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Sedentary LifestyleNCT03337204

The Engaged4Life Study: Enhancing the Health-Promoting Effects of Older Adults' Activity Portfolios

A study testing Technology-assisted self-monitoring and Workshop and Peer Mentoring in people with Sedentary Lifestyle, run by Boston College.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study designs and tests a multi-component intervention- Engaged4Life- designed to enhance physical activity (PA), cognitive activity (CA), social interaction (SI) and personal meaning (PM) in low-engaged community-dwelling older adults' everyday life activities through: 1) technology-assisted self-monitoring of… Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Sedentary Lifestyle
What is being tested?
Technology-assisted self-monitoring and Workshop and Peer Mentoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
31 Jul 2015to 22 Dec 2015
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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Age of 65 or older
  • Low-to-moderate engagement levels as determined by a score of <10 on a modified version of the Health Enhancement Lifestyle Profile (HELP) (Hwang, 2010), where only the domains of exercise, social and productive activity, and leisure were included
  • A resident of Waltham, MA
  • Willing to be randomly assigned to study arm
  • Available for relevant study dates

Who cannot join

  • Age of 64 or younger
  • Living in an assisted living or nursing home facility
  • Significant cognitive impairment (those with >2 errors on the six-item screener by Callahan, Unverzagt, Hui, Perkins, \& Hendrie, 2002)
  • Reports that a doctor has told them that it is unsafe to participate in physical activity

About this study

Official title: Enhancing the Health-Promoting Effects of Older Adults' Activity Portfolios: The Development, Feasibility and Initial Efficacy of an Ecologically Sensitive Intervention

This study designs and tests a multi-component intervention- Engaged4Life- designed to enhance physical activity (PA), cognitive activity (CA), social interaction (SI) and personal meaning (PM) in low-engaged community-dwelling older adults' everyday life activities through: 1) technology-assisted self-monitoring of PA, CA, SI, and PM activity engagement, 2) psycho-education + goal setting (via a 3-hour workshop), and 3) one-on-one peer mentoring (via phone 2X/week for 3 weeks) to support goal implementation. 15 adults age 65 or older will be randomized to receive all 3 intervention components and 15 to receive only the technology-assisted self-monitoring component.

Read the detailed description

The Social Model of Health Promotion posits that physical, cognitive, and social activity embedded within activities can help maintain or even restore cognitive and functional health in later life and stimulating activities that carry personal meaning or confer a sense of purpose may have stronger health-promoting effects than activities that are just stimulating. While the Experience Corps program-a community volunteering program for older adults designed to explicitly embed these characteristics-is an effective model for health-promotion, this program is not, as of yet, widely accessible. Further, formal volunteering is not always an activity that is attractive or accessible for older adults, and other interventions aimed at promoting social role involvement among older adults have shown only limited effectiveness in doing so. Thus, the current study explores whether it is possible to create an individually-tailored intervention that encourages older adults to 1) carefully examine their existing "activity portfolios" (technology-assisted self-monitoring), 2) empowers them with the knowledge and skills to make improvements upon their "activity portfolios" by enhancing/supplementing activities in ways that increase their overall levels of physical activity, cognitive activity, social interaction, and personal meaning (psycho-education + goal setting via a workshop), and 3) provides social support through peers in implementing their goals (one-on-one peer mentoring). Targeting a sample of community dwelling older adults who are at-risk for adverse cognitive and physical health outcomes due to their sedentary activity levels, we aim to influence positive changes in overall health and well-being in a way that is more practical, effective, and sustainable than prior interventions.

Being tested
Technology-assisted self-monitoring, Workshop and Peer Mentoring
Medical subject headings
Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Technology-assisted self-monitoringBehavioural

    Participants receive a Fitbit Zip, an iPad Mini tablet device, training on how to use the Fitbit and iPad, and are asked to complete brief surveys each night on their activity engagement that day (for two 7-day periods).

  • Workshop and Peer MentoringBehavioural

    Participants receive a 3-hour Engaged4Life Workshop (psychoeducation + goal setting) and one-on-one peer mentoring via phone 2X/week for 3 weeks.

Study groups in NCT03337204
Study groupRoleWhat they receive
Engaged4LifeExperimentalParticipants randomly assigned to this group receive: 1) technology-assisted self-monitoring of daily activity via a Fitbit Zip worn daily (for 8 weeks) and a daily tablet self-report survey (completed for a 7-day period at baseline and a second 7-day period 4-weeks later); and 2) a one-time, 3hr workshop and peer mentoring (via phone 2X/week for 3 weeks). The workshop includes psychoeducation on the relationship between active engagement and health and well-being and a goal setting activity focused on carefully assessing and then make improvements upon existing "activity portfolios". Peer mentors provide support as participants implement their goals.
Receives: Behavioral: Technology-assisted self-monitoring; Behavioral: Workshop and Peer Mentoring
Technology-assisted self-monitoring onlyActive comparatorParticipants randomly assigned to this group receive: 1) technology-assisted self-monitoring of daily activity via a Fitbit Zip worn daily (for 8 weeks) and a daily tablet self-report survey (completed for a 7-day period at baseline and a second 7-day period 4-weeks later). While it is expected that wearing the Fitbit and raising consciousness of activity engagement may initially result in behavior change, it is not expected to have a sustained impact on outcomes over time.
Receives: Behavioral: Technology-assisted self-monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical Activity: Steps per day

