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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
TrygFonden, Denmark
The Danish Medical Research Council
Sygekassernes Helsefond
Information provided by (Responsible Party):
Berit Lilienthal Heitmann, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01583335
First received: March 31, 2012
Last updated: April 20, 2012
Last verified: April 2012
  Purpose

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 Intervention
Overweight
Obesity
Predisposition
Behavioral: Lifestyle habits, including sleep and stress

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Prevention of Weight Gain Among Normal Weight, High Risk, Pre-school Children - a Randomized Controlled Interventions Study.

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Anthropometric measurements [ Time Frame: 1½ year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Changes from baseline in height and weight at 5 years

  • Anthropometric measurements [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Changes from baseline in height, weight, waist circumference, hip circumference, skinfolds, body composition measured by bio-electrical impedance at 10 years


Secondary Outcome Measures:
  • Dietary intake [ Time Frame: 1½ year ] [ Designated as safety issue: No ]
  • Meal habits [ Time Frame: 1½ year ] [ Designated as safety issue: No ]
  • Physical activity [ Time Frame: 1½ years ] [ Designated as safety issue: No ]
  • Family structure [ Time Frame: 1½ years ] [ Designated as safety issue: No ]
    Parental marital status, number of siblings, number of siblings living with the child

  • Sleep patterns [ Time Frame: 1½ years ] [ Designated as safety issue: No ]
    Sleep duration Sleep quality

  • Child stress level [ Time Frame: 1½ years ] [ Designated as safety issue: No ]
    Measured from inventory and hair cortisol

  • Parental stress level [ Time Frame: 1½ year ] [ Designated as safety issue: No ]
    Measured from inventory and hair cortisol

  • Parental socio-economic factors [ Time Frame: 1½ year ] [ Designated as safety issue: No ]
    Parental educational level, parental occupation, household income, parental ethnicity


Estimated Enrollment: 1100
Study Start Date: May 2009
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583335

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

Additional Information:
No publications provided by Bispebjerg Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Berit Lilienthal Heitmann, Professor, Ph.D., Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01583335     History of Changes
Other Study ID Numbers: Tryg-7984-07
Study First Received: March 31, 2012
Last Updated: April 20, 2012
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Bispebjerg Hospital:
Overweight
Obesity
Predisposition
Prevention
Diet
Physical activity
Sleep
Family stress

Additional relevant MeSH terms:
Disease Susceptibility
Obesity
Overweight
Body Weight
Disease Attributes
Nutrition Disorders
Overnutrition
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014