This trial is active, not recruiting.

Conditions overweight, obesity, predisposition
Treatment lifestyle habits, including sleep and stress
Sponsor Bispebjerg Hospital
Collaborator TrygFonden, Denmark
Start date May 2009
End date August 2012
Trial size 1100 participants
Trial identifier NCT01583335, Tryg-7984-07


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
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)
The control group was seen at baseline and follow-up, but not in between.
(No Intervention)
The shadow group was followed in registers exclusively

Primary Outcomes

Anthropometric measurements
time frame: 1½ year
Anthropometric measurements
time frame: 5 years
Anthropometric measurements
time frame: 10 years

Secondary Outcomes

Dietary intake
time frame: 1½ year
Meal habits
time frame: 1½ year
Physical activity
time frame: 1½ years
Family structure
time frame: 1½ years
Sleep patterns
time frame: 1½ years
Child stress level
time frame: 1½ years
Parental stress level
time frame: 1½ year
Parental socio-economic factors
time frame: 1½ year

Eligibility Criteria

Male or female participants from 2 years up to 6 years old.

Inclusion Criteria: - To participate in the intervention study children should be born between 2004-2007, normal weight and at high risk for overweight and obesity later in life. A child was classified as being at high risk if at least one or more of the following risk factors was present - a high birth weight (> 4000 grams), pre-pregnancy obesity of the mother (Body Mass Index (BMI) > 28 kg/m2) or maternal low social class (less than 10 years of education). Only children from the greater Copenhagen area was included. Exclusion Criteria: - Children were excluded prior to randomization if they had moved to another municipality after they were born, if they were protected from being contacted by researchers, if they did not have a permanent address, lived in a children's home, had died, had emigrated or temporally living abroad or had disappeared.

Additional Information

Official title Prevention of Weight Gain Among Normal Weight, High Risk, Pre-school Children - a Randomized Controlled Interventions Study.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Bispebjerg Hospital.