-12
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-06-12
Participant Flow
Twenty individuals (10 dyads) were enrolled in total: 10 participants, each enrolled with a study partner.
Participant milestones
| Measure |
Health Coaching
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.
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
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Overall Study
STARTED
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20
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Overall Study
COMPLETED
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20
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Culturally Adapted, Social Support-Based, Physical Activity Interventions for South Asian Indian Women in the United States
Baseline characteristics by cohort
| Measure |
Health Coaching
n=20 Participants
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.
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
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Age, Continuous
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48.9 years
STANDARD_DEVIATION 5.19 • n=5 Participants
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Sex: Female, Male
Female
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20 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
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Race/Ethnicity, Customized
South Asian Indian
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20 Participants
n=5 Participants
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Region of Enrollment
United States
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20 participants
n=5 Participants
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Body Mass Index
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30.31 kg/m²
STANDARD_DEVIATION 5.36 • n=5 Participants
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Education
Associates
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1 Participants
n=5 Participants
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Education
Bachelors
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6 Participants
n=5 Participants
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Education
Masters
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11 Participants
n=5 Participants
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Education
Professional
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2 Participants
n=5 Participants
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Annual Household Income
$50,000 to $79,999
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1 Participants
n=5 Participants
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Annual Household Income
$80,000 to $99,999
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2 Participants
n=5 Participants
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Annual Household Income
$100,000 or more
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17 Participants
n=5 Participants
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Number of Participants Employed
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20 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 12 weeksPopulation: Includes all twenty individuals enrolled (participants and their study partners).
Outcome measures
| Measure |
Health Coaching
n=20 Participants
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.
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
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Feasibility as Assessed by the Percentage of Participants Enrolled in the Study
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100 percentage of participants
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PRIMARY outcome
Timeframe: 12 weeksPopulation: Includes all twenty individuals enrolled (participants and their study partners).
Outcome measures
| Measure |
Health Coaching
n=20 Participants
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.
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
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Feasibility as Assessed by the Number of Participants Who Complete the Study
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20 Participants
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PRIMARY outcome
Timeframe: 12 weeksPopulation: Includes all twenty individuals enrolled (participants and their study partners).
Assessments include counseling calls ,use of Fitbit, receipt and review of newsletters
Outcome measures
| Measure |
Health Coaching
n=20 Participants
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.
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
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Feasibility as Assessed by the Number of Participants Who Complete All the Assessments
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18 Participants
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PRIMARY outcome
Timeframe: 12 weeksPopulation: Includes all twenty individuals enrolled (participants and their study partners).
Outcome measures
| Measure |
Health Coaching
n=20 Participants
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.
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
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Feasibility as Assessed by the Number of Participants Who Adhere to Treatment
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18 Participants
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SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Includes all twenty individuals enrolled (participants and their study partners).
A modified version of the validated Leisure Score Index from the Godin Leisure-Time Exercise Questionnaire (GLTEQ) was used to assess episodes, intensity, and duration of PA during a typical 7-day period within the past month. The modified GLTEQ asked the participants to recall the amount of time spent in strenuous, moderate, and mild physical activity for each day over seven days. Time spent in moderate and strenuous physical activity was summed to calculate minutes of moderate-to-vigorous activity from the modified GLTEQ. Responses to the GLTEQ at each of the study assessments were converted to estimated weekly metabolic equivalent (METS). Responses on the LTEQ were converted into estimated weekly METS using a slightly modified version of the formula used by the developers of the GLTEQ: \[(total METS = minutes of strenuous exercise / 15) × 9\] + \[(total minutes of moderate exercise / 15) × 5\] + \[(total minutes of light exercise / 15) × 3\].
Outcome measures
| Measure |
Health Coaching
n=20 Participants
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.
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
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Physical Activity (PA) as Assessed by the Modified Godin Leisure-Time Exercise Questionnaire
Baseline
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23.85 Weekly metabolic equivalent (METS)
Standard Deviation 33.60
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Physical Activity (PA) as Assessed by the Modified Godin Leisure-Time Exercise Questionnaire
12 weeks
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53.37 Weekly metabolic equivalent (METS)
Standard Deviation 35.02
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SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Includes all twenty individuals enrolled (participants and their study partners).
The average steps per day will be reported.
Outcome measures
| Measure |
Health Coaching
n=20 Participants
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.
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
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Physical Activity as Assessed by the Average Steps Per Day Measured Via Fitbit
Baseline
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8,014 steps per day
Standard Deviation 2,705
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Physical Activity as Assessed by the Average Steps Per Day Measured Via Fitbit
12 weeks
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7,885 steps per day
Standard Deviation 4,091
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SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Includes all twenty individuals enrolled (participants and their study partners).
