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

April 4, 2022 updated by: Kaiser Permanente

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goals are to help overweight and obese women (BMI ≥ 27) who are considering pregnancy to adopt improved dietary and physical activity habits and lose weight prior to becoming pregnant, and then help them maintain those habits and prevent excessive weight gain during their pregnancy. We model this intervention after successful, frequent-contact interventions designed by ourselves and other investigators. We start with face-to-face counseling followed by frequent telephone counseling contacts. The expected outcomes for mothers include reduced pregnancy-related weight gain (primary) and lower weight at the start of pregnancy (secondary) and for babies, decreased risk of exceeding national norms for weight at birth (secondary).

Study Type

Interventional

Enrollment (Actual)

326

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97227
        • Anna Edelmann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Current Kaiser Permanente Northwest (KPNW) member
  • Expects to be KPNW member for at least 2 more years
  • Body Mass Index (BMI) ≥ 27
  • Not currently pregnant
  • Access to computer with Internet
  • Completion of screening diet assessment
  • English speaking

Exclusion Criteria:

  • Taking medication (insulin or pills) for treatment of diabetes
  • Gastrointestinal disease requiring special diet or medications (for example, ulcerative colitis, celiac sprue, phenylketonuria)
  • Currently receiving treatment for cancer
  • Renal disease (kidney disease requiring special diet or medication)
  • History of bariatric surgery
  • Use of prescription weight loss medications in the last three months
  • Another household member already participating in the Prepare study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Weight management intervention
Behavioral: Weight management
Phone counseling for pre-pregnancy weight loss and weight maintenance when BMI
Other: Usual Care Control
Usual Care for planning healthy pregnancy
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduced pregnancy-related weight gain
Time Frame: 1 day at the end of pregnancy
1 day at the end of pregnancy

Secondary Outcome Measures

Outcome Measure
Time Frame
Lower weight at the start of pregnancy
Time Frame: Self-reported pre-pregnancy weight supplemented by weight at first prenatal visit (1 day)
Self-reported pre-pregnancy weight supplemented by weight at first prenatal visit (1 day)
Decreased risk of exceeding national norms for weight at birth
Time Frame: birth
birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

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

Investigators

  • Principal Investigator: Erin S LeBlanc, MD, Center for Health Research, Kaiser Permanente Northwest
  • Principal Investigator: Victor J Stevens, PhD, Center for Health Research, Kaiser Permanente Northwest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

June 21, 2019

Study Completion (Actual)

June 21, 2019

Study Registration Dates

First Submitted

January 20, 2015

First Submitted That Met QC Criteria

January 23, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Actual)

April 5, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01DK099882 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Any information from this study we present in reports or publications will not identify any individual.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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