Randomized controlled trial of prepregnancy lifestyle intervention to reduce recurrence of gestational diabetes mellitus.

BACKGROUND: Preconception lifestyle intervention holds potential for reducing gestational diabetes mellitus, but clinical trial data are lacking. OBJECTIVE: This study aimed to determine the effects of a prepregnancy weight loss intervention on gestational diabetes mellitus recurrence in women with overweight/obesity and previous gestational diabetes mellitus. STUDY DESIGN: A 2-site, randomized controlled trial comparing a prepregnancy lifestyle intervention with educational control was conducted between December 2017 and February 2022. A total of 199 English- and Spanish-speaking adults with overweight/obesity and previous gestational diabetes mellitus were randomized to a 16-week prepregnancy lifestyle intervention with ongoing treatment until conception or educational control. The primary outcome was gestational diabetes mellitus recurrence. Analyses excluded 6 participants who conceived but did not have gestational diabetes mellitus ascertained by standard methods. RESULTS: In the 63 (33%) women who conceived and had gestational diabetes mellitus ascertained (Ns=38/102 [37%] intervention vs 25/91 [28.0%] control; P=.17), those in the intervention group had significantly greater weight loss at 16 weeks compared with controls (4.8 [3.4-6.0] vs 0.7 [-0.9 to 2.3] kg; P=.001) and a greater proportion lost ≥5% of body weight (50.0% [17/34] vs 13.6% [3/22]; P=.005). There was no significant difference in the incidence of gestational diabetes mellitus recurrence between the intervention (57.9% [ns=23/38]) and the control group (44.0% [ns=11/25]; odds ratio, 1.8 [0.59-5.8]). Independent of group, greater prepregnancy weight loss predicted 21% lower odds of gestational diabetes mellitus recurrence (odds ratio, 0.79 [0.66-0.94]; P=.008). A ≥5% weight loss before conception reduced the odds of gestational diabetes mellitus recurrence by 82% (odds ratio, 0.18 [0.04-0.88]; P=.03). CONCLUSION: Lifestyle intervention produced considerable prepregnancy weight loss but did not affect gestational diabetes mellitus rates. Given that the conception rate was 50% lower than expected, this study was underpowered.

Protocol for a randomized controlled trial of pre-pregnancy lifestyle intervention to reduce recurrence of gestational diabetes: Gestational Diabetes Prevention/Prevención de la Diabetes Gestacional.

BACKGROUND: Gestational diabetes mellitus (GDM) is associated with several maternal complications in pregnancy, including preeclampsia, preterm labor, need for induction of labor, and cesarean delivery as well as increased long-term risks of type 2 diabetes, metabolic syndrome, and cardiovascular disease. Intrauterine exposure to GDM raises the risk for complications in offspring as well, including stillbirth, macrosomia, and birth trauma, and long-term risk of metabolic disease. One of the strongest risk factors for GDM is the occurrence of GDM in a prior pregnancy. Preliminary data from epidemiologic and bariatric surgery studies suggest that reducing body weight before pregnancy can prevent the development of GDM, but no adequately powered trial has tested the effects of a maternal lifestyle intervention before pregnancy to reduce body weight and prevent GDM recurrence. METHODS: The principal aim of the Gestational Diabetes Prevention/Prevención de la Diabetes Gestacional is to determine whether a lifestyle intervention to reduce body weight before pregnancy can reduce GDM recurrence. This two-site trial targets recruitment of 252 women with overweight and obesity who have previous histories of GDM and who plan to have another pregnancy in the next 1-3 years. Women are randomized within site to a comprehensive pre-pregnancy lifestyle intervention to promote weight loss with ongoing treatment until conception or an educational control group. Participants are assessed preconceptionally (at study entry, after 4 months, and at brief quarterly visits until conception), during pregnancy (at 26 weeks' gestation), and at 6 weeks postpartum. The primary outcome is GDM recurrence, and secondary outcomes include fasting glucose, biomarkers of cardiometabolic disease, prenatal and perinatal complications, and changes over time in weight, diet, physical activity, and psychosocial measures. DISCUSSION: The Gestational Diabetes Prevention /Prevención de la Diabetes Gestacional is the first randomized controlled trial to evaluate the effects of a lifestyle intervention delivered before pregnancy to prevent GDM recurrence. If found effective, the proposed lifestyle intervention could lay the groundwork for shifting current treatment practices towards the interconception period and provide evidence-based preconception counseling to optimize reproductive outcomes and prevent GDM and associated health risks. TRIAL REGISTRATION: ClinicalTrials.gov NCT02763150 . Registered on May 5, 2016.

Effect of prenatal lifestyle intervention on maternal postpartum weight retention and child body mass index z-score at 36 months.

BACKGROUND/OBJECTIVES: We previously reported results from a randomized trial showing that a behavioral intervention during pregnancy reduced excess gestational weight gain but did not impact maternal weight at 12 months. We now examine the longer-term effects of this prenatal intervention on maternal postpartum weight retention and toddler body-mass-index z scores (BMIz) over 36 months. SUBJECTS/METHODS: Pregnant women (N = 264; 13.7 weeks' gestation; 41.6% Hispanic) with overweight or obesity were randomized into usual care or prenatal intervention. Anthropometric assessments in mothers and toddlers occurred at baseline, 35 weeks' gestation and after delivery at 6, 12, 18, 24, and 36 months. RESULTS: At 36 months, prenatal intervention vs. usual care had no significant effect on the proportion of participants who returned to their early pregnancy weight or below (33.3% vs. 39.5%; p = 0.12) and had no effect on the magnitude of weight retained (2.8 [0.8, 4.8] vs 3.0 kg [1.0, 4.9], respectively; mean difference = 0.14 [-3.0, 2.7]). There was also no statistically significant intervention vs. usual care effect on infant BMIz or skinfold changes over time; toddler BMIz increased by 1.4 [-1.7, 1.0] units in the intervention group and 1.6 [-1.2, 1.8] units in the usual care group from delivery to 36 months (difference = 0.16 [-0.32. 0.63]). The proportion of toddlers at risk for obesity at 36 months was similar in intervention and usual care groups (28/77 [36.4%] vs 30/80 [37.5%]; p = 0.77). CONCLUSIONS: Compared with usual care, lifestyle intervention during pregnancy resulted in similar maternal and toddler anthropometric outcomes at 36-months postpartum in a diverse US sample of women with overweight and obesity. To sustain improved maternal weight management initiated during pregnancy, continued intervention during the postpartum years may be needed.

