MedDataX Logo

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

NCT ID: NCT03337204

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-12-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sedentary Lifestyle

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Engaged4Life

Participants 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.

Group Type EXPERIMENTAL

Technology-assisted self-monitoring

Intervention Type BEHAVIORAL

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 Mentoring

Intervention Type BEHAVIORAL

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

Technology-assisted self-monitoring only

Participants 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.

Group Type ACTIVE_COMPARATOR

Technology-assisted self-monitoring

Intervention Type BEHAVIORAL

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Technology-assisted self-monitoring

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).

Intervention Type BEHAVIORAL

Workshop and Peer Mentoring

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Boston College

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christina J Costa, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston College

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 12218768 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21073109 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23758511 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15047786 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23680986 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23968220 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P30AG048785

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2017-003

Identifier Type: -

Identifier Source: org_study_id