NIH – Exploratory/Developmental Clinical Research Grants in Obesity (R21 Clinical Trial Optional)

April 2, 2018 by School of Medicine Webmaster

The intent of this FOA is to encourage exploratory/developmental clinical research that will accelerate the development of effective interventions for prevention or treatment of overweight or obesity in adults and/or children. The goal of the R21 mechanism is to provide flexibility for initiating exploratory, short-term studies, thus allowing new ideas to be investigated in a more expeditious manner without stringent requirements for preliminary data. Such support is needed to encourage investigators to pursue new approaches, underdeveloped topics, or more creative avenues for research including new partnerships. Epidemiological research with a goal of informing translational/clinical research on prevention or treatment of obesity or overweight in adults and/or children is encouraged. The emphasis is thus on the development of exploratory clinical studies, pilot and feasibility studies, or small randomized clinical trials that will provide preliminary data for intervention, and epidemiological studies that will inform translational/clinical research.

This initiative specifically encourages the submission of applications for pilot and feasibility or exploratory clinical studies related to obesity. These studies should focus on research that is particularly innovative and/or potentially of high impact. Innovative research includes feasibility studies in which the technological, methodological, or theoretical approach to a problem lacks historical precedent or sufficient preliminary data but is highly promising. High impact research involves studies where successful outcomes would have a major effect on the area of obesity. Clinical pilot and feasibility studies could provide the data needed to design appropriately powered efficacy studies. Such trials may use pharmacological, dietary supplement, dietary, surgical, medical device, physical activity, behavioral, or neuro-modulatory interventions aimed at prevention or treatment of obesity or overweight in adults and/or children. Applications to identify novel risk factors for the development of overweight and obesity and their complications are encouraged.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

For this FOA, NIDDK emphasizes interest in novel/innovative approaches that test for initial efficacy of obesity prevention/treatment interventions. Epidemiological studies including utility of electronic health records and targeted precision medicine approaches that will inform translational/clinical research are also of interest.  Successful clinical studies supported under this funding mechanism that yield promising preliminary/pilot data are then expected to move forward to inform the design and implementation of adequately powered clinical trials, typically using the NIH R01 mechanism.  Applications that target overweight/obesity prevention or treatment/management outcomes such as body mass index (BMI), body weight, and/or body composition across the lifespan are of particular interest.

National Cancer Institute (NCI)

Obesity is associated with increased incidence of, and mortality from, certain cancers, including postmenopausal breast, pancreatic, ovarian, and colorectal cancer. The National Cancer Institute (NCI) is interested in fostering research focused on identifying effective interventions for the prevention and treatment of obesity, including novel energy intake and expenditure modalities that alter body weight and/or composition in certain subpopulations of cancer patients and those at high risk for cancer. NCI plans to support pilot human intervention studies that examine the impact of variation in dietary composition, dietary pattern, intermittent fasting, or meal timing on weight control or weight change. Populations of interest include individuals with a genetic propensity for cancer, those with cancer, and those at risk for cancer recurrence. NCI is also interested in studies that examine intervention influences on potential modifying factors (i.e., gut microbiota) and on cancer related biomarkers. Studies that target subpopulations traditionally underrepresented in research (in terms of race/ethnicity, gender, sexual orientation, socioeconomic status, or geographic location) are particularly encouraged.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is interested in clinical studies that accelerate interventions for the prevention or treatment of obesity in children, adolescents, or families.  NICHD encourages multilevel interventions that target individual, family and socio-environmental factors related to overweight and obesity. Observational studies to identify behavioral, psychosocial, and/or environmental factors that motivate or promote adherence to healthy dietary and physical activity behaviors for obesity prevention or treatment are also of interest.  Applications that focus on reducing health disparities as well as those focused on minority populations are particularly encouraged.  The National Center for Medical Rehabilitation Research (NCMRR) within NICHD is interested in approaches that address populations of individuals diagnosed with disabilities, both adults and children, primarily aimed at obesity prevention, physical activity participation, improved health status and reduction of secondary conditions. NCMRR encourages research that aims to better understand the special needs of children with disabilities, in order to develop integrated clinical and behavioral strategies to promote physical activity, reduce secondary conditions, foster healthy dietary choices, and improve health status and social participation.

