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Group Sessions or Home Visits for Early Childhood Development in India: A Cluster RCT.
Grantham-McGregor, S, Adya, A, Attanasio, O, Augsburg, B, Behrman, J, Caeyers, B, Day, M, Jervis, P, Kochar, R, Makkar, P, et al
Pediatrics. 2020;(6)
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OBJECTIVES Poor early childhood development in low- and middle-income countries is a major public health problem. Efficacy trials have shown the potential of early childhood development interventions but scaling up is costly and challenging. Guidance on effective interventions' delivery is needed. In an open-label cluster-randomized control trial, we compared the effectiveness of weekly home visits and weekly mother-child group sessions. Both included nutritional education, whose effectiveness was tested separately. METHODS In Odisha, India, 192 villages were randomly assigned to control, nutritional education, nutritional education and home visiting, or nutritional education and group sessions. Mothers with children aged 7 to 16 months were enrolled (n = 1449). Trained local women ran the two-year interventions, which comprised demonstrations and interactions and targeted improved play and nutrition. Primary outcomes, measured at baseline, midline (12 months), and endline (24 months), were child cognition, language, motor development, growth and morbidity. RESULTS Home visiting and group sessions had similar positive average (intention-to-treat) impacts on cognition (home visiting: 0.324 SD, 95% confidence interval [CI]: 0.152 to 0.496, P = .001; group sessions: 0.281 SD, 95% CI: 0.100 to 0.463, P = .007) and language (home visiting: 0.239 SD, 95% CI: 0.072 to 0.407, P = .009; group sessions: 0.302 SD, 95% CI: 0.136 to 0.468, P = .001). Most benefits occurred in the first year. Nutrition-education had no benefit. There were no consistent effects on any other primary outcomes. CONCLUSIONS Group sessions cost $38 per child per year and were as effective on average as home visiting, which cost $135, implying an increase by a factor of 3.5 in the returns to investment with group sessions, offering a more scalable model. Impacts materialize in the first year, having important design implications.
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Breastfeeding peer counselling for mothers of preterm neonates: protocol of a stepped-wedge cluster randomised controlled trial.
Laborie, S, Denis, A, Horsch, A, Occelli, P, Margier, J, Morisod Harari, M, Claris, O, Touzet, S, Fischer Fumeaux, CJ
BMJ open. 2020;(1):e032910
Abstract
INTRODUCTION Among preterm infants, mother's own milk feeding reduces neonatal morbidity and decreases the length of hospital stay. However, breastfeeding rates and duration are lower than among term infants. It is reported that peer counselling is effective in increasing breast feeding in term infants in low-income and middle-income countries, but results are mixed in high-income countries. We aim to investigate herein whether peer counselling may be a feasible and effective breastfeeding support among preterm infants in French-speaking high-income countries. METHODS AND ANALYSIS Eight European centres will participate in this stepped-wedge cluster randomised controlled trial. We plan to include 2400 hospitalised neonates born before 35 gestational weeks. Each centre will begin with an observational period. Every 3 months, a randomised cluster (centre) will begin the interventional period with peer counsellors until the end of the study. The counsellors will be trained and supervised by the trained nurses. They will have a weekly contact with participating mothers, with a face-to-face meeting at least once every fortnight. During these meetings, peer counsellors will listen to mothers' concerns, share experiences and help the mother with their own knowledge of breast feeding. The main outcome is breastfeeding rate at 2 months corrected age. Secondary outcomes are breastfeeding rates at hospital discharge and at 6 months, breastfeeding duration and severe neonatal morbidity and mortality. The mental health of the mother, mother-infant bonding and infant behaviour will be assessed using self-report questionnaires. A neurodevelopmental follow-up, a cost-effectiveness analysis and a cost-consequence at 2 years corrected age will be performed among infants in a French subgroup. ETHICS AND DISSEMINATION French, Belgian and Swiss ethics committees gave their agreement. Publications in peer-reviewed journals are planned on breast feeding, mental health and economic outcomes. TRIAL REGISTRATION NUMBER NCT03156946.
