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Chronic DiseaseNCT04297826

Reducing Chronic Disease Health Disparities in the Deep South

A study testing Harvest for Health in people with Chronic Disease, run by University of Alabama at Birmingham at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Chronic Disease
What is being tested?
Harvest for Health
Could I receive a placebo?
No, everyone receives an active treatment
How many people
137 participants
Where
2 sitesUnited States
Study dates
1 Mar 2021to 30 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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;
Show all 25Show fewer
  • (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

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

    Birmingham, Alabama, 35294-4410

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

    Jackson, Mississippi, 39216

Other trials in United States

About this study

Official title: Expanding Our Cancer Prevention and Control Infrastructure to Reduce Cancer and Other Chronic Disease Health Disparities in the Deep South

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.

Read the detailed description

Based on the investigator's previously successful gardening interventions that paired cancer survivors with Cooperative Extension Master Gardeners (MG) since 2011, now proposed; a sample of 150 older individuals living with chronic diseases in 15 counties in Alabama and Mississippi. The purpose of this larger study is to determine the efficacy of a gardening intervention that would pair older cancer survivors and individuals living with chronic disease (heart disease and diabetes) (≥ 65 years of age) with master gardeners. Vegetable gardens will be established at participants' homes, and a yearlong intervention involving bimonthly contact between participants and MGs to plan and plant gardens, check plant status, harvest, and rotate plantings will be conducted. It is hypothesized that this intervention will significantly improve fruit and vegetable consumption, physical activity, quality of life and physical functioning.

Outcomes: Outcomes will be measured by the number of participants recruited, improvements in physical functioning, physical performance (senior fitness battery and grip strength), physical activity, health-related quality of life, reassurance of worth, and self-efficacy of gardening. Additional outcomes are blood pressure, BMI, waist circumference, lipid, glucose, and HbA1c.

Background: There are roughly 15 million cancer survivors in the US, comprising 4% of the populace. The number of cancer survivors is skyrocketing due to a confluence of the following factors: 1) Americans are aging; 2) cancer is an age-related disease (>60% of cancer survivors are age 65+), and 3) improvements in early detection and treatment have resulted in many common cancers having 5-year cure rates that surpass 90%. Rising numbers of cancer survivors represent good news, but over $130 billion annually is needed to address their long-term health and psychosocial needs. Compared to others, cancer survivors are at higher risk for other cancers, cardiovascular disease, osteoporosis, and diabetes. The accelerated functional decline also is a major problem for cancer survivors, especially those who are older. Baker et al. found that compared to age-matched controls, cancer cases (n=45,494) had significantly lower physical and social functioning, vitality, mental health, and health-related quality of life (HRQoL) (p<0.001). The results of others are similar and suggest that cancer survivors face functional decline that threatens their ability to live independently, posing a burden to themselves, their families and the health care system. Thus, cancer survivorship is claimed as a national priority, and there is a call for interventions that target markedly vulnerable subsets.

Prior interventions to improve physical activity (PA) and diet quality (DQ) has proven effective in improving functional status and other health outcomes in cancer survivors. The 2 largest randomized controlled trials (RCTs) to date aimed at physical function, RENEW (Reach-out to ENhancE Wellness, n=641) and Project LEAD (Leading the way in Exercise and Diet, n=182), were led by Demark-Wahnefried (PI) and tested home-based interventions. Both RCTs resulted in significant improvements in DQ, PA and physical function, with few adverse events and low rates of attrition, but there was little capacity for dissemination once funding ended. Thus, the investigators have sought to develop interventions that build on existing programs and that have a high likelihood of translation into the community. The proposed intervention relies on (a) the extant infrastructure of the Alabama Cooperative Extension, (b) our collaborative pilot studies with Master Gardeners (MGs), (c) our data that show that gardening consists of low-to-moderate PA that combines aerobic and strength training activities associated with improved health, and (d) new observational data published in 2012 that show that gardeners have significantly better gait speed, balance, and significantly fewer chronic conditions, functional limitations and falls.

