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| Name | Class |
|---|---|
| University of New Mexico Cancer Center | OTHER |
| New Mexico State University | OTHER |
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"Harvest for Health" is a home-based vegetable gardening intervention that pairs cancer survivors with certified master gardeners (MGs) from the Cooperative Extension System, the education and outreach arm of land-grant universities nationwide.
Few lifestyle behavior change interventions have been successfully translated into practice. Addressing this research-to-practice gap is a significant research and public health priority. "Harvest for Health" is a home-based vegetable gardening intervention that pairs cancer survivors with certified Master Gardeners from the Cooperative Extension System. The parent study was started at the University of Alabama at Birmingham and is currently being conducted throughout the entire state of Alabama. Preliminary findings suggest that this intervention increases vegetable consumption and physical activity, and improves physical functioning and health-related quality of life. We propose a feasibility study to adapt this promising program to the multi-cultural population of cancer survivors and for the local context (physical, social, and cultural environment) of New Mexico. We will then implement the adapted program, "Southwest Harvest for Health" and evaluate feasibility, acceptability, and fidelity. The adaptation phase is a critical first step towards widespread dissemination, implementation, and scale-up of an evidence-based intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | All participants will receive the 10-month mentored, vegetable gardening intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| home-based, mentored vegetable gardening program | Behavioral | The mentored vegetable gardening program pairs each participant with a certified Master Gardener. The participant/Master Gardener dyads work together to plan, plant and tend to a vegetable garden at the participant's home throughout the year. Gardening supplies, plants and seeds are provided. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the Intervention | Ability to recruit 25 cancer survivors in 3 months, achieve 80% retention rates, 80% adherence to the intervention, and high acceptability of the program for both cancer survivors (participants) and Cooperative Extension Master Gardeners. | through study completion, an average of 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-post Change in Vegetable and Fruit Intake | The number of daily servings of vegetables and fruits will be measured by the Eating at America's Table Screener (EATS) questionnaire; this 10-item NCI-developed questionnaire will be able to assess whether individuals increase by more than one serving of vegetables/fruits per day. | baseline to 9-months |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cindy K Blair, PhD | University of New Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
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Distributed recruitment flyers in community locations, e.g., cancer survivor support groups, community centers. Also, oncologists, physicians, and nurse navigators referred patients (cancer survivors). Self-referrals.
Note: Master Gardeners are not participants; they were not enrolled and consented, nor did they complete outcome assessments; instead, they are volunteers from the Extension Master Gardener Program who delivered the interention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | All participants will receive the 10-month mentored, vegetable gardening intervention home-based, mentored vegetable gardening program: The mentored vegetable gardening program pairs each participant with a certified Master Gardener. The participant/Master Gardener dyads work together to plan, plant and tend to a vegetable garden at the participant's home throughout the year. Gardening supplies, plants and seeds are provided. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Only the cancer survivors enrolled in the study completed the baseline and post-intervention assessments. The Master Gardener mentors delivered the intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | All participants will receive the 10-month mentored, vegetable gardening intervention home-based, mentored vegetable gardening program: The mentored vegetable gardening program pairs each participant with a certified Master Gardener. The participant/Master Gardener dyads work together to plan, plant and tend to a vegetable garden at the participant's home throughout the year. Gardening supplies, plants and seeds are provided. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of the Intervention | Ability to recruit 25 cancer survivors in 3 months, achieve 80% retention rates, 80% adherence to the intervention, and high acceptability of the program for both cancer survivors (participants) and Cooperative Extension Master Gardeners. | (1) Percentage of participants recruited within 3 months; (2) percentage of participants who completed the study; (3) percentage of participants adhering to twice monthly communication with Master Gardener mentor; (4) percentage rating their experience with the intervention as very good or excellent. | Posted | Number | percentage of participants | through study completion, an average of 9 months |
|
9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm | All participants (cancer survivors) will receive the 10-month mentored, vegetable gardening intervention home-based, mentored vegetable gardening program: The mentored vegetable gardening program pairs each participant with a certified Master Gardener. The participant/Master Gardener dyads work together to plan, plant and tend to a vegetable garden at the participant's home throughout the year. Gardening supplies, plants and seeds are provided. Note: Data are not collected for Master Gardeners who deliver the intervention; neither baseline data, post-intervention data, nor adverse events are collected/recorded for Master Gardeners. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cindy Blair | University of New Mexico | 15059257907 | CiBlair@salud.unm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 1, 2020 | Jan 7, 2024 | Prot_SAP_ICF_000.pdf |
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| Pre-post Change in Objectively Measured Physical Activity | Physical activity will be objectively measured using the activPAL research grade monitor. | baseline to 9-months |
| Pre-post Change in Sleep Quality | Self-reported sleep quality will be assessed using the PROMIS 8-item questionnaires for sleep impairment and sleep disturbance. Raw scores range from 8 to 40; higher scores indicate worse sleep quality; T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. | baseline to 9-months |
| Pre-post Change in Physical Function | Self-reported physical function will be assessed using the 8-item physical function scale. Raw scores range from 8 to 40; higher scores indicate better physical function; T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. | baseline to 9-months |
| Pre-post Change in Physical Performance | Physical performance will be objectively measured using the Rikli & Jones Senior Fitness Battery. | baseline to 9-months |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Pre-post Change in Vegetable and Fruit Intake | The number of daily servings of vegetables and fruits will be measured by the Eating at America's Table Screener (EATS) questionnaire; this 10-item NCI-developed questionnaire will be able to assess whether individuals increase by more than one serving of vegetables/fruits per day. | Posted | Median | Inter-Quartile Range | fruit & vegetable servings/day | baseline to 9-months |
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| Secondary | Pre-post Change in Objectively Measured Physical Activity | Physical activity will be objectively measured using the activPAL research grade monitor. | Posted | Median | Inter-Quartile Range | minutes per day | baseline to 9-months |
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| Secondary | Pre-post Change in Sleep Quality | Self-reported sleep quality will be assessed using the PROMIS 8-item questionnaires for sleep impairment and sleep disturbance. Raw scores range from 8 to 40; higher scores indicate worse sleep quality; T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. | Posted | Median | Inter-Quartile Range | change in points | baseline to 9-months |
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| Secondary | Pre-post Change in Physical Function | Self-reported physical function will be assessed using the 8-item physical function scale. Raw scores range from 8 to 40; higher scores indicate better physical function; T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. | Posted | Median | Inter-Quartile Range | change in points | baseline to 9-months |
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| Secondary | Pre-post Change in Physical Performance | Physical performance will be objectively measured using the Rikli & Jones Senior Fitness Battery. | Due to the COVID-19 pandemic, the in-person assessment of physical performance was dropped. Studies at the University of New Mexico were not allowed to conduct in-person assessments in 2020 after the pandemic was declared. Therefore, no post-intervention data on physical performance was collected (for any participant), and it is not possible to calculate change in physical performance. Only baseline physical performance data was collected. | Posted | baseline to 9-months |
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| 30 |
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