LEAPTogether: An Intergenerational Intervention to Address Loneliness and Social Isolation

NCT ID: NCT05831475

Last Updated: 2024-08-22

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-07

Study Completion Date

2025-10-31

Brief Summary

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Older adult participants will engage in exercise videos twice a week for 8 weeks either while paired with a peer (same age group) or paired with a younger adult with the ability to simultaneously video chat while exercising.

Detailed Description

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Participation in this study includes:

* Completing assessments at baseline (start of study), 8 weeks, and 16 weeks
* Initial meeting with an Exercise Physiologist to determine exercise interests and preferences
* Being matched with an exercise partner
* Virtually meeting with partner to engage in exercise videos via the FlexTogether platform (meet twice a week for a total of 8 weeks)
* Attend a live group class once a month
* Completing an exit interview

Primary Objective:

To assess feasibility by monitoring adherence to an 8-week virtual paired exercise program for older adults

Secondary Objectives:

1. To mechanistically investigate the key social pairing components (i.e., older adults together, younger and older adult pairing) within a virtual program necessary to enhance social connectedness, decrease loneliness, improve well-being, and increase physical activity in older adults and younger adult participants in the short-term (pre-post) through surveys and qualitative interviews
2. To mechanistically investigate the key social pairing components (i.e., older adults together, younger and older adult pairing) within a virtual program necessary to enhance social connectedness, decrease loneliness, improve well-being, and increase physical activity in older adults and younger adult participants in the long-term (8 weeks post-intervention / 18 weeks on study) through surveys and qualitative interviews

Conditions

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Social Isolation Loneliness Intergenerational Relations

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized by the coordinator to a study arm:

Arm 1- older adult paired with older adult (40) Arm 2- older adult paired with younger adult (20 older, 20 younger)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Peer Pairings

Two older adults paired

Group Type EXPERIMENTAL

Peer Virtual Paired Exercise

Intervention Type BEHAVIORAL

Participants will be paired with someone of the same age group and will engage in exercise videos with the ability to simultaneously video chat with their partner while exercising. Participants will log on with their partner twice a week for 8 weeks.

Intergenerational Pairings

A younger adult and older adult paired

Group Type EXPERIMENTAL

Intergenerational Virtual Paired Exercise

Intervention Type BEHAVIORAL

Participants will be paired with someone older/ younger and will engage in exercise videos with the ability to simultaneously video chat with their partner while exercising. Participants will log on with their partner twice a week for 8 weeks.

Interventions

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Intergenerational Virtual Paired Exercise

Participants will be paired with someone older/ younger and will engage in exercise videos with the ability to simultaneously video chat with their partner while exercising. Participants will log on with their partner twice a week for 8 weeks.

Intervention Type BEHAVIORAL

Peer Virtual Paired Exercise

Participants will be paired with someone of the same age group and will engage in exercise videos with the ability to simultaneously video chat with their partner while exercising. Participants will log on with their partner twice a week for 8 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Verbal informed consent obtained from subject and ability for subject to comply with the requirements of the study
* Age 18-30 years for younger adults
* Age greater than or equal to 65 years for older adults
* Has access to a tablet, laptop, or desktop computer with video capabilities connected to the internet with a screen at least 13 inches across
* Able to read, write, and understand English
* Has a 5 x 6 foot space at home in which to exercise

Exclusion Criteria

* Current diagnosis of dementia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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FlexTogether

UNKNOWN

Sponsor Role collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Allison Mays

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Celina H Shirazipour, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Allison M Mays, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Sonja Rosen, MD, FACP, AGSF

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

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Cedars-Sinai Medical Center

Beverly Hills, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Allison M Mays, MD, MAS

Role: CONTACT

(310) 385-3511

Nathalie Guevara

Role: CONTACT

310-248-6242

Facility Contacts

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Allison M Mays, MD, MAS

Role: primary

310-385-3511

Nathalie E Guevara

Role: backup

3102486242

References

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Steptoe A, Shankar A, Demakakos P, Wardle J. Social isolation, loneliness, and all-cause mortality in older men and women. Proc Natl Acad Sci U S A. 2013 Apr 9;110(15):5797-801. doi: 10.1073/pnas.1219686110. Epub 2013 Mar 25.

Reference Type BACKGROUND
PMID: 23530191 (View on PubMed)

Tiwari SC. Loneliness: A disease? Indian J Psychiatry. 2013 Oct;55(4):320-2. doi: 10.4103/0019-5545.120536. No abstract available.

Reference Type BACKGROUND
PMID: 24459300 (View on PubMed)

Perissinotto CM, Stijacic Cenzer I, Covinsky KE. Loneliness in older persons: a predictor of functional decline and death. Arch Intern Med. 2012 Jul 23;172(14):1078-83. doi: 10.1001/archinternmed.2012.1993.

Reference Type BACKGROUND
PMID: 22710744 (View on PubMed)

Ronzi S, Orton L, Pope D, Valtorta NK, Bruce NG. What is the impact on health and wellbeing of interventions that foster respect and social inclusion in community-residing older adults? A systematic review of quantitative and qualitative studies. Syst Rev. 2018 Jan 30;7(1):26. doi: 10.1186/s13643-018-0680-2.

Reference Type BACKGROUND
PMID: 29382375 (View on PubMed)

Teater B. Intergenerational Programs to Promote Active Aging: The Experiences and Perspectives of Older Adults. Activities, Adaptation & Aging. 2016/01/02 2016;40(1):1-19. doi:10.1080/01924788.2016.1127041

Reference Type BACKGROUND

Peters R, Ee N, Ward SA, Kenning G, Radford K, Goldwater M, Dodge HH, Lewis E, Xu Y, Kudrna G, Hamilton M, Peters J, Anstey KJ, Lautenschlager NT, Fitzgerald A, Rockwood K. Intergenerational Programmes bringing together community dwelling non-familial older adults and children: A Systematic Review. Arch Gerontol Geriatr. 2021 May-Jun;94:104356. doi: 10.1016/j.archger.2021.104356. Epub 2021 Jan 28.

Reference Type BACKGROUND
PMID: 33567363 (View on PubMed)

Kim Y, Kim J, Lee JM, Seo DC, Jung HC. Intergenerational Taekwondo Program: A Narrative Review and Practical Intervention Proposal. Int J Environ Res Public Health. 2022 Apr 26;19(9):5247. doi: 10.3390/ijerph19095247.

Reference Type BACKGROUND
PMID: 35564642 (View on PubMed)

Rizzo N. Fitness Industry Statistics 2021-2028 [Market Research]. 2021. https://runrepeat.com/fitness-industry

Reference Type BACKGROUND

Russell D, Peplau LA, Ferguson ML. Developing a measure of loneliness. J Pers Assess. 1978 Jun;42(3):290-4. doi: 10.1207/s15327752jpa4203_11.

Reference Type BACKGROUND
PMID: 660402 (View on PubMed)

Koenig HG, Westlund RE, George LK, Hughes DC, Blazer DG, Hybels C. Abbreviating the Duke Social Support Index for use in chronically ill elderly individuals. Psychosomatics. 1993 Jan-Feb;34(1):61-9. doi: 10.1016/S0033-3182(93)71928-3.

Reference Type BACKGROUND
PMID: 8426892 (View on PubMed)

Rikli RE, Jones CJ. Development and Validation of a Functional Fitness Test for Community-Residing Older Adults. Journal of Aging and Physical Activity. 01 Apr. 1999 1999;7(2):129-161. doi:10.1123/japa.7.2.129

Reference Type BACKGROUND

Other Identifiers

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STUDY00001980

Identifier Type: -

Identifier Source: org_study_id

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