Effects of the First 1,000 Days Systems-Change Intervention on Obesity Risk Factors During Pregnancy

Background: First 1,000 Days is a systems-oriented program starting in early pregnancy lasting through the rst 24 months of infancy focused on preventing obesity and related risk factors among low income, mother-infant pairs. The program was developed in partnership with stakeholders to create an infrastructure for system-wide change. It includes screening for adverse health behaviors and socio-contextual factors, patient navigation and educational materials to support behavior change and social needs, and individualized health coaching for women at highest risk of obesity and has been shown to reduce excess gestational weight gain for women who were overweight at the start of their pregnancy. Methods: We collected information through self-administered questionnaires during the rst and third trimester of gestation and from electronic health records relating to obesity risk factors. Measures collected included behavior (i.e., diet, physical activity and screen time) and psychosocial outcomes, as well as enrollment in Women, Infant, and Children (WIC) program. We examined the extent to which participation in the program was associated with changes in behaviors and psychosocial outcomes among women during pregnancy. Results: Women completed surveys at their initial and third trimester prenatal visits (n=264). Mean age (SD) was 30.2 (5.51) years and 75% had an annual household income of <$50,000. Mean pre-pregnancy body mass index (BMI) was 27.7 kg/m 2 and 64% started pregnancy with a BMI ≥ 25 kg/m 2 . In multivariable adjusted models, we observed decreases in intake of sugary-drinks (-0.96 servings/day; 95% CI: -1.86, -0.06) and in screen time (-0.21 hours/day; 95% CI: -0.40, -0.02), and an increase in physical activity (0.87 days/week; 95% CI: 0.56, 1.17) from the rst to third trimester. We also observed a decrease in pregnancy-related anxiety score (-1.06 units; 95% CI: -1.32, -0.79) and higher odds of enrollment in Women, Infant, and Children (WIC) program (OR: 2.58; 95% CI: 1.96, 3.41). on the have shown improvement in and utilization of the Supplemental Nutrition Program for Infants and Children (WIC) resulting in improved outcomes for women and their children. 11 These studies have predominately targeted individual-level of change, 12–14 while few interventions have focused on a broader context of change using a systems-level approach. In addition, few studies have been designed to support women and infant from low-income households as they may be more vulnerable than their peers to socio-contextual factors that inuence behaviors, psychosocial status, and connection to resources. The First 1000 Days program was developed in conjunction with stakeholders to build an infrastructure for system-wide change for obesity prevention during the antenatal and postpartum periods. 15,16 The program addresses clinical, behavior, and socio-contextual factors contributing to excess weight gain during pregnancy and during the rst two years of life and has been shown to reduce excess gestational weight gain for women who were overweight at the start of their pregnancy. The purpose of this study is to examine behavior (i.e, diet, screen time, physical psychosocial (i.e., and WIC program enrollment changes from the rst to third trimester for low-income women at high risk for obesity participating in the systems-oriented First 1,000 Days program in the greater Boston area. We hypothesized that program participation would lead to improvements in behavioral risk factors and promote the use social support services during pregnancy. The results of the multivariable models adjusted for confounders for the behavior, psychosocial, and WIC enrollment outcomes are shown in Table 2. In multivariable adjusted models, we observed statistically signicant decreases in intake of sugary-drinks (-0.96 servings/week; 95% CI: -1.86, -0.05) and in screen time (-0.21 hours/day; 95% CI: -0.40, -0.02), and an increase in physical activity (0.87 days/week; 95% CI: 0.56, 1.17) from the rst to third trimester. We did not observe statistically signicant changes between the rst and third trimester for fruit and vegetable or fast-food intake. We also observed a decrease in pregnancy-related anxiety score (-1.06 units; 95% CI: -1.32, -0.79) and higher odds of enrollment in WIC (OR: 2.58; 95% CI: 1.96, 3.41).

Intervention efforts focused on the rst 1000 days have shown improvement in behaviors, psychosocial outcomes, and utilization of the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) resulting in improved outcomes for women and their children. 11 These studies have predominately targeted individual-level of change, [12][13][14] while few interventions have focused on a broader context of change using a systems-level approach. In addition, few studies have been designed to support women and infant from low-income households as they may be more vulnerable than their peers to socio-contextual factors that in uence behaviors, psychosocial status, and connection to resources. The First 1000 Days program was developed in conjunction with stakeholders to build an infrastructure for system-wide change for obesity prevention during the antenatal and postpartum periods. 15,16 The program addresses clinical, behavior, and socio-contextual factors contributing to excess weight gain during pregnancy and during the rst two years of life and has been shown to reduce excess gestational weight gain for women who were overweight at the start of their pregnancy. 16 The purpose of this study is to examine behavior (i.e, diet, screen time, physical activity), psychosocial (i.e., anxiety), and WIC program enrollment changes from the rst to third trimester for low-income women at high risk for obesity participating in the systems-oriented First 1,000 Days program in the greater Boston area. We hypothesized that program participation would lead to improvements in behavioral and psychosocial risk factors and promote the use of social support services during pregnancy.

