Metabolic Disorders

The Dose Trial: Dose Intensity of Behavioral Interventions for Childhood Obesity

Posted on by Jodi Snare

Page last updated February 4, 2026

ClinicalTrials.gov#: NCT06654323
Study Design: Intervention Trial
PCORnet Infrastructure: Common Data Model (CDM), Single IRB, Patient partners or engagement
Principal Investigator: Dr. Bill Heerman
Institution: Vanderbilt University Medical Center
PCORnet® Network Partner: STAR
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date: 2024
Study Duration: 2024 – 2030
Participating PCORnet® Clinical Research Networks: STAR
Therapeutic Area: Metabolic Disorders; Other, Pediatric Obesity
Status: Recruiting

Research Question(s):

Can children with obesity achieve meaningful improvements in their health with fewer hours of treatment than currently recommended? This study is testing whether shorter versions of a family-based lifestyle program, delivered through pediatric clinics, are just as effective as the full 26-hour version currently recommended by national guidelines. The goal is to find out if families can benefit from a lower-dose program that is easier to complete, while still helping children improve their weight, quality of life, and health behaviors.

The COVID-19 and Diabetes Assessment (CODA) Study

Posted on by Jodi Snare

Page last updated November 07, 2025

Study Website: https://codadiabetesstudy.org/ 
Study Design: Prospective Observational Study
Principal Investigator: Russell Rothman
Institution: Vanderbilt University Medical Center
PCORnet® Network Partner: STAR
Funder: NIDDK/NIH
Participating PCORnet® Clinical Research Networks: GPC, OneFlorida+, PaTH, PEDSnet, REACHnet, STAR
Therapeutic Area: Metabolic Disorders
Condition: COVID-19, Diabetes
Age Range: 18 Years and older (Adult, Older Adult)
Status: Recruiting

Research Question(s):  The study will answer important questions patients are asking about the link between diabetes and COVID-19.

  1. To what extent does COVID-19 cause worse glycemic control, vascular function, inflammation, and increased risk for blood clots in people with either type 1 or type 2 diabetes?
  2. The study will also explore the role of genomic, social, and environmental factors on metabolic function and the impact of COVID-19 infection and COVID-19 treatments on diabetes-related outcomes.

Greenlight Plus Study: A Randomized Study of Approaches to Early Childhood Obesity Prevention

Posted on by Jodi Snare

Page last updated April 14, 2026

Study Website: https://www.greenlight-program.org/
ClinicalTrials.gov#: NCT04042467
Study Design: Intervention Trial
PCORnet Infrastructure (Phase 1): Common Data Model (CDM), Single IRB, Patient partners or engagement
PCORnet Infrastructure (Phase 2): Single IRB, Patient partners or engagement
Principal Investigator: Bill Heerman
Institution: Vanderbilt University Medical Center
PCORnet® Network Partner: STAR
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date (Phase 1): 2018
Study Duration (Phase 1): 2019 - 2025
Funding Date (Phase 2): 2025
Study Duration (Phase 2): 2025 - 2031
Participating PCORnet® Clinical Research Networks: INSIGHT, OneFlorida+, PaTH, STAR
Therapeutic Area: Metabolic Disorders
Condition: Behavior, Health; Child Obesity
Status (Phase 1): Active, not recruiting
Status (Phase 2): Not yet recruiting

Research Question(s):
The research team is recruiting 900 English- and Spanish-speaking parent-infant pairs from six primary care clinics. The team is assigning the pairs by chance to receive either Greenlight or Greenlight Plus for two years. At the start of the study and throughout the child's first two years of life, the team is interviewing families and reviewing medical records to see how each baby is growing. The team wants to know how Greenlight and Greenlight Plus compare in promoting healthy weight gain for different groups based on language, race, ethnicity, and health literacy.

Understanding How Antibiotic Use Affects Childhood Obesity and Growth

Posted on by Jodi Snare

Page last updated February 4, 2026

ClinicalTrials.gov#: NCT02744846
Study Design: Retrospective Observational Study
PCORnet Infrastructure: Common Data Model (CDM), Patient partners or engagement
Principal Investigator: Jason P. Block
Institution: Harvard Pilgrim Health Care
PCORnet® Network Partner: Other
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date: 2015
Study Duration: 2015 - 2018
Participating PCORnet® Clinical Research Networks: ADVANCE, GPC, INSIGHT, OneFlorida+, PEDSnet, REACHnet, STAR
Therapeutic Area: Metabolic Disorders
Age Range: up to 11 Years (Child)
Status: Completed

Research Question(s):
How does antibiotic use before age two affect weight and growth in children?

