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Reducing Chronic Disease Health Disparities in the Deep South

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: NCT04297826
Recruitment Status : Completed
First Posted : March 6, 2020
Last Update Posted : December 15, 2022
Sponsor:
Collaborators:
University of Mississippi Medical Center
Mississippi State University
University of South Carolina
Information provided by (Responsible Party):
Monica L Baskin, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Chronic Disease Behavioral: Harvest for Health Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Expanding Our Cancer Prevention and Control Infrastructure to Reduce Cancer and Other Chronic Disease Health Disparities in the Deep South
Actual Study Start Date : March 1, 2021
Actual Primary Completion Date : March 31, 2022
Actual Study Completion Date : November 30, 2022


Arm Intervention/treatment
Experimental: Harvest for Health
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
Please see previous description




Primary Outcome Measures :
  1. Recruitment and Retention [ Time Frame: 1 year ]

    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)

  2. Treatment Delivery [ Time Frame: 1 year ]
    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.

  3. Treatment Receipt [ Time Frame: 1 year ]

    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


  4. Enactment of Treatment Skills [ Time Frame: 1 year ]
    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.

  5. Fruit and vegetable intake [ Time Frame: 1 year ]

    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.


  6. SF36 Physical Function Subscale [ Time Frame: 1 year ]
    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.

  7. Senior Fitness Test Battery [ Time Frame: 1 year ]
    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).


Secondary Outcome Measures :
  1. SF12 Health Related Quality of Life Index [ Time Frame: 1-year ]
    SF12 Health Related Quality of Life Index The SF12 Health-Related Quality of Life Index (HRQoL) will provide a global measure of HRQoL, and each of the eight subscales will be explored separate (i.e. Physical functioning, Role-physical, Bodily pain, General health, Vitality, Social functioning, Role-emotional, Mental heat). Internal consistency and reliability for all eight subscales is high, ICC ranging from 0.78 to 0.93. HRQoL weights to create Quality Adjusted Life Years (QALYs) from the SF12 will be done using methods of Brazier & colleagues.

  2. Reassurance of Worth: [ Time Frame: 1-year ]

    One of six subscales of the Revised Social Provision Scale, this measure will be used to assess the psychosocial benefits of gardening. Several gardening studies have reported enhanced self-esteem, increased independence, and increased zest for life associated with gardening. Reliability estimates range from 0.60 to 0.70.

    Social Support and Eating Habits (10 items) and Exercise Surveys (13 items): This has been widely used in diverse samples and has strong psychometric properties (α=.70), surveys will be adapted for gardening using identical anchors


  3. Self-Efficacy for Gardening [ Time Frame: 1-year ]
    This is the organizing concept in Social Cognitive Theory and is defined as people's beliefs in their capability to organize and execute courses of action to deal with prospective situations. Self-efficacy beliefs are domain-specific; thus, within the context of this study, self-efficacy is survivors' beliefs in their ability to meet the challenges of maintaining a successful vegetable garden.

  4. Physical Activity: Godin Lesiure Time Activity Questionnaire [ Time Frame: 1-year ]
    Goal achievement based on an increase of ≥30 minutes/week of moderate to vigorous activity assessed via Godin Leisure Time Activity Questionnaire. Self-reported physical activity will be provided using the Godin Leisure Time Activity Questionnaire, a validated and sensitive tool that captures physical activities.

  5. Weight [ Time Frame: 1year ]
    Participants will be weighed (to the nearest 0.1 kg) at each assessment (baseline and 1-year) while wearing light clothing without shoes using a professional digital scale regularly calibrated to current standards.

  6. Height [ Time Frame: 1year ]
    Participants' height (to the nearest 0.1 cm) will be measured without shoes using a tape measure. Height will be measured only at the baseline.

  7. Body Mass Index (BMI) [ Time Frame: 1year ]
    Using weight and height data described above, BMI will be calculated using the equation BMI = weight (kg)/height (m2).

  8. Waist Circumference [ Time Frame: 1year ]
    Waist circumference will be measured (to the nearest 0.5cm) at the end of normal expiration on base skin at the belly button using a constant-tension spring-loaded tape device. Measures will be taken in a private room rather than in a larger group setting. A privacy screen or curtain will be used when a larger room must be subdivided for the assessments.

  9. Blood Pressure [ Time Frame: 1year ]
    Participant blood pressure (BP) will be measured by trained staff using a calibrated automatic sphygmomanometer. Arm circumference will be measured to determine the proper size arm cuff, to avoid over- or under-estimation of the true BP. Participants will be asked to sit with both feet flat on the floor and to rest without talking for five minutes before measurement. BP will be measured twice according standard NHLBI protocols. The two measurements will be averaged.

  10. Total Cholesterol [ Time Frame: 1year ]
    A blood sample will be collected by trained phlebotomists to process lipid profile [including total cholesterol (TC), High Density Lipoprotein cholesterol (HDL-C), triglycerides and Low Density Lipoprotein cholesterol (LDLC)], glucose and Hemaglobin A1c (HbA1C). Samples will be stored in a cooler for transport back to lab (UAB or community location) for processing. At the lab, plasma and/or serum will be aliquoted into 0.5 ml cryovials and stored on in -80 degree freezer until analyses. Lipids, glucose, and HbA1C will be analyzed in the UAB Diabetes Research Core laboratory. (Overnight fasting is required).

  11. High Density Lipoprotein Cholesterol (HDL-C) [ Time Frame: 1year ]
    A blood sample will be collected by trained phlebotomists to process lipid profile [including total cholesterol (TC), High Density Lipoprotein cholesterol (HDL-C), triglycerides and Low Density Lipoprotein cholesterol (LDLC)], glucose and Hemaglobin A1c (HbA1C). Samples will be stored in a cooler for transport back to lab (UAB or community location) for processing. At the lab, plasma and/or serum will be aliquoted into 0.5 ml cryovials and stored on in -80 degree freezer until analyses. Lipids, glucose, and HbA1C will be analyzed in the UAB Diabetes Research Core laboratory. (Overnight fasting is required).

  12. Low Density Lipoprotein Cholesterol (LDL-C) [ Time Frame: 1year ]
    A blood sample will be collected by trained phlebotomists to process lipid profile [including total cholesterol (TC), High Density Lipoprotein cholesterol (HDL-C), triglycerides and Low Density Lipoprotein cholesterol (LDLC)], glucose and Hemaglobin A1c (HbA1C). Samples will be stored in a cooler for transport back to lab (UAB or community location) for processing. At the lab, plasma and/or serum will be aliquoted into 0.5 ml cryovials and stored on in -80 degree freezer until analyses. Lipids, glucose, and HbA1C will be analyzed in the UAB Diabetes Research Core laboratory. (Overnight fasting is required).

  13. Glucose and Hemaglobin A1c (HbA1C) [ Time Frame: 1year ]
    A blood sample will be collected by trained phlebotomists to process lipid profile [including total cholesterol (TC), High Density Lipoprotein cholesterol (HDL-C), triglycerides and Low Density Lipoprotein cholesterol (LDLC)], glucose and Hemaglobin A1c (HbA1C). Samples will be stored in a cooler for transport back to lab (UAB or community location) for processing. At the lab, plasma and/or serum will be aliquoted into 0.5 ml cryovials and stored on in -80 degree freezer until analyses. Lipids, glucose, and HbA1C will be analyzed in the UAB Diabetes Research Core laboratory. (Overnight fasting is required).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