Objectives and Scope

Studies on the prevention or treatment of overweight or obesity in children and/or adults, including dietary, physical activity, behavioral, psychosocial, neurocognitive and neuro-modulatory, pharmacologic, and surgical, and other biomedical approaches are of interest. The creative use of various devices, technologies, or communication strategies to help individuals monitor energy intake or energy expenditure in weight control programs would be appropriate. Innovative studies that test the synergy of creative partnerships among various groups such as industry, business, faith-based, academic, or community organizations to enhance obesity prevention or treatment outcomes are of interest. Studies of various approaches in combination to achieve weight maintenance or to maintain weight loss, such as physical activity or diet in combination with pharmacologic or surgical regimens would also be appropriate.

Basic laboratory research, studies that propose to use laboratory animals or stored bio-samples, and studies that do not involve human subjects are not appropriate for this announcement. This funding opportunity also is not for development or implementation of outreach programs or educational curriculum development for the treatment or prevention of overweight or obesity. It is not the intent of this mechanism to support the initial development or validation of smart phone applications, accelerometers, educational curricula in CD or video formats, games, instruments, or similar tools or technologies. However, experimental modules of application program interfaces to inform future clinical research studies and interventions to test the application of various modalities in trials for obesity prevention or treatment in order to test for efficacy addressing overweight/obesity outcomes would be appropriate.

Specific examples of research areas of interest include but are not limited to:

  • Studies of novel interventions for prevention and treatment of obesity in children and/or adults, including: modification of dietary practices or eating environments; strength training, aerobic conditioning, or other modifications of physical activity and sedentary behavior; modification of relevant associated behaviors, neurocognitive functions, and psychosocial influences that affect eating and physical activity patterns or environmental conditions that may have an impact upon energy balance.
  • Pilot and feasibility studies with interventions that promote dietary habits, food choices/preferences, or eating patterns, or that incorporate the study of various factors such as diurnal and circadian disturbances that influence body weight, body composition, or metabolic outcomes for overweight/obesity.
  • Patient-oriented research to evaluate pharmacological, surgical, and other biomedical treatments of obesity.
  • Novel and exploratory clinical studies to establish specific body composition or other phenotypic features as indicators of risk for obesity, response to its treatment, or its co-morbidities relevant to NIDDK in well characterized pediatric and/or adult patients.
  • Studies to identify behavioral, neuro-cognitive, psychosocial, and/or environmental factors that motivate or promote adherence to dietary or physical activity behaviors for obesity prevention or treatment.
  • Studies to explore social marketing approaches for promoting eating behaviors and increased physical activity aimed at weight control.
  • Intervention studies that employ community-based participatory research strategies for obesity prevention.
  • Development and application of neuroimaging and neuro-modulation technologies for studying the role of the brain and cognitive function in human obesity, including the interaction between homeostatic and non-homeostatic (e.g., reward/motivation, learning/memory, executive function) mechanisms, the interplay of homeostatic (i.e., hypothalamic and brainstem) and non-homeostatic (i.e., extra-hypothalamic and brainstem) brain systems that control eating behavior, neural control over peripheral metabolism, the effect of bariatric surgery in the CNS, and the use of neuro-modulation (e.g., devices, pharmaco-therapeutics, and cognitive therapy) as an intervention for obesity.

Investigations in understudied populations, including medically underserved populations are encouraged.

Potential applicants are encouraged to contact Scientific/Research staff as they plan their application. Scientific/Research staff welcome the opportunity to talk with applicants before applications are submitted.

Deadlines:  standard dates and standard AIDS dates apply


Filed Under: Funding Opportunities