    Measured using the Fitbit Zip pedometer

    Measured: worn daily for 8 weeks

Secondary outcomes (3)

  1. Cognitive activity (CA)(assessed daily)

    Cognitive activity (CA) assessed daily was measured as respondents' assessment of the number of cognitively stimulating activities they had participated in that day from a list of 13 activities plus one possible write-in "other" activity.

    Measured: asked daily for 7 days at baseline and again for 7 days during week 4

  2. Social interaction (SI) (assessed daily)

    Social interaction (SI) questions focused on the quantity (the number of social interactions the respondent had that day, including in-person, by telephone, or by video, but NOT including email, text, or social media) and the quality (whether the participant had a problematic social interaction that day and the perceived stress of the problematic social interaction; and whether the participant had a positive social interaction that day and the perceived positivity of that social interaction) of daily social interactions.

    Measured: asked daily for 7 days at baseline and again for 7 days during week 4

  3. Personal meaning (PM) (assessed daily)

    Respondents were asked 4 questions around whether they did anything that day that 1) benefited others, 2) left them feeling personally satisfied or accomplished, 3) felt significant in the broader scheme of things, or 4) was personally meaningful. Response options included 0 (not at all), 1 (to some extent), and 3 (to a great extent). Respondents were also asked a more global question: How much did you feel your life had purpose today? Th response scale ranged from 1 to 7 .

    Measured: asked daily for 7 days at baseline and again for 7 days during week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2017
  2. Study start31 Jul 2015
  3. Primary completion3 Nov 2015
  4. Study completion22 Dec 2015

Resources

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
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03337204
Sponsor's protocol ID
2017-003
Other IDs
P30AG048785
Status last verified
Nov 2017
First submitted
6 Nov 2017
Last updated
17 Nov 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Callahan CM, Unverzagt FW, Hui SL, Perkins AJ, Hendrie HC. Six-item screener to identify cognitive impairment among potential subjects for clinical research. Med Care. 2002 Sep;40(9):771-81. doi: 10.1097/00005650-200209000-00007.

    PubMed 12218768

  • Hwang JE. Promoting healthy lifestyles with aging: development and validation of the Health Enhancement Lifestyle Profile (HELP) using the Rasch measurement model. Am J Occup Ther. 2010 Sep-Oct;64(5):786-95. doi: 10.5014/ajot.2010.09088.

    PubMed 21073109

  • Heaven B, Brown LJ, White M, Errington L, Mathers JC, Moffatt S. Supporting well-being in retirement through meaningful social roles: systematic review of intervention studies. Milbank Q. 2013 Jun;91(2):222-87. doi: 10.1111/milq.12013.

    PubMed 23758511

  • Fried LP, Carlson MC, Freedman M, Frick KD, Glass TA, Hill J, McGill S, Rebok GW, Seeman T, Tielsch J, Wasik BA, Zeger S. A social model for health promotion for an aging population: initial evidence on the Experience Corps model. J Urban Health. 2004 Mar;81(1):64-78. doi: 10.1093/jurban/jth094.

    PubMed 15047786

  • Fried LP, Carlson MC, McGill S, Seeman T, Xue QL, Frick K, Tan E, Tanner EK, Barron J, Frangakis C, Piferi R, Martinez I, Gruenewald T, Martin BK, Berry-Vaughn L, Stewart J, Dickersin K, Willging PR, Rebok GW. Experience Corps: a dual trial to promote the health of older adults and children's academic success. Contemp Clin Trials. 2013 Sep;36(1):1-13. doi: 10.1016/j.cct.2013.05.003. Epub 2013 May 13.

    PubMed 23680986

  • Jenkinson CE, Dickens AP, Jones K, Thompson-Coon J, Taylor RS, Rogers M, Bambra CL, Lang I, Richards SH. Is volunteering a public health intervention? A systematic review and meta-analysis of the health and survival of volunteers. BMC Public Health. 2013 Aug 23;13:773. doi: 10.1186/1471-2458-13-773.

    PubMed 23968220

Questions about this trial

What is this clinical trial studying?

A study testing Technology-assisted self-monitoring and Workshop and Peer Mentoring in people with Sedentary Lifestyle, run by Boston College.

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 4 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 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

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: Steps per day (time frame: worn daily for 8 weeks). 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 NCT03337204, which also lists 6 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 17 Nov 2017.

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