Trial Outcomes & Findings for Healthy Childcare Centre of the Future (NCT NCT04193410)

NCT ID: NCT04193410

Last Updated: 2025-12-16

Results Overview

Children's Body Mass Index (BMI) was assessed by height and weight; age- and sex-specific BMI cut-off points were used to define overweight and obesity. BMI z-scores were calculated using Dutch reference values. A z-score of 0 represents the population mean. A z-score \> 0 means a BMI higher than the population mean, a z-score of \< 0 means a BMI lower than the population mean, both can pose specific health-related risks.

Recruitment status

COMPLETED

Target enrollment

315 participants

Primary outcome timeframe

Two years

Results posted on

2025-12-16

Participant Flow

Unit of analysis: Schools

Participant milestones

Participant milestones
Measure
Medium implementers
As the present study investigated the effectiveness of health-promoting activities under real-world conditions and all participating schools were free to implement activities of their choice, there were no intervention or control groups. Instead, schools were categorised on the basis of the implemented activities' intensity. This resulted in the formation of two groups: medium implementers (six schools) and low implementers (five schools). The project's effectiveness on various health outcomes was compared between these two groups.
Low implementers
As the present study investigated the effectiveness of health-promoting activities under real-world conditions and all participating schools were free to implement activities of their choice, there were no intervention or control groups. Instead, schools were categorised on the basis of the implemented activities' intensity. This resulted in the formation of two groups: medium implementers (six schools) and low implementers (five schools). The project's effectiveness on various health outcomes was compared between these two groups.
Overall Study
STARTED
143 6
172 5
Overall Study
COMPLETED
136 6
166 5
Overall Study
NOT COMPLETED
7 0
6 0

Reasons for withdrawal

Reasons for withdrawal
Measure
Medium implementers
As the present study investigated the effectiveness of health-promoting activities under real-world conditions and all participating schools were free to implement activities of their choice, there were no intervention or control groups. Instead, schools were categorised on the basis of the implemented activities' intensity. This resulted in the formation of two groups: medium implementers (six schools) and low implementers (five schools). The project's effectiveness on various health outcomes was compared between these two groups.
Low implementers
As the present study investigated the effectiveness of health-promoting activities under real-world conditions and all participating schools were free to implement activities of their choice, there were no intervention or control groups. Instead, schools were categorised on the basis of the implemented activities' intensity. This resulted in the formation of two groups: medium implementers (six schools) and low implementers (five schools). The project's effectiveness on various health outcomes was compared between these two groups.
Overall Study
Lost to Follow-up
7
6

Baseline Characteristics

The number analysed in this row differs from the overall number of participants, as we could not collect baseline data in all participants for this variable.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Medium Implementers
n=143 Participants
As the present study investigated the effectiveness of health-promoting activities under real-world conditions and all participating schools were free to implement activities of their choice, there were no intervention or control groups. Instead, schools were categorised on the basis of the implemented activities' intensity. This resulted in the formation of two groups: medium implementers (six schools) and low implementers (five schools). The project's effectiveness on various health outcomes was compared between these two groups.
Low Implementers
n=172 Participants
As the present study investigated the effectiveness of health-promoting activities under real-world conditions and all participating schools were free to implement activities of their choice, there were no intervention or control groups. Instead, schools were categorised on the basis of the implemented activities' intensity. This resulted in the formation of two groups: medium implementers (six schools) and low implementers (five schools). The project's effectiveness on various health outcomes was compared between these two groups.
Total
n=315 Participants
Total of all reporting groups
Age, Continuous
9.21 years
STANDARD_DEVIATION 1.00 • n=143 Participants
9.17 years
STANDARD_DEVIATION 0.96 • n=172 Participants
9.19 years
STANDARD_DEVIATION 0.98 • n=315 Participants
Sex: Female, Male
Female
72 Participants
n=143 Participants
105 Participants
n=172 Participants
177 Participants
n=315 Participants
Sex: Female, Male
Male
71 Participants
n=143 Participants
67 Participants
n=172 Participants
138 Participants
n=315 Participants
Race/Ethnicity, Customized
Western/Non-Western · Western
125 Participants
n=131 Participants • The number analysed in this row differs from the overall number of participants, as we could not collect baseline data in all participants for this variable.
149 Participants
n=152 Participants • The number analysed in this row differs from the overall number of participants, as we could not collect baseline data in all participants for this variable.
274 Participants
n=283 Participants • The number analysed in this row differs from the overall number of participants, as we could not collect baseline data in all participants for this variable.
Race/Ethnicity, Customized
Western/Non-Western · Non-Western
6 Participants
n=131 Participants • The number analysed in this row differs from the overall number of participants, as we could not collect baseline data in all participants for this variable.
3 Participants
n=152 Participants • The number analysed in this row differs from the overall number of participants, as we could not collect baseline data in all participants for this variable.
9 Participants
n=283 Participants • The number analysed in this row differs from the overall number of participants, as we could not collect baseline data in all participants for this variable.
Study year
Four
48 Participants
n=143 Participants
52 Participants
n=172 Participants
100 Participants
n=315 Participants
Study year
Five
37 Participants
n=143 Participants
62 Participants
n=172 Participants
99 Participants
n=315 Participants
Study year
Six
58 Participants
n=143 Participants
58 Participants
n=172 Participants
116 Participants
n=315 Participants
Socioeconomic status
Lowest tertile
32 Participants
n=131 Participants • The number analysed in this row differs from the overall number of participants, as we could not collect baseline data in all participants for this variable.
22 Participants
n=153 Participants • The number analysed in this row differs from the overall number of participants, as we could not collect baseline data in all participants for this variable.
54 Participants
n=284 Participants • The number analysed in this row differs from the overall number of participants, as we could not collect baseline data in all participants for this variable.
Socioeconomic status
Middle tertile
39 Participants
n=131 Participants • The number analysed in this row differs from the overall number of participants, as we could not collect baseline data in all participants for this variable.
47 Participants
n=153 Participants • The number analysed in this row differs from the overall number of participants, as we could not collect baseline data in all participants for this variable.
86 Participants
n=284 Participants • The number analysed in this row differs from the overall number of participants, as we could not collect baseline data in all participants for this variable.
Socioeconomic status
Highest tertile
60 Participants
n=131 Participants • The number analysed in this row differs from the overall number of participants, as we could not collect baseline data in all participants for this variable.
84 Participants
n=153 Participants • The number analysed in this row differs from the overall number of participants, as we could not collect baseline data in all participants for this variable.
144 Participants
n=284 Participants • The number analysed in this row differs from the overall number of participants, as we could not collect baseline data in all participants for this variable.
BMI z-score
-0.15 Z-score
STANDARD_DEVIATION 0.82 • n=143 Participants
-0.10 Z-score
STANDARD_DEVIATION 0.94 • n=172 Participants
-0.13 Z-score
STANDARD_DEVIATION 0.89 • n=315 Participants
Overweight/obese
Overweight/obese
43 Participants
n=143 Participants
21 Participants
n=172 Participants
64 Participants
n=315 Participants
Overweight/obese
Normal weight
100 Participants
n=143 Participants
151 Participants
n=172 Participants
251 Participants
n=315 Participants
Waist circumference
56.84 centimeters
STANDARD_DEVIATION 4.66 • n=143 Participants
58.62 centimeters
STANDARD_DEVIATION 6.77 • n=172 Participants
57.81 centimeters
STANDARD_DEVIATION 5.96 • n=315 Participants
Physical activity summary score
3.04 units on a scale
STANDARD_DEVIATION 0.64 • n=143 Participants
2.94 units on a scale
STANDARD_DEVIATION 0.67 • n=172 Participants
2.98 units on a scale
STANDARD_DEVIATION 0.66 • n=315 Participants
Vegetables at lunch
%yes
35 Participants
n=143 Participants
44 Participants
n=172 Participants
79 Participants
n=315 Participants
Healthy dietary behaviours
5.57 mean days/week
STANDARD_DEVIATION 0.96 • n=143 Participants
5.56 mean days/week
STANDARD_DEVIATION 0.95 • n=172 Participants
5.56 mean days/week
STANDARD_DEVIATION 0.95 • n=315 Participants
Soft drink consumption
4.31 mean days/week
STANDARD_DEVIATION 2.74 • n=143 Participants
4.06 mean days/week
STANDARD_DEVIATION 2.78 • n=172 Participants
4.17 mean days/week
STANDARD_DEVIATION 2.76 • n=315 Participants
School water consumption
1.43 units on a scale
STANDARD_DEVIATION 1.22 • n=143 Participants
1.25 units on a scale
STANDARD_DEVIATION 1.13 • n=172 Participants
1.33 units on a scale
STANDARD_DEVIATION 1.17 • n=315 Participants
Fruit at lunch
%yes
49 Participants
n=143 Participants
59 Participants
n=172 Participants
108 Participants
n=315 Participants
Fruit at lunch
%no
94 Participants
n=143 Participants
113 Participants
n=172 Participants
207 Participants
n=315 Participants
Vegetables at lunch
%no
108 Participants
n=143 Participants
128 Participants
n=172 Participants
236 Participants
n=315 Participants
Grains at lunch
%yes
132 Participants
n=143 Participants
161 Participants
n=172 Participants
293 Participants
n=315 Participants
Grains at lunch
%no
11 Participants
n=143 Participants
11 Participants
n=172 Participants
22 Participants
n=315 Participants
Dairy at lunch
%yes
53 Participants
n=143 Participants
58 Participants
n=172 Participants
111 Participants
n=315 Participants
Dairy at lunch
%no
90 Participants
n=143 Participants
114 Participants
n=172 Participants
204 Participants
n=315 Participants
Water at lunch
%yes
47 Participants
n=143 Participants
46 Participants
n=172 Participants
93 Participants
n=315 Participants
Water at lunch
%no
96 Participants
n=143 Participants
126 Participants
n=172 Participants
222 Participants
n=315 Participants
Butter at lunch
%yes
85 Participants
n=143 Participants
107 Participants
n=172 Participants
192 Participants
n=315 Participants
Butter at lunch
%no
58 Participants
n=143 Participants
65 Participants
n=172 Participants
123 Participants
n=315 Participants
At least two healthy food groups at lunch
%yes
125 Participants
n=143 Participants
152 Participants
n=172 Participants
277 Participants
n=315 Participants
At least two healthy food groups at lunch
%no
18 Participants
n=143 Participants
20 Participants
n=172 Participants
38 Participants
n=315 Participants

PRIMARY outcome

Timeframe: Two years

Population: The number analysed at T1 and T2 corresponds to the number of participants that were not LOF at T1 and T2.

Children's Body Mass Index (BMI) was assessed by height and weight; age- and sex-specific BMI cut-off points were used to define overweight and obesity. BMI z-scores were calculated using Dutch reference values. A z-score of 0 represents the population mean. A z-score \> 0 means a BMI higher than the population mean, a z-score of \< 0 means a BMI lower than the population mean, both can pose specific health-related risks.

Outcome measures

Outcome measures
Measure
Medium implementers
n=143 Participants
Participants from schools defined as medium implementers
Low implementers
n=172 Participants
Participants defined as low implementers
BMI Z-score
T0 (baseline)
-0.15 Z-score
Standard Deviation 0.82
-0.10 Z-score
Standard Deviation 0.94
BMI Z-score
T1 (after one year)
-0.14 Z-score
Standard Deviation 0.83
-0.03 Z-score
Standard Deviation 0.97
BMI Z-score
T2 (after two years)
-0.10 Z-score
Standard Deviation 0.88
-0.05 Z-score
Standard Deviation 0.98

SECONDARY outcome

Timeframe: Two years

Population: The number analysed at T1 and T2 corresponds to the number of participants that were not LOF at T1 and T2.

A composite score for healthy dietary behaviours was computed from four separate questions. This score was calculated by averaging the weekly consumption (ranging from never (0) to every day (7)) of breakfast consumption and intake of fruit, warm and raw vegetables, and water throughout the day, as reported in the parental questionnaire.

Outcome measures

Outcome measures
Measure
Medium implementers
n=114 Participants
Participants from schools defined as medium implementers
Low implementers
n=142 Participants
Participants defined as low implementers
Mean Number of Days Per Week of Healthy Dietary Behaviours
T0 (baseline)
5.57 mean days/week
Standard Deviation 0.96
5.56 mean days/week
Standard Deviation 0.95
Mean Number of Days Per Week of Healthy Dietary Behaviours
T1 (after one year)
5.38 mean days/week
Standard Deviation 0.94
5.56 mean days/week
Standard Deviation 0.90
Mean Number of Days Per Week of Healthy Dietary Behaviours
T2 (after two years)
5.45 mean days/week
Standard Deviation 0.90
5.52 mean days/week
Standard Deviation 0.84

SECONDARY outcome

Timeframe: Two years

Population: The number analysed at T1 and T2 corresponds to the number of participants that were not LOF at T1 and T2.

Assessed using the validated Physical Activity Questionnaire for Children (PAQ-C).The PAQ-C is a self-administered,7-day recall instrument, which provides a summary physical activity score derived from eight items, each scored on a 5-point scale. Item 1 (spare time activity) from no activity = 1; 7 times or more = 5. Items 2 to 7 (PE, lunch, right after school, evening, weekends) from lowest activity response = 1 or highest activity response = 5. Item 8 (mean of all days of the week) from none = 1; very often = 5. Item 9 (identifies students who are unusual active during the previous week). By adding up all means of the first eight items in PAQ-C, a summative score of physical activity is obtained. A score of 1 indicates low physical activity level, whereas a score of 5 indicates high physical activity level.

Outcome measures

Outcome measures
Measure
Medium implementers
n=143 Participants
Participants from schools defined as medium implementers
Low implementers
n=172 Participants
Participants defined as low implementers
Child Physical Activity Behaviour (Child-reported)
T0 (baseline)
3.04 score on a scale
Standard Deviation 0.64
2.94 score on a scale
Standard Deviation 0.67
Child Physical Activity Behaviour (Child-reported)
T1 (after one year)
3.19 score on a scale
Standard Deviation 0.58
3.25 score on a scale
Standard Deviation 0.59
Child Physical Activity Behaviour (Child-reported)
T2 (after two years)
3.12 score on a scale
Standard Deviation 0.62
3.17 score on a scale
Standard Deviation 0.65

SECONDARY outcome

Timeframe: Two years

Population: Number analysed at T1 and T2 corresponds to number of participants that were not LOF at T1 and T2.

Waist circumference is measured with a measuring tape to the nearest 0.1 cm, following the World Health Organisation's assessment protocol.

Outcome measures

Outcome measures
Measure
Medium implementers
n=143 Participants
Participants from schools defined as medium implementers
Low implementers
n=172 Participants
Participants defined as low implementers
Child Waist Circumference
T0 (baseline)
56.84 centimeters
Standard Deviation 4.66
58.62 centimeters
Standard Deviation 6.77
Child Waist Circumference
T1 (after one year)
58.49 centimeters
Standard Deviation 5.64
59.40 centimeters
Standard Deviation 6.68
Child Waist Circumference
T2 (after two years)
61.12 centimeters
Standard Deviation 5.94
61.57 centimeters
Standard Deviation 7.11

SECONDARY outcome

Timeframe: Two years

Population: The number analysed at T1 and T2 corresponds to the number of participants that were not LOF at T1 and T2.

Soft drink consumption during the past week was derived from the parental questionnaire ranging from never (0) to every day (7).

Outcome measures

Outcome measures
Measure
Medium implementers
n=114 Participants
Participants from schools defined as medium implementers
Low implementers
n=142 Participants
Participants defined as low implementers
Mean Number of Days Per Week of Soft Drink Consumption
T0 (baseline)
4.31 mean days/week
Standard Deviation 2.74
4.06 mean days/week
Standard Deviation 2.78
Mean Number of Days Per Week of Soft Drink Consumption
T2 (after two years)
3.35 mean days/week
Standard Deviation 2.61
3.43 mean days/week
Standard Deviation 2.70
Mean Number of Days Per Week of Soft Drink Consumption
T1 (after one year)
4.07 mean days/week
Standard Deviation 2.67
3.63 mean days/week
Standard Deviation 2.88

SECONDARY outcome

Timeframe: Two years

Population: The number analysed at T1 and T2 corresponds to the number of participants that were not LOF at T1 and T2.

Water consumption during school hours was derived from the child questionnaire ranging from never (0) to every day (3).

Outcome measures

Outcome measures
Measure
Medium implementers
n=143 Participants
Participants from schools defined as medium implementers
Low implementers
n=172 Participants
Participants defined as low implementers
Water Consumption During School Hours
T0 (baseline)
1.43 mean days/week
Standard Deviation 1.22
1.25 mean days/week
Standard Deviation 1.13
Water Consumption During School Hours
T1 (after one year)
1.47 mean days/week
Standard Deviation 1.13
1.40 mean days/week
Standard Deviation 1.16
Water Consumption During School Hours
T2 (after two years)
1.63 mean days/week
Standard Deviation 1.20
1.73 mean days/week
Standard Deviation 1.17

SECONDARY outcome

Timeframe: Two years

Population: The number analysed at T1 and T2 corresponds to the number of participants that were not LOF at T1 and T2.

The child lunch questionnaire assessed children's consumption of certain food types during lunch. The items were summarised into six dichotomous (yes/no) food types: fruits, vegetables, grains (bread and cereals), dairy (milk/yoghurt and cheese), water, and butter.

Outcome measures

Outcome measures
Measure
Medium implementers
n=143 Participants
Participants from schools defined as medium implementers
Low implementers
n=172 Participants
Participants defined as low implementers
Fruit Consumption at Lunch
T0 (baseline)
34.3 percentage of yes
34.3 percentage of yes
Fruit Consumption at Lunch
T1 (after one year)
31.4 percentage of yes
26.8 percentage of yes
Fruit Consumption at Lunch
T2 (after two years)
22.8 percentage of yes
23.5 percentage of yes

SECONDARY outcome

Timeframe: Two years

Population: The number analysed at T1 and T2 corresponds to the number of participants that were not LOF at T1 and T2.

The child lunch questionnaire assessed children's consumption of certain food types during lunch. The items were summarised into six dichotomous (yes/no) food types: fruits, vegetables, grains (bread and cereals), dairy (milk/yoghurt and cheese), water, and butter.

Outcome measures

Outcome measures
Measure
Medium implementers
n=143 Participants
Participants from schools defined as medium implementers
Low implementers
n=172 Participants
Participants defined as low implementers
Vegetable Consumption at Lunch
T0 (baseline)
24.5 percentage of yes
25.6 percentage of yes
Vegetable Consumption at Lunch
T1 (after one year)
31.4 percentage of yes
26.8 percentage of yes
Vegetable Consumption at Lunch
T2 (after two years)
19.9 percentage of yes
19.9 percentage of yes

SECONDARY outcome

Timeframe: Two years

Population: The number analysed at T1 and T2 corresponds to the number of participants that were not LOF at T1 and T2.

The child lunch questionnaire assessed children's consumption of certain food types during lunch. The items were summarised into six dichotomous (yes/no) food types: fruits, vegetables, grains (bread and cereals), dairy (milk/yoghurt and cheese), water, and butter.

Outcome measures

Outcome measures
Measure
Medium implementers
n=143 Participants
Participants from schools defined as medium implementers
Low implementers
n=172 Participants
Participants defined as low implementers
Grain Consumption at Lunch
T0 (baseline)
92.3 percentage of yes
93.6 percentage of yes
Grain Consumption at Lunch
T1 (after one year)
94.2 percentage of yes
93.5 percentage of yes
Grain Consumption at Lunch
T2 (after two years)
94.9 percentage of yes
92.8 percentage of yes

SECONDARY outcome

Timeframe: Two years

Population: The number analysed at T1 and T2 corresponds to the number of participants that were not LOF at T1 and T2.

The child lunch questionnaire assessed children's consumption of certain food types during lunch. The items were summarised into six dichotomous (yes/no) food types: fruits, vegetables, grains (bread and cereals), dairy (milk/yoghurt and cheese), water, and butter.

Outcome measures

Outcome measures
Measure
Medium implementers
n=143 Participants
Participants from schools defined as medium implementers
Low implementers
n=172 Participants
Participants defined as low implementers
Dairy Consumption at Lunch
T0 (baseline)
37.1 percentage of yes
33.7 percentage of yes
Dairy Consumption at Lunch
T1 (after one year)
39.4 percentage of yes
39.3 percentage of yes
Dairy Consumption at Lunch
T2 (after two years)
48.5 percentage of yes
38.0 percentage of yes

SECONDARY outcome

Timeframe: Two years

Population: The number analysed at T1 and T2 corresponds to the number of participants that were not LOF at T1 and T2.

The child lunch questionnaire assessed children's consumption of certain food types during lunch. The items were summarised into six dichotomous (yes/no) food types: fruits, vegetables, grains (bread and cereals), dairy (milk/yoghurt and cheese), water, and butter.

Outcome measures

Outcome measures
Measure
Medium implementers
n=143 Participants
Participants from schools defined as medium implementers
Low implementers
n=172 Participants
Participants defined as low implementers
Water Consumption at Lunch
T0 (baseline)
32.9 percentage of yes
26.7 percentage of yes
Water Consumption at Lunch
T1 (after one year)
38.0 percentage of yes
31.0 percentage of yes
Water Consumption at Lunch
T2 (after two years)
44.9 percentage of yes
38.6 percentage of yes

SECONDARY outcome

Timeframe: Two years

Population: The number analysed at T1 and T2 corresponds to the number of participants that were not LOF at T1 and T2.

The child lunch questionnaire assessed children's consumption of certain food types during lunch. The items were summarised into six dichotomous (yes/no) food types: fruits, vegetables, grains (bread and cereals), dairy (milk/yoghurt and cheese), water, and butter.

Outcome measures

Outcome measures
Measure
Medium implementers
n=143 Participants
Participants from schools defined as medium implementers
Low implementers
n=172 Participants
Participants defined as low implementers
Butter Consumption at Lunch
T0 (baseline)
59.4 percentage of yes
62.2 percentage of yes
Butter Consumption at Lunch
T1 (after one year)
59.1 percentage of yes
60.7 percentage of yes
Butter Consumption at Lunch
T2 (after two years)
55.1 percentage of yes
56.6 percentage of yes

SECONDARY outcome

Timeframe: Two years

Population: The number analysed at T1 and T2 corresponds to the number of participants that were not LOF at T1 and T2.

The child lunch questionnaire assessed children's consumption of certain food types during lunch. The items were summarised into six dichotomous (yes/no) food types: fruits, vegetables, grains (bread and cereals), dairy (milk/yoghurt and cheese), water, and butter. To shed more light on the nutritional value of the children's lunches, the different food types consumed were summed, and a dichotomous variable was created indicating whether children consumed at least two of the food types during lunch.

Outcome measures

Outcome measures
Measure
Medium implementers
n=143 Participants
Participants from schools defined as medium implementers
Low implementers
n=172 Participants
Participants defined as low implementers
Consumption of at Least Two Healthy Food Groups During Lunch
T0 (baseline)
87.4 percentage of yes
88.4 percentage of yes
Consumption of at Least Two Healthy Food Groups During Lunch
T1 (after one year)
86.1 percentage of yes
88.7 percentage of yes
Consumption of at Least Two Healthy Food Groups During Lunch
T2 (after two years)
89.7 percentage of yes
86.7 percentage of yes

Adverse Events

All participants

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marla Hahnraths, MSc

Maastricht University

Phone: 3882184

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place