Southwest Harvest for Health Vegetable Gardening Intervention
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|ClinicalTrials.gov Identifier: NCT04251299|
Recruitment Status : Completed
First Posted : January 31, 2020
Last Update Posted : March 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cancer Survivor||Behavioral: home-based, mentored vegetable gardening program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Southwest Harvest for Health: A Mentored Vegetable Gardening Intervention for Cancer Survivors in New Mexico|
|Actual Study Start Date :||January 17, 2020|
|Actual Primary Completion Date :||December 20, 2020|
|Actual Study Completion Date :||December 20, 2020|
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251299
|United States, New Mexico|
|University of New Mexico|
|Albuquerque, New Mexico, United States, 87131|
|Principal Investigator:||Cindy K Blair, PhD||University of New Mexico|