Study Overview
Women enrolled in this study were participants in The First 1,000 Days program, a systems-level initiative that engages stakeholders across clinical and public health sectors to reduce the prevalence of obesity and obesity risk factors among mother-infant pairs who are low-income by addressing the levels of individual, family, and socio-contextual factors that hinder progress in obesity prevention. The systemwide intervention begins when women initiate prenatal care in their rst trimester of pregnancy and offers support for mothers, their partners, and eventually the mother-partner-infant triads, throughout pregnancy and the child's rst 24 months. The conceptual framework, intervention design, evaluation methods, and primary results have been described in detail elsewhere. 15,16 A subset of women completed surveys in their rst and third trimesters of prenatal visits to examine individual-level changes in behavior and psychosocial outcomes. For this secondary analysis, a quasi-experimental pre-post design was used to evaluate the changes in the behavior and psychosocial outcomes from the rst to third trimester visit among participants.

Eligibility and Recruitment
The First 1,000 Days program was offered to women who initiated prenatal care between August 2016 and September 2017 in three community health centers in Boston, Revere, and Chelsea, Massachusetts that serve predominantly low-income, racially/ethnically diverse populations. Upon completion of the intake survey and consent, women were considered to be enrolled in the program. The intake survey was administered to women at their rst prenatal care visit which for most women was during the rst trimester. Of the 366 women who completed a rst trimester intake survey, 286 (78%) also completed a third trimester survey, and 264 (72%) women were included in the analyses as 22 women had missing vital demographic data (Fig. 1). The First 1,000 Days study protocol was approved by Partners HealthCare Institutional Review Board and registered at ClinicalTrials.gov (NCT03191591).

Program Components in Pregnancy
The First 1,000 Days program has multiple components that aim to improve primary and secondary prevention of obesity. The program components that have been previously described in detail and include: staff and provider training emphasizing obesity prevention efforts; clinical decision support tools to track gestational weight gain; rst prenatal visit universal screening for health behaviors and sociocontextual factors; patient navigation focused on healthy behavior change, social needs, and clinical and public health services; and health coaching for women at high risk of obesity. 15,16 During pregnancy, the program focused on ve behavior targets including: eating a balanced nutrition plan; drinking predominantly water and avoiding sugary-drinks; being physically active; getting recommended amounts of sleep; and reducing stress through social supports. Information regarding the behavior targets was delivered through printed materials including posters hanging in health centers and public health o ces and individual booklets provided to patients. Booklets were available in English, Spanish, Vietnamese, and Arabic and contained customizable sections for gestational weight gain recommendations and behavior changed goal setting (Fig. 2). Women could also enroll in a textmessaging program to provide behavior change support and education and received 2-3 text messages during their pregnancy. Short informational videos (Vidscrips®) were also created in English and Spanish and available to women and their partners. The videos reinforced the behavior targets of the program, answered commonly asked questions, and provided recommendations.

Data Collection and Outcome Measurements
Information was collected through self-administered questionnaires during the rst and third trimester of gestation and from electronic health records (EHR). Measures collected included behavior (i.e., diet, physical activity and screen time) and psychosocial outcomes, as well as WIC program enrollment. Surveys were available in English, Spanish, and Arabic.
Dietary behaviors, including fruit and vegetable, sugary-drinks, and fast food consumption were evaluated by asking women, "During the past 7 days, on average, how often did you eat …?". Women responded by selecting: never; once per week, 2-4 times per week, nearly daily, 2-4 times per day, or 5 or more times per day. The fruit and vegetable consumption question included fresh, cooked, canned, or frozen fruits or vegetables and excluded juices or dried fruits; mean consumption was measured in times per day. The sugary-drink question included fruit-avored drinks, juice from concentrate, punch, Kool-Aid, soda, sports drinks, sweet tea or coffee drinks, and sweetened milks; mean consumption was measured in beverages consumed weekly. The fast-food question asked about eating from a fast food restaurant; mean consumption was measured in weekly consumption. The items are from a validated food frequency questionnaire and have been previously used during pregnancy. 17,18 To evaluate physical activity, women answered, "During the past 7 days, on how many days were you physically active for a total of at least 30 minutes per day? Add up all the time you spent in any kind of physical activity that increased your heart rate and made you breathe hard some of the time." Responses to this question ranged from 0-7 days per week. This question was adapted from the Youth Risk Behavior Survey. 19 To measure screen time, women were asked, "During the past 7 days, on average, how many hours per day did you usually spend watching TV or videos. Include time spent watching on a television, computer, phone or tablet." Women selected: never, < 1 hour per day, 1, 2, 3, 4 or 5 hours per day, and 6 or more hours per day. This question was adapted from the Nurses' Health study. 20 We assessed pregnancy-related anxiety using the Pregnancy Anxiety Score, which focused on 5 topics: the extent of worry or concern about their health during pregnancy, about their baby's health normal growth and developing, about losing the baby, about having a hard labor or di cult delivery, and about taking care of a new baby 21,22 Possible responses to these questions were: never concerned, sometimes, most of the time, and almost all of the time concerned. A score was calculated by summing each of the ve questions with a possible range from 0-20. Higher scores indicate a greater extent of worry or concern. If more than two questions were missing, a score was not calculated.
WIC program enrollment was offered to participants during pregnancy who reported they were not enrolled and met the income level criteria. To evaluate the number of women receiving WIC program support, we asked women, "Do you currently receive bene ts from WIC?". Women responded by answering: yes, no, or unsure.

Confounding Factors
Based on the previous literature, we used covariates for adjusted analyses. 7,23,24 Socio-demographic variables collected in the rst and third trimester survey were used and they included maternal age and race/ ethnicity. Pre-pregnancy body mass index (BMI) was collected from the EHR.

Statistical Analysis
Data from the EHR and survey results were merged to allow for analyses. We compared participants' responses at baseline ( rst trimester of gestation) with results from third trimester surveys; each participant was measured twice, resulting in pairs of observations. We used repeated measures design, including the paired t-tests for quantitative variables and the McNemar's test for qualitative variables in unadjusted models. We also used multivariable regression models to adjust for possible confounders, Page 6/17 including maternal age, race/ethnicity and pre-pregnancy BMI. Mixed-effect linear models were applied for continuous outcomes, with a time predictor to indicate the time points of rst and third trimesters. The models accounted for clustering of observations within individuals. The adjusted mean differences between rst and third trimester and 95% con dence intervals (CI) were calculated. For the dichotomous outcome, WIC enrollment, we applied logistic regression using generalized model, tted with generalized estimating equation to address the repeated measurements. The adjusted odds ratio (OR) and 95% CI were generated for the WIC enrollment outcome. We performed analyses on complete cases and excluded participants with missing values in predictor, outcome, or covariates. A 2-sided alpha level of 0.05 was used to test for statistical signi cance in all analyses. Analyses were performed in RStudio 3.5.1 and SAS 9.4 (SAS institute, Cary, NC).

