LEAPTogether: An Intergenerational Intervention to Address Loneliness and Social Isolation (LEAPTogether)

August 21, 2024 updated by: Allison Mays, Cedars-Sinai Medical Center

Leveraging Exercise to Age in Place (LEAP) Together: An Intergenerational Intervention to Address Loneliness and Social Isolation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Cedars-Sinai Medical Center
        • Principal Investigator:
          • Celina H Shirazipour, Ph.D.
        • Contact:
        • Contact:
        • Principal Investigator:
          • Allison M Mays, MD,MAS
        • Principal Investigator:
          • Sonja Rosen, MD,FACP,AGSF
        • Sub-Investigator:
          • Nathalie Guevara
        • Sub-Investigator:
          • Bianca Luna-Luperico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peer Pairings
Two older adults paired
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.
Experimental: Intergenerational Pairings
A younger adult and older adult paired
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to an 8-week virtual paired exercise program for older adults
Time Frame: Attendance over 8-weeks
Adherence defined as attending at least 12 out of 16 sessions (70% attendance)
Attendance over 8-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
social connectedness per units in scale
Time Frame: baseline and 10 weeks
To mechanistically investigate the key social pairing components (i.e. solo, older adults together, younger and older adult pairing) within a virtual program necessary to enhance social connectedness in the short-term (pre-post) through Duke Social Support Index (min score- 11, max score- 33; higher score indicates higher social support and interaction).
baseline and 10 weeks
pre/post loneliness per units in scale
Time Frame: baseline and 10 weeks
To mechanistically investigate the key social pairing components (i.e. solo, older adults together, younger and older adult pairing) within a virtual program necessary to decrease loneliness in the short-term (pre-post) through UCLA Loneliness Survey (min score- 3, max score- 9; higher scores correspond to higher feelings of loneliness)
baseline and 10 weeks
pre/post emotional, social, and psychological well-being per units in scale
Time Frame: baseline and 10 weeks
To mechanistically investigate the key social pairing components (i.e. solo, older adults together, younger and older adult pairing) within a virtual program necessary to improve well-being in the short-term (pre-post) through Mental Health Continuum Short-Form (min score- 14, max score- 84; higher scores indicate greater levels of positive well-being)
baseline and 10 weeks
pre/post expectations regarding aging per units in scale
Time Frame: baseline and 10 weeks
To mechanistically investigate the key social pairing components (i.e. solo, older adults together, younger and older adult pairing) within a virtual program necessary to improve well-being in the short-term (pre-post) through Expectations Regarding Aging Survey (min score- 12, max score- 48; higher score indicates higher (positive) expectations of aging)
baseline and 10 weeks
pre/post generativity per units in scale
Time Frame: baseline and 10 weeks
To mechanistically investigate the key social pairing components (i.e. solo, older adults together, younger and older adult pairing) within a virtual program necessary to improve well-being in the short-term (pre-post) through Baltimore Experience Corps Trial Generativity Scale (min score- 13, max score- 65; higher score indicates higher levels of generativity)
baseline and 10 weeks
pre/post physical activity per units in scale
Time Frame: baseline and 10 weeks
To mechanistically investigate the key social pairing components (i.e. solo, older adults together, younger and older adult pairing) within a virtual program necessary to increase physical activity in older adults and younger adult participants in the short-term (pre-post) through Godin Leisure Time Exercise Questionnaire (min score- 0, max score- 24+; total of 14 or less indicates insufficient activity/sedentary lifestyle, 24 units or more indicates active lifestyle)
baseline and 10 weeks
pre/post physical activity per 30 second sit to stand
Time Frame: baseline and 10 weeks
To mechanistically investigate the key social pairing components (i.e. solo, older adults together, younger and older adult pairing) within a virtual program necessary to increase physical activity in older adults and younger adult participants in the short-term (pre-post) through 30 second sit to stand (how many times can the participant sit and stand without using their hands in a 30 second period, higher number indicates higher level of endurance)
baseline and 10 weeks
long-term social connectedness per units in scale
Time Frame: 18 weeks
To mechanistically investigate the key social pairing components (i.e. solo, older adults together, younger and older adult pairing) within a virtual program necessary to enhance social connectedness in the long-term (4.5 months/18 weeks) through Duke Social Support Index (min score- 11, max score- 33; higher score indicates higher social support and interaction).
18 weeks
long-term loneliness per units in scale
Time Frame: 18 weeks
To mechanistically investigate the key social pairing components (i.e. solo, older adults together, younger and older adult pairing) within a virtual program necessary to decrease loneliness in the long-term (4.5 months/18 weeks) through UCLA Loneliness Survey (min score- 3, max score- 9; higher scores correspond to higher feelings of loneliness)
18 weeks
long-term expectations regarding aging per units in scale
Time Frame: 18 weeks
To mechanistically investigate the key social pairing components (i.e. solo, older adults together, younger and older adult pairing) within a virtual program necessary to improve well-being in the long-term (4.5 months/18 weeks) through Expectations Regarding Aging Survey (min score- 12, max score- 48; higher score indicates higher (positive) expectations of aging)
18 weeks
long-term emotional, social, and psychological well-being per units in scale
Time Frame: 18 weeks
To mechanistically investigate the key social pairing components (i.e. solo, older adults together, younger and older adult pairing) within a virtual program necessary to improve well-being in the long-term (4.5 months/18 weeks) through Mental Health Continuum Short-Form (min score- 14, max score- 84; higher scores indicate greater levels of positive well-being)
18 weeks
long-term generativity per units in scale
Time Frame: 18 weeks
To mechanistically investigate the key social pairing components (i.e. solo, older adults together, younger and older adult pairing) within a virtual program necessary to improve well-being in the long-term (4.5 months/18 weeks) through Baltimore Experience Corps Trial Generativity Scale (min score- 13, max score- 65; higher score indicates higher levels of generativity)
18 weeks
long-term physical activity per units in scale
Time Frame: 18 weeks
To mechanistically investigate the key social pairing components within a virtual program necessary to increase physical activity in older adults and younger adult participants in the long-term (4.5 months/18 weeks) through Godin Leisure Time Exercise Questionnaire (min score- 0, max score- 24+; total of 14 or less indicates insufficient activity/sedentary lifestyle, 24 units or more indicates active lifestyle)
18 weeks
long-term physical activity per 30 second sit to stand
Time Frame: 18 weeks
To mechanistically investigate the key social pairing components within a virtual program necessary to increase physical activity in older adults and younger adult participants in the long-term (4.5 months/18 weeks) through 30 second sit to stand (how many times can the participant sit and stand without using their hands in a 30 second period, higher number indicates higher level of endurance)
18 weeks
Key social pairing components in virtual programming
Time Frame: 10 weeks
Qualitative interview to capture any other thoughts and observations from participants that are not easily captured in surveys
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Collaborators

FlexTogether

Investigators

  • Principal Investigator: Celina H Shirazipour, Ph.D., Cedars-Sinai Medical Center
  • Principal Investigator: Allison M Mays, MD, MAS, Cedars-Sinai Medical Center
  • Principal Investigator: Sonja Rosen, MD, FACP, AGSF, Cedars-Sinai Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2023

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

April 25, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00001980

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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