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PURPOSE: Water needs increase during pregnancy, and proper hydration is critical for maternal and fetal health. This study characterized weekly hydration status changes throughout pregnancy and examined change in response to a randomized, behavioral intervention. An exploratory analysis tested how underhydration during pregnancy was associated with birth outcomes. METHODS: The Healthy Mom Zone Study is a longitudinal, randomized-control trial intervention aiming to regulate gestational weight gain (GWG) in pregnant women with overweight/obesity (n=27). Fourteen women received standard of care; 13 women additionally received weekly guidance on nutrition, physical activity, water intake, and health-promoting behaviors. Hydration status was measured weekly via overnight urine osmolality (Uosm) from ~8–36 weeks gestation; underhydration was dichotomized (Uosm≥500 mOsm/kg). Gestational age- and sex-standardized birth weight and length z scores and percentiles were calculated. We used mixed-effect and linear regression models to test covariate-adjusted relationships. RESULTS: No differences existed in Uosm or other characteristics between control and intervention women at baseline. Significant interactions (p=0.01) between intervention and week of pregnancy on Uosm indicated intervention women maintained lower Uosm, whereas control women had a significant quadratic (inverse-U) relationship and greater Uosm in the second and early third trimesters. Results were consistent across robustness and sensitivity checks. Exploratory analyses suggest underhydration was associated with birth weight, but not length, in opposite ways in the second vs. third trimester. CONCLUSION: A multi-component behavioral intervention helped women with overweight/obesity maintain better hydration throughout pregnancy. Future studies should confirm birth outcome results as they have important implications for early life nutrition. Trial Registration ClinicalTrials.gov Identifier: NCT03945266; registered May 10, 2019 retrospectively

Interventions have modest impact on reducing excessive gestational weight gain (GWG) in pregnant women with overweight/obesity. This two-arm feasibility randomized control trial tested delivery of and compliance with an intervention using adapted dosages to regulate GWG, and examined pre-post change in GWG and secondary outcomes (physical activity: PA, energy intake: EI, theories of planned behavior/self-regulation constructs) compared to a usual care group. Pregnant women with overweight/obesity (N = 31) were randomized to a usual care control group or usual care + intervention group from 8 to 2 weeks gestation and completed the intervention through 36 weeks gestation. Intervention women received weekly evidence-based education/counseling (e.g., GWG, PA, EI) delivered by a registered dietitian in a 60-min face-to-face session. GWG was monitored weekly; women within weight goals continued with education while women exceeding goals received more intensive dosages (e.g., additional hands-on EI/PA sessions). All participants used mHealth tools to complete daily measures of weight (Wi-Fi scale) and PA (activity monitor), weekly evaluation of diet quality (MyFitnessPal app), and weekly/monthly online surveys of motivational determinants/self-regulation. Daily EI was estimated with a validated back-calculation method as a function of maternal weight, PA, and resting metabolic rate. Sixty-five percent of eligible women were randomized; study completion was 87%; 10% partially completed the study and drop-out was 3%. Compliance with using the mHealth tools for intensive data collection ranged from 77 to 97%; intervention women attended > 90% education/counseling sessions, and 68–93% dosage step-up sessions. The intervention group (6.9 kg) had 21% lower GWG than controls (8.8 kg) although this difference was not significant. Exploratory analyses also showed the intervention group had significantly lower EI kcals at post-intervention than controls. A theoretical, adaptive intervention with varied dosages to regulate GWG is feasible to deliver to pregnant women with overweight/obesity.

Pregnant women are at a high risk for experiencing sleep disturbances, excess energy intake, low physical activity, and excessive gestational weight gain (GWG). Scant research has examined how sleep behaviors influence energy intake, physical activity, and GWG over the course of pregnancy. This study conducted secondary analyses from the Healthy Mom Zone Study to examine between- and within-person effects of weekly sleep behaviors on energy intake, physical activity, and GWG in pregnant women with overweight/obesity (PW-OW/OB) participating in an adaptive intervention to manage GWG. The overall sample of N = 24 (M age = 30.6 years, SD = 3.2) had an average nighttime sleep duration of 7.2 h/night. In the total sample, there was a significant between-person effect of nighttime awakenings on physical activity; women with >1 weekly nighttime awakening expended 167.56 less physical activity kcals than women with

(1) Background: Energy intake (EI) underreporting is a widespread problem of great relevance to public health, yet is poorly described among pregnant women. This study aimed to describe and predict error in self-reported EI across pregnancy among women with overweight or obesity. (2) Methods: Participants were from the Healthy Mom Zone study, an adaptive intervention to regulate gestational weight gain (GWG) tested in a feasibility RCT and followed women (n = 21) with body mass index (BMI) ≥25 from 8–12 weeks to ~36 weeks gestation. Mobile health technology was used to measure daily weight (Wi-Fi Smart Scale), physical activity (activity monitor), and self-reported EI (MyFitnessPal App). Estimated EI was back-calculated daily from measured weight and physical activity data. Associations between underreporting and gestational age, demographics, pre-pregnancy BMI, GWG, perceived stress, and eating behaviors were tested. (3) Results: On average, women were 30.7 years old and primiparous (62%); reporting error was −38% ± 26 (range: −134% (underreporting) to 97% (overreporting)), representing an ~1134 kcal daily underestimation of EI (1404 observations). Estimated (back-calculated), but not self-reported, EI increased across gestation (p < 0.0001). Higher pre-pregnancy BMI (p = 0.01) and weekly GWG (p = 0.0007) was associated with greater underreporting. Underreporting was lower when participants reported higher stress (p = 0.02) and emotional eating (p < 0.0001) compared with their own average. (4) Conclusions: These findings suggest systemic underreporting in pregnant women with elevated BMI using a popular mobile app to monitor diet. Advances in technology that allow estimation of EI from weight and physical activity data may provide more accurate dietary self-monitoring during pregnancy.

OBJECTIVES: To describe changes in maternal micronutrient status between the first and third trimesters and examine differences by obesity status. METHODS: Pregnant women were recruited between 8 and 12 weeks gestation as part of the Healthy Mom Zone study. Participants provided a blood sample at enrollment and at approximately 36 weeks (n = 30). Five micronutrients (iron, zinc, copper, vitamin A, and vitamin D) were examined using 14 measured biomarkers at both time points; ferritin, zinc, and retinol were adjusted by markers of inflammation. Iron biomarkers (serum iron, ferritin, total iron binding capacity, and transferrin receptor) were measured by ELISA. Zinc and copper were measured by flame atomic absorption spectroscopy, retinol by UPLC, and 25-hydroxyvitamin D (and the C-3 epimer) by HPLC tandem mass spectrometry. RESULTS: Most women were nulliparous (64%) and all women reported taking a prenatal supplement. Mean (SD) age was 30.5 (3.0) years. Thirty-six % of women were classified as overweight and 50% as obese prepregnancy. Infant birth weight was 3407 (575) grams and only one infant was born preterm. In the first trimester, few women had micronutrient deficiencies: 2 women were iron deficient (1 with anemia) and 0 women were deficient in zinc, copper, vitamin A or vitamin D. By the third trimester, 10 women (33%) were iron deficient and 10 were zinc deficient; 4 women (13%) had co-occurring iron and zinc deficiencies. Three women were anemic (without iron deficiency) at the second measurement. Most biomarker concentrations changed significantly from first to third trimester (Table); on average, ferritin, zinc, and retinol decreased while copper and 25-hydroxyvitamin D increased (all P

Excess maternal weight gain during pregnancy elevates infants&rsquo, risk for macrosomia and early-onset obesity. Eating behavior is also related to weight gain, but the relationship to fetal growth is unclear. We examined whether Healthy Mom Zone, an individually tailored, adaptive gestational weight gain intervention, and maternal eating behaviors affected fetal growth in pregnant women (n = 27) with a BMI &gt, 24. At study enrollment (6&ndash, 13 weeks gestation) and monthly thereafter, the Three-Factor Eating Questionnaire was completed. Ultrasounds were obtained monthly from 14&ndash, 34 weeks gestation. Data were analyzed using multilevel modeling. Higher baseline levels of uncontrolled eating predicted faster rates of fetal growth in late gestation. Cognitive restraint was not associated with fetal growth, but moderated the effect of uncontrolled eating on fetal growth. Emotional eating was not associated with fetal growth. Among women with higher baseline levels of uncontrolled eating, fetuses of women in the control group grew faster and were larger in later gestation than those in the intervention group (study group &times, baseline uncontrolled eating &times, gestational week interaction, p = 0.03). This is one of the first intervention studies to use an individually tailored, adaptive design to manage weight gain in pregnancy to demonstrate potential effects on fetal growth. Results also suggest that it may be important to develop intervention content and strategies specific to pregnant women with high vs. low levels of disinhibited eating.

