A telehealth lifestyle intervention to reduce excess gestational weight gain in pregnant women with overweight or obesity (GLOW): a randomised, parallel-group, controlled trial

Assiamira Ferrara, Monique M Hedderson, Susan D Brown, Samantha F Ehrlich, Ai-Lin Tsai, Juanran Feng, Maren Galarce, Santica Marcovina, Patrick Catalano, Charles P Quesenberry, Assiamira Ferrara, Monique M Hedderson, Susan D Brown, Samantha F Ehrlich, Ai-Lin Tsai, Juanran Feng, Maren Galarce, Santica Marcovina, Patrick Catalano, Charles P Quesenberry

Abstract

Background: Excess gestational weight gain (GWG) among women with overweight or obesity synergistically increases their already elevated risk of having gestational diabetes, a caesarean delivery, a large for gestational age infant, and post-partum weight retention, and increases their child's risk of obesity. We investigated whether a primarily telehealth lifestyle intervention reduced excess GWG among women with overweight or obesity.

Methods: We did a randomised controlled trial in five antenatal clinics of Kaiser Permanente; Oakland, San Leandro, Walnut Creek, Fremont, and Santa Clara, CA, USA. Women at 8-15 weeks' gestation with singletons, pre-pregnancy BMI 25·0-40·0 kg/m2, and aged 18 years or older were randomly assigned (1:1) to receive the telehealth lifestyle intervention or usual antenatal care. Randomisation was adaptively balanced for age, BMI, and race and ethnicity. Data collectors and investigators were masked to group assignments. The core lifestyle intervention consisted of two in-person and 11 telephone sessions on behavioural strategies to improve weight, diet, and physical activity, and stress management to help women meet a trial goal of gaining at the lower limit of the Institute of Medicine (IOM) guidelines range for total GWG: 7 kg for women with overweight and 5 kg for women with obesity. Usual antenatal care included an antenatal visit at 7-10 weeks' gestation, an additional seven antenatal visits, on average, and periodic health education newsletters, including the IOM GWG guidelines and information on healthy eating and physical activity in pregnancy. The primary outcome was weekly rate of GWG expressed as excess GWG, per Institute of Medicine guidelines and mean assessed in the intention-to-treat population. The trial is registered at ClinicalTrials.gov, NCT02130232.

Findings: Between March 24, 2014, and Sept 26, 2017, 5329 women were assessed for eligibility and 200 were randomly assigned to the lifestyle intervention group and 198 to the usual care group. Analyses included 199 women in the lifestyle intervention group (one lost to follow-up) and 195 in the usual care group (three lost to follow-up). 96 (48%) women in the lifestyle intervention group and 134 (69%) women in the usual care group exceeded Institute of Medicine guidelines for rate of GWG per week (relative risk 0·70, 95% CI 0·59 to 0·83). Compared with usual care, women in the lifestyle intervention had reduced weekly rate of GWG (mean 0·26 kg per week [SD 0·15] vs 0·32 kg per week [0·13]; mean between-group difference -0·07 kg per week, 95% CI -0·09 to -0·04). No between-group differences in perinatal complications were observed.

Interpretation: Our evidence-based programme showed that health-care delivery systems could further adapt to meet the needs of their clinical settings to prevent excess GWG and improve healthy behaviours and markers of insulin resistance among women with overweight or obesity by using telehealth lifestyle interventions.

Funding: US National Institutes of Health.

Copyright © 2020 Elsevier Ltd. All rights reserved.

