NCT03337204

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

3 months

First QC Date

November 6, 2017

Last Update Submit

November 10, 2017

Conditions

Sedentary Lifestyle

Outcome Measures

Primary Outcomes (1)

  • Physical Activity: Steps per day

    Measured using the Fitbit Zip pedometer

    worn daily for 8 weeks

Secondary Outcomes (3)

  • Cognitive activity (CA)(assessed daily)

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

  • Social interaction (SI) (assessed daily)

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

  • Personal meaning (PM) (assessed daily)

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

Study Arms (2)

Engaged4Life

EXPERIMENTAL

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.

Behavioral: Technology-assisted self-monitoringBehavioral: Workshop and Peer Mentoring

Technology-assisted self-monitoring only

ACTIVE COMPARATOR

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.

Behavioral: Technology-assisted self-monitoring

Interventions

Technology-assisted self-monitoringBEHAVIORAL

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).

Engaged4LifeTechnology-assisted self-monitoring only
Workshop and Peer MentoringBEHAVIORAL

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

Engaged4Life

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.1097/00005650-200209000-00007.

    PMID: 12218768BACKGROUND

  • 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.

    PMID: 21073109BACKGROUND

  • 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.

    PMID: 23758511BACKGROUND

  • 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.

    PMID: 15047786BACKGROUND

  • 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.

    PMID: 23680986BACKGROUND

  • 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.

    PMID: 23968220BACKGROUND

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Christina J Costa, PhD

    Boston College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2017

First Posted

November 8, 2017

Study Start

July 31, 2015

Primary Completion

November 3, 2015

Study Completion

December 22, 2015

Last Updated

November 17, 2017

Record last verified: 2017-11