Clinical Research Directory

Experimental Approach to Test Predictions of Body Weight Regulation Models

The regulation of human body weight and fatness is not fully understood. Although some models of regulation have been proposed (set point, dual-intervention point, others), no studies have been designed to test their predictions. In this pilot and feasibility study, the investigators will implement an experimental approach to test the predictions of models of body weight regulation in humans. Men and women with either low body weight or obesity will be exposed to a 2-day fasting followed by a 2-day ad-libitum refeeding. During the entire fasting-refeeding period, energy intake and expenditure will be accurately measured within metabolic chambers. The investigators will therefore determine the compensatory responses to fasting elicited to prevent weight loss. The results will serve to design and power future studies to better understand body weight regulation.

Weight Status, Resilience, and Quality of Life in Indian Children

A school-based cross-sectional study that aims to generate context-specific evidence on how weight status is related to resilience, health behaviour, and quality of life among Indian adolescents. Primary Objective To assess differences in overall resilience (total score of Adolescent Resilience score from ARQ49) between normal-weight and overweight/obese Indian adolescents aged 14-16 years. Secondary Objectives 1. To compare differences in Adolescent Resilience Questionnaire (ARQ49) subscale scores between normal-weight and overweight/obese adolescents. The internal resilience factors assessed by the ARQ49 include confidence, emotional insight, negative cognition, social skills, empathy, and tolerance, while the external resilience factors include family connectedness, family availability, peer connectedness, peer availability, supportive school environment, school connectedness, and community connectedness. 2. To assess differences in internal resilience factors (diet self-efficacy, physical activity self-efficacy, self-esteem, and optimism) between normal-weight and overweight/obese adolescents and to examine parental nutrition knowledge as an external resilience resource and moderator in association analyses. 3. To compare dietary behaviors, physical activity patterns, and Pediatric Quality of Life Inventory (PedsQL) scores between normal-weight and overweight/obese adolescents. 4. To examine the associations among resilience, dietary and physical activity behaviors, and PedsQL within the overall sample and within different weight groups, and to evaluate parental nutrition knowledge as a moderator of the relationship between weight status and resilience or health outcomes. Exploratory Objective 5. To explore differences in resilience, health behaviors, and PedsQL between normal-weight and underweight Indian adolescents. Study hypotheses The investigators hypothesized that adolescents with overweight/obesity, compared with their normal-weight peers, would demonstrate lower scores on total resilience (primary outcome), as well as on internal and external resilience indices; report lower diet self-efficacy, physical activity self-efficacy, self-esteem, and optimism; report less frequent health-promoting behaviors (including lower fruit and vegetable intake and fewer days achieving ≥ 60 min/day of moderate-to-vigorous physical activity); and report lower PedsQL scores. Parental nutrition knowledge will not be treated as a between-group outcome; instead, it will be tested as a moderator in association analyses, examining whether parental nutrition knowledge influences the relationship between weight status and resilience or health outcomes. Furthermore, the investigators hypothesized that higher resilience scores would be positively associated with healthier dietary behaviors, greater physical activity participation, and higher PedsQL scores across the overall sample, with these associations expected to hold true within both normal-weight and overweight/obese groups. In addition, analyses involving underweight adolescents will be exploratory and descriptive in nature. We will explore whether underweight adolescents show different levels of resilience, health behaviors, and HRQoL compared with adolescents with normal weight.

Prevalence, Incidence and Risk Signature of Chronic Kidney Disease in Sub-Saharan Africa

Chronic kidney disease (CKD) is associated with increased cardiovascular morbidity and mortality. The prevalence of CKD is increasing worldwide and is assumed to also dramatically increase in Sub-Saharan Africa (SSA). Key shortcomings of available data on CKD in SSA are as follows: (i) Available data are based on single measurements and, therefore, cannot distinguish between harmless transient deterioration in kidney function and chronic kidney damage; (ii) Accurate information regarding renal protein loss, an important and early marker of kidney disease, is lacking; (iii) Cardiovascular risk factors for CKD, such as obesity, hypertension and diabetes, are often not searched for. Likewise non-classic potential risk factors, such as endemic infectious diseases, socioeconomic status and lifestyle have not been consistently recorded; (iv) Information to interrogate linked interaction over time between risk factors and development of CKD is unavailable. With this project, situated in a region representative of semi-rural SSA, we aim to fill this knowledge gap and (i) establish guideline conform prevalence data of CKD and its major cardiovascular risk factors, as well as (ii) prospectively define the incidence of cardiovascular- and non-classic risk factors of CKD. The data from (i) and (ii) is used to develop predictive models. A prospective cohort of 1200 individuals in a primary care facility will serve as study population. The population is representing a society in transition from rural to more urban lifestyle. In the pilot study, participants will be followed for one years and undergo the clinical and biomedical testing required to capture CKD and its classic and non-classic risk factors over time.

Building Healthy Food Environment in Schools: Evaluating Co-created Interventions in Low Resource Settings. #BetterNutrition4Adolescent

The goal of this clinical trial is to learn if a multicomponent nutrition program developed together with the students, parents, teachers and canteen operators will improve nutrition status of adolescents. It will also learn about the acceptability and feasibility of implementing the program in the school settings. The main questions it aims to answer are: What is the effect of co-created multicomponent intervention promoting healthy food behavior and environment in schools on the proportion of normal weight adolescents? What proportion of the target adolescents and teachers does the intervention reach? What proportion of the schools are willing to implement the intervention? What was the level of fidelity of implementation of all components of the intervention and the barriers and facilitators to implementation? What is the cost for maintenance, and facilitators and barriers of sustainment? School going adolescents studying in grades 7 to 9 from 26 schools in India and 26 schools in Nepal will be enrolled in the trial and their height, weight, dietary behavior, mental well-being and physical activity will be measured at baseline and at 12 months follow up. After the baseline assessment the school community (students, school environment, parents, teachers, canteen operators) will receive the intervention.

Child Health, Nutrition and Microbiome Development

Childhood malnutrition is a global public health issue with devastating consequences on the health, well-being, and psychosocial development of children. Emerging evidence suggests that malnourished children have immature gut microbiota compared to age-matched healthy controls and it does not repair even after nutritional interventions. The present study aims to characterize how the gut microbiome develops during the first two years of life in children residing in malnutrition endemic areas of Khyber Pakhtunkhwa, the region with the highest prevalence of childhood malnutrition in Pakistan and the region.