Appropriate Gestational Weight Gain in Overweight/Obese Women

The goal of this trial is to investigate the efficacy of a lifestyle intervention of healthy diet and physical activity for helping overweight/obese pregnant women to achieve appropriate gestational weight gain (GWG) for their prepregnancy body mass index (BMI). The goal of the intervention is to help women achieve the lower bound of the GWG range recommended by the Institutes of Medicine (IOM) for a given prepregnancy BMI category (i.e., 11 lbs for obese women and 15 lbs for overweight women). The lifestyle intervention will be delivered via 2 in-person counseling sessions and 11 telephone contacts with study dieticians trained in motivational interviewing techniques. The lifestyle intervention will be compared to usual medical care. Outcomes will be assessed by trained study personnel at approximately 10 weeks and 32 weeks gestation, within several days of delivery and at 6 months and 12 months postpartum.

The goal of the intervention is to help women achieve the lower bound of the GWG range recommended by the Institutes of Medicine (IOM) for a given prepregnancy BMI category (i.e., 11 lbs for obese women and 15 lbs for overweight women). The pregnancy lifestyle intervention will be delivered by trained study dieticians via individual counseling sessions: 2 in-person and 11 telephone sessions delivered on a weekly basis, followed by telephone sessions delivered every other week through the end of pregnancy.

Proportion of women exceeding the Institute of Medicine's recommendation for rate of gestational weight gain per week

Proportion of women exceeding the Institute of Medicine's recommendation for total gestational weight gain per week

Rate of gestational weight gain between approximately 10 weeks and 32 weeks gestation (kilograms per week)

Change in total calories from fat between study clinical assessments in pregnancy between 10 weeks and 32 weeks gestation

Change in proportion of calories from fat between study clinical assessments in pregnancy between 10 weeks and 32 weeks gestation

Change in physical activity between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)

Change in glucose between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)

Change in insulin between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)

Change in lipids between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)

Change in leptin between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)

Change in adiponectin between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)

Inclusion Criteria: Pregnant Pregravid BMI 25 to <40 (as determined from a measured pregravid weight in electronic medical record) Exclusion Criteria: Diabetes Cardiovascular disease Gastrointestinal disease Bariatric surgery Lung disease Thyroid disease Eating disorder Cancer Bed rest or Gestational Diabetes in the current pregnancy Planning to get pregnant again or move within 1 year of delivery Substance abuse Serious mental health disorders

Jake-Schoffman DE, Brown SD, Baiocchi M, Bibeau JL, Daubenmier J, Ferrara A, Galarce MN, Hartogensis W, Hecht FM, Hedderson MM, Moran PJ, Pagoto SL, Tsai AL, Waring ME, Kiernan M. Methods-Motivational Interviewing Approach for Enhanced Retention and Attendance. Am J Prev Med. 2021 Oct;61(4):606-617. doi: 10.1016/j.amepre.2021.04.005.

Ferrara A, Hedderson MM, Brown SD, Ehrlich SF, Tsai AL, Feng J, Galarce M, Marcovina S, Catalano P, Quesenberry CP. A telehealth lifestyle intervention to reduce excess gestational weight gain in pregnant women with overweight or obesity (GLOW): a randomised, parallel-group, controlled trial. Lancet Diabetes Endocrinol. 2020 Jun;8(6):490-500. doi: 10.1016/S2213-8587(20)30107-8. Erratum In: Lancet Diabetes Endocrinol. 2023 Apr;11(4):e6.

Brown SD, Hedderson MM, Ehrlich SF, Galarce MN, Tsai AL, Quesenberry CP, Ferrara A. Gestational weight gain and optimal wellness (GLOW): rationale and methods for a randomized controlled trial of a lifestyle intervention among pregnant women with overweight or obesity. BMC Pregnancy Childbirth. 2019 Apr 30;19(1):145. doi: 10.1186/s12884-019-2293-8.