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A randomized controlled trial to prevent childhood obesity through early childhood feeding and parenting guidance: rationale and design of study.

ABSTRACT: Early and rapid growth in Infants is strongly associated with early development and persistence of obesity in young children. Substantial research has linked child obesity/overweight to increased risks for serious health outcomes, which include adverse physical, psychological, behavioral, or social consequences.The goal of this study is to compare the effectiveness of structured Community Health Worker (CHW)--provided home visits, using an intervention created through community-based participatory research, to standard care received through the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) office visits in preventing the development of overweight (weight/length ? 85th percentile) and obesity (weight/length ? 95th percentile) in infants during their first 3 years of life. One hundred forty pregnant women in their third trimester (30-36 weeks) will be recruited and randomly assigned to the intervention or control group.This study will provide prospective data on the effects of an intervention to prevent childhood obesity in children at high risk for obesity due to ethnicity, income, and maternal body mass index (BMI). It will have wide-ranging applicability and the potential for rapid dissemination through the WIC program, and will demonstrate the effectiveness of a community approach though employing CHWs in preventing obesity during the first 3 years of life. This easy-to-implement obesity prevention intervention can be adapted for many locales and diverse communities and can provide evidence for policy change to influence health throughout life.Clinical Trials Number: NCT01905072.

SUBMITTER: Reifsnider E

PROVIDER: S-EPMC3852597 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature

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A randomized controlled trial to prevent childhood obesity through early childhood feeding and parenting guidance: rationale and design of study.

Reifsnider Elizabeth E McCormick David P DP Cullen Karen W KW Szalacha Laura L Moramarco Michael W MW Diaz Abigail A Reyna Lucy L

BMC public health 20130924

<h4>Background</h4>Early and rapid growth in Infants is strongly associated with early development and persistence of obesity in young children. Substantial research has linked child obesity/overweight to increased risks for serious health outcomes, which include adverse physical, psychological, behavioral, or social consequences.<h4>Methods/design</h4>The goal of this study is to compare the effectiveness of structured Community Health Worker (CHW)--provided home visits, using an intervention c ...[more]

PMID: 24063435

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Project description:BackgroundChildhood overweight and obesity is a persistent public health issue in the US. Risk for obesity and obesity-related morbidity throughout the life course begins in utero. Native Americans suffer the greatest disparities in the US in childhood overweight and obesity status of any racial or ethnic group. Existing early childhood home-visiting interventions provide an opportunity for addressing obesity during the first 1000 days. However, to date, no evidence-based model has been specifically designed to comprehensively target early childhood obesity prevention.MethodsThis study is a randomized controlled trial to test the efficacy of home-visiting intervention, called Family Spirit Nurture, on reducing early childhood obesity in Native American children. Participants are expectant Native American mothers ages 14-24 and their child, enrolled from pregnancy to 24 months postpartum and randomized 1:1 to receive the Family Spirit Nurture intervention or a control condition. The intervention includes 36 lessons delivered one-on-one by locally-hired Native American Family Health Coaches to participating mothers from pregnancy until 18 months postpartum. A mixed methods assessment includes maternal self-reports, maternal and child observations, and physical and biological data collected at 11 time points from 32 weeks gestation to 2 years postpartum to measure the intervention's primary impact on maternal feeding behaviors; children's healthy diet and physical activity; children's weight status. Secondary measures include maternal psychosocial factors; household food and water security; infant sleep and temperament; and maternal and child metabolic status.DiscussionNone of the 20 current federally-endorsed home-visiting models have demonstrated impacts on preventing early childhood obesity. The original Family Spirit program, upon which Family Spirit Nurture is based, demonstrated effect on maternal and child behavioral health, not including obesity related risk factors. This trial has potential to inform the effectiveness of home-visiting intervention to reduce obesity risk for tribal communities and other vulnerable populations and expand public health solutions for the world's obesity crisis.Trial registrationClinicaltrials.gov (Identifier: NCT03334266 - Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months; Retrospectively registered on 07 November 2017).

Project description:BACKGROUND:Although surveillance data are limited in the US Affiliated Pacific, Alaska, and Hawaii, existing data suggest that the prevalence of childhood obesity is similar to or in excess of other minority groups in the contiguous US. Strategies for addressing the childhood obesity epidemic in the region support the use of community-based, environmentally targeted interventions. The Children's Healthy Living Program is a partnership formed across institutions in the US Affiliated Pacific, Alaska, and Hawaii to design a community randomized environmental intervention trial and a prevalence survey to address childhood obesity in the region through affecting the food and physical activity environment. METHODS/DESIGN:The Children's Healthy Living Program community randomized trial is an environmental intervention trial in four matched-pair communities in American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, and Hawaii and two matched-pair communities in Alaska. A cross-sectional sample of children (goal n = 180) in each of the intervention trial communities is being assessed for outcomes at baseline and at 24 months (18 months post-intervention). In addition to the collection of the participant-based measures of anthropometry, diet, physical activity, sleep and acanthosis nigricans, community assessments are also being conducted in intervention trial communities. The Freely Associated States of Micronesia (Federated States of Micronesia, and Republics of Marshall Islands and Palau) is only conducting elements of the Children's Healthy Living Program sampling framework and similar measurements to provide prevalence data. In addition, anthropometry information will be collected for two additional communities in each of the 5 intervention jurisdictions to be included in the prevalence survey. The effectiveness of the environmental intervention trial is being assessed based on the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework. DISCUSSION:The Children's Healthy Living Program environmental trial is designed to focus on capacity building and to maximize the likelihood of sustainable impact on childhood obesity-related behaviors and outcomes. The multiple measures at the individual, community, and environment levels are designed to maximize the likelihood of detecting change. This approach enhances the likelihood for identifying and promoting the best methods to promote health and well-being of the children in the underserved US Affiliated Pacific Region. TRIAL REGISTRATION:NIH clinical trial # NCT01881373.

Project description:BackgroundThe family environment plays an important role in the development of children's energy balance-related behaviors. As a result, parents' energy balance-related parenting practices are important targets of preventive childhood obesity programs. Families with a lower socioeconomic position (SEP) may benefit from participating in such programs but are generally less well reached than families with a higher SEP.ObjectiveThis paper describes the application of the Intervention Mapping Protocol (IMP) for the development of an app-based preventive intervention program to promote healthy energy balance-related parenting practices among parents of children (aged 0-4 years) with a lower SEP.MethodsThe 6 steps of the IMP were used as a theory- and evidence-based framework to guide the development of an app-based preventive intervention program.ResultsIn step 1, behavioral outcomes for the app-based program (ie, children have a healthy dietary intake, sufficient sleep, and restricted screen time and sufficient physical activity) and sociocognitive (ie, knowledge, attitudes, and self-efficacy) and automatic (ie, habitual behaviors) determinants of energy balance-related parenting were identified through a needs assessment. In step 2, the behavioral outcomes were translated into performance objectives. To influence these objectives, in step 3, theory-based intervention methods were selected for each of the determinants. In step 4, the knowledge derived from the previous steps allowed for the development of the app-based program Samen Happie! through a process of continuous cocreation with parents and health professionals. In step 5, community health services were identified as potential adopters for the app. Finally, in step 6, 2 randomized controlled trials were designed to evaluate the process and effects of the app among Dutch parents of infants (trial 1) and preschoolers (trial 2). These trials were completed in November 2019 (trial 1) and February 2020 (trial 2).ConclusionsThe IMP allowed for the effective development of the app-based parenting program Samen Happie! to promote healthy energy balance-related parenting practices among parents of infants and preschoolers. Through the integration of theory, empirical evidence, and data from the target population, as well as the process of continued cocreation, the program specifically addresses parents with a lower SEP. This increases the potential of the program to prevent the development of obesity in early childhood among families with a lower SEP.Trial registrationNetherlands Trial Register NL6727, https://www.trialregister.nl/trial/6727; Netherlands Trial Register NL7371, https://www.trialregister.nl/trial/7371.

Project description:IntroductionInterventions that make extensive use of theory tend to have larger effects on behaviour. The Intervention Mapping (IM) framework incorporates theory into intervention design, implementation and evaluation, and was applied to the development of a community-based childhood obesity prevention intervention for a multi-ethnic population.MethodsIM was applied as follows: 1) Needs assessment of the community and culture; consideration of evidence-base, policy and practice; 2) Identification of desired outcomes and change objectives following identification of barriers to behaviour change mapped alongside psychological determinants (e.g. knowledge, self-efficacy, intention); 3) Selection of theory-based methods and practical applications to address barriers to behaviour change (e.g., strategies for responsive feeding); 4) Design of the intervention by developing evidence-based interactive activities and resources (e.g., visual aids to show babies stomach size). The activities were integrated into an existing parenting programme; 5) Adoption and implementation: parenting practitioners were trained by healthcare professionals to deliver the programme within Children Centres.ResultsHAPPY (Healthy and Active Parenting Programme for Early Years) is aimed at overweight and obese pregnant women (BMI?>?25); consists of 12 × 2.5 hr. sessions (6 ante-natal from 24 weeks; 6 postnatal up to 9 months); it addresses mother's diet and physical activity, breast or bottle feeding, infant diet and parental feeding practices, and infant physical activity.ConclusionWe have demonstrated that IM is a feasible and helpful method for providing an evidence based and theoretical structure to a complex health behaviour change intervention. The next stage will be to assess the impact of the intervention on behaviour change and clinical factors associated with childhood obesity. The HAPPY programme is currently being tested as part of a randomised controlled feasibility trial.

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A randomized controlled trial to prevent childhood obesity through early childhood feeding and parenting guidance: rationale and design of study.

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A randomized controlled trial to prevent childhood obesity through early childhood feeding and parenting guidance: rationale and design of study.

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