Background: High gestational weight gain is a major public health concern as it independently predicts adverse maternal and infant outcomes. Past interventions have had only limited success in effectively managing pregnancy weight gain, especially among women with overweight and obesity. Well-designed interventions are needed that take an individualized approach and target unique barriers to promote healthy weight gain. Objective: The primary aim of the study is to describe the study protocol for Healthy Mom Zone, an individually tailored, adaptive intervention for managing weight in pregnant women with overweight and obesity. Methods: The Healthy Mom Zone Intervention, based on theories of planned behavior and self-regulation and a model of energy balance, includes components (eg, education, self-monitoring, physical activity/healthy eating behaviors) that are adapted over the intervention (ie, increase in intensity) to better regulate weight gain. Decision rules inform when to adapt the intervention. In this randomized controlled trial, women are randomized to the intervention or standard care control group. The intervention is delivered from approximately 8-36 weeks gestation and includes step-ups in dosages (ie, Step-up 1 = education + physical activity + healthy eating active learning [cooking/recipes]; Step-up 2 = Step-up 1 + portion size, physical activity; Step-up 3 = Step-up 1 + 2 + grocery store feedback, physical activity); 5 maximum adaptations. Study measures are obtained at pre- and postintervention as well as daily (eg, weight), weekly (eg, energy intake/expenditure), and monthly (eg, psychological) over the study period. Analyses will include linear mixed-effects models, generalized estimating equations, and dynamical modeling to understand between-group and within-individual effects of the intervention on weight gain. Results: Recruitment of 31 pregnant women with overweight and obesity has occurred from January 2016 through July 2017. Baseline data have been collected for all participants. To date, 24 participants have completed the intervention and postintervention follow-up assessments, 3 are currently in progress, 1 dropped out, and 3 women had early miscarriages and are no longer active in the study. Of the 24 participants, 13 women have completed the intervention to date, of which 1 (8%, 1/13) received only the baseline intervention, 3 (23%, 3/13) received baseline + step-up 1, 6 (46%, 6/13) received baseline + step-up 1 + step-up 2, and 3 (23%, 3/13) received baseline + step-up 1 + step-up 2 +step-up 3. Data analysis is still ongoing through spring 2018. Conclusions: This is one of the first intervention studies to use an individually tailored, adaptive design to manage weight gain in pregnancy. Results from this study will be useful in designing a larger randomized trial to examine efficacy of this intervention and developing strategies for clinical application. Registered Report Identifier: RR1-10.2196/9220 [JMIR Res Protoc 2018;7(6):e150]

BACKGROUND High gestational weight gain is a major public health concern as it independently predicts adverse maternal and infant outcomes. Past interventions have had only limited success in effectively managing pregnancy weight gain, especially among women with overweight and obesity. Well-designed interventions are needed that take an individualized approach and target unique barriers to promote healthy weight gain. OBJECTIVE The primary aim of the study is to describe the study protocol for Healthy Mom Zone, an individually tailored, adaptive intervention for managing weight in pregnant women with overweight and obesity. METHODS The Healthy Mom Zone Intervention, based on theories of planned behavior and self-regulation and a model of energy balance, includes components (eg, education, self-monitoring, physical activity/healthy eating behaviors) that are adapted over the intervention (ie, increase in intensity) to better regulate weight gain. Decision rules inform when to adapt the intervention. In this randomized controlled trial, women are randomized to the intervention or standard care control group. The intervention is delivered from approximately 8-36 weeks gestation and includes step-ups in dosages (ie, Step-up 1 = education + physical activity + healthy eating active learning [cooking/recipes]; Step-up 2 = Step-up 1 + portion size, physical activity; Step-up 3 = Step-up 1 + 2 + grocery store feedback, physical activity); 5 maximum adaptations. Study measures are obtained at pre- and postintervention as well as daily (eg, weight), weekly (eg, energy intake/expenditure), and monthly (eg, psychological) over the study period. Analyses will include linear mixed-effects models, generalized estimating equations, and dynamical modeling to understand between-group and within-individual effects of the intervention on weight gain. RESULTS Recruitment of 31 pregnant women with overweight and obesity has occurred from January 2016 through July 2017. Baseline data have been collected for all participants. To date, 24 participants have completed the intervention and postintervention follow-up assessments, 3 are currently in progress, 1 dropped out, and 3 women had early miscarriages and are no longer active in the study. Of the 24 participants, 13 women have completed the intervention to date, of which 1 (8%, 1/13) received only the baseline intervention, 3 (23%, 3/13) received baseline + step-up 1, 6 (46%, 6/13) received baseline + step-up 1 + step-up 2, and 3 (23%, 3/13) received baseline + step-up 1 + step-up 2 +step-up 3. Data analysis is still ongoing through spring 2018. CONCLUSIONS This is one of the first intervention studies to use an individually tailored, adaptive design to manage weight gain in pregnancy. Results from this study will be useful in designing a larger randomized trial to examine efficacy of this intervention and developing strategies for clinical application. REGISTERED REPORT IDENTIFIER RR1-10.2196/9220