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Southwest Harvest for Health Vegetable Gardening Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251299
Recruitment Status : Completed
First Posted : January 31, 2020
Last Update Posted : March 25, 2021
Sponsor:
Collaborators:
University of New Mexico Cancer Center
New Mexico State University
Information provided by (Responsible Party):
Cindy Blair, PhD, MPH, University of New Mexico

Tracking Information
First Submitted Date  ICMJE January 24, 2020
First Posted Date  ICMJE January 31, 2020
Last Update Posted Date March 25, 2021
Actual Study Start Date  ICMJE January 17, 2020
Actual Primary Completion Date December 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2020)
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Southwest Harvest for Health Vegetable Gardening Intervention
Official Title  ICMJE Southwest Harvest for Health: A Mentored Vegetable Gardening Intervention for Cancer Survivors in New Mexico
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Cancer Survivor
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Single Arm
All participants will receive the 10-month mentored, vegetable gardening intervention
Intervention: Behavioral: home-based, mentored vegetable gardening program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2020)
30
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2020)
25
Actual Study Completion Date  ICMJE December 20, 2020
Actual Primary Completion Date December 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04251299
Other Study ID Numbers  ICMJE INST UNM 1905
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Cindy Blair, PhD, MPH, University of New Mexico
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of New Mexico
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • University of New Mexico Cancer Center
  • New Mexico State University
Investigators  ICMJE
Principal Investigator: Cindy K Blair, PhD University of New Mexico
PRS Account University of New Mexico
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP