Clinical trial NCT04251299: Southwest Harvest for Health Vegetable Gardening Intervention
Official title: Southwest Harvest for Health: A Mentored Vegetable Gardening Intervention for Cancer Survivors in New Mexico
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivor
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: University of New Mexico Cancer Center
name: New Mexico State University
First posted: 2020-01-31
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: "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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age 50 years or older
* Residing in Bernalillo or Sandoval County, New Mexico
* Diagnosed with an invasive cancer (any type)
* Completed primary treatment (surgery, radiation, chemotherapy)(note: endocrine therapy is allowed)
* Able to read, speak, and understand English (The future larger trial will include Spanish-Speaking participants)
* Not told by a physician to limit physical activity and no pre-existing medical condition(s) that would preclude home gardening, e.g., severe orthopedic conditions, hip or knee replacement surgery within 6 months), end-stage renal disease, paralysis, dementia, blindness, unstable angina, untreated stage 3 hypertension, or recent history of myocardial infarction, congestive heart failure, or pulmonary conditions that required oxygen or hospitalization within 6 months.
* Currently not adhering to the recommended number of fruit and vegetable servings per day (consuming fewer than 5 servings of vegetables and fruits/day and not meeting the recommended guidelines for moderate-to-vigorous physical activity (\< 150 minutes/week)
* Reside in a location that can accommodate a 4' x 8' raised garden bed or 4 (29" x 14") garden containers, or adequate (at least 4 hours) of sunlight per day and have access to running water
* No existing or recent (within the past year) experience with vegetable gardening
* Able to participate in the 10-month intervention (all three seasonal gardens; from mid-February through early November 2020)

Primary outcomes:
measure: Feasibility of the Intervention
timeFrame: through study completion, an average of 9 months
Secondary outcomes:
measure: Pre-post Change in Vegetable and Fruit Intake
timeFrame: baseline to 9-months
measure: Pre-post Change in Objectively Measured Physical Activity
timeFrame: baseline to 9-months
measure: Pre-post Change in Sleep Quality
timeFrame: baseline to 9-months
measure: Pre-post Change in Physical Function
timeFrame: baseline to 9-months
measure: Pre-post Change in Physical Performance
timeFrame: baseline to 9-months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Cindy K Blair, PhD
role: PRINCIPAL_INVESTIGATOR
References: