- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04251299
Southwest Harvest for Health Vegetable Gardening Intervention
March 22, 2021 updated by: Cindy Blair, PhD, MPH, University of New Mexico
Southwest Harvest for Health: A Mentored Vegetable Gardening Intervention for Cancer Survivors in New Mexico
"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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New Mexico
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Albuquerque, New Mexico, United States, 87131
- University of New Mexico
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Arm
All participants will receive the 10-month mentored, vegetable gardening intervention
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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through study completion, an average of 9 months
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Feasibility of the intervention
Time Frame: through study completion, an average of 9 months
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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.
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through study completion, an average of 9 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pre-post change in vegetable and fruit intake
Time Frame: baseline to 9-months
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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.
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baseline to 9-months
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Pre-post change in objectively measured physical activity
Time Frame: baseline to 9-months
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Physical activity will be objectively measured using the activPAL research grade monitor.
|
baseline to 9-months
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Pre-post change in sleep quality
Time Frame: baseline to 9-months
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Self-reported sleep quality will be assessed using the PROMIS 8-item questionnaires for sleep impairment and sleep disturbance.
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baseline to 9-months
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Pre-post change in physical function
Time Frame: baseline to 9-months
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Self-reported physical function will be assessed using the 8-item physical function scale.
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baseline to 9-months
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Pre-post change in physical performance
Time Frame: baseline to 9-months
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Physical performance will be objectively measured using the Rikli & Jones Senior Fitness Battery.
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baseline to 9-months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 17, 2020
Primary Completion (Actual)
December 20, 2020
Study Completion (Actual)
December 20, 2020
Study Registration Dates
First Submitted
January 24, 2020
First Submitted That Met QC Criteria
January 29, 2020
First Posted (Actual)
January 31, 2020
Study Record Updates
Last Update Posted (Actual)
March 25, 2021
Last Update Submitted That Met QC Criteria
March 22, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- INST UNM 1905
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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