Clinical trial NCT03439852: Modifying Physical Activity and Sedentary Time in Filipino Faith Leaders
Official title: Increasing Physical Activity in Filipino Lay Leaders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity and Sedentary Behavior
Healthy Aging
Keywords: physical activity
Sedentary time
Lead sponsor: University of Hawaii
Sponsor class: OTHER
First posted: 2018-02-20
Enrollment: 35
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cluster randomized controlled trial comparing physical activity/sedentary time intervention to delayed treatment condition
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Minutes Per Week of Hi/Light Intensity Physical Activity
timeFrame: Measured at Baseline and after 12 weeks
measure: Minutes Per Week of Moderate-to-vigorous Intensity Physical Activity
timeFrame: Measured at Baseline and after 12 weeks
measure: Minutes Per Week Hi/Light Intensity Physical Activity
timeFrame: 12 weeks after LMPA intervention ended
Secondary outcomes:
measure: Hours Per Week of Sedentary Time
timeFrame: Baseline and after 12 weeks
measure: Breaks in Sitting Time Per Hour at Home
timeFrame: baseline and after 12 weeks
measure: Breaks Per Hour in Sitting Time at Work
timeFrame: baseline and after 12 weeks
measure: Percent That Met 150 Minutes of Moderate-to-vigorous Physical Activity (MVPA) Per Week
timeFrame: baseline and after 12 weeks
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: University of Hawaii at Manoa, Office of Research Services
state: Hawaii
Study officials:
affiliation: University of Hawaii
name: Clementina Ceria-Ulep, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Hawaii
name: Cheryl L Albright, PhD
role: PRINCIPAL_INVESTIGATOR
References: