NCT04297826

Brief Summary

The study is a gardening intervention among 150 older cancer survivors and individuals living with chronic disease (cardiovascular disease and diabetes) in the states of Alabama and Mississippi. This program focuses on 15 counties where a Community Health Advisor training program is in place (Bullock, Calhoun, Dallas Madison, Marengo, Monroe, Sumter, Talladega, Walker Counties in Alabama and Boliver, Granada, Humphrey, Panola, Sunflower, and Yazoo Counties in Mississippi). Participants are paired with Cooperative Extension certified Master Gardeners to plant a vegetable garden at their place of residence (the intervention). Baseline, midpoint, and 1 year follow up will occur. Previous pilot work provides an established relationship with the Cooperative Extension as well as training mechanisms for the Master Gardeners.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

February 14, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

December 15, 2022

Status Verified

December 1, 2022

Enrollment Period

1.1 years

First QC Date

February 14, 2020

Last Update Submit

December 13, 2022

Conditions

Chronic Disease

Outcome Measures

Primary Outcomes (7)

  • Recruitment and Retention

    We will be tracking the interaction with community master gardeners and study participants using REDCap questionnaires. Information gathered will include: * Number of participants recruited * Number of visits (total) * Number of completed visits (within the window) * Number of completed visits (outside of window)

    1 year

  • Treatment Delivery

    The investigators will be administering the EATS survey to all participants designed to measure the intake of fruits and vegetables and has been used widely to track changes in fruit and vegetable intake in specific population groups. This screener termed the By Meal version, asks about usual intakes of fruits and other vegetables by the time of day. Participants list how many servings they eat, an algorithm converts the totals into an average per day; then this average is used to estimate the intake of each participant throughout the study.

    1 year

  • Treatment Receipt

    For this data point, we will administer the Reassurance of Worth instrument (Revised Social Provision Scale \[SPS10\]): This instrument posits that social support is defined in terms of its function, namely, social provisions. This theory considers the functions of social relationships across specific social roles (e.g., romantic partner, spouse, family members, friends, colleagues, etc.), especially when individuals face critical life-changing events. Social ties provide social support and that specific social ties might meet individuals' different social support needs or might influence individuals to offer social support. The scale is as follows: Strongly Disagree Disagree Agree Strongly Agree 1 2 3 4 SPS-10 can be a useful clinical and research tool to assess perceived social support not only in perinatal and pae-diatric settings, but also in general medical and mental health settings

    1 year

  • Enactment of Treatment Skills

    We will administer the self-efficacy for gardening: This investigator-created screener is designed to gather information on the degree to which participants feel confident working in their own garden. Questions are centered on: 1.) time spent in the garden, 2.) did participants partake in gardening with anyone else, 3.) and whether or not gardening influenced participants to eat more vegetables.

    1 year

  • Fruit and vegetable intake

    We will administer the EATS screener: This assessment tool was designed to measure intake of fruits and vegetables and has been used widely to track changes in fruit and vegetable intake in specific population groups. There are two versions of this screener. This version, termed the By Meal version, asks about usual intakes of fruits and other vegetables by time of day. The other version, termed the All-Day version, asks about usual intakes of all items. Both are machine scan-able. Goal achievement is based on an increase of ≥1 serving/ day of Fruits and vegetables assessed via the EATS score pre-and post-program intervention.

    1 year

  • SF36 Physical Function Subscale

    Goal achievement based on an increase of ≥5 points on the SF36 Physical Function subscale (PFSS) The SF36 PFSS is a 10-item subscale assessing general physical function and is valid and reliable for use in healthy and chronically-ill adults. Internal consistency is excellent: α=0.89 to 0.92. It has published norms, is sensitive to change, and has performed well in our past studies; we have found it free of ceiling effects.

    1 year

  • Senior Fitness Test Battery

    Goal achievement is based on an improvement in \> 4 of 6 performance tests Senior Fitness Test Battery tests several physical function domains: lower and upper body strength (30-second chair stand, arm curl), endurance (2-minute step test), flexibility (chair sit and-reach, back scratch), agility/dynamic balance (8-ft Get Up \& Go), and gait speed (8-foot walk); the test battery provides an objective measure of physical function, is sensitive to change, not associated with ceiling effects, and has normative scores. Additional test include grip strength, objectively measured via dynamometer (disability and functional limitation predictor).

    1 year

Secondary Outcomes (13)

  • SF12 Health Related Quality of Life Index

    1-year

  • Reassurance of Worth:

    1-year

  • Self-Efficacy for Gardening

    1-year

  • Physical Activity: Godin Lesiure Time Activity Questionnaire

    1-year

  • Weight

    1year

  • +8 more secondary outcomes

Study Arms (1)

Harvest for Health

EXPERIMENTAL

The study is a gardening intervention among 150 older cancer survivors and individuals living with chronic disease (cardiovascular disease and diabetes) in the states of Alabama and Mississippi. This program focuses on 15 counties where a Community Health Advisor training program is in place (Bullock, Calhoun, Dallas Madison, Marengo, Monroe, Sumter, Talladega, Walker Counties in Alabama and Boliver, Granada, Humphrey, Panola, Sunflower, and Yazoo Counties in Mississippi). Participants are paired with Cooperative Extension certified Master Gardeners to plant a vegetable garden at their place of residence (the intervention). Baseline, midpoint, and 1 year follow up will occur. Previous pilot work provides an established relationship with the Cooperative Extension as well as training mechanisms for the Master Gardeners.

Behavioral: Harvest for Health

Interventions

Harvest for HealthBEHAVIORAL

Please see previous description

Harvest for Health

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Men and women diagnosed with a cancer of favorable prognosis (localized and regional staged female breast, and prostate cancers; localized colon \& rectum, uterine cervix \& corpus, kidney/renal pelvis, non-Hodgkin lymphoma, oral cavity/pharynx, and esophagus cancers; and in situ bladder cancer); and have no medical conditions that would preclude gardening or the consumption of a diet high in fruits and vegetables (e.g., pharmacologic doses of warfarin) -In addition, men and women living who are medically stable, but managing chronic disease (cardiovascular disease and/ or diabetes) are eligible.
  • We will include individuals who:
  • (1) are diagnosed with a loco-regionally staged cancer associated with an 80% or greater 5-year survival rate (localized and regional staged female breast, and prostate cancers; localized colon \& rectum, uterine cervix \& corpus, kidney/renal pelvis, non-Hodgkin lymphoma, oral cavity/pharynx, and esophagus cancers; and in situ bladder cancer)
  • (2) diagnosed with diabetes or cardiovascular disease
  • (3) reside in the 15 counties;
  • (4) completed primary curative cancer treatments, i.e., surgery, chemotherapy or radiation therapy;
  • (5) are at least 65 years of age;
  • (6) are at higher risk of functional decline (≥ 2 physical function (PF) limitations as defined by the SF12PF subscale);
  • (7) currently eat less than 5 servings of fruits and vegetables (F/V)/ day;
  • (8) exercise less than 150 minutes/ week;
  • (9) speak and write in English (some of our scales are not validated in other populations/languages); and
  • (10) are willing to participate in the follow-up assessments;
  • (11) competent to provide informed consent;
  • (12) Access to a phone and/ or email and internet
  • We will exclude individuals who:
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Various Counties (Bullock, Calhoun, Dallas, Madison, Marengo, Monroe, Sumter, Talladega, Walker)

Birmingham, Alabama, 35294-4410, United States

Location

Various Counties (Bolivar, Grenada, Humphreys, Panola, Sunflower, Yazoo)

Jackson, Mississippi, 39216, United States

Location

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MeSH Terms

Conditions

Chronic Disease

Interventions

Health

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

  • Monica Baskin, PhD, MPH

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 14, 2020

First Posted

March 6, 2020

Study Start

March 1, 2021

Primary Completion

March 31, 2022

Study Completion

November 30, 2022

Last Updated

December 15, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Only aggregated, de-identified data will be retained. Currently, there is no plan to share this data outside of the immediate investigative team.

Locations

US(2)