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

NCT01583335 | Completed

• 1 other identifier: Tryg-7984-07
• Study Type: interventional
• Target: 1,202
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Overweight; Obesity

Keywords

Overweight; Obesity; Susceptibility; Prevention; Diet; Physical activity; Sleep; Family stress

Outcome Measures

Primary Outcomes (3)

• Anthropometric measurements

  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

  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

  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

Secondary Outcomes (25)

• Dietary intake

  1.3 years

• Priority of serving fruit and vegetables

  1.3 years

• Physical activity

  1.3 years

• Sleep duration

  1.3 years

• Child stress level

  1.3 years

Study Arms (3)

Improved lifestyle

EXPERIMENTAL

Behavioral: Lifestyle habits, including sleep and stress

Control group

NO INTERVENTION

The control group was seen at baseline and follow-up, but not in between.

Shadow group

NO INTERVENTION

The shadow group was followed in registers exclusively

Interventions

Lifestyle habits, including sleep and stress BEHAVIORAL

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

Improved lifestyle

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• TrygFonden, Denmark: collaborator
• The Danish Medical Research Council: collaborator
• Sygekassernes Helsefond: collaborator

Study Sites (1)

Parker Institute, Research Unit for Dietary Studies

Frederiksberg, 2000, Denmark

Location

Related Publications (5)

• Rohde JF, Larsen SC, Handel MN, Olsen NJ, Stougaard M, Heitmann BL. Associations between Parental Stress and Subsequent Changes in Dietary Intake and Quality among Preschool Children Susceptible to Obesity. Int J Environ Res Public Health. 2021 Mar 30;18(7):3590. doi: 10.3390/ijerph18073590.

  PMID: 33808371 DERIVED

• Zheng M, Rangan A, Olsen NJ, Heitmann BL. Longitudinal association of nighttime sleep duration with emotional and behavioral problems in early childhood: results from the Danish Healthy Start Study. Sleep. 2021 Jan 21;44(1):zsaa138. doi: 10.1093/sleep/zsaa138.

  PMID: 32691048 DERIVED

• Olsen NJ, Rohde JF, Handel MN, Stougaard M, Mortensen EL, Heitmann BL. Joining Parents' Bed at Night and Overweight among 2- to 6-Year-Old Children - Results from the 'Healthy Start' Randomized Intervention. Obes Facts. 2018;11(5):372-380. doi: 10.1159/000492003. Epub 2018 Oct 12.

  PMID: 30308484 DERIVED

• Handel MN, Larsen SC, Rohde JF, Stougaard M, Olsen NJ, Heitmann BL. Effects of the Healthy Start randomized intervention trial on physical activity among normal weight preschool children predisposed to overweight and obesity. PLoS One. 2017 Oct 9;12(10):e0185266. doi: 10.1371/journal.pone.0185266. eCollection 2017.

  PMID: 28991907 DERIVED

• Olsen NJ, Buch-Andersen T, Handel MN, Ostergaard LM, Pedersen J, Seeger C, Stougaard M, Traerup M, Livemore K, Mortensen EL, Holst C, Heitmann BL. The Healthy Start project: a randomized, controlled intervention to prevent overweight among normal weight, preschool children at high risk of future overweight. BMC Public Health. 2012 Aug 1;12:590. doi: 10.1186/1471-2458-12-590.

  PMID: 22852799 DERIVED

Related Links

• Click here for latest information about the "Sund Start" study.

MeSH Terms

Conditions

Overweight; Obesity; Disease Susceptibility; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Behavior

Study Officials

• Berit L Heitmann, Professor

  Parker Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Ph.D.

Study Record Dates

• First Submitted: March 31, 2012
• First Posted: April 24, 2012
• Study Start: May 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: June 1, 2018
• Last Updated: May 15, 2020

Record last verified: 2020-05

Locations

DK (1)