  • (1) are not competent due to mental health or other very serious comorbid conditions (e.g., severe orthopedic conditions or scheduled for a hip or knee replacement with 6 months, paralysis, unstable angina or who have experienced a myocardial infarction, congestive heart failure or pulmonary conditions that require hospitalization or oxygen within 6 months, stroke, degenerative neurological conditions, unstable angina (UA), percutaneous coronary intervention (PCI)/coronary artery bypass grafting (CABG), severe valve disease or New York Heart Association (NYHA_ class III-IV heart failure);
  • (2) have any medical condition substantially limiting moderate physical activity;
  • (3) currently taking pharmacologic doses of warfarin (does not include doses taken to maintain a port);
  • (4) do not reside in a location that can accommodate 4 or more Earthboxes or 1-raised bed (4'x 8'), and that get at least 4 hours of sun a day;
  • (5) do not have running water;
  • (6) have recent experience with vegetable gardening, e.g. planted a vegetable garden within the past year;
  • (7) have a history of lymphedema flares, axillary node dissection of 10 or more lymph nodes per side;
  • (8) life expectancy of less than 1 year ;
  • (9) Untreated cardiac conditions including complex congenital heart disease, or untreated complex arrhythmias; or
  • (10) Current substance abuse

Information from the National Library of Medicine

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): NCT04297826


Locations
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United States, Alabama
Various Counties (Bullock, Calhoun, Dallas, Madison, Marengo, Monroe, Sumter, Talladega, Walker)
Birmingham, Alabama, United States, 35294-4410
United States, Mississippi
Various Counties (Bolivar, Grenada, Humphreys, Panola, Sunflower, Yazoo)
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Alabama at Birmingham
University of Mississippi Medical Center
Mississippi State University
University of South Carolina
Investigators
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Principal Investigator: Monica Baskin, PhD, MPH University of Alabama at Birmingham
Publications:
Centers for Disease Control and Prevention. Prevalence of Diagnosed Diabetes - 2013. https://www.cdc.gov/diabetes/data/statistics-report/diagnosed.html2018.
National Cancer Institute. State Cancer Profiles, 2011-2015. Accessed Februrary 28, 2019 at http://statecancerprofiles.cancer.govn.d.
Centers for Disease Control and Prevention. National Center for Chronic Disease Prevention and Health Promotion. Chronic Disease Indicators (CDI) Data [online]. [accessed Mar 11, 2019]. URL: https://nccd.cdc.gov/cdi. 2016.
US Burden of Disease Collaborators; Mokdad AH, Ballestros K, Echko M, Glenn S, Olsen HE, Mullany E, Lee A, Khan AR, Ahmadi A, Ferrari AJ, Kasaeian A, Werdecker A, Carter A, Zipkin B, Sartorius B, Serdar B, Sykes BL, Troeger C, Fitzmaurice C, Rehm CD, Santomauro D, Kim D, Colombara D, Schwebel DC, Tsoi D, Kolte D, Nsoesie E, Nichols E, Oren E, Charlson FJ, Patton GC, Roth GA, Hosgood HD, Whiteford HA, Kyu H, Erskine HE, Huang H, Martopullo I, Singh JA, Nachega JB, Sanabria JR, Abbas K, Ong K, Tabb K, Krohn KJ, Cornaby L, Degenhardt L, Moses M, Farvid M, Griswold M, Criqui M, Bell M, Nguyen M, Wallin M, Mirarefin M, Qorbani M, Younis M, Fullman N, Liu P, Briant P, Gona P, Havmoller R, Leung R, Kimokoti R, Bazargan-Hejazi S, Hay SI, Yadgir S, Biryukov S, Vollset SE, Alam T, Frank T, Farid T, Miller T, Vos T, Barnighausen T, Gebrehiwot TT, Yano Y, Al-Aly Z, Mehari A, Handal A, Kandel A, Anderson B, Biroscak B, Mozaffarian D, Dorsey ER, Ding EL, Park EK, Wagner G, Hu G, Chen H, Sunshine JE, Khubchandani J, Leasher J, Leung J, Salomon J, Unutzer J, Cahill L, Cooper L, Horino M, Brauer M, Breitborde N, Hotez P, Topor-Madry R, Soneji S, Stranges S, James S, Amrock S, Jayaraman S, Patel T, Akinyemiju T, Skirbekk V, Kinfu Y, Bhutta Z, Jonas JB, Murray CJL. The State of US Health, 1990-2016: Burden of Diseases, Injuries, and Risk Factors Among US States. JAMA. 2018 Apr 10;319(14):1444-1472. doi: 10.1001/jama.2018.0158.