Primary Publication(s):

Block JP, Bailey LC, Gillman M, et al. Early Antibiotic Exposure and Weight Outcomes in Young Children. Pediatrics, 2018; 142(6), p.e20180290. doi:10.1542/peds.2018-0290

Heerman WJ, Daley MF, Boone-Heinonen J, et al. Maternal antibiotic use during pregnancy and childhood obesity at age 5 years. Int J Obes (Lond). 2019;43(6):1202-1209. doi:10.1038/s41366-018-0316-6

Comparing the Benefits and Harms of Three Types of Weight Loss Surgery — The PCORnet® Bariatric Study

Posted on by Jodi Snare

Page last updated November 12, 2025

Study Website: The PCORnet Bariatric Study (PBS)
ClinicalTrials.gov#: NCT02741674
Study Design: Retrospective Observational Study
PCORnet Infrastructure: Common Data Model (CDM), Patient partners or engagement
Principal Investigator: David Arterburn
Institution: Kaiser Permanente Washington Health Research Institute
PCORnet® Network Partner: Legacy PCORnet Partner
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date: 2015
Study Duration: 2016 – 2018
Participating PCORnet® Clinical Research Networks: GPC, INSIGHT, OneFlorida+, PaTH, PEDSnet, REACHnet, STAR
Therapeutic Area: Metabolic Disorders
Condition: Bariatrics, Body Weight, Diabetes, Gastric Bypass, Obesity
Age Range: up to 79 Years (Child,  Adult,  Older Adult)
Status: Completed

Research Question(s):
We don’t know much about the long-term effectiveness of bariatric interventions. Can we use PCORnet to compare compare weight loss and safety among three popular bariatric procedures?

Primary Publication(s):

Inge TH, Coley RY., Bazzano LA,. et al. Comparative effectiveness of bariatric procedures among adolescents: the PCORnet bariatric study. SOARD, 2018, 14(9):1374-1386. doi.org/10.1016/j.soard.2018.04.002

McTigue KM, Wellman R, Nauman E, et al. PCORnet Bariatric Study Collaborative. Comparing the 5-Year Diabetes Outcomes of Sleeve Gastrectomy and Gastric Bypass: The National Patient-Centered Clinical Research Network (PCORNet) Bariatric Study. JAMA Surg. 2020;155(5):e200087. doi:10.1001/jamasurg.2020.0087

A Patient-Centered PaTH to Addressing Diabetes

Posted on by Jodi Snare

Page last updated November 12, 2025

Study Website: The PaTH to Health: Diabetes Study
ClinicalTrials.gov#: NCT02788903
Study Design: Retrospective Observational Study
PCORnet Infrastructure: Common Data Model (CDM), Patient partners or engagement
Principal Investigator: Jennifer Kraschnewski
Institution: Penn State
PCORnet® Network Partner: PaTH
Funder: Patient-Centered Outcomes Research Institute (PCORI); (project webpage)
Funding Date: 2016
Study Duration: 2016 – 2021
Participating PCORnet® Clinical Research Networks: GPC, PaTH
Therapeutic Area: Metabolic Disorders
Condition: COVID-19; Diabetes; Obesity
Age Range: 18 Years and older (Adult, Older Adult)
Status: Completed

Research Question(s):

  1. How often is intensive behavioral therapy (IBT) being utilized in primary care and how has it impacted weight and diabetes outcomes for patients with and at-risk of type 2 diabetes?
  2. What is the impact of telemedicine utilization during the COVID-19 pandemic for patients with and at-risk of type 2 diabetes?
  3. What are demographic and clinical characteristics associated with severe COVID-19 outcomes across multiple phases of the COVID pandemic for patients with or at-risk of type 2 diabetes?

Primary Publication(s):

Kraschnewski JL, Kong L, Francis E, et al. A Patient-Centered PaTH to Address Diabetes: Protocol for a Study on the Impact of Obesity Counseling. JMIR Res Protoc. 2019 Apr 4;8(4):e12054. doi.org/10.2196/12054

Soleymani T, Lehman EB, Kong L, et al. Bariatric surgery and COVID-19 outcomes: results from the PaTH to Health: Diabetes study. Surg Obes Relat Dis. 2024;20(11):1039-1045. doi:10.1016/j.soard.2024.05.016

Medications and Weight Gain in PCORnet: The MedWeight Study

Posted on by Jodi Snare

Page last updated October 29, 2025

Study Website: Medications and Weight Gain in PCORnet: The MedWeight Study
Study Design: Prospective Observational Study
PCORnet Infrastructure: Common Data Model (CDM), Single IRB, Patient partners or engagement
Principal Investigator: Jason P. Block
Institution: Harvard Pilgrim Healthcare Institute
PCORnet® Network Partner: Legacy PCORnet Partner
Funder: NIH
Funding Date: 2020
Study Duration: 2020 – 2024
Participating PCORnet® Clinical Research Networks: GPC, OneFlorida+, PEDSnet, STAR
Therapeutic Area: Metabolic Disorders
Condition: Obesity; Diabetes
Age Range: Children 5 to 19 Years and Adults 20+ Years (Child, Adult)
Status: Completed

Research Question(s):
How do six classes of commonly prescribed medications influence weight, risk for diabetes, and cholesterol over time?

Publication(s):

Sun JW, Young JG, Sarvet AL, et al. Comparison of rates of Type 2 Diabetes in adults and children treated with anticonvulsant mood stabilizers. JAMA Netw Open. 2022;5(4). doi:10.1001/jamanetworkopen.2022.6484

Petimar J, Young JG, Yu H, et al. Medication-Induced Weight Change Across Common Antidepressant Treatments : A Target Trial Emulation Study. Ann Intern Med. 2024;177(8):993-1003. doi:10.7326/M23-2742

Lin PD, Rifas-Shiman S, Merriman J, et al. Trends of Antihypertensive Prescription Among US Adults From 2010 to 2019 and Changes Following Treatment Guidelines: Analysis of Multicenter Electronic Health Records. J Am Heart Assoc. 2024;13(9):e032197. doi:10.1161/JAHA.123.032197