Sedentary Behavior
Conditions
Keywords
physical activity, social support
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 .
Interventions
BEHAVIORALDyad-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
BEHAVIORALFitbit 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.
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
Sponsors
National Center for Advancing Translational Sciences (NCATS)
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as Assessed by the Percentage of Participants Enrolled in the Study | 12 weeks | — |
| Feasibility as Assessed by the Number of Participants Who Complete the Study | 12 weeks | — |
| 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 |
| Feasibility as Assessed by the Number of Participants Who Adhere to Treatment | 12 weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity-related Social Support as Assessed by the Social Support for Physical Activity Survey (Self Support Subscale) | Baseline, 12 weeks | 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. |
| Physical Activity Related Autonomy Support as Assessed by the Climate Questionnaire (Autonomy Support - Study Partner Subscale) | Baseline, 12 weeks | 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. |
| Physical Activity (PA) as Assessed by the Modified Godin Leisure-Time Exercise Questionnaire | Baseline, 12 weeks | 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: \[(total METS = minutes of strenuous exercise / 15) × 9\] + \[(total minutes of moderate exercise / 15) × 5\] + \[(total minutes of light exercise / 15) × 3\]. |
| Cognitive Impairment as Measured by the Montreal Cognitive Assessment (MoCA) | 12 weeks | Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome. |
| Physical Activity Related Autonomy Support as Assessed by the Climate Questionnaire (Autonomy Support - Self Support Subscale) | Baseline, 12 weeks | 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. |
| Physical Activity as Assessed by the Average Steps Per Day Measured Via Fitbit | Baseline, 12 weeks | The average steps per day will be reported. |
| Self-efficacy for Physical Activity as Assessed by the Self-efficacy for Physical Activity (SEPA) Scale | Baseline, 12 weeks | 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 |
| Physical Activity-related Social Support as Assessed by the Social Support for Physical Activity Survey (Study Partner Subscale) | Baseline, 12 weeks | 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. |
Countries
United States
Participant flow
Pre-assignment details
Twenty individuals (10 dyads) were enrolled in total: 10 participants, each enrolled with a study partner.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Health Coaching |
|---|---|
| Age, Continuous | 48.9 years STANDARD_DEVIATION 5.19 |
| Annual Household Income $100,000 or more | 17 Participants |
| Annual Household Income $50,000 to $79,999 | 1 Participants |
| Annual Household Income $80,000 to $99,999 | 2 Participants |
| Body Mass Index | 30.31 kg/m² STANDARD_DEVIATION 5.36 |
| Education Associates | 1 Participants |
| Education Bachelors | 6 Participants |
| Education Masters | 11 Participants |
| Education Professional | 2 Participants |
| Number of Participants Employed | 20 Participants |
| Race/Ethnicity, Customized South Asian Indian | 20 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Feasibility as Assessed by the Number of Participants Who Adhere to Treatment
Time frame: 12 weeks
Population: Includes all twenty individuals enrolled (participants and their study partners).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Coaching | Feasibility as Assessed by the Number of Participants Who Adhere to Treatment | 18 Participants |
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
Time frame: 12 weeks
Population: Includes all twenty individuals enrolled (participants and their study partners).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Coaching | Feasibility as Assessed by the Number of Participants Who Complete All the Assessments | 18 Participants |
Primary
Feasibility as Assessed by the Number of Participants Who Complete the Study
Time frame: 12 weeks
Population: Includes all twenty individuals enrolled (participants and their study partners).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Coaching | Feasibility as Assessed by the Number of Participants Who Complete the Study | 20 Participants |
Primary
Feasibility as Assessed by the Percentage of Participants Enrolled in the Study
Time frame: 12 weeks
Population: Includes all twenty individuals enrolled (participants and their study partners).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Health Coaching | Feasibility as Assessed by the Percentage of Participants Enrolled in the Study | 100 percentage of participants |
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.
Time frame: 12 weeks
Population: Includes all twenty individuals enrolled (participants and their study partners).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Cognitive Impairment as Measured by the Montreal Cognitive Assessment (MoCA) | 25.9 score on a scale | Standard Deviation 2.74 |
Secondary
Physical Activity as Assessed by the Average Steps Per Day Measured Via Fitbit
The average steps per day will be reported.