Ripple Effect of Lifestyle Interventions During Pregnancy on Untreated Partners' Weight.

OBJECTIVE: Weight-loss interventions have a positive "ripple effect" on untreated partners' weight, but ripple effects in pregnancy are unknown. The objective of this study was to determine whether prenatal lifestyle interventions that reduce gestational weight gain in pregnant women have a positive ripple effect on untreated partners' weight. METHODS: Two clinical trials with the same outcome measures randomly assigned pregnant women to a lifestyle intervention or usual care. Untreated partners were randomly assigned according to their pregnant partner's group allocation and were assessed at study entry (~13 weeks' gestation), 35 weeks' gestation, and 6 and 12 months after delivery. RESULTS: A total of 122 partners (100% male, 23% Hispanic, 82% married, and 48% with obesity) were randomly assigned to the intervention (n = 59) or usual care (n = 63). There was no intervention or intervention-by-time interaction effect on partner weight (P = 0.795). Partner weight changes were not statistically significant (P = 0.120) from study entry to 35 weeks' gestation (mean 0.19 kg; 95% CI: -0.73 to 1.24) or to 12 months after delivery (mean 0.82 kg; 95% CI: -0.26 to 1.91). CONCLUSIONS: There was no evidence of a ripple effect on partner weight. In a self-selected sample, partners of pregnant women appeared not to experience sympathy weight gain.

Does Partial Meal Replacement During Pregnancy Reduce 12-Month Postpartum Weight Retention?

OBJECTIVE: This randomized trial tested whether a behavioral intervention with meal replacements in pregnancy could increase the proportion of women who returned to prepregnancy weight and reduce postpartum weight retention by 12 months after delivery. METHODS: Women (N = 264; 13.7 weeks' gestation) with overweight or obesity were randomly assigned to usual care or intervention. The intervention reduced excess gestational weight gain and was discontinued at delivery. At follow-up, 83.7% completed the 12-month assessment. RESULTS: Compared with usual care, prenatal intervention had no significant effect on odds of achieving prepregnancy weight (38/128 [29.7%] vs. 41/129 [31.8%]; P = 0.98) or in reducing the magnitude of weight retained (3.3 vs. 3.1 kg; P = 0.82) at 12 months. After delivery, significant (P < 0.0001) declines in meal replacements, practice of weight control behaviors, and dietary restraint were observed in the intervention group. Independent of group, lower gestational weight gain was the strongest predictor of achieving prepregnancy weight at 12 months (P = 0.0008). CONCLUSIONS: A prenatal behavioral intervention with meal replacements that reduced pregnancy weight gain had no significant effect on 12-month postpartum weight retention.

Randomized controlled clinical trial of behavioral lifestyle intervention with partial meal replacement to reduce excessive gestational weight gain.

Background: Behavioral lifestyle interventions during pregnancy can prevent excessive gestational weight gain (GWG) in women with normal weight; however, effective interventions to reduce GWG in ethnically diverse women with obesity are lacking. Objective: A randomized controlled trial was conducted to test whether a behavioral lifestyle intervention with partial meal replacement reduces GWG rate in Hispanic and non-Hispanic women with overweight or obesity relative to enhanced usual care. Design: Participants (n = 257) were recruited in San Luis Obispo, California, and Providence, Rhode Island, between November 2012 and May 2016. Participants were pregnant (mean ± SD: 13.6 ± 1.8 wk of gestation) with overweight or obesity and had a mean age of 30.3 y; 41.6% of participants were Hispanic. Women were randomly assigned within site and by ethnicity to enhanced usual care (n = 128) or to a behavioral lifestyle intervention with partial meal replacement (n = 129). The primary outcome was GWG per week of observation. Secondary outcomes were proportions exceeding Institute of Medicine (IOM) guidelines for total GWG, changes in weight-control behaviors and cardiovascular disease risk factors, and incidence of pregnancy complications. Study retention was 99.6% (256 of 257). Results: The intervention compared with usual care resulted in less mean ± SD weekly GWG (0.33 ± 0.25 compared with 0.39 ± 0.23 kg/wk; P = 0.02) and total GWG (9.4 ± 6.9 compared with 11.2 ± 7.0 kg; P = 0.03) and reduced the proportion of women who exceeded IOM guidelines for total GWG (41.1% compared with 53.9%; P = 0.03). No significant group × time × demographic subgroup (ethnicity, BMI, age, parity, and income) interactions were observed. Among intervention participants, greater meal replacement intake was related to reduced GWG rate (ß = -0.07; 95% CI:-0.12, -0.03; P = 0.002). The intervention compared with usual care increased weight-control strategies (P < 0.0001) and cognitive restraint (P < 0.0001) and reduced triglycerides (P = 0.03). Conclusion: Prenatal behavioral intervention with partial meal replacement significantly reduced GWG in Hispanic and non-Hispanic women with overweight or obesity. This trial was registered at www.clinicaltrials.gov as NCT01545934.