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

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
DOI: 10.1016/j.cct.2023.107305

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

Katherine A Sauder et al. Contemp Clin Trials. 2023 Oct.

. 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
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.

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Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

**Figure 1.**
Power for post-conception maternal BMI (left) and glycemia (right).

See this image and copyright information in PMC

References

1. Sauder KA, Ritchie ND, Reducing intergenerational obesity and diabetes risk, Diabetologia 64(3) (2021) 481–490. - PMC - PubMed
1. Godfrey KM, Barker DJ, Fetal nutrition and adult disease, Am J Clin Nutr 71(5 Suppl) (2000) 1344S–52S. - PubMed
1. Branum AM, Kirmeyer SE, Gregory EC, Prepregnancy Body Mass Index by Maternal Characteristics and State: Data From the Birth Certificate, 2014, Natl Vital Stat Rep 65(6) (2016) 1–11. - PubMed
1. Deputy NP, Kim SY, Conrey EJ, Bullard KM, Prevalence and Changes in Preexisting Diabetes and Gestational Diabetes Among Women Who Had a Live Birth - United States, 2012–2016, MMWR Morb Mortal Wkly Rep 67(43) (2018) 1201–1207. - PMC - PubMed
1. Centers for Disease Control and Prevention, National Vital Statistics System, 2018. https://www.cdc.gov/nchs/nvss/births.htm. (Accessed September 25, 2019.

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

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

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