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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03337204
Other study ID # 2017-003
Secondary ID P30AG048785
Status Completed
Phase N/A
First received November 6, 2017
Last updated November 10, 2017
Start date July 31, 2015
Est. completion date December 22, 2015

Study information

Verified date November 2017
Source Boston College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 22, 2015
Est. primary completion date November 3, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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).
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Boston College National Institute on Aging (NIA)

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Physical Activity: Steps per day Measured using the Fitbit Zip pedometer worn daily for 8 weeks
Secondary 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. asked daily for 7 days at baseline and again for 7 days during week 4
Secondary 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. asked daily for 7 days at baseline and again for 7 days during week 4
Secondary 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 . asked daily for 7 days at baseline and again for 7 days during week 4
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