Pediatric Obesity Observational Prospective Trial: Microbiome and Metabolism During Obesity Target Therapeutics

Intervention Cohorts: A prospective, longitudinal observational case control study will be performed. All subjects will receive Healthy Lifestyle Program (HLP) standard of care, which includes intensive lifestyle modification and free participation in Bull City Fit. Four groups of participants receiving obesity treatment will be enrolled: (1) HLP-only, (2) HLP + Low carbohydrate diet, (3) HLP + weight loss medication(s) and (4) HLP + Bariatric surgery. Consistent with the observational design of this study, study participants will be assigned to each group as per usual HLP clinical care, based on established standards and guidelines, expert medical provider recommendations, and family preference.

Comparison Cohort: two comparison groups be enrolled:(1c) healthy siblings of enrolled intervention subjects and (2c) age/sex matched controls recruited from the Duke Children's Primary Care Clinic.

Up to 350 participants will be enrolled, with the goal of 295 evaluable participant data. The study period is six months for all groups with the exception of the bariatric surgery group which will last from baseline until after surgery, up to 12 months. The comparison groups will have one visit at baseline only.

Stool Sample Collection: Participants in both intervention and comparison groups will provide a fecal sample at enrollment or within 3 days of enrollment. Participants in intervention groups (Groups 1-4) will provide additional fecal samples at 1.5, 3, 4.5, and 6 months. Given that the ability to collect fecal samples is unpredictable, the investigator will develop a standard operating procedure along the following guidelines:

1. At the first visit, if the subject cannot provide a sample at the time of enrollment, the investigator will give the participant/parent a cooler/ice pack and sample collection kit. The investigator will ask the subject to provide the "baseline" sample within 3 days of the first visit. The sample will be refrigerated for up to 24 hours prior to pick up by the clinical research staff or delivery by the parent/guardian, with compensation for miles. With pick up or delivery a new cooler and freezer pack as well as sample collection kit will be provided for the following sample collection.
2. Within a 2-week window, centered on collection points 1.5 and 4.5 months, the subjects will provide additional samples. They may either have the samples picked up within 24 hours of collection (with refrigeration from collection to pick up) or get reimbursed for mileage.
3. For the 3-month and 6-month collections, which occur in conjunction with a regularly scheduled Healthy Lifestyles visit, the patients will collect a sample within 24 hours prior to the visit and bring with them to clinic. At the 3-month visit they will be sent home with new collection kits, freezer packs, and coolers.
4. If a patient cannot provide a sample within 24 hours of a clinic visit or a sample is missed, we will still collect a sample as soon as the patient is able to provide it and arrange for pickup or delivery as outlined below, noting the sample as "out of window."