Time frame: Baseline, 12 weeks
Population: Includes all twenty individuals enrolled (participants and their study partners).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Health Coaching | Physical Activity as Assessed by the Average Steps Per Day Measured Via Fitbit | Baseline | 8,014 steps per day |
| Health Coaching | Physical Activity as Assessed by the Average Steps Per Day Measured Via Fitbit | 12 weeks | 7,885 steps per day |
Secondary
Physical Activity (PA) as Assessed by the Modified Godin Leisure-Time Exercise Questionnaire
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: \[(total METS = minutes of strenuous exercise / 15) × 9\] + \[(total minutes of moderate exercise / 15) × 5\] + \[(total minutes of light exercise / 15) × 3\].
Time frame: Baseline, 12 weeks
Population: Includes all twenty individuals enrolled (participants and their study partners).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Health Coaching | Physical Activity (PA) as Assessed by the Modified Godin Leisure-Time Exercise Questionnaire | Baseline | 23.85 Weekly metabolic equivalent (METS) | Standard Deviation 33.6 |
| Health Coaching | Physical Activity (PA) as Assessed by the Modified Godin Leisure-Time Exercise Questionnaire | 12 weeks | 53.37 Weekly metabolic equivalent (METS) | Standard Deviation 35.02 |
Secondary
Physical Activity Related Autonomy Support as Assessed by the Climate Questionnaire (Autonomy Support - Self Support Subscale)
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.
Time frame: Baseline, 12 weeks
Population: Includes all twenty individuals enrolled (participants and their study partners).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Health Coaching | Physical Activity Related Autonomy Support as Assessed by the Climate Questionnaire (Autonomy Support - Self Support Subscale) | Baseline | 3.88 score on a scale | Standard Deviation 1.97 |
| Health Coaching | Physical Activity Related Autonomy Support as Assessed by the Climate Questionnaire (Autonomy Support - Self Support Subscale) | 12 weeks | 5.99 score on a scale | Standard Deviation 0.89 |
Secondary
Physical Activity Related Autonomy Support as Assessed by the Climate Questionnaire (Autonomy Support - Study Partner Subscale)
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.
Time frame: Baseline, 12 weeks
Population: Includes all twenty individuals enrolled (participants and their study partners).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Health Coaching | Physical Activity Related Autonomy Support as Assessed by the Climate Questionnaire (Autonomy Support - Study Partner Subscale) | Baseline | 3.62 score on a scale | Standard Deviation 1.94 |
| Health Coaching | Physical Activity Related Autonomy Support as Assessed by the Climate Questionnaire (Autonomy Support - Study Partner Subscale) | 12 weeks | 6.05 score on a scale | Standard Deviation 0.94 |
Secondary
Physical Activity-related Social Support as Assessed by the Social Support for Physical Activity Survey (Self Support Subscale)
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.
Time frame: Baseline, 12 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Health Coaching | Physical Activity-related Social Support as Assessed by the Social Support for Physical Activity Survey (Self Support Subscale) | Baseline | 14.3 score on a scale | Standard Deviation 5.36 |
| Health Coaching | Physical Activity-related Social Support as Assessed by the Social Support for Physical Activity Survey (Self Support Subscale) | 12 weeks | 29 score on a scale | Standard Deviation 8.23 |
Secondary
Physical Activity-related Social Support as Assessed by the Social Support for Physical Activity Survey (Study Partner Subscale)
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.
Time frame: Baseline, 12 weeks
Population: Includes all twenty individuals enrolled (participants and their study partners).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Health Coaching | Physical Activity-related Social Support as Assessed by the Social Support for Physical Activity Survey (Study Partner Subscale) | Baseline | 16.45 score on a scale | Standard Deviation 8.27 |
| Health Coaching | Physical Activity-related Social Support as Assessed by the Social Support for Physical Activity Survey (Study Partner Subscale) | 12 weeks | 31.75 score on a scale | Standard Deviation 8.01 |
Secondary
Self-efficacy for Physical Activity as Assessed by the Self-efficacy for Physical Activity (SEPA) Scale
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
Time frame: Baseline, 12 weeks
Population: Includes all twenty individuals enrolled (participants and their study partners).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Health Coaching | Self-efficacy for Physical Activity as Assessed by the Self-efficacy for Physical Activity (SEPA) Scale | Baseline | 11.45 score on a scale | Standard Deviation 4.25 |
| Health Coaching | Self-efficacy for Physical Activity as Assessed by the Self-efficacy for Physical Activity (SEPA) Scale | 12 Weeks | 12.95 score on a scale | Standard Deviation 3.99 |