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Rationale and design for the community activation for prevention study (CAPs): A randomized controlled trial of community gardening.

ABSTRACT: BACKGROUND:Engaging in health-promoting behaviors (e.g., healthy fruit- and vegetable-rich diet, physical activity) and living in supportive social and built environments are consistently and significantly associated with reductions in cancer, heart disease, diabetes, and other chronic diseases. Interventions to change diet and physical activity behaviors should aim to educate individuals, change the environments in which people live, work and recreate, improve access, availability, and affordability of healthy foods, and create safe places the facilitate active lifestyles. This trial will assess whether community gardening increases fruit and vegetable consumption and physical activity, improves social support and mental health, and reduces age-associated weight gain and sedentary time among a multi-ethnic, mixed-income population. METHODS/DESIGN:A randomized controlled trial of community gardening began in Denver, Colorado in January 2017. Over 3?years, we will recruit 312 consenting participants on Denver Urban Gardens' waitlists and randomize them to garden or remain on the waitlist. At baseline (pre-gardening), harvest time, and post-intervention, study participants will complete three 24-hour dietary recalls, a 7-day activity monitoring period using accelerometry, a health interview and physical anthropometry. DISCUSSION:This project addresses health-promoting behaviors among a multi-ethnic, mixed-income adult population in a large metropolitan area. If successful, this trial will provide evidence that community gardening supports and sustains healthy and active lifestyles, which can reduce risk of cancer and other chronic diseases. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT03089177: Registered on 03/17/17.

SUBMITTER: Litt JS

PROVIDER: S-EPMC5963280 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Rationale and design for the community activation for prevention study (CAPs): A randomized controlled trial of community gardening.

Litt J S JS Alaimo K K Buchenau M M Villalobos A A Glueck D H DH Crume T T Fahnestock L L Hamman R F RF Hebert J R JR Hurley T G TG Leiferman J J Li K K

Contemporary clinical trials 20180318

<h4>Background</h4>Engaging in health-promoting behaviors (e.g., healthy fruit- and vegetable-rich diet, physical activity) and living in supportive social and built environments are consistently and significantly associated with reductions in cancer, heart disease, diabetes, and other chronic diseases. Interventions to change diet and physical activity behaviors should aim to educate individuals, change the environments in which people live, work and recreate, improve access, availability, and ...[more]

PMID: 29563043

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Project description:BackgroundUnhealthy diet, physical inactivity, and social disconnection are important modifiable risk factors for non-communicable and other chronic diseases, which might be alleviated through nature-based community interventions. We tested whether a community gardening intervention could reduce these common health risks in an adult population that is diverse in terms of age, ethnicity, and socioeconomic status.MethodsIn this observer-blind, randomised, controlled trial, we recruited individuals who were on Denver Urban Garden waiting lists for community gardens in Denver and Aurora (CO, USA), aged 18 years or older, and had not gardened in the past 2 years. Participants were randomly assigned (1:1), using a randomised block design in block sizes of two, four, or six, to receive a community garden plot (intervention group) or remain on a waiting list and not garden (control group). Researchers were masked to group allocation. Primary outcomes were diet, physical activity, and anthropometry; secondary outcomes were perceived stress and anxiety. During spring (April to early June, before randomisation; timepoint 1 [T1]), autumn (late August to October; timepoint 2 [T2]), and winter (January to March, after the intervention; timepoint 3 [T3]), participants completed three diet recalls, 7-day accelerometry, surveys, and anthropometry. Analyses were done using the intention-to-treat principle (ie, including all participants randomly assigned to groups, and assessed as randomised). We used mixed models to test time-by-intervention hypotheses at an α level of 0·04, with T2 and T3 intervention effects at an α level of 0·005 (99·5% CI). Due to potential effects of the COVID-19 pandemic on outcomes, we excluded all participant data collected after Feb 1, 2020. This study is registered with ClinicalTrials.gov, NCT03089177, and data collection is now complete.FindingsBetween Jan 1, 2017, and June 15, 2019, 493 adults were screened and 291 completed baseline measures and were randomly assigned to the intervention (n=145) or control (n=146) groups. Mean age was 41·5 years (SD 13·5), 238 (82%) of 291 participants were female, 52 (18%) were male, 99 (34%) identified as Hispanic, and 191 (66%) identified as non-Hispanic. 237 (81%) completed measurements before the beginning of the COVID-19 pandemic. One (<1%) participant in the intervention group had an adverse allergic event in the garden. Significant time-by-intervention effects were observed for fibre intake (p=0·034), with mean between-group difference (intervention minus control) at T2 of 1·41 g per day (99·5% CI -2·09 to 4·92), and for moderate-to-vigorous physical activity (p=0·012), with mean between-group difference of 5·80 min per day (99·5% CI -4·44 to 16·05). We found no significant time-by-intervention interactions for combined fruit and vegetable intake, Healthy Eating Index (measured using Healthy Eating Index-2010), sedentary time, BMI, and waist circumference (all p>0·04). Difference score models showed greater reductions between T1 and T2 in perceived stress and anxiety among participants in the intervention group than among those in the control group.InterpretationCommunity gardening can provide a nature-based solution, accessible to a diverse population including new gardeners, to improve wellbeing and important behavioural risk factors for non-communicable and chronic diseases.FundingAmerican Cancer Society, University of Colorado Cancer Centre, University of Colorado Boulder, National Institutes of Health, US Department of Agriculture National Institute of Food and Agriculture, Michigan AgBioResearch Hatch projects.

