Trial Outcomes & Findings for Modifying Physical Activity and Sedentary Time in Filipino Faith Leaders (NCT NCT03439852)

Last Updated: 2023-06-18

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

35 participants

Primary outcome timeframe

Measured at Baseline and after 12 weeks

Results posted on

2023-06-18

Participant Flow

Recruitment occurred onsite at Catholic churches in the community.

If the participants' self reported height/weight (i.e, BMI) (collected anonymously to determine eligibility prior to signing a consent form) was below our BMI cutpoint, but their measured height and weight exceeded our BMI cutpoint (measured after consent form signed), participants were excluded from study before condition-specific information was provided.

Participant milestones

Participant milestones
Measure	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. 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	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
Baseline to 12 Weeks STARTED	12	23
Baseline to 12 Weeks COMPLETED	8	16
Baseline to 12 Weeks NOT COMPLETED	4	7
12weeks to 24weeks STARTED	8	16
12weeks to 24weeks COMPLETED	6	16
12weeks to 24weeks NOT COMPLETED	2	0
24 Weeks to 36 Weeks Follow up STARTED	6	16
24 Weeks to 36 Weeks Follow up COMPLETED	5	16
24 Weeks to 36 Weeks Follow up NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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	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
Baseline to 12 Weeks Failed complete 12 wk survey	4	7
12weeks to 24weeks failed complete 12 or 24 wk surveys	2	0
24 Weeks to 36 Weeks Follow up failed to complete 36 wk survey	1	0

Baseline Characteristics

Modifying Physical Activity and Sedentary Time in Filipino Faith Leaders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Light to Moderate Physical Activity/Sedentary Time n=12 Participants 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. 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	Delayed Treatment/Healthy Aging n=23 Participants 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	Total n=35 Participants Total of all reporting groups
Age, Continuous	65.5 years STANDARD_DEVIATION 6.6 • n=5 Participants	63.8 years STANDARD_DEVIATION 6.1 • n=7 Participants	64.4 years STANDARD_DEVIATION 6.2 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	18 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants	22 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	23 participants n=7 Participants	35 participants n=5 Participants
Minutes per week physical activity	180 minutes per week STANDARD_DEVIATION 207 • n=5 Participants	171 minutes per week STANDARD_DEVIATION 175 • n=7 Participants	174 minutes per week STANDARD_DEVIATION 183 • n=5 Participants
Minutes/week of High-Light physical activity	445 minutes per week STANDARD_DEVIATION 274 • n=5 Participants	335 minutes per week STANDARD_DEVIATION 300 • n=7 Participants	370 minutes per week STANDARD_DEVIATION 293 • n=5 Participants
Breaks per hour at baseline	2.5 breaks per hour STANDARD_DEVIATION 1.7 • n=5 Participants	1.1 breaks per hour STANDARD_DEVIATION 1.0 • n=7 Participants	1.8 breaks per hour STANDARD_DEVIATION 1.3 • n=5 Participants
Sitting time hours per day	5.4 hours per day STANDARD_DEVIATION 4.9 • n=5 Participants	6.3 hours per day STANDARD_DEVIATION 6.3 • n=7 Participants	5.8 hours per day STANDARD_DEVIATION 5.6 • n=5 Participants
Breaks per hour in sitting time at work	2.6 breaks per hour STANDARD_DEVIATION 1.8 • n=5 Participants	1.5 breaks per hour STANDARD_DEVIATION 1.5 • n=7 Participants	2.05 breaks per hour STANDARD_DEVIATION 1.65 • n=5 Participants

PRIMARY outcome

Timeframe: Measured at Baseline and after 12 weeks

Population: Analyses were performed on randomized participants who provided both a baseline and 12-week (follow-up) assessment (survey), regardless of the level of physical activity/sedentary time they reported during a phone call, the number of condition-specific telephone calls they received, or the number of LMPA/ST condition group cohesion sessions they attended. Four participants in LMPA/ST condition and 7 participants in DT/HG condition did not provide a 12-week assessment.

Outcome measures

Outcome measures
Measure	Light-to-Moderate Physical Activity and Sedentary TIme Condition n=11 Participants The telephone counseling plus group cohesion intervention was 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 were identified and future cumulative club goals for PA/ST set. In addition, each member received 12 weekly phone calls from health coaches who used motivational interviewing to set individualized LMPA/ST goals setting, reduce barriers, and facilitate social support for LMPA/ST change.	Delayed Treatment/Healthy Aging Condition n=23 Participants Delayed Treatment (DT) / Healthy Aging materials Condition lasted for 12 weeks and participants received 12 phone calls using a previously developed contact-matched protocol that used mailed healthy aging information and telephone calls to assess daily symptom ratings. After the initial 12 weeks they then received the LMPA/ST intervention
Minutes Per Week of Hi/Light Intensity Physical Activity Baseline	445 minutes per week Standard Deviation 274	335 minutes per week Standard Deviation 300
Minutes Per Week of Hi/Light Intensity Physical Activity 12 weeks	626 minutes per week Standard Deviation 271	493 minutes per week Standard Deviation 330

PRIMARY outcome

Timeframe: Measured at Baseline and after 12 weeks

Population: Analyses on participants who provided a pre and post intervention survey, regardless of the level of physical activity/sedentary time they reported during a phone call, the number of condition-specific telephone calls they received, or the number of LMPA/ST group cohesion sessions they attended. Four participants in LMPA/ST condition and 7 participants in DT/HG condition did not provide a 12-week assessment.