MG Programs exist in land grant universities in all 50 United States. Certified MGs complete > 100 hrs. of instruction and community service (CS) and 25 hrs./year of CS to maintain active status. In surveying 184 MGs in AL, it was found that 71% were "extremely interested" in mentoring a cancer survivor on vegetable gardening for their CS, and an extra 26% stated that "they were interested and wanted to learn more." Thus, the project is of great interest and builds on an extant infrastructure for sustainability. Ultimately, this intervention could be disseminated to states with 3 growing seasons and adapted to colder weather in those with 2 growing seasons. The intervention also could be adapted for persons with other types of chronic diseases in which physical functioning and lifestyle behaviors are key. Finally, this project is significant because the intervention has great potential for sustainability since gardening: (a) involves many activities which prevent satiation common with other forms of exercise; (b) provides a sense of achievement and zest for life that come from nurturing and observing new life and growth, and (c) imparts natural prompts since plants require regular care (watering) and attention (harvesting) and serve as continual and dynamic behavioral cues.

Conditions
Chronic Disease
Being tested
Harvest for Health
Medical subject headings
Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Harvest for HealthBehavioural

    Please see previous description

Study groups in NCT04297826
Study groupRoleWhat they receive
Harvest for HealthExperimentalThe 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.
Receives: Behavioral: Harvest for Health

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 1 year

  2. 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.

    Measured: 1 year

  3. 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

    Measured: 1 year

  4. 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.

    Measured: 1 year

  5. 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.

    Measured: 1 year

  6. 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.

    Measured: 1 year

  7. 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).

    Measured: 1 year

Secondary outcomes (13)

  1. SF12 Health Related Quality of Life Index

    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.

    Measured: 1-year

  2. Reassurance of Worth:

    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

    Measured: 1-year

  3. Self-Efficacy for Gardening

    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.

    Measured: 1-year

  4. Physical Activity: Godin Lesiure Time Activity Questionnaire

    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.

    Measured: 1-year

  5. Weight

    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.

    Measured: 1year

  6. Height

    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.

    Measured: 1year

  7. Body Mass Index (BMI)

    Using weight and height data described above, BMI will be calculated using the equation BMI = weight (kg)/height (m2).

    Measured: 1year

  8. Waist Circumference

    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.

    Measured: 1year

  9. Blood Pressure

    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.

    Measured: 1year

  10. Total Cholesterol

    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).

    Measured: 1year

  11. High Density Lipoprotein Cholesterol (HDL-C)

    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).

    Measured: 1year

  12. Low Density Lipoprotein Cholesterol (LDL-C)

    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).

    Measured: 1year

  13. Glucose and Hemaglobin A1c (HbA1C)

    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).

    Measured: 1year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2020
  2. Study start1 Mar 2021
  3. Primary completion31 Mar 2022
  4. Study completion30 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
137 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04297826
Sponsor's protocol ID
524356
Status last verified
Dec 2022
First submitted
14 Feb 2020
Last updated
15 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Only aggregated, de-identified data will be retained. Currently, there is no plan to share this data outside of the immediate investigative team.

Publications

  • Partridge EE, Fouad MN, Hinton AW, Hardy CM, Liscovicz N, White-Johnson F, Higginbotham JC. The deep South network for cancer control: eliminating cancer disparities through community-academic collaboration. Fam Community Health. 2005 Jan-Mar;28(1):6-19. doi: 10.1097/00003727-200501000-00004.

    PubMed 15625502

  • Lisovicz N, Johnson RE, Higginbotham J, Downey JA, Hardy CM, Fouad MN, Hinton AW, Partridge EE. The Deep South Network for cancer control. Building a community infrastructure to reduce cancer health disparities. Cancer. 2006 Oct 15;107(8 Suppl):1971-9. doi: 10.1002/cncr.22151.

    PubMed 16921494

  • Centers for Disease Control and Prevention. Prevalence of Diagnosed Diabetes - 2013. https://www.cdc.gov/diabetes/data/statistics-report/diagnosed.html2018.

  • Castle PE, Gage JC, Partridge EE, Rausa A, Gravitt PE, Scarinci IC. Human papillomavirus genotypes detected in clinician-collected and self-collected specimens from women living in the Mississippi Delta. BMC Infect Dis. 2013 Jan 7;13:5. doi: 10.1186/1471-2334-13-5.

