Prepare, a randomized trial to promote and evaluate weight loss among overweight and obese women planning pregnancy: Study design and rationale

Abstract

Background Women who are overweight or have obesity at pregnancy onset, and those who gain excessive weight during pregnancy, are at increased risk of pregnancy-related complications and large for gestational age infants. Objective This report describes methodology for the Prepare study, a randomized, controlled clinical trial testing a preconception and pregnancy weight management program for women who are overweight or have obesity (BMI ≥ 27 kg/m2). Outcomes This trial examines multiple pregnancy and neonatal outcomes, with the primary outcome being gestational weight gain (GWG). Secondary outcomes include change in weight before conception, offspring birth weight adjusted for gestational age, offspring weight for length, and pregnancy diet quality and physical activity level. Methods Nonpregnant women who anticipate becoming pregnant in the next 2 years are randomly assigned to an intervention program or a usual care control condition. Intervention participants receive weight management counseling by telephone before and during pregnancy, with weekly contacts during the first 6 months and monthly contacts for the next 18 months. Intervention participants also have unlimited access to a study website that provides self-management tools. All participants who become pregnant are contacted at 20 weeks' gestation to assess physical activity levels and dietary habits. All other outcome data are obtained from medical records. Intervention satisfaction is assessed via questionnaire. Summary This clinical trial tests the efficacy of an intervention program designed to help overweight and obese women achieve healthy lifestyle changes that will result in a healthy weight prior to pregnancy and appropriate weight gain during pregnancy.

Weight loss prior to pregnancy and subsequent gestational weight gain: Prepare, a randomized clinical trial

“…We recruited participants from Kaiser Permanente Northwest (KPNW), a nonprofit integrated healthcare system serving individuals in Oregon and Southwest Washington. The study was conducted and reported in accordance with a previously published protocol 6 that was approved by the KPNW institutional review board. A Data and Safety Monitoring Board provided independent study monitoring.…”

“…5 We conducted a pragmatic randomized clinical trial to test the efficacy of a behavioral weight management intervention initiated before pregnancy for women who were overweight or obese and were planning pregnancy. 6 The intervention consisted of individualized health coaching phone sessions. We hypothesized that women assigned to the intervention would lose more weight before pregnancy and gain less weight during pregnancy than women assigned to a usual care control arm, resulting in a lower likelihood of exceeding National Academy of Medicine (NAM) guidelines for GWG, 4,7 lower infant birthweight, and better perinatal outcomes.…”

Reaching women with obesity to support weight loss before pregnancy: feasibility and qualitative assessment

“…A couple of trials are currently recruiting in this area. 34,35 Hopefully these on-going trials will be able to provide some answers on what type of programs can help women of reproductive age to lose weight, and whether these programs can lead to better obstetric outcomes, and healthier metabolic status for women and their offspring.…”

The acceptability and feasibility of a planned pre-pregnancy weight loss intervention (the Plan-it Study): A Protocol Paper

“…Two Cochrane reviews investigating the effectiveness of preconception and antenatal health programs and interventions to improve pregnancy outcomes or reduce weight in obese women, identified no eligible studies [10,11]. A more recent scoping review of randomised controlled trials of behavioural interventions supporting women of childbearing age in the prevention and treatment of overweight and obesity, only identified one intervention in the preconception period, the Prepare study protocol [12], which has gestational weight gain as the primary outcome.…”