The Self-efficacy for physical activity scale total score ranges from 5 to 25, a higher score indicating more confidence in one's ability to engage in physical activity
Outcome measures
| Measure |
Health Coaching
n=20 Participants
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.
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
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Self-efficacy for Physical Activity as Assessed by the Self-efficacy for Physical Activity (SEPA) Scale
Baseline
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11.45 score on a scale
Standard Deviation 4.25
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Self-efficacy for Physical Activity as Assessed by the Self-efficacy for Physical Activity (SEPA) Scale
12 Weeks
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12.95 score on a scale
Standard Deviation 3.99
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SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Includes all twenty individuals enrolled (participants and their study partners).
The Social Support for Physical Activity survey assess the level of support for exercising from both the individual (self) and their study partner. All participants completed both subscales: self-support subscale and study partner support subscale. Each subscale total score ranges from 13 to 104, with higher scores indicating greater social support. The study partner support subscale is reported.
Outcome measures
| Measure |
Health Coaching
n=20 Participants
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.
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
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Physical Activity-related Social Support as Assessed by the Social Support for Physical Activity Survey (Study Partner Subscale)
Baseline
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16.45 score on a scale
Standard Deviation 8.27
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Physical Activity-related Social Support as Assessed by the Social Support for Physical Activity Survey (Study Partner Subscale)
12 weeks
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31.75 score on a scale
Standard Deviation 8.01
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SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Data was not collected from 1 individual in the health coaching arm at 12 weeks because the participant did not fill out that portion of the survey.
The Social Support for Physical Activity survey assess the level of support for exercising from both the individual (self) and their study partner. All participants completed both subscales: self-support subscale and study partner support subscale. The survey consists of two subscales: self-support and study partner support. Each subscale total score ranges from 13 to 104, with higher scores indicating greater social support. The self support subscale is reported.
Outcome measures
| Measure |
Health Coaching
n=20 Participants
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.
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
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Physical Activity-related Social Support as Assessed by the Social Support for Physical Activity Survey (Self Support Subscale)
Baseline
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14.3 score on a scale
Standard Deviation 5.36
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Physical Activity-related Social Support as Assessed by the Social Support for Physical Activity Survey (Self Support Subscale)
12 weeks
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29 score on a scale
Standard Deviation 8.23
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SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Includes all twenty individuals enrolled (participants and their study partners).
The Climate questionnaire (autonomy support) asses the level of autonomy support provided by both the individual (self) and their study partner. All participants completed both subscales: self-support and study partner support. The study partner subscale is a 6 item questionnaire and each is scored from 1 (strongly disagree) to 7 (strongly agree). The sum of the 6 items were divided by 6, to generate a scale from 1 to 7, with higher scores indicating greater autonomy support. The study partner subscale is reported.
Outcome measures
| Measure |
Health Coaching
n=20 Participants
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.
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
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Physical Activity Related Autonomy Support as Assessed by the Climate Questionnaire (Autonomy Support - Study Partner Subscale)
Baseline
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3.62 score on a scale
Standard Deviation 1.94
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Physical Activity Related Autonomy Support as Assessed by the Climate Questionnaire (Autonomy Support - Study Partner Subscale)
12 weeks
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6.05 score on a scale
Standard Deviation 0.94
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SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Includes all twenty individuals enrolled (participants and their study partners).
The Climate questionnaire (autonomy support) asses the level of autonomy support provided by both the individual (self) and their study partner. All participants completed both subscales: self-support and study partner support. The self support subscale is a 6 item questionnaire and each is scored from 1 (strongly disagree) to 7 (strongly agree). The sum of the 6 items were divided by 6, to generate a scale from 1 to 7, with higher scores indicating greater autonomy support. The self support subscale reported.
Outcome measures
| Measure |
Health Coaching
n=20 Participants
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.
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
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Physical Activity Related Autonomy Support as Assessed by the Climate Questionnaire (Autonomy Support - Self Support Subscale)
Baseline
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3.88 score on a scale
Standard Deviation 1.97
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Physical Activity Related Autonomy Support as Assessed by the Climate Questionnaire (Autonomy Support - Self Support Subscale)
12 weeks
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5.99 score on a scale
Standard Deviation 0.89
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SECONDARY outcome
Timeframe: 12 weeksPopulation: Includes all twenty individuals enrolled (participants and their study partners).
Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.
Outcome measures
| Measure |
Health Coaching
n=20 Participants
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.
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
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Cognitive Impairment as Measured by the Montreal Cognitive Assessment (MoCA)
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25.9 score on a scale
Standard Deviation 2.74
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Adverse Events
Health Coaching
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Nitha Mathew Joseph, PhD, RN, CNE, CGNC
The University of Texas Health Science Center at Houston
Phone: 713-500-2165
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place