Modifying Physical Activity and Sedentary Time in Filipino Faith Leaders

NCT03439852 | Completed Results DMC

• 1 other identifier: R15MD011474
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity and Sedentary Behavior; Healthy Aging

Keywords

physical activity; Sedentary time

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (4)

• Hours Per Week of Sedentary Time

  Baseline and after 12 weeks

• Breaks in Sitting Time Per Hour at Home

  baseline and after 12 weeks

• Breaks Per Hour in Sitting Time at Work

  baseline and after 12 weeks

• Percent That Met 150 Minutes of Moderate-to-vigorous Physical Activity (MVPA) Per Week

  baseline and after 12 weeks

Study Arms (2)

Light to Moderate Physical Activity/Sedentary behavior

EXPERIMENTAL

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/Healthy Aging

NO INTERVENTION

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

Interventions

Light-to-Moderate Physical Activity / Sedentary Time BEHAVIORAL

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

Light to Moderate Physical Activity/Sedentary behavior

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age: less than 55 years OR older than 75 years of age
• Planning to move (off the island of Oahu) in the next 9 months
• Body Mass Index: If BMI is \< 18.5 or \> 40 (we will be measuring their height and weight to determine BMI at enrollment)
• Currently exercising: Regularly (weekly) active at a moderate intensity\* or higher \>60 minutes a week (\* = brisk walk)
• Currently in Treatment: Actively having cancer treatment or in physical therapy following surgery/stroke
• A recent (in last 6 months) diagnosis of: Cancer, Heart disease, had a heart attack, Lung disease, Chronic Kidney Disease, Stroke, or underwent surgery
• Physician recommends that person have only supervised physical activity (i.e., in a health care / physical therapy setting)
• 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:
• Asthma or other respiratory disease made worse by exercise
• A heart valve problem or is taking medications for a heart condition
• Severe osteoarthritis
• 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)
• Diagnosis/Treatment for Cancer over last 12 months or had a Stroke in the past (\> 6 months ago)
• Resting blood pressure ≥ 160/90 (with or without medications) (need MD clearance if do not know BP)

Sponsors & Collaborators

• University of Hawaii: lead

Study Sites (1)

University of Hawaii at Manoa, Office of Research Services

Honolulu, Hawaii, 96822, United States

Location

MeSH Terms

Conditions

Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Sharleen Andreshak
• Organization: University of Hawaii at Manoa, Office of Research Studies

sfa2@hawaii.edu

808 356 5762

Study Officials

• Clementina Ceria-Ulep, PhD

  University of Hawaii

  PRINCIPAL INVESTIGATOR

• Cheryl L Albright, PhD

  University of Hawaii

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators blinded to outcome follow-up data reported by study condition until completion of intervention period. Outcomes assessor blinded to participant identity - data entered only with ID number
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cluster randomized controlled trial comparing physical activity/sedentary time intervention to delayed treatment condition

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: February 20, 2018
• Study Start: March 11, 2018
• Primary Completion: January 22, 2020
• Study Completion: May 31, 2021
• Last Updated: June 18, 2023
• Results First Posted: June 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)