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

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ClinicalTrials.gov Identifier: NCT01583335
Recruitment Status : Completed
First Posted : April 24, 2012
Last Update Posted : April 5, 2019
Sponsor:
Collaborators:
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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1202 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
Actual Study Completion Date : June 2018

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: 1.3 years ]

    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


  2. Anthropometric measurements [ Time Frame: 5 years ]

    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


  3. Anthropometric measurements [ Time Frame: 10 years ]

    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



Secondary Outcome Measures :
  1. Dietary intake [ Time Frame: 1.3 years ]
    Four day dietary record completed Wednesday-Saturday

  2. Priority of serving fruit and vegetables [ Time Frame: 1.3 years ]
    How high do you prioritize that fruit and vegetables are served at the meals? (Scale from 1 to 4, 1 being low and 4 being high. Higher values considered better outcome)

  3. Physical activity [ Time Frame: 1.3 years ]
    Children's Physical Activity Questionnaire (C-PAQ. 7-day recording of sports, games and leisure time activities outside daycare. The response options were indicated by doing a particular activity ("yes" or "no") and by an indication of total time used on the activity during the week (minutes per week). All minutes per week were summed to obtain an indication of overall physical activity level. Higher values considered better outcome)

  4. Sleep duration [ Time Frame: 1.3 years ]
    7 day sleep record from completed questionnaire (average number of minutes sleep summed from 7 day record on sleep- and wake time points)

  5. Child stress level [ Time Frame: 1.3 years ]
    Measured concentration of cortisol in hair samples

  6. Parental stress level [ Time Frame: 1.3 year ]
    Measured concentration of cortisol in hair samples

  7. Sleep quality [ Time Frame: 1.3 year ]
    Child's sleep is considered (calm all night, a little disturbed, disturbed with occasional awakenings, very disturbed with several awakenings. Calm all night considered best outcome).

  8. Child stress level [ Time Frame: 1.3 year ]
    Strengths and Difficulties Questionnaire (SDQ). Scored 0-2 and summed to Total Difficulties score (0-40, lower score indicate better outcome), and Prosocial Behavior score (0-10, lower score indicate worst outcome)

  9. Parental stress level [ Time Frame: 1.3 years ]
    Modified version of the Swedish Parental Stress Index (PSI). Each question was scored between 0 and 2 (0 considered best score and 2 the worst), according to its estimated indication of an overall stress level. Analysis of intercorrelations among the 10 questions and a principal component analysis suggested that 9 of the 10 questions could be added together to get a score for the overall family stress level (0-18)

  10. Parental occupation [ Time Frame: 1.3 years ]
    Question from completed questionnaire on parental occupation (Unemployed, at-home, early retired, on leave, trainee, student, self-employed without employees, self-employed with employees, middle management, white-collar worker, blue-collar, trained worker, untrained worker, other)

  11. Household income [ Time Frame: 1.3 years ]
    Annual household income (numerical)

  12. Daily physical activity: Enjoys being active [ Time Frame: 1.3 years ]
    If the child enjoyed being physically active (Never, often, some times, usually, always. Always considered best outcome)

  13. Meal habits: Eating breakfast together [ Time Frame: 1.3 years ]
    How many times per week does the family eat breakfast together (None, 1 day, 2-3 days, 4-5 days, 6-7 days. 6-7 days considered best outcome).

  14. Meal habits: Eating dinner together [ Time Frame: 1.3 years ]
    How many times per week does the family eat dinner together (None, 1 day, 2-3 days, 4-5 days, 6-7 days. 6-7 days considered best outcome).

  15. Meal habits: Mealtime situation [ Time Frame: 1.3 years ]
    How would you describe the meals with the child (Very conflictive, little conflictive, very cozy, little cozy, don't know. Very cozy considered best outcome).

  16. Meal habits: Pickiness [ Time Frame: 1.3 years ]
    How would you describe your child's way of eating (Picky, open to new tastes, eats everything. Eats everything considered best outcome).

  17. Meal habits: Appetite [ Time Frame: 1.3 years ]
    How would you describe your child's appetite (Too big appetite, good appetite, normal appetite, too small appetite, don't know. Normal appetite considered best outcome).

  18. Sleep quality: Difficulties falling asleep [ Time Frame: 1.3 years ]
    Difficulties falling asleep (yes/no. No considered best outcome)

  19. Sleep quality: Difficulties waking up [ Time Frame: 1.3 years ]
    Difficulties waking up (yes/no. No considered best outcome)

  20. Sleep quality: Sleep onset latency [ Time Frame: 1.3 years ]
    Sleep onset latency (numerical. Lower values considered better outcome)

  21. Sleep quality: Bedtime routines [ Time Frame: 1.3 years ]
    Routine activities before bedtime (No, < 1/week, 1-2 times/week, 3-4 times/week, 5-6 times/week, every day. Every day considered best outcome)

  22. Sleep quality: Joining parents' bed [ Time Frame: 1.3 years ]
    Child joining parents' bed (yes/no. If yes, how often (< 1/month, 1-3 times/month,1-3 times/week, 4-6 times/week, every night)

  23. Sleep quality: Falling asleep [ Time Frame: 1.3 years ]
    Child afraid to fall asleep (Never, rarely, some times, often, very often. Never considered best outcome)

  24. Sleep quality: Dreams [ Time Frame: 1.3 years ]
    Child has frightening/upsetting dreams (Never, rarely, some times, often, very often. Never considered best outcome)

  25. Daily physical activity: Means of transportation [ Time Frame: 1.3 years ]
    Means of transportation to and from day-care, and frequency (Walk, strolling, bike on its own, biked by parent, and bus, train or car, number of times per week (1,2,3,4 or 5. Walking or biking on its own considered best outcome).

  26. Daily physical activity: Activity compared to other children [ Time Frame: 1.3 years ]
    How active is the child compared to other children at similar age? (as active, somewhat active, very active, don't know. Very active considered best outcome)

  27. Daily physical activity: Activity with parents [ Time Frame: 1.3 years ]
    Frequency of which one or both parents were physically active with the child (once per week, 2-4 times per week, 5-7 times per week, multiple times per day. Multiple times per day considered best outcome)



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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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 ClinicalTrials.gov identifier (NCT number): NCT01583335


Locations
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Denmark
Parker Institute, Research Unit for Dietary Studies
Frederiksberg, Denmark, 2000
Sponsors and Collaborators
Bispebjerg Hospital
TrygFonden, Denmark
The Danish Medical Research Council
Sygekassernes Helsefond
Investigators
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Study Director: Berit L Heitmann, Professor Parker Institute

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Berit Lilienthal Heitmann, Professor, Ph.D., Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01583335     History of Changes
Other Study ID Numbers: Tryg-7984-07
First Posted: April 24, 2012    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019

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

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