Southwest Harvest for Health Vegetable Gardening Intervention

Cancer Survivor Clinical Trial

Official title:

Southwest Harvest for Health: A Mentored Vegetable Gardening Intervention for Cancer Survivors in New Mexico

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04251299
• Other study ID #: INST UNM 1905
• Status: Completed
• Phase: N/A
• Start date: January 17, 2020
• Est. completion date: December 20, 2020

Study information

• Verified date: March 2021
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 20, 2020
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cancer Survivor

Intervention

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.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (3)

Lead Sponsor	Collaborator
University of New Mexico	New Mexico State University, University of New Mexico Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adaptation -- systematic documentation using the Framework for Reporting Adaptations and Modifications Enhanced (FRAME) tool (Stirman et al., Implementation Science, 2019)	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	through study completion, an average of 9 months
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.	through study completion, an average of 9 months
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.	baseline to 9-months
Secondary	Pre-post change in objectively measured physical activity	Physical activity will be objectively measured using the activPAL research grade monitor.	baseline to 9-months
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.	baseline to 9-months
Secondary	Pre-post change in physical function	Self-reported physical function will be assessed using the 8-item physical function scale.	baseline to 9-months
Secondary	Pre-post change in physical performance	Physical performance will be objectively measured using the Rikli & Jones Senior Fitness Battery.	baseline to 9-months