Clinical Research Directory

Implementing Modified Practices to Leverage Evidence for Movement, Engagement, and Nutrition Topics in Early Childcare and Education

The goal of this cluster-randomized, controlled trial is to learn if a professional development program for childcare educators, called the Boston Healthy Child Care Initiative, can help improve the nutritional quality of meals/snacks served and the availability of physical activity opportunities in childcare programs, and also to learn if this results in improved diet quality and physical activity for young children who attend childcare, especially in under-resourced settings. The main questions it aims to answer are: Do childcare programs that receive professional development through the Boston Healthy Child Care Initiative improve the nutritional quality of the meals they serve, as measured by the Healthy Eating Index (HEI-2020), and do they also provide more physical activity opportunities to young children throughout the day? Do young children (ages 2-5 years) attending childcare programs that receive the Boston Healthy Child Care Initiative eat more nutritious foods/beverages (as measured by the HEI-2020) and engage in less sedentary time at childcare? Researchers will compare a group of childcare programs who participate in the Boston Healthy Child Care Initiative, and a sample of children who attend those programs, to a similar group of childcare programs who do not participate to see if the quality of meals served, the amounts of physical activity opportunities scheduled, young children's dietary quality, and the minutes/day spent in physical activity increase from before to after the Boston Healthy Child Care Initiative. Childcare educator participants will: * Complete the Boston Healthy Child Care Initiative professional development program (for the intervention group only) * Share copies of menus, schedules, and written policies about nutrition and physical activity in the childcare program Child participants will: * Wear ActiGraph wGT3X-BT accelerometers for two days while at childcare to measure physical activity levels. They will do this for two days each at baseline, midline, and follow-up after the initiative concludes. * Be observed during mealtimes by trained researchers to visually estimate how much they consume at meals and snacks in childcare.

The Growing Well Study

What are the study aims? To understand more about eating habits and age-appropriate food/drink portion sizes of children aged 6 months-5 years old, and how this affects their growth and dental health. Why is this research important? Healthy diets in early years are important for growth and development. However, clear guidance for parents on what and how much children should eat is missing due to lack of up-to-date information. What will the investigators do? Information will be collected at two time points. At baseline, parents/guardians of children aged 6 months-4 years from Leeds, Doncaster and East London will complete questionnaires about their child's sociodemographic information and food intake. They will be asked to record what their child eats for three separate one-day periods using an online system called 'myfood24'. Parents will also attend one in-person session for measuring their child's length/height, weight, and waist circumference. At follow-up one year later, parents/guardians will complete surveys again, with another in-person session to look at growth and assess dental health. What do the investigators expect to achieve and what happens next? They want to understand how growth and dental health are influenced by nutrient intakes, dietary patterns, and portion sizes for key food groups. They will also identify how much of different foods children should be eating, and whether commercial foods and sweet drinks are relevant. They will explore which dietary factors can support healthier children; and how low intakes of key foods or vitamins/minerals in vulnerable groups could be redressed. The study will provide unique information, allowing for development of recommendations for parents and policy-makers on age-appropriate portions, on achieving good nutrition in UK children and within special dietary groups, and on dietary considerations in caring for children's teeth.

Health, Body Composition, and Nutrition Research Among Women in Kazakhstan

This study aims to investigate the association between dietary intake, physical activity, sleep quality, and body composition in women in Kazakhstan. The study will recruit approximately 200 women aged 20 years and older undergoing routine DEXA examinations in Astana. Participants will complete validated questionnaires assessing diet, physical activity, sleep quality, and sarcopenia risk, alongside functional assessments. DEXA scans will provide measurements of fat mass, lean mass, visceral adipose tissue, bone mineral density, and appendicular skeletal muscle mass. The primary objective is to evaluate associations between dietary quality and DEXA-derived outcomes. Secondary objectives include assessing sarcopenia prevalence and examining relationships between physical activity, sleep quality, supplement use, and body composition. An optional second stage will explore associations between body composition and existing inflammatory and metabolic biomarkers from medical records. The findings are expected to provide the first comprehensive DEXA-based dataset on women's body composition and lifestyle factors in Kazakhstan and inform public health strategies.

The SWITCH Dietary and Behavioural Intervention Study

The overall objective of this study is to evaluate the effectiveness of an optimized lifestyle intervention based on dietary advice, behavioral support, and provision of key foods compared to dietary advice with behavioral support or dietary advice alone. The intervention aims to improve nutritional status, metabolic risk factors, and planetary sustainability. A total of 300 participants (150 men and 150 women) who meet all inclusion criteria and none of the exclusion criteria will be recruited. The study will be conducted at the Centre for Lifestyle Intervention at Östra Hospital in Gothenburg, led by researchers from Chalmers University of Technology, University of Gothenburg, and Sahlgrenska University Hospital. Participants will be recruited from two different socioeconomic areas in Gothenburg to examine how dietary interventions function in diverse population groups. The study follows a twelve-week randomized, controlled, parallel intervention design. Participants will be randomized into three groups, each with 100 individuals: Optimized lifestyle intervention group - receiving dietary advice, behavioral support, and provision of key foods. Behavioral support intervention group - receiving dietary advice and behavioral support. Control group - receiving dietary advice according to the SWITCH diet. The SWITCH diet, developed within the EU project SWITCH, is designed to align with European dietary guidelines and promote sustainable and healthy eating habits. It emphasizes whole grains, vegetables, fruits, legumes, and sustainable seafood while limiting processed foods, added sugars, and salt. Throughout the study, participants will undergo clinical assessments at baseline, midpoint (week 7), and endpoint (week 13). Key measurements include anthropometric data, blood pressure, blood glucose, blood lipids, and inflammatory markers. Dietary intake and sustainability aspects of food consumption will also be evaluated. Participants in the intervention groups will receive personalized coaching and access to practical resources, such as meal plans, recipes, and visual educational materials. The primary outcome of the study is the difference in cardiometabolic risk factors (e.g., blood lipids, blood pressure, glucose, insulin resistance markers) between the intervention groups. Secondary outcomes include changes in dietary intake, nutritional status markers, inflammatory markers, and sustainability measures (e.g., CO₂ emissions, land use, biodiversity impact). Additionally, exploratory analyses will investigate associations between diet, lifestyle changes, gut microbiota, and metabolic responses. This study aims to generate valuable insights into the effectiveness of different dietary intervention strategies in real-life Nordic conditions. The results will contribute to the development of evidence-based recommendations for sustainable and health-promoting dietary patterns.