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Short-Term Effects of an Obesity Prevention Program Among Low-Income Hispanic Families With Preschoolers.
Hughes, SO, Power, TG, Beck, A, Betz, D, Goodell, LS, Hopwood, V, Jaramillo, JA, Lanigan, J, Martinez, AD, Micheli, N, et al
Journal of nutrition education and behavior. 2020;(3):224-239
Abstract
OBJECTIVE To assess the short-term effects of an obesity prevention program promoting eating self-regulation and healthy food preferences in low-income Hispanic children. DESIGN Randomized controlled trial with pretest, posttest, and 6- and 12-month assessments. SETTING AND PARTICIPANTS Head Start and similar early learning institutions in Houston, TX, and Pasco, WA. A total of 255 families with preschoolers randomized into prevention (n = 136) and control (n = 119) groups. INTERVENTION Multicomponent family-based prevention program. Fourteen waves lasted 7 weeks each with 8-10 mother-child dyads in each group. MAIN OUTCOME MEASURES Parent assessments included feeding practices, styles, and knowledge. Child assessments included child eating self-regulation, willingness to try new foods, and parent report of child fruit and vegetable preferences. Parent and child heights and weights were measured. ANALYSIS Multilevel analyses were employed to consider the nested nature of the data: time points within families within waves. RESULTS The program had predicted effects on parental feeding practices, styles, and knowledge in the pre- to post-comparisons. Effects on child eating behavior were minimal; only the number of different vegetables tried showed significant pre-post differences. CONCLUSIONS AND IMPLICATIONS Short-term effects of this prevention program highlight the importance of family-focused feeding approaches to combating child overweight and obesity.
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Gastrointestinal Symptoms in Infants of Mothers With a Psychiatric History and the Role of Depression and Bonding.
de Kruijff, I, Choenni, V, Groeneweg, JT, Vlieger, AM, Benninga, MA, Kok, R, Kamperman, AM, Lambregtse-van den Berg, MP
Journal of pediatric gastroenterology and nutrition. 2019;(6):662-667
Abstract
OBJECTIVES Gastroesophageal reflux (GER), excessive crying, and constipation are common gastrointestinal symptoms in infancy of multifactorial origin in which psychosocial stress factors play an important role. The aims of this observational study were to investigate the presence of gastrointestinal symptoms in infants of mothers with or without a history of a psychiatric disorder, their association with maternal depressive symptoms, and the possible mediating role of bonding. METHODS One hundred one mothers with a history of a psychiatric disorder and 60 control mothers were included. Infant gastrointestinal symptoms, maternal depressive symptoms, and mother-infant bonding were assessed using validated questionnaires and diagnostic criteria at 1.5 months postpartum. RESULTS The mean total score on the Infant Gastroesophageal Reflux Questionnaire Revised reported in infants of mothers with psychiatric disorder (13.4 standard deviation 5.4) was significantly higher than that in infants of control mothers (10.8 standard deviation 5.4; P = .003). No significant differences were found in the presence of excessive crying (modified Wessel criteria and subjective experience) and constipation (ROME IV criteria) between both groups. Infant GER was associated with maternal depressive symptoms (P = 0.027) and bonding problems (P = <0.001). Constipation was related to maternal depressive symptoms (P = 0.045), and excessive crying (Wessel and subjective criteria) was associated with bonding problems (P = 0.022 and P = 0.002, respectively). The effect of maternal depressive symptomatology on infant GER symptoms and excessive crying was mediated by bonding problems. CONCLUSION Maternal psychiatric history is associated with infant gastrointestinal symptoms, in which mother-infant bonding is a mediating factor.
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Effectiveness of weekly cell phone counselling calls and daily text messages to improve breastfeeding indicators.
