PREPARE: A Randomized Trial of a Pre-pregnancy Weight Loss Intervention

Summary

The US obesity epidemic is being transmitted to the next generation. Growing evidence suggests that both a mothers' weight at pregnancy onset, and excessive weight gain during pregnancy, are associated with increased risk of pregnancy-related complications such as gestational diabetes and pre-eclampsia, and an increased risk that her child will become obese and face obesity-related health issues in later life.

Currently, over one-third of reproductive-aged women in the U.S. are obese \[body mass index (BMI) ≥ 30\]. Our research team has shown that we can improve birth weight outcomes in babies of obese women who start a weight-management intervention program at 14 to 15 weeks of their pregnancy (soon after their first prenatal visit). However, organogenesis and metabolic programming begin early in the first trimester, well before the first prenatal visit. Therefore, waiting to address mothers' weight, physical activity, and diet quality until the first prenatal visit is not optimal. Given the need to reach overweight and obese women prior to pregnancy, and the Institute of Medicine's (IOM's) recent recommendation, based on observational studies, that women should reach a healthy weight before conceiving, this randomized clinical trial will evaluate a comprehensive preconception weight loss program.

Conditions

• Overweight
• Obese

Interventions

BEHAVIORAL

Weight management

Phone counseling for pre-pregnancy weight loss and weight maintenance when BMI \</=25, and when pregnant, weight gain within IOM guidelines.

OTHER

Usual Care Control

Usual care control participants receive general dietary advice as it relates to planning for a healthy pregnancy (e.g. folate requirements, prenatal vitamins, smoking cessation, alcohol cessation, and prenatal food safety).

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Kaiser Permanente

  lead OTHER

Principal Investigators

• Erin S LeBlanc, MD · Center for Health Research, Kaiser Permanente Northwest

• Victor J Stevens, PhD · Center for Health Research, Kaiser Permanente Northwest

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-06-30

Primary Completion

2019-06-21

Completion

2019-06-21

Countries

• United States

Study Locations