Project description:BackgroundObesity is an established, modifiable risk factor of multiple myeloma (MM); yet, no lifestyle interventions are routinely recommended for patients with overweight or obesity with MM precursor conditions. Prolonged nightly fasting is a simple, practical dietary regimen supported by research, suggesting that the synchronization of feeding-fasting timing with sleep-wake cycles favorably affects metabolic pathways implicated in MM. We describe the design and rationale of a randomized controlled pilot trial evaluating the efficacy of a regular, prolonged nighttime fasting schedule among individuals with overweight or obesity at high risk for developing MM or a related lymphoid malignancy.ObjectiveWe aim to investigate the effects of 4-month prolonged nightly fasting on body composition and tumor biomarkers among individuals with overweight or obesity with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), or smoldering Waldenström macroglobulinemia (SWM).MethodsIndividuals with MGUS, SMM, or SWM aged ≥18 years and a BMI of ≥25 kg/m2 are randomized to either a 14-hour nighttime fasting intervention or a healthy lifestyle education control group. Participants' baseline diet and lifestyle patterns are characterized through two 24-hour dietary recalls: questionnaires querying demographic, comorbidity, lifestyle, and quality-of-life information; and wrist actigraphy measurements for 7 days. Fasting intervention participants are supported through one-on-one telephone counseling by a health coach and automated SMS text messaging to support fasting goals. Primary end points of body composition, including visceral and subcutaneous fat (by dual-energy x-ray absorptiometry); bone marrow adiposity (by bone marrow histology); and tumor biomarkers, specifically M-proteins and serum free light-chain concentrations (by gel-based and serum free light-chain assays), are assessed at baseline and after the 4-month study period; changes therein from baseline are evaluated using a repeated measures mixed-effects model that accounts for the correlation between baseline and follow-up measures and is generally robust to missing data. Feasibility is assessed as participant retention (percent dropout in each arm) and percentage of days participants achieved a ≥14-hour fast.ResultsThe PROlonged nightly FASTing (PROFAST) study was funded in June 2022. Participant recruitment commenced in April 2023. As of July 2023, six participants consented to the study. The study is expected to be completed by April 2024, and data analysis and results are expected to be published in the first quarter of 2025.ConclusionsPROFAST serves as an important first step in exploring the premise that prolonged nightly fasting is a strategy to control obesity and obesity-related mechanisms of myelomagenesis. In evaluating the feasibility and impact of prolonged nightly fasting on body composition, bone marrow adipose tissue, and biomarkers of tumor burden, this pilot study may generate hypotheses regarding metabolic mechanisms underlying MM development and ultimately inform clinical and public health strategies for MM prevention.Trial registrationClinicalTrials.gov NCT05565638; http://clinicaltrials.gov/ct2/show/NCT05565638.International registered report identifier (irrid)DERR1-10.2196/51368.

Project description:BackgroundRecent advances in the treatment algorithms of early breast cancer have markedly improved overall survival. However, anthracycline- and trastuzumab-associated cardiotoxicity may lead to dose-reduction or halt in potentially life-saving adjuvant cancer therapy. Early initiated neurohormonal blockade may prevent or attenuate the cardiotoxicity-induced reduction in cardiac function, but prior studies have been inconclusive. The angiotensin receptor-neprilysin inhibitor sacubitril/valsartan has been shown to be superior to traditional treatment in heart failure with reduced ejection fraction, but its cardioprotective effects in the cardio-oncology setting remains to be tested.ObjectiveTo assess if sacubitril/valsartan given concomitantly with early breast cancer treatment regimens including anthracyclines, with or without trastuzumab, may prevent cardiac dysfunction.MethodsPRADA II is a randomized, placebo-controlled, double blind, multi-center, investigator-initiated clinical trial. Breast cancer patients from four university hospitals in Norway, scheduled to receive (neo-)adjuvant chemotherapy with epirubicin independently of additional trastuzumab/pertuzumab treatment, will be randomized 1:1 to sacubitril/valsartan or placebo. The target dose is 97/103 mg b.i.d. The patients will be examined with cardiovascular magnetic resonance (CMR), echocardiography, circulating cardiovascular biomarkers and functional testing at baseline, at end of anthracycline treatment and following 18 months after enrolment. The primary outcome measure of the PRADA II trial is the change in left ventricular ejection fraction (LVEF) by CMR from baseline to 18 months. Secondary outcomes include change in LV function by global longitudinal strain by CMR and echocardiography and change in circulating cardiac troponin concentrations.ResultsThe study is ongoing. Results will be published when the study is completed.ConclusionPRADA II is the first randomized, placebo-controlled study of sacubitril/valsartan in a cardioprotective setting during (neo-)adjuvant breast cancer therapy. It may provide new insight in prevention of cardiotoxicity in patients receiving adjuvant or neo-adjuvant therapy containing anthracyclines. Furthermore, it may enable identification of patients at higher risk of developing cardiotoxicity and identification of those most likely to respond to cardioprotective therapy.Trial registrationThe trial is registered in the ClinicalTrials.gov registry (identifier NCT03760588 ). Registered 30 November 2018.

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Rationale and design for the community activation for prevention study (CAPs): A randomized controlled trial of community gardening.

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Rationale and design for the community activation for prevention study (CAPs): A randomized controlled trial of community gardening.

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