Prevention of Overweight in Infancy (POInz)
6 de julio de 2020 actualizado por: Barry Taylor, University of Otago
Primary Prevention of Rapid Weight Gain in Early Childhood: a Randomised Controlled Trial
Obesity is one of the biggest threats to health in the 21st century. Rapid weight gain in the first year of life tends to lead to overweight in children, which in turn leads to overweight in adults. This rapid early weight gain occurs most often at weaning when eating patterns emerge. Infant sleep problems also appear to be associated with the risk of becoming overweight, and contribute to maternal post-natal depression. We propose to undertake a 4-arm randomised controlled trial to determine whether extra education and support for families around weaning and development of early food and activity habits, with or without intervention to improve infant sleep, will decrease the current risk patterns of rapid excessive early childhood weight gain in New Zealand. This would provide strong evidence for the value of such a strategy in the long term control of the obesity epidemic and its consequent complications.
This is a two-year intervention with follow-ups at 3.5, 5 and 11 years of age.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
We plan on undertaking a 4-arm randomised controlled trial to test the following hypotheses:
- That anticipatory guidance and extra education and support in infancy around weaning and decreasing/avoiding television watching will delay the timing of introduction of solid foods, will be associated with more successful introduction of nutrient dense foods with appropriate portion size and decrease small screen exposure leading to a lower number of children with excessive weight velocity in infancy and early childhood.
- That anticipatory guidance, education and extra support around the early development of infant sleeping patterns will decrease sleep problems, increase infant sleeping time, decrease arousals at night and lower sleep latency which will in turn influence rate of early infant weight gain.
- That interventions 1 and 2 will interact additively with regard to infant and early childhood weight gain.
- That intervention 2 will lead to lower rates of maternal depression and increased family well being.
Tipo de estudio
Intervencionista
Inscripción (Actual)
802
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
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South Island
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Dunedin, South Island, Nueva Zelanda, 9013
- University of Otago
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
16 años a 55 años (Niño, Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Mothers booked for delivery in Dunedin, New Zealand
Exclusion Criteria:
- Women booked after 34 weeks gestation,
- Identified congenital abnormality likely to affect feeding and/or growth
- Home address outside of metropolitan Dunedin or Invercargill,
- Families who are likely to shift out of metropolitan Dunedin or Invercargill in the next 2 years.
- Unable to communicate in English or te reo Maori.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Standard well child care
Standard Well Child Care (SWCC) - 8 Core visits at 2-4 weeks, 6 weeks, 3, 5, 8-10 and 15 months, 2 and 3 years.
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Experimental: Food Activity Breast feeding support
FAB (Food Activity Breast feeding support) 8 extra parent contacts for augmented education and support around breast feeding, food and activity
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Standard well child care plus 7 extra parent contacts for augmented education and support around breast feeding, food and activity with 1 before birth and then at 1-2 weeks, and 3, 4, 7, 9, 13, and 18 months post-partum.
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Experimental: Sleep
Prevention of sleep problems in first 6 months and then active early intervention for sleep problems from 6 months to 24 months
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Standard well child care plus 2 extra contacts focussed on Sleep with 1 before birth (anticipatory guidance), and sleep problem prevention at 3 weeks.
A sleep problem intervention starting at 6 months was possible for those indicating their child had a sleep problem at 6 months of age.
Main prevention advice focussed on placing baby to sleep awake, maximising night-day differences and use of sleep place in parents bedroom for first 6 months.
Intervention after 6 months uses preferentially a technique called "parental presence", and if this does not fit family a technique called "camping out" and finally, if neither of the first two fit family, controlled crying.
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Experimental: FAB + Sleep
combination of interventions used in arms 2 and 3
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Standard well child care plus 7 extra parent contacts for augmented education and support around breast feeding, food and activity with 1 before birth and then at 1-2 weeks, and 3, 4, 7, 9, 13, and 18 months post-partum.
Standard well child care plus 2 extra contacts focussed on Sleep with 1 before birth (anticipatory guidance), and sleep problem prevention at 3 weeks.
A sleep problem intervention starting at 6 months was possible for those indicating their child had a sleep problem at 6 months of age.
Main prevention advice focussed on placing baby to sleep awake, maximising night-day differences and use of sleep place in parents bedroom for first 6 months.
Intervention after 6 months uses preferentially a technique called "parental presence", and if this does not fit family a technique called "camping out" and finally, if neither of the first two fit family, controlled crying.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
BMI z score
Periodo de tiempo: 24 months (end of intervention)
|
BMI z score derived from ht and weight and using World Health Organisation (WHO) growth standards
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24 months (end of intervention)
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BMI z score
Periodo de tiempo: 60 months of age (followup at 5 years of age)
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BMI z score derived from ht and weight and using WHO growth standards
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60 months of age (followup at 5 years of age)
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BMI z score
Periodo de tiempo: Follow-up at 11 years of age
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BMI z score derived from height and weight and using WHO reference data
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Follow-up at 11 years of age
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Dietary intake
Periodo de tiempo: 24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up)
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Dietary information (foods, food groups, nutrients) via food frequency questionnaire
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24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up)
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Television viewing
Periodo de tiempo: 24 months (end of intervention) and 60 months (end of follow-up)
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Hours of screen use by parental questionnaire
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24 months (end of intervention) and 60 months (end of follow-up)
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Major/ Moderate sleep problems
Periodo de tiempo: 24 months (end of intervention)
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Parents indicate presence of sleep problems in child
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24 months (end of intervention)
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Physical activity (PA)
Periodo de tiempo: 24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up)
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PA measured using actical accelerometry over 5-7 days
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24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up)
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Duration of exclusive and any breast feeding
Periodo de tiempo: 24 months
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Measured by repeated questionnaire
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24 months
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Parental depression score
Periodo de tiempo: Measured at multiple timepoints between pregnancy and 24 months (end of intervention) and 60 months (end of follow-up)
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Edinburgh Postnatal Depression questionnaire
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Measured at multiple timepoints between pregnancy and 24 months (end of intervention) and 60 months (end of follow-up)
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Sleep
Periodo de tiempo: 24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up)
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Measured by questionnaire and accelerometry at multiple timepoints
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24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up)
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Number of night awakenings
Periodo de tiempo: 24 months (end of intervention) and 60 months (end of follow-up)
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Measured by questionnaire and accelerometry at multiple timepoints
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24 months (end of intervention) and 60 months (end of follow-up)
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Self-regulation
Periodo de tiempo: 42 and 60 months
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Measured by questionnaire and laboratory based measures at follow-up only
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42 and 60 months
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Body composition
Periodo de tiempo: 60 months and 11 years (further follow-up)
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Measured by dual-energy x-ray absorptiometry at follow-up only
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60 months and 11 years (further follow-up)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Barry J Taylor, FRACP, University of Otago
- Investigador principal: Rachael Taylor, PhD, University of Otago
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Taylor BJ, Gray AR, Galland BC, Heath AM, Lawrence J, Sayers RM, Cameron S, Hanna M, Dale K, Coppell KJ, Taylor RW. Targeting Sleep, Food, and Activity in Infants for Obesity Prevention: An RCT. Pediatrics. 2017 Mar;139(3):e20162037. doi: 10.1542/peds.2016-2037.
- Taylor RW, Heath AL, Galland BC, Cameron SL, Lawrence JA, Gray AR, Tannock GW, Lawley B, Healey D, Sayers RM, Hanna M, Meredith-Jones K, Hatch B, Taylor BJ. Three-year follow-up of a randomised controlled trial to reduce excessive weight gain in the first two years of life: protocol for the POI follow-up study. BMC Public Health. 2016 Aug 11;16(1):771. doi: 10.1186/s12889-016-3383-4.
- Taylor RW, Iosua E, Heath AM, Gray AR, Taylor BJ, Lawrence JA, Hanna M, Cameron SL, Sayers R, Galland B. Eating frequency in relation to BMI in very young children: a longitudinal analysis. Public Health Nutr. 2017 Jun;20(8):1372-1379. doi: 10.1017/S1368980017000143. Epub 2017 Feb 27.
- Galland BC, Sayers RM, Cameron SL, Gray AR, Heath AM, Lawrence JA, Newlands A, Taylor BJ, Taylor RW. Anticipatory guidance to prevent infant sleep problems within a randomised controlled trial: infant, maternal and partner outcomes at 6 months of age. BMJ Open. 2017 Jun 2;7(5):e014908. doi: 10.1136/bmjopen-2016-014908.
- Moir C, Meredith-Jones K, Taylor BJ, Gray A, Heath AM, Dale K, Galland B, Lawrence J, Sayers RM, Taylor RW. Early Intervention to Encourage Physical Activity in Infants and Toddlers: A Randomized Controlled Trial. Med Sci Sports Exerc. 2016 Dec;48(12):2446-2453. doi: 10.1249/MSS.0000000000001055.
- Fangupo LJ, Heath AL, Williams SM, Somerville MR, Lawrence JA, Gray AR, Taylor BJ, Mills VC, Watson EO, Galland BC, Sayers RM, Hanna MB, Taylor RW. Impact of an early-life intervention on the nutrition behaviors of 2-y-old children: a randomized controlled trial. Am J Clin Nutr. 2015 Sep;102(3):704-12. doi: 10.3945/ajcn.115.111823. Epub 2015 Jul 29.
- Cameron SL, Heath AL, Gray AR, Churcher B, Davies RS, Newlands A, Galland BC, Sayers RM, Lawrence JA, Taylor BJ, Taylor RW. Lactation Consultant Support from Late Pregnancy with an Educational Intervention at 4 Months of Age Delays the Introduction of Complementary Foods in a Randomized Controlled Trial. J Nutr. 2015 Jul;145(7):1481-90. doi: 10.3945/jn.114.202689. Epub 2015 May 20.
- Meredith-Jones K, Haszard J, Moir C, Heath AL, Lawrence J, Galland B, Taylor B, Gray A, Sayers R, Taylor R. Physical activity and inactivity trajectories associated with body composition in pre-schoolers. Int J Obes (Lond). 2018 Sep;42(9):1621-1630. doi: 10.1038/s41366-018-0058-5. Epub 2018 Mar 15.
- Taylor RW, Haszard JJ, Meredith-Jones KA, Galland BC, Heath AM, Lawrence J, Gray AR, Sayers R, Hanna M, Taylor BJ. 24-h movement behaviors from infancy to preschool: cross-sectional and longitudinal relationships with body composition and bone health. Int J Behav Nutr Phys Act. 2018 Nov 26;15(1):118. doi: 10.1186/s12966-018-0753-6.
- Taylor RW, Gray AR, Heath AM, Galland BC, Lawrence J, Sayers R, Healey D, Tannock GW, Meredith-Jones KA, Hanna M, Hatch B, Taylor BJ. Sleep, nutrition, and physical activity interventions to prevent obesity in infancy: follow-up of the Prevention of Overweight in Infancy (POI) randomized controlled trial at ages 3.5 and 5 y. Am J Clin Nutr. 2018 Aug 1;108(2):228-236. doi: 10.1093/ajcn/nqy090.
- Hatch B, Galland BC, Gray AR, Taylor RW, Sayers R, Lawrence J, Taylor B. Consistent use of bedtime parenting strategies mediates the effects of sleep education on child sleep: secondary findings from an early-life randomized controlled trial. Sleep Health. 2019 Oct;5(5):433-443. doi: 10.1016/j.sleh.2019.03.002. Epub 2019 May 20.
- Leong C, Haszard JJ, Heath AM, Tannock GW, Lawley B, Cameron SL, Szymlek-Gay EA, Gray AR, Taylor BJ, Galland BC, Lawrence JA, Otal A, Hughes A, Taylor RW. Using compositional principal component analysis to describe children's gut microbiota in relation to diet and body composition. Am J Clin Nutr. 2020 Jan 1;111(1):70-78. doi: 10.1093/ajcn/nqz270.
- Meredith-Jones K, Galland B, Haszard J, Gray A, Sayers R, Hanna M, Taylor B, Taylor R. Do young children consistently meet 24-h sleep and activity guidelines? A longitudinal analysis using actigraphy. Int J Obes (Lond). 2019 Dec;43(12):2555-2564. doi: 10.1038/s41366-019-0432-y. Epub 2019 Sep 2.
- Askie LM, Espinoza D, Martin A, Daniels LA, Mihrshahi S, Taylor R, Wen LM, Campbell K, Hesketh KD, Rissel C, Taylor B, Magarey A, Seidler AL, Hunter KE, Baur LA. Interventions commenced by early infancy to prevent childhood obesity-The EPOCH Collaboration: An individual participant data prospective meta-analysis of four randomized controlled trials. Pediatr Obes. 2020 Jun;15(6):e12618. doi: 10.1111/ijpo.12618. Epub 2020 Feb 6.
- Roy M, Haszard JJ, Savage JS, Yolton K, Beebe DW, Xu Y, Galland B, Paul IM, Mindell JA, Mihrshahi S, Wen LM, Taylor B, Richards R, Te Morenga L, Taylor RW. Bedtime, body mass index and obesity risk in preschool-aged children. Pediatr Obes. 2020 Sep;15(9):e12650. doi: 10.1111/ijpo.12650. Epub 2020 May 6.
- Taylor RW, Haszard JJ, Healey D, Meredith-Jones KA, Taylor BJ, Galland BC. Adherence to 24-h movement behavior guidelines and psychosocial functioning in young children: a longitudinal analysis. Int J Behav Nutr Phys Act. 2021 Aug 25;18(1):110. doi: 10.1186/s12966-021-01185-w.
- Fangupo LJ, Haszard JJ, Taylor BJ, Gray AR, Lawrence JA, Taylor RW. Ultra-Processed Food Intake and Associations With Demographic Factors in Young New Zealand Children. J Acad Nutr Diet. 2021 Feb;121(2):305-313. doi: 10.1016/j.jand.2020.08.088. Epub 2020 Oct 21.
- Adebowale TO, Taylor BJ, Gray AR, Galland BC, Heath AM, Fortune S, Meredith-Jones KA, Sullivan T, McIntosh D, Brosnan B, Taylor RW. Long-Term Follow-Up of a Randomized Controlled Trial to Reduce Excessive Weight Gain in Infancy: Protocol for the Prevention of Overweight in Infancy (POI) Follow-Up Study at 11 Years. JMIR Res Protoc. 2020 Nov 30;9(11):e24968. doi: 10.2196/24968.
- Haszard JJ, Russell CG, Byrne RA, Taylor RW, Campbell KJ. Early maternal feeding practices: Associations with overweight later in childhood. Appetite. 2019 Jan 1;132:91-96. doi: 10.1016/j.appet.2018.10.008. Epub 2018 Oct 9.
- Taylor BJ, Heath AL, Galland BC, Gray AR, Lawrence JA, Sayers RM, Dale K, Coppell KJ, Taylor RW. Prevention of Overweight in Infancy (POI.nz) study: a randomised controlled trial of sleep, food and activity interventions for preventing overweight from birth. BMC Public Health. 2011 Dec 19;11:942. doi: 10.1186/1471-2458-11-942.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de mayo de 2009
Finalización primaria (Actual)
1 de abril de 2016
Finalización del estudio (Actual)
1 de abril de 2017
Fechas de registro del estudio
Enviado por primera vez
3 de mayo de 2009
Primero enviado que cumplió con los criterios de control de calidad
3 de mayo de 2009
Publicado por primera vez (Estimar)
5 de mayo de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de julio de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
6 de julio de 2020
Última verificación
1 de julio de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 105891.01.P.NH
- HRC 08/374 (Otro número de subvención/financiamiento: NZ Health Research Council)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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