Evidence map›Paper›PMID 37516162›Full record

ArticleContemporary clinical trials2023

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

Abstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Katherine A SauderLifecourse 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.
Katharine GamalskiLifecourse 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.
Jayna DeRoeckOffice of Research, Denver Health and Hospital Authority, 777 Bannock Street, Denver, CO 80204, USA. Electronic address: jayna.deroeck@dhha.org.
Fatima Pacheco VasquezLifecourse 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.
Dana DabeleaLifecourse 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.
Deborah H GlueckLifecourse 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.
Victoria A CatenacciDepartment of Medicine, University of Colorado Anschutz Medical Campus, 12348 E Montview Blvd C263, Aurora, CO 80045, USA. Electronic address: vicki.catenacci@cuanschutz.edu.
Stefka FabbriDepartment of Obstetrics and Gynecology, Denver Health and Hospital Authority, 777 Bannock Street, Denver, CO 80204, USA. Electronic address: stefka.fabbri@dhha.org.
Natalie D RitchieOffice of Research, Denver Health and Hospital Authority, 777 Bannock Street, Denver, CO 80204, USA. Electronic address: natalie.ritchie@dhha.org.

Funding

NDPP-NextGen: A clinical trial to reduce intergenerational obesity and diabetes risksR01DK130900 · NIDDK · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI RITCHIE, NATALIE DAWN, SAUDER, KATHERINE A. · 2022 to 2025
$2.7M
NIDDK NIH HHS R01 DK130900
6 · The paper itself

Abstract

backgroundIntrauterine 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.

methodsThis 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.

conclusionThis 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.

Indexed as

Body Mass IndexObesityPreconception CareAdultBlood GlucoseExerciseFemaleHumansLife StyleOverweightPregnancyPregnancy in ObesityRandomized Controlled Trials as TopicBlood GlucoseAdiposityHyperglycemiaLifestyle interventionNational Diabetes Prevention ProgramObesityPreconception

Identifiers

PMID37516162
PMCPMC11044980

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.