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

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Lifestyle habits, including sleep and stress
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Overweight, Obesity, Susceptibility, Prevention, Diet, Physical activity, Sleep, Family stress

Eligibility Criteria

2 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Parker Institute, Research Unit for Dietary Studies

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Improved lifestyle

Control group

Shadow group

Arm Description

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

The shadow group was followed in registers exclusively

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Dietary intake
Four day dietary record completed Wednesday-Saturday
Priority of serving fruit and vegetables
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)
Physical activity
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)
Sleep duration
7 day sleep record from completed questionnaire (average number of minutes sleep summed from 7 day record on sleep- and wake time points)
Child stress level
Measured concentration of cortisol in hair samples
Parental stress level
Measured concentration of cortisol in hair samples
Sleep quality
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).
Child stress level
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)
Parental stress level
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)
Daily physical activity: Enjoys being active
If the child enjoyed being physically active (Never, often, some times, usually, always. Always considered best outcome)
Meal habits: Eating breakfast together
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).
Meal habits: Eating dinner together
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).
Meal habits: Mealtime situation
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).
Meal habits: Pickiness
How would you describe your child's way of eating (Picky, open to new tastes, eats everything. Eats everything considered best outcome).
Meal habits: Appetite
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).
Sleep quality: Difficulties falling asleep
Difficulties falling asleep (yes/no. No considered best outcome)
Sleep quality: Difficulties waking up
Difficulties waking up (yes/no. No considered best outcome)
Sleep quality: Sleep onset latency
Sleep onset latency (numerical. Lower values considered better outcome)
Sleep quality: Bedtime routines
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)
Sleep quality: Joining parents' bed
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)
Sleep quality: Falling asleep
Child afraid to fall asleep (Never, rarely, some times, often, very often. Never considered best outcome)
Sleep quality: Dreams
Child has frightening/upsetting dreams (Never, rarely, some times, often, very often. Never considered best outcome)
Daily physical activity: Means of transportation
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).
Daily physical activity: Activity compared to other children
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)
Daily physical activity: Activity with parents
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)

Full Information

First Posted
March 31, 2012
Last Updated
May 13, 2020
Sponsor
Bispebjerg Hospital
Collaborators
TrygFonden, Denmark, The Danish Medical Research Council, Sygekassernes Helsefond
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1. Study Identification

Unique Protocol Identification Number
NCT01583335
Brief Title
The Healthy Start Project: Primary Prevention of Overweight in Preschool Children Susceptible to Future Overweight
Official Title
Prevention of Weight Gain Among Normal Weight, Obesity Susceptible, Pre-school Children - a Randomized Controlled Interventions Study.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
Collaborators
TrygFonden, Denmark, The Danish Medical Research Council, Sygekassernes Helsefond

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Overweight, Obesity, Susceptibility, Prevention, Diet, Physical activity, Sleep, Family stress

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Improved lifestyle
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group was seen at baseline and follow-up, but not in between.
Arm Title
Shadow group
Arm Type
No Intervention
Arm Description
The shadow group was followed in registers exclusively
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle habits, including sleep and stress
Intervention Description
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
Primary Outcome Measure Information:
Title
Anthropometric measurements
Description
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
Time Frame
1.3 years
Title
Anthropometric measurements
Description
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
Time Frame
5 years
Title
Anthropometric measurements
Description
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
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Dietary intake
Description
Four day dietary record completed Wednesday-Saturday
Time Frame
1.3 years
Title
Priority of serving fruit and vegetables
Description
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)
Time Frame
1.3 years
Title
Physical activity
Description
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)
Time Frame
1.3 years
Title
Sleep duration
Description
7 day sleep record from completed questionnaire (average number of minutes sleep summed from 7 day record on sleep- and wake time points)
Time Frame
1.3 years
Title
Child stress level
Description
Measured concentration of cortisol in hair samples
Time Frame
1.3 years
Title
Parental stress level
Description
Measured concentration of cortisol in hair samples
Time Frame
1.3 year
Title
Sleep quality
Description
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).
Time Frame
1.3 year
Title
Child stress level
Description
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)
Time Frame
1.3 year
Title
Parental stress level
Description
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)
Time Frame
1.3 years
Title
Daily physical activity: Enjoys being active
Description
If the child enjoyed being physically active (Never, often, some times, usually, always. Always considered best outcome)
Time Frame
1.3 years
Title
Meal habits: Eating breakfast together
Description
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).
Time Frame
1.3 years
Title
Meal habits: Eating dinner together
Description
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).
Time Frame
1.3 years
Title
Meal habits: Mealtime situation
Description
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).
Time Frame
1.3 years
Title
Meal habits: Pickiness
Description
How would you describe your child's way of eating (Picky, open to new tastes, eats everything. Eats everything considered best outcome).
Time Frame
1.3 years
Title
Meal habits: Appetite
Description
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).
Time Frame
1.3 years
Title
Sleep quality: Difficulties falling asleep
Description
Difficulties falling asleep (yes/no. No considered best outcome)
Time Frame
1.3 years
Title
Sleep quality: Difficulties waking up
Description
Difficulties waking up (yes/no. No considered best outcome)
Time Frame
1.3 years
Title
Sleep quality: Sleep onset latency
Description
Sleep onset latency (numerical. Lower values considered better outcome)
Time Frame
1.3 years
Title
Sleep quality: Bedtime routines
Description
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)
Time Frame
1.3 years
Title
Sleep quality: Joining parents' bed
Description
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)
Time Frame
1.3 years
Title
Sleep quality: Falling asleep
Description
Child afraid to fall asleep (Never, rarely, some times, often, very often. Never considered best outcome)
Time Frame
1.3 years
Title
Sleep quality: Dreams
Description
Child has frightening/upsetting dreams (Never, rarely, some times, often, very often. Never considered best outcome)
Time Frame
1.3 years
Title
Daily physical activity: Means of transportation
Description
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).
Time Frame
1.3 years
Title
Daily physical activity: Activity compared to other children
Description
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)
Time Frame
1.3 years
Title
Daily physical activity: Activity with parents
Description
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)
Time Frame
1.3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berit L Heitmann, Professor
Organizational Affiliation
Parker Institute
Official's Role
Study Director
Facility Information:
Facility Name
Parker Institute, Research Unit for Dietary Studies
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
33808371
Citation
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.
Results Reference
derived
PubMed Identifier
32691048
Citation
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.
Results Reference
derived
PubMed Identifier
30308484
Citation
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.
Results Reference
derived
PubMed Identifier
28991907
Citation
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.
Results Reference
derived
PubMed Identifier
22852799
Citation
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.
Results Reference
derived
Links:
URL
http://www.sundstart.nu
Description
Click here for latest information about the "Sund Start" study.

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

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