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

Outcome measures

Outcome measures
Measure	Light-to-Moderate Physical Activity and Sedentary TIme Condition n=11 Participants The telephone counseling plus group cohesion intervention was 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 were identified and future cumulative club goals for PA/ST set. In addition, each member received 12 weekly phone calls from health coaches who used motivational interviewing to set individualized LMPA/ST goals setting, reduce barriers, and facilitate social support for LMPA/ST change.	Delayed Treatment/Healthy Aging Condition n=23 Participants Delayed Treatment (DT) / Healthy Aging materials Condition lasted for 12 weeks and participants received 12 phone calls using a previously developed contact-matched protocol that used mailed healthy aging information and telephone calls to assess daily symptom ratings. After the initial 12 weeks they then received the LMPA/ST intervention
Minutes Per Week of Moderate-to-vigorous Intensity Physical Activity baseline	180 minutes per week Standard Deviation 207	171 minutes per week Standard Deviation 175
Minutes Per Week of Moderate-to-vigorous Intensity Physical Activity 12-weeks	238 minutes per week Standard Deviation 191	308 minutes per week Standard Deviation 268

PRIMARY outcome

Timeframe: 12 weeks after LMPA intervention ended

Population: Analyses on participants who provided a 12 wk maintenance ( 12 wks after intervention ended) survey, regardless of the level of physical activity/sedentary time they reported during a phone call, the number of condition-specific telephone calls they received, or the number of LMPA/ST condition group cohesion sessions attended. Six participants in LMPA/ST condition and 6 in DT/HA condition did not provide a 24-week survey. At 36 weeks, 6 in DT/HA did not provide a survey

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.

Outcome measures

Outcome measures
Measure	Light-to-Moderate Physical Activity and Sedentary TIme Condition n=6 Participants The telephone counseling plus group cohesion intervention was 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 were identified and future cumulative club goals for PA/ST set. In addition, each member received 12 weekly phone calls from health coaches who used motivational interviewing to set individualized LMPA/ST goals setting, reduce barriers, and facilitate social support for LMPA/ST change.	Delayed Treatment/Healthy Aging Condition n=17 Participants Delayed Treatment (DT) / Healthy Aging materials Condition lasted for 12 weeks and participants received 12 phone calls using a previously developed contact-matched protocol that used mailed healthy aging information and telephone calls to assess daily symptom ratings. After the initial 12 weeks they then received the LMPA/ST intervention
Minutes Per Week Hi/Light Intensity Physical Activity Maintenance	695 Minutes per week Standard Deviation 408	550 Minutes per week Standard Deviation 461
Minutes Per Week Hi/Light Intensity Physical Activity Post-intervention	626 Minutes per week Standard Deviation 271	504 Minutes per week Standard Deviation 430

SECONDARY outcome

Timeframe: Baseline and after 12 weeks

Population: Table reports data from surveys collected at baseline and 12 weeks and the results from repeated measures analyses for 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.

Outcome measures

Outcome measures
Measure	Light-to-Moderate Physical Activity and Sedentary TIme Condition n=12 Participants The telephone counseling plus group cohesion intervention was 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 were identified and future cumulative club goals for PA/ST set. In addition, each member received 12 weekly phone calls from health coaches who used motivational interviewing to set individualized LMPA/ST goals setting, reduce barriers, and facilitate social support for LMPA/ST change.	Delayed Treatment/Healthy Aging Condition n=23 Participants Delayed Treatment (DT) / Healthy Aging materials Condition lasted for 12 weeks and participants received 12 phone calls using a previously developed contact-matched protocol that used mailed healthy aging information and telephone calls to assess daily symptom ratings. After the initial 12 weeks they then received the LMPA/ST intervention
Hours Per Week of Sedentary Time Baseline	5.4 Hours per week Standard Deviation 4.9	6.3 Hours per week Standard Deviation 6.3
Hours Per Week of Sedentary Time 12 Weeks	5.4 Hours per week Standard Deviation 3.9	6.5 Hours per week Standard Deviation 5.1

SECONDARY outcome

Timeframe: baseline and after 12 weeks

Population: Participants were sent 3 surveys after baseline, at 12wk, 24wk, and 36 wks, if a participant did not complete one of these surveys he/she was still sent the next survey unless they had asked to be dropped from study

