An interventional study of Light-to-Moderate Physical Activity / Sedentary Time in Physical Activity and Sedentary Behavior and Healthy Aging, sponsored by University of Hawaii. Completed at 1 site in United States. Open to participants aged 55 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-18.
Sponsored by University of Hawaii · Not applicable, Interventional, and Prevention
The outcomes of this application will provide nursing researchers with information about ways to increase physical activity (PA) and decrease sedentary time (ST) in at-risk older Filipinos adults who are lay leaders in Filipino Catholic clubs in Hawaii. The proposed 12-week PA/ST program will include both a group-based component (3 group discussions during monthly club meetings) and a personalized telephone counseling component (12 weekly calls from nursing students to problem solve barriers to increasing light-to-moderate physical activity and decreasing / breaking up sedentary time). The project will stimulate multidisciplinary research at our School of Nursing and School of Medicine and has the potential to help older at-risk Filipinos reach national guidelines for healthy levels of physical activity and lower the amount of time they spend sitting/being sedentary.
Asian-Americans (A-As) are under-represented in chronic disease research, including lifestyle interventions. A-As are 42% of population in Hawaii and across the U.S. they are projected to more than double to 34.4 million by 2060, with a much higher proportion of older A-As compared to other races. Within A-As, Filipino-Americans have high rates of hypertension, diabetes, and chronic kidney disease, especially as they age. This is largely due to unhealthy diets, high BMIs, sedentary behaviors, and low physical activity (PA). Our previous work found Filipino seniors are under-active and spend > 8 hours a day in sedentary time (ST). About 90% of Filipinos in Hawaii are Catholic and previous PA interventions involving faith-based organizations have been shown to be culturally relevant for ethnic minorities and can effectively increase PA. Our innovative application focuses on changing both PA and ST in 250 Filipino lay leaders who represent their parish within the Oahu Council of Filipino Catholic Clubs (OCFCCs). OCFCCs maintain Filipinos' Catholic traditions and their cultural heritage. This project builds on our previous research with Filipino leaders from these clubs, and our expertise with effective PA and ST interventions. Team includes 3 nursing faculty, 1 medical school faculty, a project director, and from 9-12 graduate /undergraduate nursing students. The students will participate in a community-engaged 3-yr research project relevant both to their future research efforts and their use of self-management strategies with patients who at-risk for chronic diseases. The investigators will develop, implement, and test the efficacy of a culturally tailored PA/ST intervention for under-active/sedentary Filipino seniors (ages: 55-75 yrs) some of who may have multiple morbidities under medical control. The investigators will initially strengthen our partnership with OCFCC by engaging council members in semi-structured meetings where key cultural and familial issues that hinder/facilitate PA/ST will be discussed, the project's name/logo will be created, and plans to facilitate clubs' engagement across 3-year project will be solidified. Specific Aims: 1) test the efficacy of a Light-to-Moderate PA-LMPA/ST intervention with ten OCFCC clubs (25 lay leaders/club; n = 250 total) that will be randomly assigned to either a 12wk LMPA/ST intervention consisting of 3 group discussions during club meetings plus 12 counseling calls, or to Delayed Treatment condition initially given health education materials and 12 contact-matched calls on topics unrelated to PA/ST; then, the LMPA/ST intervention. 2) test maintenance of LMPA/ST 12 wks after LMPA/ST intervention ends. 3) analyze LMPA/ST self-report \& accelerometer data collected at baseline, 12, 24, and 36 wks, and test demographic, psychosocial, environmental, and group factors as mediators/moderators of change in LMPA/ST. 4) discuss project findings with statewide Diocesan Congress of Filipino Catholic Clubs and the feasibility of using lay leaders to change the LMPA/ST of their parishioners from churches across Hawaii via a train-the-trainer lay leader model. This project will stimulate community engaged/team science research at our School of Nursing and enhance students' research skills.
1,273 studies on the registry are indexed under Sedentary Behavior; 300 are open to participants now.
This study's enrollment of 35 is below the median of 60 across 1,076 interventional studies indexed under Sedentary Behavior.
Browse Sedentary Behavior studies →University of Hawaii is the lead sponsor of 97 studies on the registry; 21 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Compared within Sedentary Behavior, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Need health care provider's approval/clearance before enrollment if potential participant has the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The telephone counseling plus group cohesion intervention is designed to increase Light-to-Moderate intensity physical activity (LMPA) and reduce Sedentary time (ST). The 12-wk intervention includes group discussions during 3 regular monthly club meetings when clubs' accumulated milestones for LMPA/ST min/wk will be identified and future cumulative club goals for PA/ST set. In addition, each member will receive 12 weekly personalized phone calls from health coaches who will use motivational interviewing to set individualized LMPA/ST goals setting, reduce barriers, and facilitate social support for LMPA/ST change.
