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

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02346162
• Other study ID #: R01DK099882
• Secondary ID: R01DK099882
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: June 21, 2019

Study information

• Verified date: April 2022
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: June 21, 2019
• Est. primary completion date: June 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Obese
• Overweight
• Weight Loss

Intervention

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).

Locations

Country	Name	City	State
United States	Anna Edelmann	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced pregnancy-related weight gain		1 day at the end of pregnancy
Secondary	Lower weight at the start of pregnancy		Self-reported pre-pregnancy weight supplemented by weight at first prenatal visit (1 day)
Secondary	Decreased risk of exceeding national norms for weight at birth		birth