A pre-conception clinical trial to reduce intergenerational obesity and diabetes risks: The NDPP-NextGen trial protocol

Katherine A Sauder; Katharine Gamalski; Jayna DeRoeck; Fatima Pacheco Vasquez; Dana Dabelea; Deborah H Glueck; Victoria A Catenacci; Stefka Fabbri; Natalie D Ritchie

doi:10.1016/j.cct.2023.107305

A pre-conception clinical trial to reduce intergenerational obesity and diabetes risks: The NDPP-NextGen trial protocol

Contemp Clin Trials. 2023 Oct:133:107305. doi: 10.1016/j.cct.2023.107305. Epub 2023 Jul 27.

Authors

Katherine A Sauder¹, Katharine Gamalski², Jayna DeRoeck³, Fatima Pacheco Vasquez⁴, Dana Dabelea⁵, Deborah H Glueck⁶, Victoria A Catenacci⁷, Stefka Fabbri⁸, Natalie D Ritchie⁹

Affiliations

¹ Lifecourse Epidemiology of Adiposity and Diabetes (LEAD) Center, University of Colorado Anschutz Medical Campus, 1890 N Revere Court F426, Aurora, CO 80045, USA; Department of Pediatrics, University of Colorado School of Medicine, 12348 E Montview Blvd C263, Aurora, CO 80045, USA; Department of Epidemiology, Colorado School of Public Health, 13001 E 17th Pl B119, Aurora, CO 80045, USA. Electronic address: katherine.sauder@cuanschutz.edu.
² Lifecourse Epidemiology of Adiposity and Diabetes (LEAD) Center, University of Colorado Anschutz Medical Campus, 1890 N Revere Court F426, Aurora, CO 80045, USA. Electronic address: katharine.gamalski@cuanschutz.edu.
³ Office of Research, Denver Health and Hospital Authority, 777 Bannock Street, Denver, CO 80204, USA. Electronic address: jayna.deroeck@dhha.org.
⁴ Lifecourse Epidemiology of Adiposity and Diabetes (LEAD) Center, University of Colorado Anschutz Medical Campus, 1890 N Revere Court F426, Aurora, CO 80045, USA. Electronic address: fatima.pachecovasquez@cuanschutz.edu.
⁵ Lifecourse Epidemiology of Adiposity and Diabetes (LEAD) Center, University of Colorado Anschutz Medical Campus, 1890 N Revere Court F426, Aurora, CO 80045, USA; Department of Pediatrics, University of Colorado School of Medicine, 12348 E Montview Blvd C263, Aurora, CO 80045, USA; Department of Epidemiology, Colorado School of Public Health, 13001 E 17th Pl B119, Aurora, CO 80045, USA. Electronic address: dana.dabelea@cuanschutz.edu.
⁶ Lifecourse Epidemiology of Adiposity and Diabetes (LEAD) Center, University of Colorado Anschutz Medical Campus, 1890 N Revere Court F426, Aurora, CO 80045, USA; Department of Pediatrics, University of Colorado School of Medicine, 12348 E Montview Blvd C263, Aurora, CO 80045, USA. Electronic address: deborah.glueck@cuanschutz.edu.
⁷ Department of Medicine, University of Colorado Anschutz Medical Campus, 12348 E Montview Blvd C263, Aurora, CO 80045, USA. Electronic address: vicki.catenacci@cuanschutz.edu.
⁸ Department of Obstetrics and Gynecology, Denver Health and Hospital Authority, 777 Bannock Street, Denver, CO 80204, USA. Electronic address: stefka.fabbri@dhha.org.
⁹ Office of Research, Denver Health and Hospital Authority, 777 Bannock Street, Denver, CO 80204, USA. Electronic address: natalie.ritchie@dhha.org.

PMID: 37516162
PMCID: PMC11044980 (available on 2024-10-01)
DOI: 10.1016/j.cct.2023.107305

Abstract

Background: Intrauterine exposure to maternal overweight/obesity or diabetes transmits risks to offspring, perpetuating a disease cycle across generations. Prenatal interventions to reduce maternal weight or dysglycemia have limited impact, while postpartum interventions can alter the intrauterine environment only if child-bearing continues. Efficacious preconception interventions are needed, especially for underserved populations, and with the potential to be scaled up sustainably. Research is also needed to assess intervention effects at conception, throughout pregnancy, and among offspring.

Methods: This two-arm, parallel randomized clinical trial will include 360 biological females with overweight/obesity and moderate-to-high likelihood of pregnancy within 24 months. Participants will be randomized 1:1 to a yearlong pre-conception lifestyle intervention based on the National Diabetes Prevention Program (NDPP-NextGen) or usual care. Data collection will occur at enrollment (before conception), post-conception (<8 weeks gestation), late pregnancy (28-32 weeks gestation), and delivery (before discharge) for participants who become pregnant within 24 months of enrollment. Main outcomes are post-conception body mass index (<8 weeks gestation; primary outcome), post-conception fasting glucose (<8 weeks gestation; secondary outcome), and neonatal adiposity (<2 days post-birth). Additional clinical, behavioral, perinatal and offspring data will be collected, and biospecimens (blood, urine, stool, cord blood) will be banked for future ancillary studies.

Conclusion: This clinical trial will evaluate an intervention model (NDPP-NextGen) with potential to improve maternal health among the >50% of US females with overweight/obesity or diabetes risks in pregnancy. If successful, it can be scaled among >1800 organizations delivering NDPP in the United States to benefit the health of future generations.

Keywords: Adiposity; Hyperglycemia; Lifestyle intervention; National Diabetes Prevention Program; Obesity; Preconception.

Publication types

Clinical Trial Protocol
Research Support, N.I.H., Extramural
Randomized Controlled Trial

MeSH terms

Adult
Blood Glucose / metabolism
Body Mass Index*
Exercise
Female
Humans
Life Style
Obesity* / therapy
Obesity, Maternal
Overweight / therapy
Preconception Care* / methods
Pregnancy

Substances

Blood Glucose

Grants and funding

R01 DK130900/DK/NIDDK NIH HHS/United States