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NCT Number: NCT05831475

LEAPTogether: 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.

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Key information

Conditions

Social Isolation Behavior Intergenerational Relations Loneliness Motor Activity Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center

Beverly Hills, California, 90211, United States

Location status: Recruiting

Location contact

Allison M Mays, MD, MAS

CONTACT

[email protected]

310-385-3511

Allison M Mays, MD,MAS

PRINCIPAL_INVESTIGATOR

Bianca Luna-Luperico

SUB_INVESTIGATOR

Celina H Shirazipour, Ph.D.

PRINCIPAL_INVESTIGATOR

Nathalie E Guevara

CONTACT

[email protected]

3102486242

Nathalie Guevara

SUB_INVESTIGATOR

Sonja Rosen, MD,FACP,AGSF

PRINCIPAL_INVESTIGATOR

About this study

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:

  • 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
  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intergenerational Virtual Paired Exercise

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.

Peer Virtual Paired Exercise

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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).

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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).

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Allison M Mays, MD, MAS

CONTACT

[email protected]

(310) 385-3511

Nathalie Guevara

CONTACT

[email protected]

310-248-6242

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Collaborators

  • FlexTogether

Registry information

Official study title

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

Acronym: LEAPTogether

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 26, 2023
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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