Patel, A, Kuhite, P, Puranik, A, Khan, SS, Borkar, J, Dhande, L
BMC pediatrics. 2018;(1):337
Abstract
BACKGROUND Every year, nearly one million deaths occur due to suboptimal breastfeeding. If universally practiced, exclusive breastfeeding alone prevents 11.6% of all under 5 deaths. Among strategies to improve exclusive breastfeeding rates, counselling by peers or health workers, has proven to be highly successful. With growing availability of cell phones in India, they are fast becoming a medium to spread information for promoting healthcare among pregnant women and their families. This study was conducted to assess effectiveness of cell phones for personalized lactation consultation to improve breastfeeding practices. METHODS This was a two arm, pilot study in four urban maternity hospitals, retrained in Baby Friendly Hospital Initiative. The enrolled mother-infant pairs resided in slums and received healthcare services at the study sites. The control received routine healthcare services, whereas, the intervention received weekly cell phone counselling and daily text messages, in addition to counselling the routine healthcare services. RESULTS 1036 pregnant women were enrolled (518 - intervention and 518 - control). Rates of timely initiation of breastfeeding were significantly higher in intervention as compared to control (37% v/s 24%, p < 0.001). Pre-lacteal feeding rates were similar and low in both groups (intervention: 19%, control: 18%, p = 0.68). Rate of exclusive breastfeeding was similar between groups at 24 h after delivery, but significantly higher in the intervention at all subsequent visits (control vs. intervention: 24 h: 74% vs 74%, p = 1.0; 6 wk.: 81% vs 97%, 10 wk.: 78% vs 98%, 14 wk.: 71% vs 96%, 6 mo: 49% vs 97%, p < 0.001 for the last 4 visits). Adjusting for covariates, women in intervention were more likely to exclusively breastfeed than those in the control (AOR [95% CI]: 6.3 [4.9-8.0]). CONCLUSION Using cell phones to provide pre and postnatal breastfeeding counselling to women can substantially augment optimal practices. High rates of exclusive breastfeeding at 6 months were achieved by sustained contact and support using cell phones. This intervention shows immense potential for scale up by incorporation in both, public and private health systems. TRIAL REGISTRATION This study was retrospectively registered with Clinical Trial Registry of India ( http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=3060 ) Trial Number: CTRI/2011/06/001822 on date 20/06/2011.
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Strengthening integration of clinical and public health systems to prevent maternal-child obesity in the First 1,000Days: A Collective Impact approach.
Blake-Lamb, T, Boudreau, AA, Matathia, S, Tiburcio, E, Perkins, ME, Roche, B, Kotelchuck, M, Shtasel, D, Price, SN, Taveras, EM
Contemporary clinical trials. 2018;:46-52
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INTRODUCTION Obesity interventions may be most effective if they begin in the earliest stages of life, support changes across family, clinical, and public health systems, and address socio-contextual factors. METHODS The First 1000Days is a systematic program starting in early pregnancy lasting through the first 24months of infancy to prevent obesity among low-income mother-infant pairs in three community health centers in Massachusetts. The program uses a Collective Impact approach to create the infrastructure for sustained, system-wide changes for obesity prevention across early life clinical and public health services, including Obstetrics, Pediatrics, Adult Medicine, Behavioral Health, Nutrition, Community Health, the Women, Infants and Children (WIC) program, and the Maternal, Infant and Childhood Home Visiting program. Program components include 1) staff and provider training; 2) enhanced gestational weight gain and infant overweight tracking; 3) universal screening of adverse health behaviors and socio-contextual factors; 4) universal patient navigation to support individual behavior change and social needs, while strengthening integration of clinical and public health services; 5) individualized health coaching for mother-infant pairs at high risk of obesity; and 6) educational materials to support behavior change. RESULTS A quasi-experimental evaluation design will examine changes, between 2015 and 2019, in gestational weight gain and prevalence of infant overweight from 0 to 24months of age. CONCLUSIONS The First 1000Days program will examine the effectiveness of an early life obesity prevention program for mother-infant pairs. If successful, the program could provide a model for chronic disease prevention and health promotion among vulnerable families starting in early life.
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Prevalence and Predictors of Breastfeeding After Childhood Abuse.
Eagen-Torkko, M, Low, LK, Zielinski, R, Seng, JS
Journal of obstetric, gynecologic, and neonatal nursing : JOGNN. 2017;(3):465-479
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OBJECTIVE To describe the prevalence and predictors of breastfeeding intent and outcomes in women with histories of childhood maltreatment trauma (CMT), including those with posttraumatic stress disorder (PTSD). DESIGN Secondary analysis of a prospective observational cohort study of the effects of PTSD on perinatal outcomes. SETTING Prenatal clinics in three health systems in the Midwestern United States. PARTICIPANTS Women older than 18 years expecting their first infants, comprising three groups: women who experienced CMT but did not have PTSD (CMT-resilient), women with a history of CMT and PTSD (CMT-PTSD), and women with no history of CMT (CMT-nonexposed). METHODS Secondary analysis of an existing data set in which first-time mothers were well-characterized on trauma history, PTSD, depression, feeding plans, feeding outcomes, and several other factors relevant to odds of breastfeeding success. RESULTS Intent to breastfeed was similar among the three groups. Women in the CMT-resilient group were twice as likely to breastfeed exclusively at 6 weeks (60.5%) as women in the CMT-PTSD group (31.1%). Compared with women in the CMT-nonexposed group, women in the CMT-resilient group were more likely to exclusively breastfeed. Four factors were associated with increased likelihood of any breastfeeding at 6 weeks: prenatal intent to breastfeed, childbirth education, partnered, and a history of CMT. Four factors were associated with decreased odds of breastfeeding: African American race, PTSD, major depression, and low level of education (high school or less). CONCLUSION Posttraumatic stress disorder is more important than childhood maltreatment trauma history in determining likelihood of breastfeeding success. Further research on the promotion of breastfeeding among PTSD-affected women who have experienced CMT is indicated.
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Results and lessons learned from a prevention of weight gain program for low-income overweight and obese young mothers: Mothers In Motion.
Chang, MW, Brown, R, Nitzke, S
BMC public health. 2017;(1):182
Abstract
BACKGROUND Mothers In Motion (MIM), a community-based lifestyle behavioral intervention, was designed and conducted to help low-income overweight and obese young mothers prevent further weight gain via promotion of stress management, healthy eating, and physical activity. This paper presents intervention effect on body weight (primary outcome) and summarizes lessons learned. METHODS Participants (N = 612) were recruited from 7 Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) offices in Michigan and were individually randomized to an intervention n= 410) or a comparison (n =202) group (2: 1 ratio). During the 16-week intervention, intervention participants watched theory-based culturally sensitive videos (in DVD format) featuring peers from the target audience to learn skills for managing stress, eating healthier, and being more physically active. They also dialed into peer support group teleconferences to enhance skills learned in the videos and increase motivation for lifestyle behavioral changes. Body weight, the primary outcome, was measured at baseline, immediately after the 16-week intervention, and 3 months after the 16-week intervention. Intervention effect was tested via general linear mixed model for repeated measures, using baseline measures as adjusting covariates. RESULTS At baseline, the mean age of the participants was 28.5 ± 5.0 years (intervention: 28.4 ± 5.0, comparison: 28.9 ± 5.0); the mean body weight was 190.2 ± 1.4 lbs (intervention: 191.8 ± 30.0, comparison: 188.5 ± 29.1); and the mean body mass index (BMI) was 32.2 ± 4.4 (intervention: 32.2 ± 4.4, comparison: 31.7 ± 4.2). Of sample, 64.7% were obese. At 3 months after the 16-week intervention, no significant weight differences were found between the intervention (188.3 ± 10.6 lbs, BMI: 31.6 ± 1.8) and comparison groups (187.7 ± 10.6 lbs, BMI: 31.53 ± 1.8) when controlling for baseline body weight. CONCLUSIONS This lifestyle behavioral intervention that focused on stress management, healthy eating and physical activity was not effective in helping low-income overweight and obese young mothers prevent further weight gain. TRIAL REGISTRATION Clinical Trials NCT01839708 . This trial was registered retrospectively on February 28, 2013.
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The synchronized trial on expectant mothers with depressive symptoms by omega-3 PUFAs (SYNCHRO): Study protocol for a randomized controlled trial.
