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

NCT02346162 | Completed DMC

• 1 other identifier: R01DK099882
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obese

Keywords

Pre-pregnancy; Weight management

Outcome Measures

Primary Outcomes (1)

• Reduced pregnancy-related weight gain

  1 day at the end of pregnancy

Secondary Outcomes (2)

• Lower weight at the start of pregnancy

  Self-reported pre-pregnancy weight supplemented by weight at first prenatal visit (1 day)

• Decreased risk of exceeding national norms for weight at birth

  birth

Study Arms (2)

Intervention

EXPERIMENTAL

Weight management intervention

Behavioral: Weight management

Usual Care Control

OTHER

Usual Care for planning healthy pregnancy

Other: Usual Care Control

Interventions

Weight management BEHAVIORAL

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

Intervention

Usual Care Control 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).

Usual Care Control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Anna Edelmann

Portland, Oregon, 97227, United States

Location

Related Publications (3)

• 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.

  PMID: 32687819 RESULT

• 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.

  PMID: 36238226 DERIVED

• 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.

  PMID: 34313765 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Erin S LeBlanc, MD

  Center for Health Research, Kaiser Permanente Northwest

  PRINCIPAL INVESTIGATOR

• Victor J Stevens, PhD

  Center for Health Research, Kaiser Permanente Northwest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2015
• First Posted: January 26, 2015
• Study Start: June 1, 2015
• Primary Completion: June 21, 2019
• Study Completion: June 21, 2019
• Last Updated: April 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)