Modifying Physical Activity and Sedentary Time in Filipino Faith Leaders

Healthy Aging Clinical Trial

Official title:

Increasing Physical Activity in Filipino Lay Leaders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03439852
• Other study ID #: R15MD011474
• Status: Completed
• Phase: N/A
• Start date: March 11, 2018
• Est. completion date: May 31, 2021

Study information

• Verified date: May 2023
• Source: University of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 31, 2021
• Est. primary completion date: January 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

Inclusion Criteria:

• Member in one of 10 Filipino Catholic Clubs (within the Oahu Council of Filipino Catholic Clubs) on the island of Oahu in the state of Hawaii

Exclusion Criteria:

1. Age: less than 55 years OR older than 75 years of age

2. Planning to move (off the island of Oahu) in the next 9 months

3. Body Mass Index: If BMI is < 18.5 or > 40 (we will be measuring their height and weight to determine BMI at enrollment)

4. Currently exercising: Regularly (weekly) active at a moderate intensity* or higher >60 minutes a week (* = brisk walk)

5. Currently in Treatment: Actively having cancer treatment or in physical therapy following surgery/stroke

6. A recent (in last 6 months) diagnosis of: Cancer, Heart disease, had a heart attack, Lung disease, Chronic Kidney Disease, Stroke, or underwent surgery

7. Physician recommends that person have only supervised physical activity (i.e., in a health care / physical therapy setting)

8. Needs a cane or walker (or other assistive device) to walk especially outdoors on uneven surfaces

Need health care provider's approval/clearance before enrollment if potential participant has the following:

1. Asthma or other respiratory disease made worse by exercise

2. A heart valve problem or is taking medications for a heart condition

3. Severe osteoarthritis

4. Insulin dependent Type 1 or Type 2 diabetes (or often has a blood glucose > 235 mg/dl or 13mmol/L) (need MD clearance if do not know blood glucose)

5. Diagnosis/Treatment for Cancer over last 12 months or had a Stroke in the past (> 6 months ago)

6. Resting blood pressure = 160/90 (with or without medications) (need MD clearance if do not know BP)

7. Has chest pain when exercising or recently (last 4 weeks) developed any chest pain (i.e., when not doing physical activity)

8. Has tendency to lose consciousness or collapse from dizziness

9. Has a bone or joint problem that could be aggravated by physical activity

Related Conditions & MeSH terms

• Healthy Aging
• Physical Activity and Sedentary Behavior

Intervention

Behavioral:
• Light-to-Moderate Physical Activity / Sedentary Time
12 weeks of telephone counseling -motivational interviewing designed to increase leisure-time physical activity and decrease amount of sitting each day

Locations

Country	Name	City	State
United States	University of Hawaii at Manoa, Office of Research Services	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
University of Hawaii

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Measured at Baseline and after 12 weeks
Primary	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	Measured at Baseline and after 12 weeks
Primary	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.	12 weeks after LMPA intervention ended
Secondary	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.	Baseline and after 12 weeks
Secondary	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	baseline and after 12 weeks
Secondary	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	baseline and after 12 weeks
Secondary	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).	baseline and after 12 weeks