Behavioral: Light-to-Moderate Physical Activity / Sedentary Time
Delayed Treatment (DT) / Healthy Aging materials Condition is for 12 weeks and participants receive 12 phone calls using a previously developed contact-matched protocol that uses mailed healthy aging information and telephone calls to assess symptom ratings. After the initial 12 weeks they then receive the LMPA/ST intervention
12 weeks of telephone counseling -motivational interviewing designed to increase leisure-time physical activity and decrease amount of sitting each day
Also known as: LMPA/ST
Minutes Per Week of Hi/Light Intensity Physical Activity
The Community Health Activities Model Program for Seniors (CHAMPS) survey was used to assess this outcome. Participants reported the number of times/week they do a specific physical activity, and then choose one of 6 time frames that represent the amount of time they did that activity, from less than one hr/week to 9 or more hours/week. Minutes per week of high-light intensity were defined as the sum of all the minutes of physical activities with \>2 and \<3 Metabolic Equivalents (METs).
Time frame: Measured at Baseline and after 12 weeks
Minutes Per Week of Moderate-to-vigorous Intensity Physical Activity
The CHAMPS survey was used to assess this outcome. Minutes per week of moderate-to-vigorous intensity physical activity were defined as the sum of all the minutes of physical activities with \>3 METs. For both conditions this was from baseline to at 12 weeks
Time frame: Measured at Baseline and after 12 weeks
Minutes Per Week Hi/Light Intensity Physical Activity
The CHAMPS survey was used to assess this outcome. Participants reported the number of times/week they do a specific physical activity, and then choose one of 6 time frames that represent the amount of time they did that activity, from less than one hr/week to 9 or more hours/week. Minutes per week of high-light intensity were defined as the sum of all the minutes of physical activities with \>2 and \<3 METs. For LMPA/ST condition, their post-intervention was at 12 weeks and their maintenance was at 24 weeks. For DT/HA condition, their post-intervention was at 24 weeks and their maintenance was at 36 weeks.
Time frame: 12 weeks after LMPA intervention ended
Hours Per Week of Sedentary Time
Sedentary behavior was measured via the Measure of Older Adults' Sedentary Time (MOST), a validated survey with good test-retest reliability and results from ST interventions have found it sensitive to change. The survey asked respondents to report the time they spent doing 7 different tasks/activities (over last week) while sitting or lying (other than sleeping/napping/ill in bed) including: (1) TV or video/DVD watching, (2) other screen use/internet use: computer/tablet/Smartphone, (3) reading, (4) socializing with friends or family (in-person or when talking on phone), (5) driving/riding in car or city bus, (6) doing hobbies, and (7) any other activities. The total time spent sitting for each task/activity and total across all tasks was calculated.
Time frame: Baseline and after 12 weeks
Breaks in Sitting Time Per Hour at Home
The Workplace Sitting Breaks Questionnaire (SITBRQ) asked respondents to consider the past 7 days, and report how many breaks from sitting were taken in an hour at work and at home. This could include standing, stretching, or taking a short walk. Participants were asked to not count breaks to prepare meals at home
Time frame: baseline and after 12 weeks
Breaks Per Hour in Sitting Time at Work
The Workplace Sitting Breaks Questionnaire (SITBRQ) asked respondents to consider the past 7 days, and report how many breaks from sitting were taken in an hour at work. This could include standing, stretching, or taking a short walk. Participants were asked to not count lunch breaks/coffee breaks at work
Time frame: baseline and after 12 weeks
Percent That Met 150 Minutes of Moderate-to-vigorous Physical Activity (MVPA) Per Week
Outcome was a binary variable reporting whether a participant met 150 min per week of MVPA at each of the two time points (1=met the recommendation, 0=did not meet).
