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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG073053 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This randomized controlled trial will test whether a recently developed community-based intergenerational mentoring program known as Generation Xchange (GenX) can enhance antiviral resistance in older African-American women and men in a low-SES urban community. Additional studies will identify the biological processes that promote resistance to respiratory virus infections and viral disease in older African-American women and men.
This randomized controlled intervention trial (planned n=160) will test whether participation in the Generation Xchange (GenX) intergenerational mentoring program can reduces vulnerability to respiratory virus infections (COVID, influenzas, colds), increase antiviral immune activity (Type I interferon responses), and reduce inflammatory immune activity in older African-American women and men living in a socioeconomically disadvantaged urban community. Blood samples will also be collected to determine which biological factors are most important in protecting older African-Americans from respiratory virus infection, and which of those factors is affected by the GenX intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate GenX | Experimental | Participants immediately commence GenX program activity (intergenerational mentoring) |
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| Delayed GenX | Active Comparator | Participants engage in parallel training/educational activities, and subsequently commence GenX program activity after 3 months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GenX intergenerational mentoring program | Behavioral | GenX trains older adults to collaborate with K-3rd grade teachers in mentoring high-need elementary school students in core reading and math skills. |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Type I interferon antiviral activity (bioassay International Units / mL) | Blood cell production of Type I interferon activity will stimulated by exposure to a fixed dose of model viral protein (TruCulture Resiquimod R848 tubes) and quantifying Type I interferon concentration in the cell culture supernatant fluid using the standard Armstrong bioassay (Armstrong, J.A. Cytopathic effect inhibition assay for interferon: microculture plate assay. Methods in enzymology 78, 381-387 (1981).) Antiviral activity is quantified as International Units of Interferon activity / mL. | 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory virus antibody concentration (WHO international units BAU/mL) | Respiratory virus infection (cold, influenza, COVID) will be assessed by multiplex IgG serological assay (MesoScale Discovery V-PLEX COVID-19 Respiratory Panel 2; https://www.mesoscale.com/products/covid-19-respiratory-panel-2-igg-k15372u/). Concentrations are quantified as WHO international Binding Antibody Units / mL. | 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Antiviral cell prevalence | Levels of key antiviral immune cells (e.g., dendritic cells, CD8+ T cells, etc.) will be assessed in blood samples by flow cytometry | 10 months |
| Antiviral gene regulation | Activity of antiviral genes (RNA) and transcription factors will be assessed in blood cells |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Cole, Ph.D. | Professor of Medicine & Psychiatry | Principal Investigator |
| Teresa E Seeman, Ph.D. | Professor of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA School of Medicine | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31589939 | Background | Seeman T, Merkin SS, Goldwater D, Cole SW. Intergenerational mentoring, eudaimonic well-being and gene regulation in older adults: A pilot study. Psychoneuroendocrinology. 2020 Jan;111:104468. doi: 10.1016/j.psyneuen.2019.104468. Epub 2019 Sep 27. |
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No IPD will be shared.
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| ID | Term |
|---|---|
| D012327 | RNA Virus Infections |
| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| D007239 | Infections |
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Randomized to Immediate GenX intervention vs. Waitlist Control delayed intervention
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All data collected, assayed, coded, and analyzed by researchers blind to study condition and participant identity
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| Pro-inflammatory cytokine concentration (pg/mL) | Blood plasma and blood cell culture supernatant fluids will be assayed for expression of pro-inflammatory cytokines (e.g., IL1B, IL6, TNF) using the MesoScale Discovery U-PLEX Macrophage M1 Combo 1 hu assay (https://www.mesoscale.com/products/u-plex-macrophage-m1-combo-1-human-k15336k/). Measurement units are pg of cytokine / mL. | 10 months |
| 10 months |
| Well-being | Surveys will measure eudaimonic well-being and hedonic well-being | 10 months |
| Loneliness | Surveys will measure loneliness, social isolation, and social support | 10 months |
| Depressive symptoms | Surveys will measure symptoms of depression | 10 months |