    PubMed 23289357

  • Castle PE, Rausa A, Walls T, Gravitt PE, Partridge EE, Olivo V, Niwa S, Morrissey KG, Tucker L, Katki H, Scarinci I. Comparative community outreach to increase cervical cancer screening in the Mississippi Delta. Prev Med. 2011 Jun;52(6):452-5. doi: 10.1016/j.ypmed.2011.03.018. Epub 2011 Apr 8.

    PubMed 21497619

  • Litton AG, Castle PE, Partridge EE, Scarinci IC. Cervical cancer screening preferences among African American women in the Mississippi Delta. J Health Care Poor Underserved. 2013 Feb;24(1):46-55. doi: 10.1353/hpu.2013.0017.

    PubMed 23377716

  • Scarinci IC, Garcia FA, Kobetz E, Partridge EE, Brandt HM, Bell MC, Dignan M, Ma GX, Daye JL, Castle PE. Cervical cancer prevention: new tools and old barriers. Cancer. 2010 Jun 1;116(11):2531-42. doi: 10.1002/cncr.25065.

    PubMed 20310056

  • Scarinci IC, Litton AG, Garces-Palacio IC, Partridge EE, Castle PE. Acceptability and usability of self-collected sampling for HPV testing among African-American women living in the Mississippi Delta. Womens Health Issues. 2013 Mar-Apr;23(2):e123-30. doi: 10.1016/j.whi.2012.12.003. Epub 2013 Feb 12.

    PubMed 23410619

  • Carroll WR, Foushee HR Jr, Hardy CM, Floyd T, Sinclair CF, Scarinci I. Tobacco use among rural African American young adult males. Otolaryngol Head Neck Surg. 2011 Aug;145(2):259-63. doi: 10.1177/0194599811404968. Epub 2011 Apr 26.

    PubMed 21521898

  • Sinclair CF, Foushee HR, Pevear JS 3rd, Scarinci IC, Carroll WR. Patterns of blunt use among rural young adult African-American men. Am J Prev Med. 2012 Jan;42(1):61-4. doi: 10.1016/j.amepre.2011.08.023.

    PubMed 22176848

  • Sinclair CF, Foushee HR, Scarinci I, Carroll WR. Perceptions of harm to health from cigarettes, blunts, and marijuana among young adult African American men. J Health Care Poor Underserved. 2013 Aug;24(3):1266-75. doi: 10.1353/hpu.2013.0126.

    PubMed 23974397

  • Partridge EE, Hardy CM, Baskin ML, Fouad M, Willis L, James G, Wynn T. Shifting Community-Based Participatory Infrastructure from Education/Outreach to Research: Challenges and Solutions. Prog Community Health Partnersh. 2015;9 Suppl(Suppl):33-9. doi: 10.1353/cpr.2015.0019.

    PubMed 26213402

  • Pekmezi D, Ainsworth C, Holly T, Williams V, Benitez T, Wang K, Rogers LQ, Marcus B, Demark-Wahnefried W. Rationale, design, and baseline findings from a pilot randomized trial of an IVR-Supported physical activity intervention for cancer prevention in the Deep South: the DIAL study. Contemp Clin Trials Commun. 2017 Dec;8:218-226. doi: 10.1016/j.conctc.2017.10.008. Epub 2017 Nov 2.

    PubMed 29503878

  • Robinson JC, Carson TL, Johnson ER, Hardy CM, Shikany JM, Green E, Willis LM, Marron JV Jr, Li Y, Lee CH, Baskin ML. Assessing environmental support for better health: active living opportunity audits in rural communities in the southern United States. Prev Med. 2014 Sep;66:28-33. doi: 10.1016/j.ypmed.2014.05.021. Epub 2014 Jun 2.

    PubMed 24954744

  • Ard JD, Carson TL, Shikany JM, Li Y, Hardy CM, Robinson JC, Williams AG, Baskin ML. Weight loss and improved metabolic outcomes amongst rural African American women in the Deep South: six-month outcomes from a community-based randomized trial. J Intern Med. 2017 Jul;282(1):102-113. doi: 10.1111/joim.12622. Epub 2017 May 17.

    PubMed 28514081

Questions about this trial

What is this clinical trial studying?

A study testing Harvest for Health in people with Chronic Disease, run by University of Alabama at Birmingham at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment and Retention (time frame: 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04297826, which also lists 110 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.

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