Nishi, D, Su, KP, Usuda, K, Chiang, YJ, Guu, TW, Hamazaki, K, Nakaya, N, Sone, T, Sano, Y, Tachibana, Y, et al
BMC psychiatry. 2016;(1):321
Abstract
BACKGROUND Maternal depression can be harmful to both mothers and their children. Omega-3 polyunsaturated fatty acid (PUFA) supplementation has been investigated as an alternative intervention for pregnant women with depressive symptoms because of the supporting evidence from clinical trials in major depression, the safety advantage, and its anti-inflammatory and neuroplasticity effects. This study examines the efficacy of omega-3 PUFA supplementation for pregnant women with depressive symptoms in Taiwan and Japan, to provide evidence available for Asia. The rationale and protocol of this trial are reported here. METHODS The Synchronized Trial on Expectant Mothers with Depressive Symptoms by Omega-3 PUFAs (SYNCHRO) is a multicenter, double-blind, parallel group, randomized controlled trial. Participants will be randomized to either the omega-3 PUFAs arm (1,200 mg eicosapentaenoic acid and 600 mg docosahexaenoic acid daily) or placebo arm. Primary outcome is total score on the Hamilton Rating Scale for Depression (HAMD) at 12 weeks after the start of the intervention. We will randomize 56 participants to have 90 % power to detect a 4.7-point difference in mean HAMD scores with omega-3 PUFAs compared with placebo. Because seafood consumption varies across countries and this may have a major effect on the efficacy of omega-3 PUFA supplementation, 56 participants will be recruited at each site in Taiwan and Japan, for a total number of 112 participants. Secondary outcomes include depressive symptoms at 1 month after childbirth, diagnosis of major depressive disorder, changes in omega-3 PUFAs concentrations and levels of biomarkers at baseline and at 12 weeks' follow-up, and standard obstetric outcomes. Data analyses will be by intention to treat. The trial was started in June 2014 and is scheduled to end in February 2018. DISCUSSION The trial is expected to provide evidence that can contribute to promoting mental health among mothers and children in Asian populations. TRIAL REGISTRATION Clinicaltrials.gov: NCT02166424 . Registered 15 June 2014; University Hospital Medical Information Network (UMIN) Center: UMIN000017979. Registered 20 May 2015.
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An Early Feeding Practices Intervention for Obesity Prevention.
Daniels, LA, Mallan, KM, Nicholson, JM, Thorpe, K, Nambiar, S, Mauch, CE, Magarey, A
Pediatrics. 2015;(1):e40-9
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OBJECTIVE Report long-term outcomes of the NOURISH randomized controlled trial (RCT), which evaluated a universal intervention commencing in infancy to provide anticipatory guidance to first-time mothers on "protective" complementary feeding practices that were hypothesized to reduce childhood obesity risk. METHODS The NOURISH RCT enrolled 698 mothers (mean age 30.1 years, SD = 5.3) with healthy term infants (51% female). Mothers were randomly allocated to usual care or to attend two 6-session, 12-week group education modules. Outcomes were assessed 5 times: baseline (infants 4.3 months); 6 months after module 1 (infants 14 months); 6 months after module 2 (infants 2 years) and at 3.5 and 5 years of age. Maternal feeding practices were self-reported using validated questionnaires. BMI Z-score was calculated from measured child height and weight. Linear mixed models evaluated intervention (group) effect across time. RESULTS Retention at age 5 years was 61%. Across ages 2 to 5 years, intervention mothers reported less frequent use of nonresponsive feeding practices on 6 of 9 scales. At 5 years, they also reported more appropriate responses to food refusal on 7 of 12 items (Ps ≤ .05). No statistically significant group effect was noted for anthropometric outcomes (BMI Z-score: P = .06) or the prevalence of overweight/obesity (control 13.3% vs intervention 11.4%, P = .66). CONCLUSIONS Anticipatory guidance on complementary feeding resulted in first-time mothers reporting increased use of protective feeding practices. These intervention effects were sustained up to 5 years of age and were paralleled by a nonsignificant trend for lower child BMI Z-scores at all postintervention assessment points.