LEAPTogether: An Intergenerational Intervention to Address Loneliness and Social Isolation

Sponsor
Cedars-Sinai Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05831475
Collaborator
FlexTogether (Other)
80
1
2
24
3.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Intergenerational Virtual Paired Exercise
  • Behavioral: Peer Virtual Paired Exercise
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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)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)
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Leveraging Exercise to Age in Place (LEAP) Together: An Intergenerational Intervention to Address Loneliness and Social Isolation
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Adherence to an 8-week virtual paired exercise program for older adults [Attendance over 8-weeks]

    Adherence defined as attending at least 12 out of 16 sessions (70% attendance)

Secondary Outcome Measures

  1. social connectedness per units in scale [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).

  2. pre/post loneliness per units in scale [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)

  3. pre/post emotional, social, and psychological well-being per units in scale [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)

  4. pre/post expectations regarding aging per units in scale [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)

  5. pre/post generativity per units in scale [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)

  6. pre/post physical activity per units in scale [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)

  7. pre/post physical activity per 30 second sit to stand [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)

  8. long-term social connectedness per units in scale [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).

  9. long-term loneliness per units in scale [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)

  10. long-term expectations regarding aging per units in scale [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)

  11. long-term emotional, social, and psychological well-being per units in scale [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)

  12. long-term generativity per units in scale [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)

  13. long-term physical activity per units in scale [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)

  14. long-term physical activity per 30 second sit to stand [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)

  15. Key social pairing components in virtual programming [10 weeks]

    Qualitative interview to capture any other thoughts and observations from participants that are not easily captured in surveys

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cedars-Sinai Medical Center Beverly Hills California United States 90211

Sponsors and Collaborators

  • Cedars-Sinai Medical Center
  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Allison Mays, Principal Investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT05831475
Other Study ID Numbers:
  • STUDY00001980
First Posted:
Apr 26, 2023
Last Update Posted:
Apr 26, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Allison Mays, Principal Investigator, Cedars-Sinai Medical Center

Study Results

No Results Posted as of Apr 26, 2023