Results
Of the 286 women who completed a survey at their initial and third trimester prenatal visit, 264 were included in nal analyses. Baseline demographic characteristics of participants, summarized in Table 1. Women were a mean (SD) age of 30.8 (5.51) years and initiated their rst prenatal care visit at a mean (SD) gestational age of 10.4 (4.65) weeks. Women had a mean (SD) pre-pregnancy BMI of 27.7 (6.43) kg/m 2 and 64% started pregnancy with a BMI ≥ 25 kg/m 2 . At the rst trimester visit, 33% of women were enrolled in WIC. 220 (83%) women received patient navigation and/or health coach phone-calls and booklets, 41(16%) received booklets only, and 3 (1%) did not receive a phone-call or booklet.  The First 1000 Days program was created to build an infrastructure for system-wide change, and our ndings revel that the program is effective in improving maternal outcomes that aid in obesity prevention during antenatal and postpartum periods. In this study, we examined behavior, psychosocial, and community resource connection changes in women from low-income households who participated in the First 1000 Days program. We found participation in the program was associated with a decrease in intake of sugary-drinks, screen time, and pregnancy-related anxiety score; and an increase in physical activity from the rst to third trimester. Women also had higher odds of enrollment in WIC after program participation.
Similar to other interventions during pregnancy, the First 1000 Days program showed improvement in dietary behaviors illustrating that a systems-level approach can be an effective method for promoting behavior change. Previous interventions have found improvements in overall dietary intake as measured via Healthy Eating Index and the Semi Quantitative Food Frequency Questionnaire, 25-27 decreased consumption of processed foods, 28 and increased consumption of fruits and vegetables. 29 We found a decrease in consumption of sugary-drinks that has been shown to be critical in reducing post-partum weight retention, 30 but we did not see changes in fruit, vegetables, and junk food intake. Other reasons, such as neighborhood characteristics and food environment, despite our systems-level approach, may have continued to make changes in these dietary areas more challenging for women. 31 We found a positive program effect on physical activity and screen time, though ndings from previous interventions that have targeted physical activity are equivocal and few interventions have targeted screen time. 13,26,27,29,32 A meta-analysis of 13 studies that examined the effectiveness of physical activity interventions during pregnancy found increases in metabolic equivalents and physical tness. 33 Ainscough and colleagues 26 found a mean difference of 141.1 minutes per week of physical activity between the intervention and control groups in their trial that targeted individual-level change. Although measured differently and in different units, we also found an increase of physical activity of 0.87 days per week. By improving physical activity levels and sedentary behaviors, such as screen time, programs can help improve pregnancy and infant outcomes including gestational diabetes mellitus, excess gestational weight gain, maternal mental health, and infants born large-for-gestational-age. 13,26 In addition to behavior changes, we also found that women decreased their anxiety levels, consistent with what has been demonstrated in the literature. 14,34 A meta-analysis revealed that interventions during pregnancy from four randomized control trials were shown to decrease anxiety scores resulting in a pooled estimate of -1.74 units, similar to our ndings of -1.06 units and thereby improving women's mental health during the antenatal period. Another key component of the First 1000 Days program was connecting women to community resources including WIC program, food banks, and social services. By connecting women to community resources and engaging those organizations as stakeholders, the program was able to in uence organizational and community factors that impact maternal health.
As previously reported, the First 1000 Days program has been shown to reduce excess gestational weight gain for low-income women who were overweight at the start of their pregnancy. 16 In addition, women who participated in the program were also satis ed with the program, believed it improved their health and well-being, and that it provided an appropriate amount of services. 16 The changes in behavior and mental health likely contributed to the reduction in excess gestational weight gain. Although several programs have demonstrated improvements in behaviors, mental health, and gestational weight gain, many of these studies have focused on the individual level, 12,35−37 whereas the First 1000 Days program focused on system-wide change. The results of this current study demonstrate that a system-wide approach can be effective in supporting women during pregnancy and advantages of this approach are the connections between clinical and public health programs that target individual-level behaviors and socio-contextual risk factors simultatneously. 16,38 This study presents with several limitations. Because the First 1000 Days program utilized a system-wide change approach, i.e., the program had multiple components, we were unable to discern which component impacted the most change. The pre-post quasi-experimental design without a comparison group is susceptible to temporal confounders, but this needs to be balanced with a pragmatic approach to real-world implementation.

Conclusions
We found that women who participated in the First 1000 Days systems-oriented maternal and infant obesity prevention program decreased their sugary-drink consumption, screen time, and pregnancyrelated anxiety score; increased their physical activity; and increased enrollment in WIC from the rst to third trimester. The changes in behaviors, psychosocial status, and connections to resources are critical to maternal and child health outcomes. The ndings indicate that the system-wide First 1000 Days Program can be an effective approach beyond individual change interventions for obesity prevention during the antenatal and postpartum periods for low-income women. Ethics Approval and consent to participate: All experimental protocols involving human data were in accordance with institutional guidelines. Women received a fact sheet at their initial prenatal visit and survey completion served as consent for participation. The Partners Healthcare institutional review board approved the study protocol and method for obtaining consent.

Consent for publication: Not applicable
Availability of data and materials: The datasets used during the current study are available from the corresponding author on reasonable request.
Competing Interests: The authors declare that they have no competing interests.
Funding: This study was supported by grant number G2015-0007 from the Boston Foundation. Dr. Taveras' effort was partially supported by grant number 1K24DK105989 from the National Institute of Diabetes and Digestive and Kidney Diseases and the MGH ECOR Scholars Program. The content is solely the responsibility of the authors and does not necessarily represent the o cial views of the funders.
Authors' contributions: MS and LMG conceptualized and designed the study, analyzed and interpreted the data, and drafted the initial manuscript. ML analyzed the data and critically reviewed the manuscript for important intellectual content. MP, SP, MK, and TLB assisted with interpretation of the data and critically reviewed the manuscript for important intellectual content. ET conceptualized and designed the study, interpreted the data, and critically reviewed the manuscript for important intellectual content. All authors read and approved the nal manuscript.  Examples of First 1,000 Days Pregnancy booklet supporting behavioral changes.