US Department of Agriculture: Economic Research Service. Rural-Urban Continuum Codes. https://www.ers.usda.gov/data-products/rural-urban-continuum-codes/n.d.
US Department of Health and Human Services. State Cancer Profiles: Age-Adjusted Mortality Rates by Cancer Site (2011-2015). In: National Cancer Institute, ed. https://statecancerprofiles.cancer.gov/index.htmln.d.
Centers for Disease Control and Prevention. Compressed Mortality File 1999-2016 on CDC WONDER Online Database. http://wonder.cdc.gov/cmf-icd10.html2017.
Centers for Disease Control and Prevention. Behavioral Risk Factor Surveillance System Survey Data. In: US Department of Health and Human Services, ed.2015.
Morales M. Health Literacy Research Methods: A Pilot Study Investigation With Adult Beginning Readers. International Journal of Qualitative Methods 2017;16:1609406917709913.
Rogers EM. Diffusion of Innovations New York: Free Press; 1995.
Economic Impact of Cancer n.d.
Sommerfeld AJ, Waliczek TM, Zajicek JM. Growing Minds: Evaluating the Effect of Gardening on Quality of Life and Physical Activity Level of Older Adults. 2010;20:705.
Bandura A. Social foundations of thought and action. Englewood Cliffs, NJ: Princeton Hall International; 1986.
Bandura A. Self-efficacy: The exercise of control. New York: Freeman; 1997.
Bronfenbrenner U. The ecology of human development Cambridge, MA: Harvard University Press; 1979.
Bieri JG, Brown ED, Smith JC. Determination of individual carotenoids in human plasma by high performance liquid chromatography. J Liq Chromatogr 1985;8:473-84.
Ware JE, Kosinski M. SF-36® Physical & Mental Health Summary Scales: A manual for users of Version 2 (2nd ed). Lincoln, RI: QualityMetric Inc.; 2007.
Rikli RE, Jones CJ. Development and validation of a functional fitness test for community-residing older adults. J Aging Phys Act 1999;7:129-61.
Rikli RE, Jones CJ. Functional fitness normative scores for community-residing older adults, ages 60-94. J Aging Phys Act 1999;7:162-81.
Rikli RE, Jones CJ. Senior fitness test manual. Champaign, IL: Human Kinetics; 2001.
Waliczek TM, Sommerfeld AJ, Zajicek JM. Growing Minds: Evaluating the Effect of Gardening on Quality of Life and Physical Activity Level of Older Adults. Horttechnology 2010;20:705-10.
Cutrona CE, Russell D. The provisions of social relationships and adaptation stress. In: Jones WH, Perlman D, eds. Advances in personal relationships. Greenwich, CT: JAI Press; 1987:37-67.
Sallis JF, Pinski RB, Grossman RM, Patterson TL, Nader PR. The development of self-efficacy scales for health related diet and exercise behaviors. Health Educ Res 1988;3:283-92.
Bandura A. Social learning theory. Englewood Cliffs, N.J.: Prentice Hall; 1977.
Bandura A. Social foundations of thought and action : a social cognitive theory. Englewood Cliffs, N.J.: Prentice-Hall; 1986.
Bandura A. Self-efficacy : the exercise of control. New York: W.H. Freeman; 1997.

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Responsible Party: Monica L Baskin, Professor, Director, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04297826    
Other Study ID Numbers: 524356
First Posted: March 6, 2020    Key Record Dates
Last Update Posted: December 15, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only aggregated, de-identified data will be retained. Currently, there is no plan to share this data outside of the immediate investigative team.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes