The Healthy Start Project: Primary Prevention of Overweight in Preschool Children Predisposed to Future Overweight
|ClinicalTrials.gov Identifier: NCT01583335|
Recruitment Status : Active, not recruiting
First Posted : April 24, 2012
Last Update Posted : January 28, 2015
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 at high risk of becoming obese: 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 predisposed to becoming 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.
|Condition or disease||Intervention/treatment||Phase|
|Overweight Obesity Predisposition||Behavioral: Lifestyle habits, including sleep and stress||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prevention of Weight Gain Among Normal Weight, High Risk, Pre-school Children - a Randomized Controlled Interventions Study.|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||August 2012|
|Estimated Study Completion Date :||December 2020|
|Experimental: Improved lifestyle||
Behavioral: 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
No Intervention: Control group
The control group was seen at baseline and follow-up, but not in between.
No Intervention: Shadow group
The shadow group was followed in registers exclusively
- Anthropometric measurements [ Time Frame: 1½ year ]Changes from baseline in height, weight, waist circumference, hip circumference, skinfolds, body composition measured by bio-electrical impedance at 1½ year
- Anthropometric measurements [ Time Frame: 5 years ]Changes from baseline in height and weight at 5 years
- Anthropometric measurements [ Time Frame: 10 years ]Changes from baseline in height, weight, waist circumference, hip circumference, skinfolds, body composition measured by bio-electrical impedance at 10 years
- Dietary intake [ Time Frame: 1½ year ]
- Meal habits [ Time Frame: 1½ year ]
- Physical activity [ Time Frame: 1½ years ]
- Family structure [ Time Frame: 1½ years ]Parental marital status, number of siblings, number of siblings living with the child
- Sleep patterns [ Time Frame: 1½ years ]Sleep duration Sleep quality
- Child stress level [ Time Frame: 1½ years ]Measured from inventory and hair cortisol
- Parental stress level [ Time Frame: 1½ year ]Measured from inventory and hair cortisol
- Parental socio-economic factors [ Time Frame: 1½ year ]Parental educational level, parental occupation, household income, parental ethnicity
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01583335
|Institute of Preventive Medicine|
|Copenhagen, Denmark, 1357|
|Study Director:||Berit L Heitmann, Professor||Institute of Preventive Medicine|