Southwest Harvest for Health Vegetable Gardening Intervention

Overview

"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.

Full Title of Study: “Southwest Harvest for Health: A Mentored Vegetable Gardening Intervention for Cancer Survivors in New Mexico”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 20, 2020

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.

Interventions

  • Behavioral: 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.

Arms, Groups and Cohorts

  • Experimental: Single Arm
    • All participants will receive the 10-month mentored, vegetable gardening intervention

Clinical Trial Outcome Measures

Primary Measures

  • Adaptation — systematic documentation using the Framework for Reporting Adaptations and Modifications Enhanced (FRAME) tool (Stirman et al., Implementation Science, 2019)
    • Time Frame: through study completion, an average of 9 months
    • Adaptation is “the degree to which an intervention is modified in the process of its adoption and implementation.” Adaptation requires a careful balance between achieving fit, i.e., modifying a program to meet the needs of a new target population or local context, and maintaining fidelity, i.e., minimizing changes that could negatively affect the program’s effectiveness. Adaptation of the Harvest for Health intervention for the local context (physical, social, and cultural environment) of New Mexico
  • Feasibility of the intervention
    • Time Frame: through study completion, an average of 9 months
    • 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.

Secondary Measures

  • Pre-post change in vegetable and fruit intake
    • Time Frame: baseline to 9-months
    • 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.
  • Pre-post change in objectively measured physical activity
    • Time Frame: baseline to 9-months
    • Physical activity will be objectively measured using the activPAL research grade monitor.
  • Pre-post change in sleep quality
    • Time Frame: baseline to 9-months
    • Self-reported sleep quality will be assessed using the PROMIS 8-item questionnaires for sleep impairment and sleep disturbance.
  • Pre-post change in physical function
    • Time Frame: baseline to 9-months
    • Self-reported physical function will be assessed using the 8-item physical function scale.
  • Pre-post change in physical performance
    • Time Frame: baseline to 9-months
    • Physical performance will be objectively measured using the Rikli & Jones Senior Fitness Battery.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of New Mexico
  • Collaborator
    • University of New Mexico Comprehensive Cancer Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Cindy Blair, PhD, MPH, Assistant Professor – University of New Mexico
  • Overall Official(s)
    • Cindy K Blair, PhD, Principal Investigator, University of New Mexico

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.