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

NCT ID: NCT02346162

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 326 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2019-06-21

Brief 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.

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).

Conditions

Overweight; Obese

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Weight management intervention

Group Type: EXPERIMENTAL

Weight management

Intervention Type: BEHAVIORAL

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

Usual Care Control

Usual Care for planning healthy pregnancy

Group Type: OTHER

Usual Care Control

Intervention Type: OTHER

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).

Interventions

Weight management

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

Intervention Type: BEHAVIORAL

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).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erin S LeBlanc, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Health Research, Kaiser Permanente Northwest

Victor J Stevens, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Health Research, Kaiser Permanente Northwest

Locations

Anna Edelmann

Portland, Oregon, United States

Countries

United States

References

LeBlanc ES, Smith NX, Vesco KK, Paul IM, Stevens VJ. Weight loss prior to pregnancy and subsequent gestational weight gain: Prepare, a randomized clinical trial. Am J Obstet Gynecol. 2021 Jan;224(1):99.e1-99.e14. doi: 10.1016/j.ajog.2020.07.027. Epub 2020 Jul 18.

Reference Type: RESULT

PMID: 32687819 (View on PubMed)

LeBlanc ES, Boisvert C, Catlin C, Lee MH, Smith N, Vesco KK, Savage J, Mitchell DC, Gruss I, Stevens VJ. Prepare randomized clinical trial: Acceptability, engagement, and lifestyle effects of a weight loss intervention beginning in pre-pregnancy. Obes Sci Pract. 2022 Feb 24;8(5):603-616. doi: 10.1002/osp4.596. eCollection 2022 Oct.

Reference Type: DERIVED

PMID: 36238226 (View on PubMed)

LeBlanc ES, Smith NX, Vesco KK, Hillier TA, Stevens VJ. Weight Loss Prior to Pregnancy and Early Gestational Glycemia: Prepare, a Randomized Clinical Trial. J Clin Endocrinol Metab. 2021 Nov 19;106(12):e5001-e5010. doi: 10.1210/clinem/dgab547.

Reference Type: DERIVED

PMID: 34313765 (View on PubMed)

Other Identifiers

R01DK099882

Identifier Type: NIH

Identifier Source: secondary_id

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R01DK099882

Identifier Type: NIH

Identifier Source: org_study_id

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