Evidence map›Paper›PMID 32389808›Full record

ArticleContemporary clinical trials2020

Rationale and study design for lifestyle intervention in preparation for pregnancy (LIPP): A randomized controlled trial.

M L Erickson, J T Mey, C L Axelrod, D Paul, L Gordesky, K Russell, H Barkoukis, P O'Tierney-Ginn, R A Fielding, J P Kirwan and 1 more

Registry-linked trialOpen access · greenAbstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03146156 (Lifestyle Intervention in Preparation for Pregnancy), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
0.8field-weighted citation impact, top 22% of its field
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.

NCT03146156 nacompletednot on this map

Lifestyle Intervention in Preparation for Pregnancy (LIPP)

TypeinterventionalSponsorTufts Medical CenterRan2017 to 2025Enrolled99ConditionsObesity, Lifestyle-related Condition, Macrosomia, FetalArmsLifestyle Intervention
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Trial
  4. Review
  5. Review
  6. Article
  7. Article
  8. 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

11 authors at 1 institution in 1 country.

M L EricksonIntegrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America.
J T MeyIntegrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America.
C L AxelrodIntegrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America; Department of Translational Services, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America.
D PaulDepartment of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America.
L GordeskyDepartment of Reproductive Biology, Center for Reproductive Health, MetroHealth Medical, 2500 MetroHealth Dr, Cleveland, OH 44109, United States of America.
K RussellMother Infant Research Institute, Tufts Medical Center, 800 Washington St, Boston, MA 02111, United States of America.
H BarkoukisDepartment of Nutrition, Case Western Reserve University, 10900 Euclid Ave, Cleveland, OH 44106, United States of America.
P O'Tierney-GinnDepartment of Reproductive Biology, Center for Reproductive Health, MetroHealth Medical, 2500 MetroHealth Dr, Cleveland, OH 44109, United States of America; Mother Infant Research Institute, Tufts Medical Center, 800 Washington St, Boston, MA 02111, United States of America.
R A FieldingNutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, 711 Washington St, Boston, MA 02111, United States of America.
J P KirwanIntegrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, United States of America; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, United States of America. Electronic address: John.Kirwan@pbrc.edu.
P M CatalanoDepartment of Reproductive Biology, Center for Reproductive Health, MetroHealth Medical, 2500 MetroHealth Dr, Cleveland, OH 44109, United States of America; Mother Infant Research Institute, Tufts Medical Center, 800 Washington St, Boston, MA 02111, United States of America. Electronic address: pcatalano@tuftsmedicalcenter.org.
Tufts Medical Center · US

Funding

Tracking & Evaluation CoreU54GM104940 · NIGMS · LSU PENNINGTON BIOMEDICAL RESEARCH CTR · PI Peter Todd Katzmarzyk · 2012 to 2026
$69.1M
Clinical and Translational Science Collaborative of ClevelandUL1TR002548 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI MCCOMSEY, GRACE A · 2018 to 2022
$35.5M
Training in Botanical Approaches to Combat Metabolic SyndromeT32AT004094 · NCCIH · LSU PENNINGTON BIOMEDICAL RESEARCH CTR · PI BRANTLEY, PHILLIP J, STEPHENS, JACQUELINE M · 2009 to 2024
$5.7M
Training in Obesity ResearchT32DK064584 · NIDDK · LSU PENNINGTON BIOMEDICAL RESEARCH CTR · PI CORBY K MARTIN, Christopher D Morrison · 2003 to 2026
$5.3M
Lifestyle Intervention in Preparation for Pregnancy (LIPP)R01HD088061 · NICHD · TUFTS MEDICAL CENTER · PI CATALANO, PATRICK, KIRWAN, JOHN P. · 2017 to 2022
$3.6M
NCATS NIH HHS UL1 TR002548NCCIH NIH HHS T32 AT004094NICHD NIH HHS R01 HD088061NIDDK NIH HHS T32 DK064584NIGMS NIH HHS U54 GM104940
6 · The paper itself

Abstract

introductionMaternal obesity increases neonatal risk for obesity and metabolic syndrome later in life. Prior attempts to break this intergenerational obesity cycle by limiting excessive gestational weight gain have failed to reduce neonatal adiposity. Alternatively, pre-conception lifestyle interventions may improve the in utero metabolic milieu during early pregnancy leading to improved fetal outcomes. This randomized controlled trial (RCT) is evaluating whether a lifestyle intervention to reduce weight and improve maternal metabolism in preparation for pregnancy (LIPP) attenuates neonatal adiposity, compared to standard medical advice. MATERIAL AND

methodsOverweight/class 1 obese women after a previous pregnancy, ~12 weeks postpartum, preparing for a subsequent pregnancy, will be block randomized (1:1) to either LIPP or standard of care in a parallel design. Randomization is stratified by lactation status and overweight vs. class 1 obesity. The LIPP program consists of intensive short-term weight loss followed by weight maintenance until conception using supervised exercise and a low glycemic Mediterranean diet. PRIMARY OUTCOMES: Group differences in neonatal adiposity at birth assessed by PEA POD and placental mitochondrial lipid metabolism. SECONDARY OUTCOMES: Group differences in maternal pregravid and gestational body composition, insulin sensitivity, β-cell function, fasting metabolic and inflammatory biomarkers, and overall quality of life. Exploratory outcomes include umbilical cord blood insulin resistance, lipid profile and inflammation. DISCUSSION: This RCT will determine the efficacy of maternal weight loss prior to pregnancy on reducing neonatal adiposity. Findings may change standard obstetrical care by providing Level 1 evidence on lifestyle interventions improving neonatal outcomes for women planning for pregnancy. CLINICAL

trial registrationNCT03146156.

Indexed as

Gestational Weight GainPregnancy ComplicationsFemaleHumansLife StyleOverweightPregnancyPrenatal CareRandomized Controlled Trials as TopicWeight GainFetal adiposityGestational weight gainLifestyle interventionMaternal obesityMediterranean dietPostpartumPostpartum weight lossPregnancy

Identifiers

PMID32389808
PMCPMC7375196
OpenAlexW3022528604

What OpenQuestion holds

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Registered trials

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 OpenQuestion graph.