Time frame: baseline and after 12 weeks
Recruitment occurred onsite at Catholic churches in the community.
| Milestone | Light to Moderate Physical Activity/Sedentary Time | Delayed Treatment/Healthy Aging |
|---|---|---|
| Started | 12 | 23 |
| Completed | 8 | 16 |
| Not completed | 4 | 7 |
| Withdrew: Failed complete 12 wk survey | 4 | 7 |
| Milestone | Light to Moderate Physical Activity/Sedentary Time | Delayed Treatment/Healthy Aging |
|---|---|---|
| Started | 8 | 16 |
| Completed | 6 | 16 |
| Not completed | 2 | 0 |
| Withdrew: Failed complete 12 or 24 wk surveys | 2 | 0 |
| Milestone | Light to Moderate Physical Activity/Sedentary Time | Delayed Treatment/Healthy Aging |
|---|---|---|
| Started | 6 | 16 |
| Completed | 5 | 16 |
| Not completed | 1 | 0 |
| Withdrew: Failed to complete 36 wk survey | 1 | 0 |
The Community Health Activities Model Program for Seniors (CHAMPS) survey was used to assess this outcome. Participants reported the number of times/week they do a specific physical activity, and then choose one of 6 time frames that represent the amount of time they did that activity, from less than one hr/week to 9 or more hours/week. Minutes per week of high-light intensity were defined as the sum of all the minutes of physical activities with \>2 and \<3 Metabolic Equivalents (METs).
| minutes per week | Light-to-Moderate Physical Activity and Sedentary TIme Condition | Delayed Treatment/Healthy Aging Condition |
|---|---|---|
| Baseline | 445 ± 274 | 335 ± 300 |
| 12 weeks | 626 ± 271 | 493 ± 330 |
The CHAMPS survey was used to assess this outcome. Minutes per week of moderate-to-vigorous intensity physical activity were defined as the sum of all the minutes of physical activities with \>3 METs. For both conditions this was from baseline to at 12 weeks
| minutes per week | Light to Moderate Physical Activity/Sedentary Behavior Condition | Delayed Treatment/Healthy Aging Condition |
|---|---|---|
| baseline | 180 ± 207 | 171 ± 175 |
| 12-weeks | 238 ± 191 | 308 ± 268 |
The CHAMPS survey was used to assess this outcome. Participants reported the number of times/week they do a specific physical activity, and then choose one of 6 time frames that represent the amount of time they did that activity, from less than one hr/week to 9 or more hours/week. Minutes per week of high-light intensity were defined as the sum of all the minutes of physical activities with \>2 and \<3 METs. For LMPA/ST condition, their post-intervention was at 12 weeks and their maintenance was at 24 weeks. For DT/HA condition, their post-intervention was at 24 weeks and their maintenance was at 36 weeks.
| Minutes per week | Light to Moderate Physical Activity/Sedentary Behavior Condition | Delayed Treatment/Healthy Aging Condition |
|---|---|---|
| Post-intervention | 626 ± 271 | 504 ± 430 |
| Maintenance | 695 ± 408 | 550 ± 461 |
Sedentary behavior was measured via the Measure of Older Adults' Sedentary Time (MOST), a validated survey with good test-retest reliability and results from ST interventions have found it sensitive to change. The survey asked respondents to report the time they spent doing 7 different tasks/activities (over last week) while sitting or lying (other than sleeping/napping/ill in bed) including: (1) TV or video/DVD watching, (2) other screen use/internet use: computer/tablet/Smartphone, (3) reading, (4) socializing with friends or family (in-person or when talking on phone), (5) driving/riding in car or city bus, (6) doing hobbies, and (7) any other activities. The total time spent sitting for each task/activity and total across all tasks was calculated.
| Hours per week | Light to Moderate Physical Activity/Sedentary Time Condition | Delayed Treatment/Healthy Aging Condition |
|---|---|---|
| Baseline | 5.4 ± 4.9 | 6.3 ± 6.3 |
| 12 Weeks | 5.4 ± 3.9 | 6.5 ± 5.1 |
The Workplace Sitting Breaks Questionnaire (SITBRQ) asked respondents to consider the past 7 days, and report how many breaks from sitting were taken in an hour at work and at home. This could include standing, stretching, or taking a short walk. Participants were asked to not count breaks to prepare meals at home
| breaks per hour | Light to Moderate Physical Activity/Sedentary Time Condition | Delayed Treatment/Healthy Aging Condition |
|---|---|---|
| baseline | 2.5 ± 1.7 | 1.1 ± 1.0 |
| 12 weeks | 4.6 ± 1.5 | 1.7 ± 1.4 |
The Workplace Sitting Breaks Questionnaire (SITBRQ) asked respondents to consider the past 7 days, and report how many breaks from sitting were taken in an hour at work. This could include standing, stretching, or taking a short walk. Participants were asked to not count lunch breaks/coffee breaks at work
| breaks per hour in sitting at work | Light to Moderate Physical Activity/Sedentary Time Condition | Delayed Treatment/Healthy Aging Condition |
|---|---|---|
| baseline | 2.6 ± 1.8 | 1.5 ± 1.5 |
| 12 weeks | 4.2 ± 1.3 | 1.4 ± 1.7 |
Outcome was a binary variable reporting whether a participant met 150 min per week of MVPA at each of the two time points (1=met the recommendation, 0=did not meet).