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

Outcome measures

Outcome measures
Measure	Light-to-Moderate Physical Activity and Sedentary TIme Condition n=12 Participants The telephone counseling plus group cohesion intervention was 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 were identified and future cumulative club goals for PA/ST set. In addition, each member received 12 weekly phone calls from health coaches who used motivational interviewing to set individualized LMPA/ST goals setting, reduce barriers, and facilitate social support for LMPA/ST change.	Delayed Treatment/Healthy Aging Condition n=23 Participants Delayed Treatment (DT) / Healthy Aging materials Condition lasted for 12 weeks and participants received 12 phone calls using a previously developed contact-matched protocol that used mailed healthy aging information and telephone calls to assess daily symptom ratings. After the initial 12 weeks they then received the LMPA/ST intervention
Breaks in Sitting Time Per Hour at Home baseline	2.5 breaks per hour Standard Deviation 1.7	1.1 breaks per hour Standard Deviation 1.0
Breaks in Sitting Time Per Hour at Home 12 weeks	4.6 breaks per hour Standard Deviation 1.5	1.7 breaks per hour Standard Deviation 1.4

SECONDARY outcome

Timeframe: baseline and after 12 weeks

Population: number ofbreaks 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

Outcome measures

Outcome measures
Measure	Light-to-Moderate Physical Activity and Sedentary TIme Condition n=12 Participants The telephone counseling plus group cohesion intervention was 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 were identified and future cumulative club goals for PA/ST set. In addition, each member received 12 weekly phone calls from health coaches who used motivational interviewing to set individualized LMPA/ST goals setting, reduce barriers, and facilitate social support for LMPA/ST change.	Delayed Treatment/Healthy Aging Condition n=23 Participants Delayed Treatment (DT) / Healthy Aging materials Condition lasted for 12 weeks and participants received 12 phone calls using a previously developed contact-matched protocol that used mailed healthy aging information and telephone calls to assess daily symptom ratings. After the initial 12 weeks they then received the LMPA/ST intervention
Breaks Per Hour in Sitting Time at Work baseline	2.6 breaks per hour in sitting at work Standard Deviation 1.8	1.5 breaks per hour in sitting at work Standard Deviation 1.5
Breaks Per Hour in Sitting Time at Work 12 weeks	4.2 breaks per hour in sitting at work Standard Deviation 1.3	1.4 breaks per hour in sitting at work Standard Deviation 1.7

SECONDARY outcome

Timeframe: baseline and after 12 weeks

Population: Participants were sent 3 surveys following baseline each 12 weeks apart (thus baseline, 12wk, 24wk, and 36wk). Some people did not complete one or more of the follow-up surveys. They were sent a survey at each time points unless they told us they no longer wanted to participate in the study.

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).

Outcome measures

Outcome measures
Measure	Light-to-Moderate Physical Activity and Sedentary TIme Condition n=12 Participants The telephone counseling plus group cohesion intervention was 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 were identified and future cumulative club goals for PA/ST set. In addition, each member received 12 weekly phone calls from health coaches who used motivational interviewing to set individualized LMPA/ST goals setting, reduce barriers, and facilitate social support for LMPA/ST change.	Delayed Treatment/Healthy Aging Condition n=23 Participants Delayed Treatment (DT) / Healthy Aging materials Condition lasted for 12 weeks and participants received 12 phone calls using a previously developed contact-matched protocol that used mailed healthy aging information and telephone calls to assess daily symptom ratings. After the initial 12 weeks they then received the LMPA/ST intervention
Percent That Met 150 Minutes of Moderate-to-vigorous Physical Activity (MVPA) Per Week 12-wks met 150 min MVPA	5 Participants	10 Participants
Percent That Met 150 Minutes of Moderate-to-vigorous Physical Activity (MVPA) Per Week baseline met 150 min MVPA	6 Participants	9 Participants

Adverse Events

Light to Moderate Physical Activity/Sedentary Time

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Delayed Treatment/Healthy Aging

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Light to Moderate Physical Activity/Sedentary Time n=12 participants at risk 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. 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	Delayed Treatment/Healthy Aging n=23 participants at risk 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
Surgical and medical procedures Serious adverse event - hospitalization	0.00% 0/12 • Continuous systematic collection adverse events after enrollment first began March, 2018 via surveys (collected 12, 24, 36 weeks after enrollment) and verbal questions at the end of telephone calls held weekly after enrollment for first 12 -24 weeks depending on condition. reported to study staff by participant on intervention phone call	4.3% 1/23 • Number of events 1 • Continuous systematic collection adverse events after enrollment first began March, 2018 via surveys (collected 12, 24, 36 weeks after enrollment) and verbal questions at the end of telephone calls held weekly after enrollment for first 12 -24 weeks depending on condition. reported to study staff by participant on intervention phone call

Other adverse events

Adverse event data not reported

Additional Information

Sharleen Andreshak

University of Hawaii at Manoa, Office of Research Studies

Phone: 808 356 5762

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place