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Completed

NCT Number: NCT04251299

Southwest Harvest for Health Vegetable Gardening Intervention

"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.

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Key information

Conditions

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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. 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.

  4. 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. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Collaborators

  • New Mexico State University
  • University of New Mexico Cancer Center

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 31, 2020
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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