| Participants | Light to Moderate Physical Activity/Sedentary Time Condition | Delayed Treatment/Healthy Aging Condition |
|---|---|---|
| baseline met 150 min MVPA | 6 | 9 |
| 12-wks met 150 min MVPA | 5 | 10 |
Collected over Continuous systematic collection adverse events after enrollment first began March, 2018 via surveys (collected 12, 24, 36 weeks after enrollment) and verbal questions at the end of telephone calls held weekly after enrollment for first 12 -24 weeks depending on condition.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Light to Moderate Physical Activity/Sedentary Time | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Delayed Treatment/Healthy Aging | 0/23 (0%) | 1/23 (4.3%) | 0/23 (0%) |
| Event | Light to Moderate Physical Activity/Sedentary Time | Delayed Treatment/Healthy Aging |
|---|---|---|
| Serious adverse event - hospitalizationSurgical and medical procedures | 0/12 | 1/23 |
Adults recruited from community-based Catholic Churches
| Age, Continuous(years) | Light to Moderate Physical Activity/Sedentary Time | Delayed Treatment/Healthy Aging | Total |
|---|---|---|---|
| Mean | 65.5 ± 6.6 | 63.8 ± 6.1 | 64.4 ± 6.2 |
| Sex: Female, Male(Participants) | Light to Moderate Physical Activity/Sedentary Time | Delayed Treatment/Healthy Aging | Total |
|---|---|---|---|
| Female | 10 | 18 | 28 |
| Male | 2 | 5 | 7 |
| Race (NIH/OMB)(Participants) | Light to Moderate Physical Activity/Sedentary Time | Delayed Treatment/Healthy Aging | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 12 | 22 | 34 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 1 | 1 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Light to Moderate Physical Activity/Sedentary Time | Delayed Treatment/Healthy Aging | Total |
|---|---|---|---|
| United States | 12 | 23 | 35 |
| Minutes per week physical activity(minutes per week) | Light to Moderate Physical Activity/Sedentary Time | Delayed Treatment/Healthy Aging | Total |
|---|---|---|---|
| Mean | 180 ± 207 | 171 ± 175 | 174 ± 183 |
| Minutes/week of High-Light physical activity(minutes per week) | Light to Moderate Physical Activity/Sedentary Time | Delayed Treatment/Healthy Aging | Total |
|---|---|---|---|
| Mean | 445 ± 274 | 335 ± 300 | 370 ± 293 |
| Breaks per hour at baseline(breaks per hour) | Light to Moderate Physical Activity/Sedentary Time | Delayed Treatment/Healthy Aging | Total |
|---|---|---|---|
| Mean | 2.5 ± 1.7 | 1.1 ± 1.0 | 1.8 ± 1.3 |
| Sitting time hours per day(hours per day) | Light to Moderate Physical Activity/Sedentary Time | Delayed Treatment/Healthy Aging | Total |
|---|---|---|---|
| Mean | 5.4 ± 4.9 | 6.3 ± 6.3 | 5.8 ± 5.6 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Deidentified data will be available for Univ. of Hawaii graduate students/post-doctoral fellows who have been involved in the project for dissertations or publications, first, then to others. Individuals wishing to use our data will be required to fill out a Data Sharing Request Form, which asks for information on the type of data set being requested, anticipated data use, research questions, study design, variables, analysis plan, and human subjects approval. We will also plan for general release and sharing of deidentified data (following the acceptance for publication of the main findings from the study) as we believe this to be essential for expedited translation of research results into larger arenas to improve human health.
Ran from Mar 2018 to primary completion in Jan 2020, 22 months.
Results were first posted in Jun 2023, 3 years 4 months after primary completion.
Of 733 non-industry interventional studies with no phase under Sedentary Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's 22 months is above that.
Counting every sponsor, half of 741 studies reached it within 14 months; a quarter within 6 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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