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A Randomized Trial of Weight Change in a National Home Visiting Program.

ABSTRACT: INTRODUCTION:Clinical trials have demonstrated significant impact in reducing weight and incidence of type 2 diabetes mellitus. However, the intensity of these trials limits their scalability to real world settings. The purpose of this study was to embed a lifestyle intervention for overweight and obese mothers within the routine practice of a parent education, home visiting organization. DESIGN:Pragmatic trial that used a stratified random design. SETTING/PARTICIPANTS:Overweight or obese mothers of preschool children located across St. Louis, Missouri, enrolled in Parents As Teachers, a home visiting organization reaching women and children nationwide. INTERVENTION:A lifestyle intervention derived from the Diabetes Prevention Program was embedded within Parents As Teachers entitled Healthy Eating and Active Living Taught at Home (HEALTH). MAIN OUTCOME MEASURES:Outcomes included the proportion of women that achieved 5% weight loss at 24 months and improvements in clinical and behavioral outcomes at 12 and 24 months. Participants were enrolled from 2012 to 2014 and data analysis began in 2016. RESULTS:Women in the usual care versus intervention group were significantly less likely to achieve 5% weight loss at 24 months (11% vs 26%, p=0.01). At 12 months, there was a 2.8-kg difference in weight between groups (p=0.0006), and by 24 months a 4.7-kg difference in weight (3.2 [SD=7.6] kg vs -1.5 [SD=8.3] kg, p=0.002); group differences in waist circumference were also evident by 12 months (2.1 [SD=8.4] cm vs -0.7 [SD=9.8] cm, p=0.04) and 24 months (3.8 [SD=10.6] cm vs -2.5 [SD=9.1] cm, p=0.005), as were improvements in behavioral outcomes. There was no difference in blood pressure between groups. CONCLUSIONS:HEALTH achieved modest but clinically significant weight loss outcomes, and reduced weight gain in mothers of young children. The scalability of this embedded intervention offers the potential to reach mothers in Parents As Teachers programs nationally. TRIAL REGISTRATION:This study is registered at www.clinicaltrials.gov NCT01567033.

SUBMITTER: Haire-Joshu D

PROVIDER: S-EPMC5826618 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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A Randomized Trial of Weight Change in a National Home Visiting Program.

Haire-Joshu Debra D Schwarz Cynthia D CD Steger-May Karen K Lapka Christy C Schechtman Kenneth K Brownson Ross C RC Tabak Rachel G RG

American journal of preventive medicine 20180301 3

<h4>Introduction</h4>Clinical trials have demonstrated significant impact in reducing weight and incidence of type 2 diabetes mellitus. However, the intensity of these trials limits their scalability to real world settings. The purpose of this study was to embed a lifestyle intervention for overweight and obese mothers within the routine practice of a parent education, home visiting organization.<h4>Design</h4>Pragmatic trial that used a stratified random design.<h4>Setting/participants</h4>Over ...[more]