Figures

Figure
Figure
Trial profile

References

    1. National Vital Statistics System QuickStats: gestational weight gain among women with full-term, singleton births, compared with recommendations—48 states and the district of Columbia, 2015. MMWR Morb Mortal Wkly Rep. 2016;65
    1. Goldstein RF, Abell SK, Ranasinha S, et al. Gestational weight gain across continents and ethnicity: systematic review and meta-analysis of maternal and infant outcomes in more than one million women. BMC Med. 2018;16:153.
    1. Institute of Medicine . The National Academic Press; Washington, DC: 2009. Weight gain during pregnancy, reexamining the guidelines.
    1. Goldstein RF, Abell SK, Ranasinha S, et al. Association of gestational weight gain with maternal and infant outcomes: a systematic review and meta-analysis. JAMA. 2017;317:2207–2225.
    1. Sridhar SB, Darbinian J, Ehrlich SF, et al. Maternal gestational weight gain and offspring risk for childhood overweight or obesity. Am J Obstet Gynecol. 2014;211:259.e1–259.e8.
    1. Vesco KK, Karanja N, King JC, et al. Efficacy of a group-based dietary intervention for limiting gestational weight gain among obese women: a randomized trial. Obesity. 2014;22:1989–1996.
    1. Peaceman AM, Clifton RG, Phelan S, et al. Lifestyle interventions limit gestational weight gain in women with overweight or obesity: LIFE-moms prospective meta-analysis. Obesity. 2018;26:1396–1404.
    1. Yeo S, Samuel-Hodge CD, Smith R, Leeman J, Ferraro AM, Asafu-Adjei JK. Challenges of integrating an evidence-based intervention in health departments to prevent excessive gestational weight gain among low-income women. Public Health Nurs. 2016;33:224–231.
    1. Ferrara A, Hedderson MM, Ching J, Kim C, Peng T, Crites YM. Referral to telephonic nurse management improves outcomes in women with gestational diabetes. Am J Obstet Gynecol. 2012;206:491–495.
    1. Diabetes Prevention Program (DPP) Research Group The diabetes prevention program (DPP): description of lifestyle intervention. Diabetes Care. 2002;25:2165–2171.
    1. Brown SD, Hedderson MM, Ehrlich SF, et al. 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;19:145.
    1. Saghaei M, Saghaei S. Implementation of an open-source customizable minimization program for allocation of patients to parallel groups in clinical trials. J Biomed Sci Eng. 2011;4:734–739.
    1. Miller WR, Rollnick S. The Guilford Press; New York: 2002. Motivational Interviewing: Preparing people for change.
    1. Bandura A. Prentice Hall; Englewood Cliffs, NJ: 1986. Social foundations of thought and action: a social cognitive theory.
    1. Prochaska JO, DiClemente CC. In: Coping and substance use. Shiffman S, Wills T, editors. Academic Press; New York: 1985. Common processes of self-change in smoking, weight control and psychological distress; pp. 345–363.
    1. Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985;28:412–419.
    1. Aris IM, Kleinman KP, Belfort MB, Kaimal A, Oken E. A 2017 US reference for singleton birth weight percentiles using obstetric estimates of gestation. Pediatrics. 2019;144
    1. Carpenter MW, Coustan DR. Criteria for screening tests for gestational diabetes. Am J Obstet Gynecol. 1982;144:768–773.
    1. Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004;159:702–706.
    1. Raab GM, Day S, Sales J. How to select covariates to include in the analysis of a clinical trial. Control Clin Trials. 2000;21:330–342.
    1. Vanderweele TJ, Vansteelandt S. Odds ratios for mediation analysis for a dichotomous outcome. Am J Epidemiol. 2010;172:1339–1348.
    1. Labor USDo Occupational outlook handbook: dietitians and nutritionists. Sept 4, 2019.
    1. Koivusalo SB, Rönö K, Klemetti MM, et al. Gestational diabetes mellitus can be prevented by lifestyle intervention: the Finnish gestational diabetes prevention study (RADIEL): a randomized controlled trial. Diabetes Care. 2016;39:24–30.
    1. Simmons D, Devlieger R, van Assche A, et al. Effect of physical activity and/or healthy eating on GDM risk: The DALI lifestyle study. J Clin Endocrinol Metab. 2017;102:903–913.
    1. Poston L, Bell R, Croker H, et al. Effect of a behavioural intervention in obese pregnant women (the UPBEAT study): a multicentre, randomised controlled trial. Lancet Diabetes Endocrinol. 2015;3:767–777.
    1. Moran LJ, Fraser LM, Sundernathan T, et al. The effect of an antenatal lifestyle intervention in overweight and obese women on circulating cardiometabolic and inflammatory biomarkers: secondary analyses from the LIMIT randomised trial. BMC Med. 2017;15:32.
    1. Dodd JM, Turnbull D, McPhee AJ, et al. Antenatal lifestyle advice for women who are overweight or obese: LIMIT randomised trial. BMJ. 2014;348
    1. International Weight Management in Pregnancy (i-WIP) Collaborative Group Effect of diet and physical activity based interventions in pregnancy on gestational weight gain and pregnancy outcomes: meta-analysis of individual participant data from randomised trials. BMJ. 2017;358
    1. Hattersley AT, Beards F, Ballantyne E, Appleton M, Harvey R, Ellard S. Mutations in the glucokinase gene of the fetus result in reduced birth weight. Nat Genet. 1998;19:268–270.
    1. Broskey NT, Wang P, Li N, et al. Early pregnancy weight gain exerts the strongest effect on birth weight, posing a critical time to prevent childhood obesity. Obesity. 2017;25:1569–1576.
    1. Katzmarzyk PT, Barlow S, Bouchard C, et al. An evolving scientific basis for the prevention and treatment of pediatric obesity. Int J Obes. 2014;38:887–905.

Source: PubMed

Спонсоры и соавторы

Заболевания

Медикаментозные вмешательства

Подписаться