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The Healthy Start Project: Primary Prevention of Overweight in Preschool Children Susceptible to Future Overweight

13 de mayo de 2020 actualizado por: Berit Lilienthal Heitmann, Bispebjerg Hospital

Prevention of Weight Gain Among Normal Weight, Obesity Susceptible, Pre-school Children - a Randomized Controlled Interventions Study.

Obesity prevention should remain a priority, although there is some evidence of a possible leveling off in some age groups across European countries and in USA, Japan and Australia. Besides adult health problems such as type-2 diabetes and cardiovascular diseases, obesity in childhood is associated with psychological and social problems, low self-esteem, stigmatization and being teased and bullied by friends. Danish research suggests that the causes behind the increase in obesity occurrence are present already in early childhood, and that prevention of obesity therefore has to start early. Research has suggested that at least three sub-groups can be considered susceptible to develop obesity: Children with obesity among their 1st degree relatives; children with a high birth weight or children coming from socially disadvantaged families (low socioeconomic status). Earlier intervention programs has showed little effect in preventing excessive weight gain and knowledge on how to develop effective intervention programs that reduce overweight and obesity remains limited. It has been suggested that future prevention programs may be more successful if specifically targeting groups that are at high risk, as mention above, of excessive weight gain.

Based on these suggestions, the "Sund Start" project was initiated. The purpose of the study was to determine whether aiming prevention towards 2-6 years old Danish children who were yet normal weight, but were considered susceptible to develop overweight or obese could prevent later on risk of becoming overweight or obese. Furthermore, to investigate if it was possible to improve diet habits, increase physical activity, reduce stress and improve sleeping habits among children at high risk for later on overweight and obesity.

The "Sund Start" project will contribute with knowledge about whether targeting normal weight, predisposed children is effective in preventing overweight and obesity, and if reduced stress and improved sleep, should be considered important new obesity prevention tools. Moreover, the project will contribute with knowledge about how to change lifestyle and its effects on development of overweight and obesity in high risk Danish preschool children.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

In 2009, data on all births between 2004 and 2007 in 11 selected municipalities from the greater Copenhagen area was obtained from the Danish national birth register at the National Board of Health. This register contains information on all births, whether at hospital or home, on factors such as birth weight and length, height and pre-pregnant weight of the mother, parity, and Central Personal Registry number (CPR-number). Data on socioeconomic status was obtained from the administrative birth forms. This was done manually using the CPR-numbers obtained from the birth register.

After selection of the children eligible for participation, the children were allocated to three groups, (intervention group, control group, shadow group) using computer based randomization. All siblings were allocated to the same group. After the random allocation, children from the intervention group and the control group were sent a letter with an invitation to participate in the project. Children from the shadow group were also identified, and their general practitioners were contacted and asked for information on each child's height and weight.

Tipo de estudio

Intervencionista

Inscripción (Actual)

1202

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

  • Dinamarca
      • Frederiksberg, Dinamarca, 2000
        • Parker Institute, Research Unit for Dietary Studies

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

2 años a 6 años (Niño)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Born between 2004-2007
  • Born in 11 selected municipalities in the greater Copenhagen area
  • Classified as susceptible to overweight and obesity (At least one of the following risk factors present: A high birth weight (> 4000 grams), maternal pre-pregnancy obesity (BMI > 28 kg/m^2), or maternal low education (<= 10 years)
  • Normal weight at baseline examination

Exclusion Criteria:

  • Moved to another municipality after birth,
  • Had requested protection from participation in statistical or scientific surveys based on data delivered from the Danish Central Person Registry
  • No permanent address
  • Lived in a children's home
  • Had died
  • Had emigrated
  • Registered in the Danish Central Person Registry as being disappeared or had unknown life status
  • Not speaking Danish
  • Overweight (including obesity) at baseline examination

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
Experimental: Improved lifestyle
Conductual: Lifestyle habits, including sleep and stress
The intervention group was offered up to 10 individual consultations focusing on improving diet, physical activity and sleep habits and reducing stress. Moreover, the intervention group was offered participation in monthly cooking classes and playing arrangements
Sin intervención: Control group
The control group was seen at baseline and follow-up, but not in between.
Sin intervención: Shadow group
The shadow group was followed in registers exclusively

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Anthropometric measurements
Periodo de tiempo: 1.3 years

Changes between baseline and 1.3 years follow.up per intervention year in:

Height in cm Weight in kg BMI in kg/m^2 BMI z-score in SD Waist circumference in cm Hip circumference in cm Sum of four skinfolds (biceps, triceps, subscapular and suprailiac) in cm Body composition measured by bio-electrical impedance
1.3 years
Anthropometric measurements
Periodo de tiempo: 5 years

Changes between baseline and 5 years follow.up per intervention year in:

Height in cm Weight in kg BMI in kg/m^2 BMI z-score in SD
5 years
Anthropometric measurements
Periodo de tiempo: 10 years

Changes between baseline and 10 years follow.up per intervention year in:

Height in cm Weight in kg BMI in kg/m^2 BMI z-score in SD
10 years

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Dietary intake
Periodo de tiempo: 1.3 years
Four day dietary record completed Wednesday-Saturday
1.3 years
Priority of serving fruit and vegetables
Periodo de tiempo: 1.3 years
How high do you prioritize that fruit and vegetables are served at the meals? (Scale from 1 to 4, 1 being low and 4 being high. Higher values considered better outcome)
1.3 years
Physical activity
Periodo de tiempo: 1.3 years
Children's Physical Activity Questionnaire (C-PAQ. 7-day recording of sports, games and leisure time activities outside daycare. The response options were indicated by doing a particular activity ("yes" or "no") and by an indication of total time used on the activity during the week (minutes per week). All minutes per week were summed to obtain an indication of overall physical activity level. Higher values considered better outcome)
1.3 years
Sleep duration
Periodo de tiempo: 1.3 years
7 day sleep record from completed questionnaire (average number of minutes sleep summed from 7 day record on sleep- and wake time points)
1.3 years
Child stress level
Periodo de tiempo: 1.3 years
Measured concentration of cortisol in hair samples
1.3 years
Parental stress level
Periodo de tiempo: 1.3 year
Measured concentration of cortisol in hair samples
1.3 year
Sleep quality
Periodo de tiempo: 1.3 year
Child's sleep is considered (calm all night, a little disturbed, disturbed with occasional awakenings, very disturbed with several awakenings. Calm all night considered best outcome).
1.3 year
Child stress level
Periodo de tiempo: 1.3 year
Strengths and Difficulties Questionnaire (SDQ). Scored 0-2 and summed to Total Difficulties score (0-40, lower score indicate better outcome), and Prosocial Behavior score (0-10, lower score indicate worst outcome)
1.3 year
Parental stress level
Periodo de tiempo: 1.3 years
Modified version of the Swedish Parental Stress Index (PSI). Each question was scored between 0 and 2 (0 considered best score and 2 the worst), according to its estimated indication of an overall stress level. Analysis of intercorrelations among the 10 questions and a principal component analysis suggested that 9 of the 10 questions could be added together to get a score for the overall family stress level (0-18)
1.3 years
Daily physical activity: Enjoys being active
Periodo de tiempo: 1.3 years
If the child enjoyed being physically active (Never, often, some times, usually, always. Always considered best outcome)
1.3 years
Meal habits: Eating breakfast together
Periodo de tiempo: 1.3 years
How many times per week does the family eat breakfast together (None, 1 day, 2-3 days, 4-5 days, 6-7 days. 6-7 days considered best outcome).
1.3 years
Meal habits: Eating dinner together
Periodo de tiempo: 1.3 years
How many times per week does the family eat dinner together (None, 1 day, 2-3 days, 4-5 days, 6-7 days. 6-7 days considered best outcome).
1.3 years
Meal habits: Mealtime situation
Periodo de tiempo: 1.3 years
How would you describe the meals with the child (Very conflictive, little conflictive, very cozy, little cozy, don't know. Very cozy considered best outcome).
1.3 years
Meal habits: Pickiness
Periodo de tiempo: 1.3 years
How would you describe your child's way of eating (Picky, open to new tastes, eats everything. Eats everything considered best outcome).
1.3 years
Meal habits: Appetite
Periodo de tiempo: 1.3 years
How would you describe your child's appetite (Too big appetite, good appetite, normal appetite, too small appetite, don't know. Normal appetite considered best outcome).
1.3 years
Sleep quality: Difficulties falling asleep
Periodo de tiempo: 1.3 years
Difficulties falling asleep (yes/no. No considered best outcome)
1.3 years
Sleep quality: Difficulties waking up
Periodo de tiempo: 1.3 years
Difficulties waking up (yes/no. No considered best outcome)
1.3 years
Sleep quality: Sleep onset latency
Periodo de tiempo: 1.3 years
Sleep onset latency (numerical. Lower values considered better outcome)
1.3 years
Sleep quality: Bedtime routines
Periodo de tiempo: 1.3 years
Routine activities before bedtime (No, < 1/week, 1-2 times/week, 3-4 times/week, 5-6 times/week, every day. Every day considered best outcome)
1.3 years
Sleep quality: Joining parents' bed
Periodo de tiempo: 1.3 years
Child joining parents' bed (yes/no. If yes, how often (< 1/month, 1-3 times/month,1-3 times/week, 4-6 times/week, every night)
1.3 years
Sleep quality: Falling asleep
Periodo de tiempo: 1.3 years
Child afraid to fall asleep (Never, rarely, some times, often, very often. Never considered best outcome)
1.3 years
Sleep quality: Dreams
Periodo de tiempo: 1.3 years
Child has frightening/upsetting dreams (Never, rarely, some times, often, very often. Never considered best outcome)
1.3 years
Daily physical activity: Means of transportation
Periodo de tiempo: 1.3 years
Means of transportation to and from day-care, and frequency (Walk, strolling, bike on its own, biked by parent, and bus, train or car, number of times per week (1,2,3,4 or 5. Walking or biking on its own considered best outcome).
1.3 years
Daily physical activity: Activity compared to other children
Periodo de tiempo: 1.3 years
How active is the child compared to other children at similar age? (as active, somewhat active, very active, don't know. Very active considered best outcome)
1.3 years
Daily physical activity: Activity with parents
Periodo de tiempo: 1.3 years
Frequency of which one or both parents were physically active with the child (once per week, 2-4 times per week, 5-7 times per week, multiple times per day. Multiple times per day considered best outcome)
1.3 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Bispebjerg Hospital

Colaboradores

TrygFonden, Denmark
Sygekassernes Helsefond
The Danish Medical Research Council

Investigadores

  • Director de estudio: Berit L Heitmann, Professor, Parker Institute

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

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 agosto de 2012

Finalización del estudio (Actual)

1 de junio de 2018

Fechas de registro del estudio

Enviado por primera vez

31 de marzo de 2012

Primero enviado que cumplió con los criterios de control de calidad

20 de abril de 2012

Publicado por primera vez (Estimar)

24 de abril de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de mayo de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

13 de mayo de 2020

Última verificación

1 de mayo de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • Tryg-7984-07

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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