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Designing, Conducting, and Documenting Human Nutrition Plant-Derived Intervention Trials.

ABSTRACT: Best practices for designing, conducting, documenting, and reporting human nutrition randomized controlled trials were developed and published in Advances in Nutrition. Through an example of the randomized clinical trial on blueberries and bone health funded by the National Institutes of Health, this paper will illustrate the elements of those best practices that apply specifically to plant-based intervention clinical trials. Unique study design considerations for human feeding interventions with bioactive plant compounds include the difficulty of blinding the intervention, background nutritional status of participants, carry-over effects of the intervention, benefits of a run-in period, lack of safety/tolerability data, and nutrition-specific regulatory policies. Human nutrition randomized controlled trials are the gold standard for establishing causal relations between an intervention and health outcome measures. Rigorous studies and documentation define the quality of the evidence-base to inform public health guidelines and to establish personalized dietary recommendations for the health-promoting plant components.

SUBMITTER: Weaver CM

PROVIDER: S-EPMC8733730 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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Designing, Conducting, and Documenting Human Nutrition Plant-Derived Intervention Trials.

Weaver Connie M CM Hodges J Kalina JK

Frontiers in nutrition 20211223

Best practices for designing, conducting, documenting, and reporting human nutrition randomized controlled trials were developed and published in Advances in Nutrition. Through an example of the randomized clinical trial on blueberries and bone health funded by the National Institutes of Health, this paper will illustrate the elements of those best practices that apply specifically to plant-based intervention clinical trials. Unique study design considerations for human feeding interventions wit ...[more]

PMID: 35004813

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Project description:Introductionn-of-1 trials are undertaken to optimise the evaluation of health technologies in individual patients. They involve a single patient receiving treatments, both interventional and control, consecutively over set periods of time, the order of which is decided at random. Although n-of-1 trials are undertaken in medical research it could be argued they have the utility to be undertaken more frequently. We undertook the National Institute for Health Research (NIHR) commissioned DIAMOND (Development of generalisable methodology for n-of-1 trials delivery for very low volume treatments) project to develop key points to assist clinicians and researchers in designing and conducting n-of-1 trials.MethodsThe key points were developed by undertaking a stakeholder workshop, followed by a discussion within the study team and then a stakeholder dissemination and feedback event. The stakeholder workshop sought to gain the perspectives of a variety of stakeholders (including clinicians, researchers and patient representatives) on the design and use of n-of-1 trials. A discussion between the study team was held to reflect on the workshop and draft the key points. Lastly, the stakeholders from the workshop were invited to a dissemination and feedback session where the proposed key points were presented and their feedback gained.ResultsA set of 22 key points were developed based on the insights from the workshop and subsequent discussions. They provide guidance on when an n-of-1 trial might be a viable or appropriate study design and discuss key decisions involved in the design of n-of-1 trials, including determining an appropriate number of treatment periods and cycles, the choice of comparator, recommended approaches to randomisation and blinding, the use of washout periods and approaches to analysis.ConclusionsThe key points developed in the project will support clinical researchers to understand key considerations when designing n-of-1 trials. It is hoped they will support the wider implementation of the study design.

Project description:IntroductionNutrition during the complementary feeding period (6-23 months) is critical to ensure optimal growth and reduce the risk of diet-related disease across the life course. Strategies to reduce multiple forms of malnutrition (stunting, overweight/obesity and anaemia) in infants and young children (IYC) are a key priority in low-income and middle-income countries, including Peru. This study aims to co-design and develop prototypes for interventions to address the multiple forms of malnutrition in IYC in urban Peru, using a participatory design approach.Methods and analysisThe study will be based within peri-urban communities in two areas of Peru (Lima and Huánuco city). Following the identification of key nutritional challenges for IYC aged 6-23 months through formative research (phase I), we will conduct a series of workshops bringing together healthcare professionals from government health centres and caregivers of IYC aged 6-23 months. Workshops (on idea generation; creating future scenarios; storyboarding and early implementation and feedback) will take place in parallel in the two study areas. Through these workshops, we will engage with community participants to explore, experiment, co-design and iteratively validate new design ideas to address the challenges around IYC complementary feeding from phase I. Workshop outputs and transcripts will be analysed qualitatively using affinity diagramming and thematic analyses. The intervention prototypes will be evaluated qualitatively and piloted with the participating communities.Ethics and disseminationEthical approval for this study was obtained from the Ethical Review Committee of the Instituto de Investigación Nutricional (IIN) Peru (388-2019/CIEI-IIN), Loughborough University (C19-87) and confirmed by Cardiff University. Findings of the participatory design process will be disseminated through a deliberative workshop in Lima, Peru with national and regional government stakeholders, as well as participants and researchers involved in the design process. Further dissemination will take place through policy briefs, conferences and academic publications.

Project description:BackgroundWith rates of childhood obesity continually increasing, effective physical activity and nutrition interventions are needed. Formative research is used to tailor interventions to different cultural and geographic contexts and can be vital in adapting intervention strategies in the face of significant disruptive circumstances (like COVID-19).ObjectiveWe conducted formative research via in-person and web-based focus groups among middle schoolers and parents to better understand the facilitators and barriers to physical activity and fruit and vegetable consumption and to inform the design of a large intervention for a low-income, urban setting in the US Midwest.MethodsWe conducted 2 phases of qualitative focus groups with parents (n=20) and 6th-9th grade middle schoolers (n=23). Phase 1 was conducted prior to the COVID-19 pandemic in late 2019, and phase 2 was conducted during the COVID-19 pandemic in the summer of 2020. Focus groups were transcribed and thematically coded using the Dedoose software.ResultsThe main facilitators of physical activity prior to the pandemic included the opportunity to have fun, peer influence, competition (for some), and incentives, while the main barriers to physical activity were time constraints and social discomfort. The main facilitators of eating fruits and vegetables included parental influence, preparation technique, and convenience, while barriers included dislike of vegetables, time constraints, and preparation or freshness. During the pandemic, facilitators of physical activity remained the same, while additional barriers to physical activity such as lack of motivation and limited time spent outside of the home were reported. For fruit and vegetable consumption, both facilitators and barriers remained the same for both time periods. Additionally, for some participants, the pandemic offered an opportunity to offer more fruits and vegetables to middle schoolers throughout the day.ConclusionsSome themes identified were common to those reported in previous studies, such as peer influence on physical activity and parental influence on fruit and vegetable consumption. Novel themes such as lack of motivation to be active and limited time outside the home helped improve intervention adaptation, specifically during the COVID-19 pandemic. The continuity of formative research after a major unexpected change in the intervention context can be essential in targeting areas of an intervention that can be retained and those that need to be adjusted.

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Designing, Conducting, and Documenting Human Nutrition Plant-Derived Intervention Trials.

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Designing, Conducting, and Documenting Human Nutrition Plant-Derived Intervention Trials.

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