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Increasing Physical Activity in Filipino Lay Leaders From Catholic Clubs Within a Faith-based Council

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ClinicalTrials.gov Identifier: NCT03439852
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
University of Hawaii

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.

Condition or disease Intervention/treatment Phase
Physical Activity Behavioral: Light-to-Moderate Physical Activity / Sedentary Time Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: cluster randomized controlled trial comparing intervention to delayed treatment condition
Masking: Single (Outcomes Assessor)
Masking Description: data management / data entry blinded to study condition
Primary Purpose: Prevention
Official Title: Increasing Physical Activity in Filipino Lay Leaders
Actual Study Start Date : March 11, 2018
Estimated Primary Completion Date : February 22, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Light to Moderate Physical Activity/Sedentary Time
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 Name: LMPA/ST

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



Primary Outcome Measures :
  1. Change from baseline in Light to moderate intensity physical activity [ Time Frame: baseline, 12 weeks, ]
    change in minutes per week of light-to-moderate intensity physical activity

  2. Change from baseline in Light to moderate intensity physical activity [ Time Frame: baseline, 24 weeks ]
    change in minutes per week of light-to-moderate intensity physical activity

  3. Change from baseline in Light to moderate intensity physical activity [ Time Frame: baseline, 36 weeks ]
    change in minutes per week of light-to-moderate intensity physical activity at 36 weeks


Secondary Outcome Measures :
  1. Change from baseline in Sedentary time [ Time Frame: baseline , 12 weeks ]
    change from baseline in hours/week spent sitting or lying down to 12 weeks

  2. Change from baseline in Sedentary time [ Time Frame: baseline, 24 weeks ]
    change from baseline in hours/wk spent sitting or lying down to 24 weeks

  3. Change from baseline in Sedentary time [ Time Frame: baseline, 36 weeks ]
    change from baseline in hours/wk spent sitting or lying down to 36 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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. You recommend that your patient 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439852


Contacts
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Contact: Mark Yabui 8086921809 myabui@hawaii.edu
Contact: James Kowalski 8089564968 jamesmk@hawaii.edu

Locations
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United States, Hawaii
Mark Yabui Recruiting
Honolulu, Hawaii, United States, 96822
Contact: Mark Yabui    808-692-1809    myabui@hawaii.edu   
Contact: James Kowalski    8089564968    jamesmk@hawaii.edu   
Principal Investigator: Clementina D Ceria-Ulep, PhD, RN         
Principal Investigator: Cheryl L Albright, PhD, MPH         
Sub-Investigator: Rhea Faye D Felicilda-Reynaldo, EdD, RN         
Sub-Investigator: Eunjung Lim, PhD         
Sub-Investigator: Alice Tse, PhD, RN         
Sponsors and Collaborators
University of Hawaii
Investigators
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Principal Investigator: Clementina Ceria-Ulep, PhD University of Hawaii
Principal Investigator: Cheryl L Albright, PhD University of Hawaii
  Study Documents (Full-Text)

Documents provided by University of Hawaii:
Informed Consent Form  [PDF] May 21, 2018


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Responsible Party: University of Hawaii
ClinicalTrials.gov Identifier: NCT03439852     History of Changes
Other Study ID Numbers: R15MD011474 ( U.S. NIH Grant/Contract )
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Time Frame: 2020, unknown
Access Criteria: completion of a form with research question and analysis justification

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Hawaii:
physical activity