This study is testing the effects on weight loss of a capsule-delivered device that expands in the stomach to help create a sense of fullness. The device then leaves the stomach, disintegrates and is excreted. In this study participants will receive either the device or a placebo capsule that looks the same. Participants will receive dietary and exercise counseling at most visits to help them lose weight. The 24-week losses of participants who get the device will be compared to the losses of those who get the placebo capsule to determine the effect on weight loss. Changes in other health markers will also be assessed.
Many youth and young adults (YYAs) with type 1 diabetes (T1D) and type 2 diabetes (T2D), particularly those of minority race/ethnicity, do not achieve optimal glycemic control and household food insecurity (HFI) may be a key barrier. HFI is the limited or uncertain availability of nutritionally adequate and safe foods. The SEARCH Food Security (SFS) cohort study is designed as an ancillary study to the ongoing NIH/NIDDK-funded SEARCH for Diabetes in Youth 4 Cohort study. The aims of the SFS study are to (1) Initiate a food insecurity cohort study of 1,187 YYAs aged 15-35 years (53% minority) with T1D and T2D by adding two data collection time points to the ongoing SEARCH 4 study in three of the five SEARCH sites, including South Carolina, Colorado and Washington; (2) Evaluate how HFI influences changes in glycemic control in YYAs with T1D and T2D; (3) Identify the pathways through which food insecurity may act; and (4) Evaluate the influence of HFI on changes in health care utilization and medical and non-medical health care costs in YYAs with T1D and T2D.
This research will develop and test a nutrition-focused mobile-support program for head and neck cancer patients and their caregivers at the end of treatment.
Phase I: To guide system development, we will conduct interviews with 15 individuals with head and neck cancer and their caregivers to understand the nutritional challenges faced at the end of treatment. We will also recruit 128 oncology dietitians to complete online surveys to identify key caregiver nutritional support tasks and caregiver demands.
Phase II: After system development, we will recruit 33 head and neck cancer patients and their main supporters to pretest our nutrition support system. Participants will be asked to complete two surveys and a one-time clinic session. The clinic session will include information and resources about symptoms and concerns and after the visit, the program will provide follow-up resources and mobile support for one month. Lastly, we we will conduct individual/small group interviews with 10 head and neck health care providers to evaluate feasibility and recommendations for future system development.
The information from this study may help us to improve supportive care programs in the future to help others as they complete head and neck cancer treatment.