Physical ActivityNCT01528761
Prosocial Behavior and Volunteerism to Promote Physical Activity in Older Adults
A study testing Prosocial Behavior Physical Activity (PBPA) and Healthy Aging (HA) in people with Physical Activity, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this 12-month study is to compare how well two programs help older adults make physical activity a regular habit. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Prosocial Behavior Physical Activity (PBPA) and Healthy Aging (HA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2011to 28 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 55 years or older
- physically underactive
- no evidence of any major psychological illness
- residence within 20 miles of study site
- plans to remain in area for duration of study
Who cannot join
- currently engaging in regular physical activity
- self-reported evidence of cardiovascular disease
- self-reported evidence of diabetes
- self-reported falling within the past year
- alcohol consumption greater than 14 drinks per week
- inability to understand English
Show all 9Show fewer
- plans to move from area
- participation in another medical intervention study
- severe hearing or sight impairments
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
About this study
The purpose of this 12-month study is to compare how well two programs help older adults make physical activity a regular habit.
Read the detailed description
Although only a small percentage of older adults engage in habitual physical activity, previous studies have demonstrated interventions that include cognitive-behavioral strategies can enhance long-term, independent physical activity. In addition, there are episodic charity events, such as charity walks, that attract large numbers of participants of all age ranges to engage in moderate-intensity physical activity. These actions are a form of prosocial behavior, defined as voluntary, intentional behavior that results in benefits for another. The opportunity to help others seems to be a motive in inspiring these individuals to at least engage in one session of moderate physical activity. Thus, the current research project contemplates whether prosocial behavior may be implemented as a viable behavioral incentive for long-term physical activity.
Participants in the Prosocial Behavior Physical Activity (PBPA) intervention will receive a cognitive-behavioral intervention to teach participants the behavioral skills necessary to engage in long-term (12-month) independent physical activity. Participants in the Healthy Aging (HA) intervention will receive excellent educational sessions based on a number of topics of relevance to older adults. Both programs will provide supervised stretching sessions so that participants learn how to safely and effectively improve flexibility, which helps reduce the likelihood of falls and disability. However, the PBPA intervention will also allow participants to earn food for donation to Second Harvest Food Bank based on their regular physical activity and volunteer time.
- Conditions
- Physical Activity
- Being tested
- Prosocial Behavior Physical Activity (PBPA), Healthy Aging (HA)
- Keywords
- physical activity, older adults, physical function, health-related quality of life, prosocial behavior, social cognitive theory
- Medical subject headings
- Motor Activity, Altruism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosocial Behavior Physical Activity (PBPA)Behavioural
The PBPA condition involves a cognitive-behavioral intervention to teach participants the behavioral skills to engage in independent physical activity. Participants will engage in supervised physical activity delivered two times a week during months 1 to 3 at the William G. White, Jr. Family YMCA in Winston-Salem, NC. During months 4 to 6, supervised sessions will be held once per week, and sessions will be held once per month in months 7 to 9. Participants will engage in completely independent physical activity in months 10 to 12. PBPA participants will also be able to earn boxes of food for donation to the Second Harvest Food Bank (SHFB) of Northwest North Carolina based upon their weekly physical activity. Lowe's Foods, a regional grocery chain, will donate the food. Participants in the PBPA intervention also will receive a 12-month membership to the William G. White, Jr. Family YMCA at no cost.
Healthy Aging (HA)Other
The HA group will receive a health education intervention based on topics from several sources, including the National Institute on Aging's Age Pages, University of Pittsburgh's 10 Keys to Healthy Aging; and Stanford University's Successful Aging program, among other topics . The HA intervention will receive ongoing staff contact, and will provide participants with excellent information on health-related topics. Biweekly 45-minute lectures will be given during months 1 to 6, and once per month during months 7 to 9. After each session, participants will engage in a 15-minute stretching routine. During months 10 to 12, no lectures will be given. After completion of the 12-month assessments, participants will receive a 12-month membership to the YMCA at no cost.
