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History of Changes for Study: NCT04251299
Southwest Harvest for Health Vegetable Gardening Intervention
Latest version (submitted March 22, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 29, 2020 None (earliest Version on record)
2 March 11, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
3 March 22, 2021 Recruitment Status, Study Status and Sponsor/Collaborators
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Study NCT04251299
Submitted Date:  January 29, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: INST UNM 1905
Brief Title: Southwest Harvest for Health Vegetable Gardening Intervention
Official Title: Southwest Harvest for Health: A Mentored Vegetable Gardening Intervention for Cancer Survivors in New Mexico
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2020
Overall Status: Recruiting
Study Start: January 17, 2020
Primary Completion: December 20, 2020 [Anticipated]
Study Completion: February 28, 2021 [Anticipated]
First Submitted: January 24, 2020
First Submitted that
Met QC Criteria:
January 29, 2020
First Posted: January 31, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
January 29, 2020
Last Update Posted: January 31, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of New Mexico
Responsible Party: Principal Investigator
Investigator: Cindy Blair, PhD, MPH
Official Title: Assistant Professor
Affiliation: University of New Mexico
Collaborators: University of New Mexico Comprehensive Cancer Center
New Mexico State University
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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.
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.
Open or close this module Conditions
Conditions: Cancer Survivor
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Supportive Care
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 25 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Single Arm
All participants will receive the 10-month mentored, vegetable gardening 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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
2. 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 Outcome Measures:
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.
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.
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.
Open or close this module Eligibility
Minimum Age: 50 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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)
Open or close this module Contacts/Locations
Central Contact Person: Cindy K Blair, PhD
Telephone: 505-925-7907
Email: CiBlair@salud.unm.edu
Central Contact Backup: Elizabeth M Harding, PhD
Telephone: 505-272-2274
Email: Harvest4Health@salud.unm.edu
Study Officials: Cindy K Blair, PhD
Principal Investigator
University of New Mexico
Locations: United States, New Mexico
University of New Mexico
[Recruiting]
Albuquerque, New Mexico, United States, 87131
Contact:Contact: Cindy K Blair, PhD 505-925-7907 CiBlair@salud.unm.edu
Contact:Contact: Elizabeth M Harding, PhD 505-272-2274 Harvest4Health@salud.unm.edu
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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