Mood and quality of life changes in pregnancy and postpartum and the effect of a behavioral intervention targeting excess gestational weight gain in women with overweight and obesity: a parallel-arm randomized controlled pilot trial.

BACKGROUND: Intensive lifestyle interventions in pregnancy have shown success in limiting gestational weight gain, but the effects on mood and quality of life in pregnancy and postpartum are less known. The purpose was to quantify changes in mental and physical quality of life and depressive symptoms across pregnancy and the postpartum period, to determine the association between gestational weight gain and change in mood and quality of life, and to assess the effect of a behavioral intervention targeting excess gestational weight gain on these outcomes. METHODS: A three group parallel-arm randomized controlled pilot trial of 54 pregnant women who were overweight or obese was conducted to test whether the SmartMoms® intervention decreased the proportion of women with excess gestational weight gain. Individuals randomized to Usual Care (n = 17) did not receive any weight management services from interventionists. Individuals randomized to the SmartMoms® intervention (n = 37) were provided with behavioral weight management counseling by interventionists either in clinic (In-Person, n = 18) or remotely through a smartphone application (Phone, n = 19). In a subset of 43 women, mood and mental and physical quality of life were assessed with the Beck Depression Inventory-II and the Rand 12-Item short form, respectively, in early pregnancy, late pregnancy, 1-2 months postpartum, and 12 months postpartum. RESULTS: The SmartMoms® intervention and Usual Care groups had higher depressive symptoms (p < 0.03 for SmartMoms® intervention, p < 0.01 for Usual Care) and decreased physical health (p < 0.01) from early to late pregnancy. Both groups returned to early pregnancy mood and physical quality of life postpartum. Mental health did not change from early to late pregnancy (p = 0.8), from early pregnancy to 1-2 months (p = 0.5), or from early pregnancy to 12 months postpartum (p = 0.9), respectively. There were no significant intervention effects. Higher gestational weight gain was associated with worsened mood and lower physical quality of life across pregnancy. CONCLUSION: High depressive symptoms and poor quality of life may be interrelated with the incidence of excess gestational weight gain. The behavioral gestational weight gain intervention did not significantly impact these outcomes, but mood and quality of life should be considered within future interventions and clinical practice to effectively limit excess gestational weight gain. TRIAL REGISTRATION: NCT01610752 , Expecting Success, Registered 31 May 2012.

Food Photography Is Not an Accurate Measure of Energy Intake in Obese, Pregnant Women.

Background: To improve weight management in pregnant women, there is a need to deliver specific, data-based recommendations on energy intake. Objective: This cross-sectional study evaluated the accuracy of an electronic reporting method to measure daily energy intake in pregnant women compared with total daily energy expenditure (TDEE). Methods: Twenty-three obese [mean ± SEM body mass index (kg/m2): 36.9 ± 1.3] pregnant women (aged 28.3 ±1.1 y) used a smartphone application to capture images of their food selection and plate waste in free-living conditions for ≥6 d in early (13-16 wk) and late (35-37 wk) pregnancy. Energy intake was evaluated by the smartphone application SmartIntake and compared with simultaneous assessment of TDEE obtained by doubly labeled water. Accuracy was defined as reported energy intake compared with TDEE (percentage of TDEE). Ecological momentary assessment prompts were used to enhance data reporting. Two-one-sided t tests for the 2 methods were used to assess equivalency, which was considered significant when accuracy was >80%. Results: Energy intake reported by the SmartIntake application was 63.4% ± 2.3% of TDEE measured by doubly labeled water (P = 1.00). Energy intake reported as snacks accounted for 17% ± 2% of reported energy intake. Participants who used their own phones compared with participants who used borrowed phones captured more images (P = 0.04) and had higher accuracy (73% ± 3% compared with 60% ± 3% of TDEE; P = 0.01). Reported energy intake as snacks was significantly associated with the accuracy of SmartIntake (P = 0.03). To improve data quality, excluding erroneous days of likely underreporting (<60% TDEE) improved the accuracy of SmartIntake, yet this was not equivalent to TDEE (-22% ± 1% of TDEE; P = 1.00). Conclusions: Energy intake in obese, pregnant women obtained with the use of an electronic reporting method (SmartIntake) does not accurately estimate energy intake compared with doubly labeled water. However, accuracy improves by applying criteria to eliminate erroneous data. Further evaluation of electronic reporting in this population is needed to improve compliance, specifically for reporting frequent intake of small meals. This trial was registered at www.clinicaltrials.gov as NCT01954342.

Effectiveness of SmartMoms, a Novel eHealth Intervention for Management of Gestational Weight Gain: Randomized Controlled Pilot Trial.

BACKGROUND: Two-thirds of pregnant women exceed gestational weight gain (GWG) recommendations. Because excess GWG is associated with adverse outcomes for mother and child, development of scalable and cost-effective approaches to deliver intensive lifestyle programs during pregnancy is urgent. OBJECTIVE: The aim of this study was to decrease the proportion of women who exceed the Institute of Medicine (IOM) 2009 GWG guidelines. METHODS: In a parallel-arm randomized controlled trial, 54 pregnant women (age 18-40 years) who were overweight (n=25) or obese (n=29) were enrolled to test whether an intensive lifestyle intervention (called SmartMoms) decreased the proportion of women with excess GWG, defined as exceeding the 2009 IOM guidelines, compared to no intervention (usual care group). The SmartMoms intervention was delivered through mobile phone (remote group) or in a traditional in-person, clinic-based setting (in-person group), and included a personalized dietary intake prescription, self-monitoring weight against a personalized weight graph, activity tracking with a pedometer, receipt of health information, and continuous personalized feedback from counselors. RESULTS: A significantly smaller proportion of women exceeded the IOM 2009 GWG guidelines in the SmartMoms intervention groups (in-person: 56%, 10/18; remote: 58%, 11/19) compared to usual care (85%, 11/13; P=.02). The remote intervention was a lower cost to participants (mean US $97, SD $6 vs mean US $347, SD $40 per participant; P<.001) and clinics (US $215 vs US $419 per participant) and with increased intervention adherence (76.5% vs 60.8%; P=.049). CONCLUSIONS: An intensive lifestyle intervention for GWG can be effectively delivered via a mobile phone, which is both cost-effective and scalable. TRIAL REGISTRATION: Clinicaltrials.gov NCT01610752; https://clinicaltrials.gov/ct2/show/NCT01610752 (Archived by WebCite at http://www.webcitation.org/6sarNB4iW).

Strategies for Successful Recruitment of Pregnant Patients Into Clinical Trials.

Clinical research in the pregnant population allows for delivery of quality, evidence-based care in obstetrics. However, in recent years, the field of obstetrics has faced severe challenges in the recruitment of the pregnant population into clinical trials, a struggle also shared by several other medical disciplines. We candidly describe our failure to recruit a healthy population of overweight and obese pregnant women in their first trimester. We were then able to glean unsuccessful and successful recruitment approaches and improve our recruitment effort by autopsy of failed strategies and with guidance from a survey disseminated to improve our understanding of community feelings about participating in research while pregnant. These "lessons learned" taught us that active recruitment within this population is a necessity; that is, direct (face-to-face discussions at obstetric appointments) compared with indirect (flyers and general emails) modalities and that prenatal care provider support of the proposed research study is vital to a patient's willingness to participate. By implementation of "lessons learned," we describe how we successfully recruited a similar pregnant population 1 year later. The Clinical Trials related to our article are as follows: 1) Expecting Success: NCT01610752, https://clinicaltrials.gov/ct2/show/NCT01610752; 2) MomEE: NCT01954342, https://clinicaltrials.gov/ct2/show/NCT01954342; and 3) Participate While Pregnant Survey: NCT02699632, https://clinicaltrials.gov/ct2/show/NCT02699632.