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

13 mai 2020 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

1202

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

2 ans à 6 ans (Enfant)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Improved lifestyle
Comportemental: 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
Aucune intervention: Control group
The control group was seen at baseline and follow-up, but not in between.
Aucune intervention: Shadow group
The shadow group was followed in registers exclusively

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Anthropometric measurements
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Dietary intake
Délai: 1.3 years
Four day dietary record completed Wednesday-Saturday
1.3 years
Priority of serving fruit and vegetables
Délai: 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
Délai: 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
Délai: 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
Délai: 1.3 years
Measured concentration of cortisol in hair samples
1.3 years
Parental stress level
Délai: 1.3 year
Measured concentration of cortisol in hair samples
1.3 year
Sleep quality
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 1.3 years
Difficulties falling asleep (yes/no. No considered best outcome)
1.3 years
Sleep quality: Difficulties waking up
Délai: 1.3 years
Difficulties waking up (yes/no. No considered best outcome)
1.3 years
Sleep quality: Sleep onset latency
Délai: 1.3 years
Sleep onset latency (numerical. Lower values considered better outcome)
1.3 years
Sleep quality: Bedtime routines
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Bispebjerg Hospital

Collaborateurs

TrygFonden, Denmark
Sygekassernes Helsefond
The Danish Medical Research Council

Les enquêteurs

  • Directeur d'études: Berit L Heitmann, Professor, Parker Institute

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mai 2009

Achèvement primaire (Réel)

1 août 2012

Achèvement de l'étude (Réel)

1 juin 2018

Dates d'inscription aux études

Première soumission

31 mars 2012

Première soumission répondant aux critères de contrôle qualité

20 avril 2012

Première publication (Estimation)

24 avril 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 mai 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 mai 2020

Dernière vérification

1 mai 2020

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Tryg-7984-07

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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