# Promoting fat loss during pregnancy in women with grade 2 and 3 obesity

> **NIH NIH R01** · LSU PENNINGTON BIOMEDICAL RESEARCH CTR · 2021 · $605,002

## Abstract

PROJECT SUMMARY
Maternal obesity and excess weight gain in pregnancy are the leading causes of maternal and fetal morbidity.
Randomized trials in women with obesity have shown that lifestyle interventions in pregnancy produce modest
reductions in gestational weight gain, yet unfortunately fail to produce clinically significant improvements in
maternal and child outcomes as long hoped. Several well-defined prospective cohort studies suggest that for
women with obesity, weight maintenance during pregnancy – and specifically loss in fat mass – may be
required to reduce adverse maternal and child outcomes. However, there are no randomized controlled trials
testing the health effects of weight maintenance and significant maternal fat mass loss during pregnancy in
women with obesity. Our novel preliminary energy balance and body composition data showed that weight
maintenance during pregnancy could be achieved with careful timing of caloric restriction during the second
trimester and eucaloric goals during the 3rd trimester of pregnancy. Based on these and our other preliminary
data, we propose a highly rigorous proof-of-principle trial to determine the effects of a 6-month gestational
intervention with calorie restriction and food provision to promote maternal weight maintenance and fat loss in
women with grades 2 and 3 obesity. Pregnant women with grades 2 and 3 obesity (N = 100; 30% Hispanic;
30% Black) will be randomized to usual care or a gestational fat mass loss (FML) intervention. The principal
aims are to determine the effects of FML during pregnancy on changes in 1) maternal weight, fat mass, and
cardiometabolic risk factors; and, 2) safety measures, including fetal and neonatal growth. All women will be
assessed at baseline (13-16 weeks), 27-29 weeks, and 35-37 weeks gestation and at 2 weeks postpartum;
safety measures are collected every 4 weeks throughout the trial. This project is significant because findings
have the potential to set the stage for a revision in national recommendations that currently encourage weight
gain during pregnancy in women with severe obesity; findings may lead to new guidelines that encourage
practitioners to not delay intensive weight management treatment in women with obesity who become
pregnant and present for healthcare. The study is also innovative; there have been no randomized controlled
trials evaluating the effects of a an intervention intensive enough to actually achieve weight maintenance
during pregnancy and provide much needed safety and efficacy data to inform practice recommendations for
diverse women with severe obesity who lack effective treatment options.

## Key facts

- **NIH application ID:** 10164778
- **Project number:** 5R01DK124806-02
- **Recipient organization:** LSU PENNINGTON BIOMEDICAL RESEARCH CTR
- **Principal Investigator:** Suzanne Phelan
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $605,002
- **Award type:** 5
- **Project period:** 2020-05-15 → 2025-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10164778

## Citation

> US National Institutes of Health, RePORTER application 10164778, Promoting fat loss during pregnancy in women with grade 2 and 3 obesity (5R01DK124806-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10164778. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*