Trial Outcomes & Findings for Southwest Harvest for Health Vegetable Gardening Intervention (NCT NCT04251299)
NCT ID: NCT04251299
Last Updated: 2025-03-11
Results Overview
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.
COMPLETED
NA
30 participants
through study completion, an average of 9 months
2025-03-11
Participant Flow
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.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
|
30
|
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Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Southwest Harvest for Health Vegetable Gardening Intervention
Baseline characteristics by cohort
| Measure |
Single Arm
n=30 Participants
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.
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|---|---|
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Age, Continuous
|
68 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
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22 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic White
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 9 monthsPopulation: (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.
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.
Outcome measures
| Measure |
Single Arm
n=30 Participants
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.
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|---|---|
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Feasibility of the Intervention
Percentage recruited within 3 months
|
100 percentage of participants
|
|
Feasibility of the Intervention
Percent retention (completed study)
|
100 percentage of participants
|
|
Feasibility of the Intervention
Percentage adherence (twice monthly communication with mentor)
|
89 percentage of participants
|
|
Feasibility of the Intervention
Percentage Satisfaction (very good or excellent)
|
90 percentage of participants
|
SECONDARY outcome
Timeframe: baseline to 9-monthsThe 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.
Outcome measures
| Measure |
Single Arm
n=30 Participants
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.
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|---|---|
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Pre-post Change in Vegetable and Fruit Intake
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1.2 fruit & vegetable servings/day
Interval -0.4 to 2.2
|
SECONDARY outcome
Timeframe: baseline to 9-monthsPhysical activity will be objectively measured using the activPAL research grade monitor.
Outcome measures
| Measure |
Single Arm
n=30 Participants
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.
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|---|---|
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Pre-post Change in Objectively Measured Physical Activity
light-intensity physical activity
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-1.1 minutes per day
Interval -10.6 to 3.4
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|
Pre-post Change in Objectively Measured Physical Activity
moderate-intensity physical activity
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-4.2 minutes per day
Interval -13.8 to 3.7
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SECONDARY outcome
Timeframe: baseline to 9-monthsSelf-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.
Outcome measures
| Measure |
Single Arm
n=30 Participants
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.
|
|---|---|
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Pre-post Change in Sleep Quality
Sleep impairment
|
-0.2 change in points
Interval -6.0 to 5.1
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|
Pre-post Change in Sleep Quality
Sleep disturbance
|
-0.4 change in points
Interval -1.7 to 2.4
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SECONDARY outcome
Timeframe: baseline to 9-monthsSelf-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.
Outcome measures
| Measure |
Single Arm
n=30 Participants
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.
|
|---|---|
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Pre-post Change in Physical Function
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0.0 change in points
Interval -7.0 to 4.3
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SECONDARY outcome
Timeframe: baseline to 9-monthsPopulation: 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.
Physical performance will be objectively measured using the Rikli \& Jones Senior Fitness Battery.
Outcome measures
Outcome data not reported
Adverse Events
Single Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place