Modifying Physical Activity and Sedentary Time in Filipino Faith Leaders

May 24, 2023 updated by: University of Hawaii

Increasing Physical Activity in Filipino Lay Leaders

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96822
        • University of Hawaii at Manoa, Office of Research Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Delayed Treatment/Healthy Aging
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
Experimental: Light to Moderate Physical Activity/Sedentary behavior
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
12 weeks of telephone counseling -motivational interviewing designed to increase leisure-time physical activity and decrease amount of sitting each day
Other Names:
  • LMPA/ST

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Minutes Per Week of Hi/Light Intensity Physical Activity
Time Frame: Measured at Baseline and after 12 weeks
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
Minutes Per Week of Moderate-to-vigorous Intensity Physical Activity
Time Frame: Measured at Baseline and after 12 weeks
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
Minutes Per Week Hi/Light Intensity Physical Activity
Time Frame: 12 weeks after LMPA intervention ended
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hours Per Week of Sedentary Time
Time Frame: Baseline and after 12 weeks
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
Breaks in Sitting Time Per Hour at Home
Time Frame: baseline and after 12 weeks
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
Breaks Per Hour in Sitting Time at Work
Time Frame: baseline and after 12 weeks
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
Percent That Met 150 Minutes of Moderate-to-vigorous Physical Activity (MVPA) Per Week
Time Frame: baseline and after 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Hawaii

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Clementina Ceria-Ulep, PhD, University of Hawaii
  • Principal Investigator: Cheryl L Albright, PhD, University of Hawaii

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 22, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R15MD011474 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

IPD Sharing Time Frame

2020, unknown

IPD Sharing Access Criteria

completion of a form with research question and analysis justification

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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