NCT04251299

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

March 11, 2025

Completed
Last Updated

March 11, 2025

Status Verified

February 1, 2025

Enrollment Period

11 months

First QC Date

January 24, 2020

Results QC Date

January 7, 2024

Last Update Submit

February 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Pre-post Change in Vegetable and Fruit Intake

    baseline to 9-months

  • Pre-post Change in Objectively Measured Physical Activity

    baseline to 9-months

  • Pre-post Change in Sleep Quality

    baseline to 9-months

  • Pre-post Change in Physical Function

    baseline to 9-months

  • Pre-post Change in Physical Performance

    baseline to 9-months

Study Arms (1)

Single Arm

EXPERIMENTAL

All participants will receive the 10-month mentored, vegetable gardening intervention

Behavioral: home-based, mentored vegetable gardening program

Interventions

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.

Single Arm

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Results Point of Contact

Title
Dr. Cindy Blair
Organization
University of New Mexico

Study Officials

  • Cindy K Blair, PhD

    University of New Mexico

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 24, 2020

First Posted

January 31, 2020

Study Start

January 17, 2020

Primary Completion

December 20, 2020

Study Completion

December 20, 2020

Last Updated

March 11, 2025

Results First Posted

March 11, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations