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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01583335
Recruitment Status : Active, not recruiting
First Posted : April 24, 2012
Last Update Posted : January 28, 2015
TrygFonden, Denmark
The Danish Medical Research Council
Sygekassernes Helsefond
Information provided by (Responsible Party):
Berit Lilienthal Heitmann, Bispebjerg Hospital

Brief Summary:

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

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toddler Health

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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

  2. Anthropometric measurements [ Time Frame: 5 years ]
    Changes from baseline in height and weight at 5 years

  3. 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

Secondary Outcome Measures :
  1. Dietary intake [ Time Frame: 1½ year ]
  2. Meal habits [ Time Frame: 1½ year ]
  3. Physical activity [ Time Frame: 1½ years ]
  4. Family structure [ Time Frame: 1½ years ]
    Parental marital status, number of siblings, number of siblings living with the child

  5. Sleep patterns [ Time Frame: 1½ years ]
    Sleep duration Sleep quality

  6. Child stress level [ Time Frame: 1½ years ]
    Measured from inventory and hair cortisol

  7. Parental stress level [ Time Frame: 1½ year ]
    Measured from inventory and hair cortisol

  8. Parental socio-economic factors [ Time Frame: 1½ year ]
    Parental educational level, parental occupation, household income, parental ethnicity

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01583335

Institute of Preventive Medicine
Copenhagen, Denmark, 1357
Sponsors and Collaborators
Bispebjerg Hospital
TrygFonden, Denmark
The Danish Medical Research Council
Sygekassernes Helsefond
Study Director: Berit L Heitmann, Professor Institute of Preventive Medicine

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Berit Lilienthal Heitmann, Professor, Ph.D., Bispebjerg Hospital Identifier: NCT01583335     History of Changes
Other Study ID Numbers: Tryg-7984-07
First Posted: April 24, 2012    Key Record Dates
Last Update Posted: January 28, 2015
Last Verified: January 2015

Keywords provided by Berit Lilienthal Heitmann, Bispebjerg Hospital:
Physical activity
Family stress

Additional relevant MeSH terms:
Disease Susceptibility
Body Weight
Signs and Symptoms
Disease Attributes
Pathologic Processes