| Study group | Role | What they receive |
|---|---|---|
| Prosocial Behavior Physical Activity | Experimental | The PBPA condition involves a cognitive-behavioral intervention to teach participants the behavioral skills to engage in independent physical activity. Participants will engage in supervised physical activity delivered two times a week during months 1 to 3 at the William G. White, Jr. Family YMCA in Winston-Salem, NC. During months 4 to 6, supervised sessions will be held once per week, and sessions will be held once per month in months 7 to 9. Participants will engage in completely independent physical activity in months 10 to 12. PBPA participants will also be able to earn boxes of food for donation to the Second Harvest Food Bank (SHFB) of Northwest North Carolina based upon their weekly physical activity. Lowe's Foods, a regional grocery chain, will donate the food. Participants in the PBPA intervention also will receive a 12-month membership to the William G. White, Jr. Family YMCA at no cost. Receives: Behavioral: Prosocial Behavior Physical Activity (PBPA) |
| Healthy Aging (HA) | Active comparator | Behavioral: Healthy Aging (HA) The HA group will receive a health education intervention based on topics from several sources, including the National Institute on Aging's Age Pages, University of Pittsburgh's 10 Keys to Healthy Aging; and Stanford University's Successful Aging program, among other topics . The HA intervention will receive ongoing staff contact, and will provide participants with excellent information on health-related topics. Biweekly 45-minute lectures will be given during months 1 to 6, and once per month during months 7 to 9. After each session, participants will engage in a 15-minute stretching routine. During months 10 to 12, no lectures will be given. After completion of the 12-month assessments, participants will receive a 12-month membership to the YMCA at no cost. Receives: Other: Healthy Aging (HA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical activity
Self-reported physical activity will be assessed using a questionnaire at 4 time points among all participants; (1) at baseline before randomization; (2) 3 months after the interventions begin; (3) 6 months after the interventions begin; and (4) 12 months after the interventions begin
Measured: 12 months
Secondary outcomes (1)
physical function
A series of 3 physical function tests will be administered to all participants at three time points: (1) at baseline before randomization; (2) 3 months after the interventions begin; and (3) 12 months after the interventions begin. All of the tests are brief and uncomplicated to perform.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study start15 Aug 2011
- Primary completion28 Mar 2017
- Study completion28 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Capri G Foy, Ph.D., Principal investigator, Wake Forest University Baptist Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528761
- Sponsor's protocol ID
- IRB00017741
- Other IDs
- 1R01HL109429-04
- Status last verified
- Aug 2018
- First submitted
- 31 Jan 2012
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Foy CG, Vitolins MZ, Case LD, Harris SJ, Massa-Fanale C, Hopley RJ, Gardner L, Rudiger N, Yamamoto K, Swain B, Goff DC Jr, Danhauer SC, Booth D, Gaspari J. Incorporating prosocial behavior to promote physical activity in older adults: rationale and design of the Program for Active Aging and Community Engagement (PACE). Contemp Clin Trials. 2013 Sep;36(1):284-97. doi: 10.1016/j.cct.2013.07.004. Epub 2013 Jul 19.
PubMed 23876672Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.
PubMed 39360568
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosocial Behavior and Volunteerism to Promote Physical Activity in Older Adults
- ClinicalTrials.gov ID
- NCT01528761
- Acronym / sponsor ID
- IRB00017741
- Conditions
- Physical Activity
- Keywords
- physical activity, older adults, physical function, health-related quality of life, prosocial behavior, social cognitive theory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 15 Aug 2011 (actual)
- Primary completion
- 28 Mar 2017 (actual)
- Study completion
- 28 Mar 2017 (actual)
- First posted
- 8 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this 12-month study is to compare how well two programs help older adults make physical activity a regular habit.
Detailed description
Although only a small percentage of older adults engage in habitual physical activity, previous studies have demonstrated interventions that include cognitive-behavioral strategies can enhance long-term, independent physical activity. In addition, there are episodic charity events, such as charity walks, that attract large numbers of participants of all age ranges to engage in moderate-intensity physical activity. These actions are a form of prosocial behavior, defined as voluntary, intentional behavior that results in benefits for another. The opportunity to help others seems to be a motive in inspiring these individuals to at least engage in one session of moderate physical activity. Thus, the current research project contemplates whether prosocial behavior may be implemented as a viable behavioral incentive for long-term physical activity.