PMID: 29455756

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Project description:To test the efficacy of a nurse home visiting program (HVP) on child development, maternal and environmental outcomes in the first years of life. We conducted a randomized controlled trial to test the efficacy of Primeiros Laços, a nurse HVP for adolescent mothers living in a poor urban area of São Paulo, Brazil. Eighty adolescent mothers were included and randomized to receive either Primeiros Laços (intervention group, n = 40) or healthcare as usual (control group, n = 40). Primeiros Laços is a home visiting intervention delivered by trained nurses that starts during the first 16 weeks of pregnancy and continues to the child's age of 24 months. Participants were assessed by blind interviewers at 8-16 weeks of pregnancy (baseline), 30 weeks of pregnancy, and 3, 6, 12, and 24 months of child's age. We assessed oscillatory power in the mid-range alpha frequency via electroencephalography when the children were aged 6 months. Child development was measured by the Bayley Scales of Infant Development Third Edition (BSID-III). Weight and length were measured by trained professionals and anthropometric indexes were calculated. The home environment and maternal interaction with the child was measured by the Home Observation and Measurement of the Environment. Generalized estimating equation models were used to examine intervention effects on the trajectories of outcomes. Standardized effect sizes (Cohen's d) were calculated using marginal means from endpoint assessments of all outcomes. The trial was registered at clinicaltrial.gov: NCT02807818. Our analyses showed significant positive effects of the intervention on child expressive language development (coefficient = 0.89, 95% CI [0.18, 1.61], p = 0.014), maternal emotional/verbal responsivity (coefficient = 0.97, 95% CI [0.37, 1.58], p = 0.002), and opportunities for variety in daily stimulation (coefficient = 0.37, 95% CI [0.09, 0.66], p = 0.009). Standardized effect sizes of the intervention were small to moderate. Primeiros Laços is a promising intervention to promote child development and to improve the home environment of low-income adolescent mothers. However, considering the limitations of our study, future studies should be conducted to assess Primeiros Laços potential to benefit this population.Clinical Trial Registration: The study was registered at clinicaltrial.gov (Registration date: 21/06/2016 and Registration number: NCT02807818).

Project description:BackgroundAdolescence represents a critical period for the development of overweight that tracks into adulthood. This risk is significantly heightened for adolescents that become pregnant, many of whom experience postpartum weight retention. The aim of this study was to evaluate Balance Adolescent Lifestyle Activities and Nutrition Choices for Energy (BALANCE), a multicomponent obesity prevention intervention targeting postpartum adolescents participating in a national home visiting child development-parent education program.MethodsA group randomized, nested cohort design was used with 1325 adolescents, 694 intervention and 490 control, (mean age = 17.8 years, 52 % underrepresented minorities) located across 30 states. Participatory methods were used to integrate lifestyle behavior change strategies within standard parent education practice. Content targeted replacement of high-risk obesogenic patterns (e.g. sweetened drink and high fat snack consumption, sedentary activity) with positive behaviors (e.g. water intake, fruit and vegetables, increased walking). Parent educators delivered BALANCE through home visits, school based classroom-group meetings, and website activities. Control adolescents received standard child development information. Phase I included baseline to posttest (12 months); Phase II included baseline to follow-up (24 months).ResultsWhen compared to the control group, BALANCE adolescents who were ≥12 weeks postpartum were 89 % more likely (p = 0.02) to maintain a normal BMI or improve an overweight/obese BMI by 12 months; this change was not sustained at 24 months. When compared to the control group, BALANCE adolescents significantly improved fruit and vegetable intake (p = .03). In stratified analyses, water intake improved among younger BALANCE teens (p = .001) and overweight/obese BALANCE teens (p = .05) when compared to control counterparts. There were no significant differences between groups in sweetened drink and snack consumption or walking.ConclusionPrevention of postpartum weight retention yields immediate health benefits for the adolescent mother and may prevent the early development or progression of maternal obesity, which contributes to the intergenerational transmission of obesity to her offspring. Implementing BALANCE through a national home visiting organization may hold promise for promoting positive lifestyle behaviors associated with interruption of the progression of maternal obesity.Trial registrationClinical Trials Registry NCT01617486 .

Project description:Background: Early childhood is a key period for reducing the social inequalities that affect health. Some parenting support and home visitation programs have proven to be effective in assisting parents during this period. France's Protection Maternelle et Infantile (maternal and child welfare) services (PMIs) are at the heart of this primary prevention and may adapt their intervention to improve parenting support. In this manuscript, we describe the protocol of the PERL study, an intervention based on a home visiting program. Method and design: The PERL study is a single-center, randomized, controlled interventional trial. The aim was to assess the impact of a preventive home visiting program on the development of young children and parent-baby interaction. Visits were made by PMI nurses to 64 randomly recruited families from the general population. All families who had a baby born after 37 weeks of pregnancy between September 2018 and December 2019, and who resided in the trial area were eligible. Participants were randomly allocated to the intervention group or the control group. The PMI nurses made 12 home visits in the first year, 6 in the second year, and 4 in the third and fourth years of the child's life. Primary and secondary outcomes were measured when the child was 4 and 24 months old. These measurements recorded (i) the child's developmental milestones, in particular, language and socio emotional skills, (ii) early interaction, maternal sensitivity, and attachment patterns, (iii) maternal psychopathology including depression. Discussion: This study aims to assess the impact of home visits, made by specifically-trained and supervised nurses, on the child's development and parent-child interactions. Such interventions are complementary to other preventive programs addressing the impact of social inequalities on perinatal health. Placing nurses' professional skills at the center of this project may prove an effective and cost-saving intervention compared to existing programs. The study proposes a prevention model that is in keeping with the principle of reducing social inequalities in health by providing support from the earliest age through public service. Clinical Trial Registration: The clinical trial number is NCT03506971, registered on April 24, 2018.

Project description:ContextPostnatal maternal depression (PND) is a significant risk factor for infant mental health. Although often targeted alongside other factors in perinatal home-visiting programs with vulnerable families, little impact on PND has been observed.ObjectiveThis study evaluates the impact on PND symptomatology of a multifocal perinatal home-visiting intervention using psychologists in a sample of women presenting risk factors associated with infant mental health difficulties.Methods440 primiparous women were recruited at their seventh month of pregnancy. All were future first-time mothers, under 26, with at least one of three additional psychosocial risk factors: low educational level, low income, or planning to raise the child without the father. The intervention consisted of intensive multifocal home visits through to the child's second birthday. The control group received care as usual. PND symptomatology was assessed at baseline and three months after birth using the Edinburgh Postnatal Depression Scale (EPDS).ResultsAt three months postpartum, mean (SD) EPDS scores were 9.4 (5.4) for the control group and 8.6 (5.4) for the intervention group (p = 0.18). The difference between the mean EPDS scores was 0.85 (95% CI: 0.35; 1.34). The intervention group had significantly lower EPDS scores than controls in certain subgroups: women with few depressive symptoms at inclusion (EPDS <8): difference = 1.66 (95%CI: 0.17; 3.15), p = 0.05, adjusted for baseline EPDS score), women who were planning to raise the child with the child's father: difference = 1.45 (95%CI: 0.27; 2.62), p = 0.04 (adjusted); women with a higher educational level: difference = 1.59 (95%CI: 0.50; 2.68) p = 0.05 (adjusted).ConclusionCAPEDP failed to demonstrate an overall impact on PND. However, post-hoc analysis reveals the intervention was effective in terms of primary prevention and in subgroups of women without certain risk factors. Effective overall reduction of PND symptomatology for young, first-time mothers presenting additional psychosocial risk factors may require more tailored interventions.Trial registrationClinicalTrials.gov NCT00392847 Promoting Parental Skills and Enhancing Attachment in Early Childhood (CAPEDP).

Project description:IntroductionFamilies living in extreme poverty require interventions to support early-childhood development (ECD) due to broad risks. This longitudinal cluster randomised trial examines the effectiveness of Sugira Muryango (SM), a home-visiting intervention linked to Rwanda's social protection system to promote ECD and reduce violence compared with usual care (UC).MethodsFamilies with children aged 6-36 months were recruited in 284 geographical clusters across three districts. Cluster-level randomisation (allocated 1:1 SM:UC) was used to prevent diffusion. SM was hypothesised to improve child development, reduce violence and increase father engagement. Developmental outcomes were assessed using the Ages and Stages Questionnaire (ASQ-3) and the Malawi Development Assessment Tool (MDAT) and anthropometric assessments of growth. Violence was assessed using questions from UNICEF Multiple Indicators Cluster Survey (MICS) and Rwanda Demographic and Health Surveys (DHS). Father engagement was assessed using the Home Observation for Measurement of the Environment. Blinded enumerators conducted interviews and developmental assessments.ResultsA total of 541 SM families and 508 UC families were enrolled and included in the analyses. Study attrition (2.0% children; 9.6% caregivers) was addressed by hot deck imputation. Children in SM families improved more on gross motor (d=0.162, 95%?CI 0.065 to 0.260), communication (d=0.081, 95%?CI 0.005 to 0.156), problem solving (d=0.101, 95%?CI 0.002 to 0.179) and personal-social development (d=0.096, 95%?CI -0.015 to 0.177) on the ASQ-3. SM families showed increased father engagement (OR=1.592, 95%?CI 1.069 to 2.368), decreased harsh discipline (incidence rate ratio, IRR=0.741, 95%?CI 0.657 to 0.835) and intimate partner violence (IRR=0.616, 95%?CI:0.458 to 0.828). There were no intervention-related improvements on MDAT or child growth.ConclusionSocial protection programmes provide a means to deliver ECD intervention.Trial registration numberNCT02510313.

Project description:ImportanceImproving birth outcomes for low-income mothers is a public health priority. Intensive nurse home visiting has been proposed as an intervention to improve these outcomes.ObjectiveTo determine the effect of an intensive nurse home visiting program on a composite outcome of preterm birth, low birth weight, small for gestational age, or perinatal mortality.Design, setting, and participantsThis was a randomized clinical trial that included 5670 Medicaid-eligible, nulliparous pregnant individuals at less than 28 weeks' gestation, enrolled between April 1, 2016, and March 17, 2020, with follow-up through February 2021.InterventionsParticipants were randomized 2:1 to Nurse Family Partnership program (n = 3806) or control (n = 1864). The program is an established model of nurse home visiting; regular visits begin prenatally and continue through 2 postnatal years. Nurses provide education, assessments, and goal-setting related to prenatal health, child health and development, and maternal life course. The control group received usual care services and a list of community resources. Neither staff nor participants were blinded to intervention group.Main outcomes and measuresThere were 3 primary outcomes. This article reports on a composite of adverse birth outcomes: preterm birth, low birth weight, small for gestational age, or perinatal mortality based on vital records, Medicaid claims, and hospital discharge records through February 2021. The other primary outcomes of interbirth intervals of less than 21 months and major injury or concern for abuse or neglect in the child's first 24 months have not yet completed measurement. There were 54 secondary outcomes; those related to maternal and newborn health that have completed measurement included all elements of the composite plus birth weight, gestational length, large for gestational age, extremely preterm, very low birth weight, overnight neonatal intensive care unit admission, severe maternal morbidity, and cesarean delivery.ResultsAmong 5670 participants enrolled, 4966 (3319 intervention; 1647 control) were analyzed for the primary maternal and neonatal health outcome (median age, 21 years [1.2% non-Hispanic Asian, Indigenous, or Native Hawaiian and Pacific Islander; 5.7% Hispanic; 55.2% non-Hispanic Black; 34.8% non-Hispanic White; and 3.0% more than 1 race reported [non-Hispanic]). The incidence of the composite adverse birth outcome was 26.9% in the intervention group and 26.1% in the control group (adjusted between-group difference, 0.5% [95% CI, -2.1% to 3.1%]). Outcomes for the intervention group were not significantly better for any of the maternal and newborn health primary or secondary outcomes in the overall sample or in either of the prespecified subgroups.Conclusions and relevanceIn this South Carolina-based trial of Medicaid-eligible pregnant individuals, assignment to participate in an intensive nurse home visiting program did not significantly reduce the incidence of a composite of adverse birth outcomes. Evaluation of the overall effectiveness of this program is incomplete, pending assessment of early childhood and birth spacing outcomes.Trial registrationClinicalTrials.gov Identifier: NCT03360539.

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A Randomized Trial of Weight Change in a National Home Visiting Program.

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A Randomized Trial of Weight Change in a National Home Visiting Program.

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