Participants in the Prosocial Behavior Physical Activity (PBPA) intervention will receive a cognitive-behavioral intervention to teach participants the behavioral skills necessary to engage in long-term (12-month) independent physical activity. Participants in the Healthy Aging (HA) intervention will receive excellent educational sessions based on a number of topics of relevance to older adults. Both programs will provide supervised stretching sessions so that participants learn how to safely and effectively improve flexibility, which helps reduce the likelihood of falls and disability. However, the PBPA intervention will also allow participants to earn food for donation to Second Harvest Food Bank based on their regular physical activity and volunteer time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prosocial Behavior Physical Activity | Experimental | Behavioral: Prosocial Behavior Physical Activity (PBPA)The PBPA condition involves a cognitive-behavioral intervention to teach participants the behavioral skills to engage in independent physical activity. Participants will engage in supervised physical activity delivered two times a week during months 1 to 3 at the William G. White, Jr. Family YMCA in Winston-Salem, NC. During months 4 to 6, supervised sessions will be held once per week, and sessions will be held once per month in months 7 to 9. Participants will engage in completely independent physical activity in months 10 to 12. PBPA participants will also be able to earn boxes of food for donation to the Second Harvest Food Bank (SHFB) of Northwest North Carolina based upon their weekly physical activity. Lowe's Foods, a regional grocery chain, will donate the food. Participants in the PBPA intervention also will receive a 12-month membership to the William G. White, Jr. Family YMCA at no cost. |
| Healthy Aging (HA) | Active comparator | Other: Healthy Aging (HA)Behavioral: Healthy Aging (HA) The HA group will receive a health education intervention based on topics from several sources, including the National Institute on Aging's Age Pages, University of Pittsburgh's 10 Keys to Healthy Aging; and Stanford University's Successful Aging program, among other topics . The HA intervention will receive ongoing staff contact, and will provide participants with excellent information on health-related topics. Biweekly 45-minute lectures will be given during months 1 to 6, and once per month during months 7 to 9. After each session, participants will engage in a 15-minute stretching routine. During months 10 to 12, no lectures will be given. After completion of the 12-month assessments, participants will receive a 12-month membership to the YMCA at no cost. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 55 years or older
- physically underactive
- no evidence of any major psychological illness
- residence within 20 miles of study site
- plans to remain in area for duration of study
Key exclusion criteria (9 listed)
- currently engaging in regular physical activity
- self-reported evidence of cardiovascular disease
- self-reported evidence of diabetes
- self-reported falling within the past year
- alcohol consumption greater than 14 drinks per week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prosocial Behavior Physical Activity (PBPA)The PBPA condition involves a cognitive-behavioral intervention to teach participants the behavioral skills to engage in independent physical activity. Participants will engage in supervised physical activity delivered two times a week during months 1 to 3 at the William G. White, Jr. Family YMCA in Winston-Salem, NC. During months 4 to 6, supervised sessions will be held once per week, and sessions will be held once per month in months 7 to 9. Participants will engage in completely independent physical activity in months 10 to 12. PBPA participants will also be able to earn boxes of food for donation to the Second Harvest Food Bank (SHFB) of Northwest North Carolina based upon their weekly physical activity. Lowe's Foods, a regional grocery chain, will donate the food. Participants in the PBPA intervention also will receive a 12-month membership to the William G. White, Jr. Family YMCA at no cost. | Behavioural | Prosocial Behavior Physical Activity |
| Healthy Aging (HA)The HA group will receive a health education intervention based on topics from several sources, including the National Institute on Aging's Age Pages, University of Pittsburgh's 10 Keys to Healthy Aging; and Stanford University's Successful Aging program, among other topics . The HA intervention will receive ongoing staff contact, and will provide participants with excellent information on health-related topics. Biweekly 45-minute lectures will be given during months 1 to 6, and once per month during months 7 to 9. After each session, participants will engage in a 15-minute stretching routine. During months 10 to 12, no lectures will be given. After completion of the 12-month assessments, participants will receive a 12-month membership to the YMCA at no cost. | Other | Healthy Aging (HA) |
Primary outcome
physical activity
Time frame: 12 months
Self-reported physical activity will be assessed using a questionnaire at 4 time points among all participants; (1) at baseline before randomization; (2) 3 months after the interventions begin; (3) 6 months after the interventions begin; and (4) 12 months after the interventions begin
1 secondary outcome
physical function
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Background: PubMed 23876672Foy CG, Vitolins MZ, Case LD, Harris SJ, Massa-Fanale C, Hopley RJ, Gardner L, Rudiger N, Yamamoto K, Swain B, Goff DC Jr, Danhauer SC, Booth D, Gaspari J. Incorporating prosocial behavior to promote physical activity in older adults: rationale and design of the Program for Active Aging and Community Engagement (PACE). Contemp Clin Trials. 2013 Sep;36(1):284-97. doi: 10.1016/j.cct.2013.07.004. Epub 2013 Jul 19.
- Derived from this study: PubMed 39360568Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Capri G Foy, Ph.D. principal investigator
Wake Forest University Baptist Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prosocial Behavior Physical Activity (PBPA) and Healthy Aging (HA) in people with Physical Activity, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physical activity (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01528761, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.