Trial Outcomes & Findings for Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns (NCT NCT04522921)
NCT ID: NCT04522921
Last Updated: 2025-08-22
Results Overview
BMI-SDS was calculated using World Health Organization Anthro-Plus software.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
211 participants
Primary outcome timeframe
Mean changes from baseline to 10-weeks (post camp intervention)
Results posted on
2025-08-22
Participant Flow
Participant milestones
| Measure |
Control-group (CG)
Standard weight-loss diet (15E%/day protein) for the 10 weeks they attend the camp and increased follow-up.
Increased follow-up contact after attending a weight loss camp: After leaving the camp, the children and their families with increased follow-up contact will be contacted once every month within the first 6 month and once every other month until 52-weeks follow-up (8 times total). The children and their families will be contacted by phone, facetime or skype as they prefer, within a predetermined and known timeframe. The conversation will focus on individual topics chosen by the child/parent.
|
Intervention Group (IG)
A higher protein diet (25E%/day) for the 10 weeks they attend the camp and increased follow-up.
Increased follow-up contact after attending a weight loss camp: After leaving the camp, the children and their families with increased follow-up contact will be contacted once every month within the first 6 month and once every other month until 52-weeks follow-up (8 times total). The children and their families will be contacted by phone, facetime or skype as they prefer, within a predetermined and known timeframe. The conversation will focus on individual topics chosen by the child/parent.
|
SARS CoV-group
Standard weight-loss diet (15E% of protein) during the camp. However, they were sent home for five weeks due to a COVID19 lockdown.
|
|---|---|---|---|
|
Overall Study
STARTED
|
75
|
86
|
34
|
|
Overall Study
COMPLETED
|
71
|
74
|
34
|
|
Overall Study
NOT COMPLETED
|
4
|
12
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control-group
n=75 Participants
In the control group, no changes were. This group received a standard care lifestyle camp for 10-weeks.
|
Intervention-group
n=86 Participants
In the intervention group, the aim was to replace carbohydrates-rich foods at breakfast and two in-between meals with naturally protein-containing foods (e.g., dairy products, nuts, egg, meat-products) to increase the amount of protein from \~ 10-15E% to \~ 25E% per day with minimal changes in total caloric intake.
|
SARS CoV-group
n=34 Participants
The SARS CoV-group were affected by the COVID-19 lockdown of the camps.Thus, they were sent home for five weeks with no control of dietary intake and physical activity. They received standard care during their stay at camp.
|
Total
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
12.2 years
STANDARD_DEVIATION 1.4 • n=75 Participants
|
12.1 years
STANDARD_DEVIATION 1.5 • n=86 Participants
|
12.5 years
STANDARD_DEVIATION 1.1 • n=34 Participants
|
12.2 years
STANDARD_DEVIATION 1.4 • n=195 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=75 Participants
|
35 Participants
n=86 Participants
|
19 Participants
n=34 Participants
|
90 Participants
n=195 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=75 Participants
|
51 Participants
n=86 Participants
|
15 Participants
n=34 Participants
|
105 Participants
n=195 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body weight
|
73.6 Kg
STANDARD_DEVIATION 14.6 • n=75 Participants
|
72.7 Kg
STANDARD_DEVIATION 18.0 • n=86 Participants
|
73.4 Kg
STANDARD_DEVIATION 12.5 • n=34 Participants
|
73.2 Kg
STANDARD_DEVIATION 16.5 • n=195 Participants
|
|
Height
|
1.59 Meter
STANDARD_DEVIATION 0.1 • n=75 Participants
|
1.59 Meter
STANDARD_DEVIATION 0.1 • n=86 Participants
|
1.60 Meter
STANDARD_DEVIATION 0.1 • n=34 Participants
|
1.59 Meter
STANDARD_DEVIATION 0.1 • n=195 Participants
|
|
Body mass index standard deviation score (BMI-SDS)
|
2.65 standard deviation
STANDARD_DEVIATION 0.7 • n=75 Participants
|
2.66 standard deviation
STANDARD_DEVIATION 0.7 • n=86 Participants
|
2.57 standard deviation
STANDARD_DEVIATION 0.6 • n=34 Participants
|
2.65 standard deviation
STANDARD_DEVIATION 0.7 • n=195 Participants
|
|
Body fat
|
41.4 percentage of body fat
STANDARD_DEVIATION 6.6 • n=67 Participants • Some participants had missing values on body composition.
|
41.0 percentage of body fat
STANDARD_DEVIATION 6.8 • n=84 Participants • Some participants had missing values on body composition.
|
42.4 percentage of body fat
STANDARD_DEVIATION 6.0 • n=34 Participants • Some participants had missing values on body composition.
|
41.2 percentage of body fat
STANDARD_DEVIATION 6.7 • n=185 Participants • Some participants had missing values on body composition.
|
|
Skeletal muscle mass
|
23.0 Kg
STANDARD_DEVIATION 4.8 • n=67 Participants • Some participants had missing values on body composition.
|
23.2 Kg
STANDARD_DEVIATION 5.8 • n=84 Participants • Some participants had missing values on body composition.
|
22.8 Kg
STANDARD_DEVIATION 4.2 • n=34 Participants • Some participants had missing values on body composition.
|
23.1 Kg
STANDARD_DEVIATION 5.4 • n=185 Participants • Some participants had missing values on body composition.
|
|
Blood pressure (systolic)
|
111.1 mmHg
STANDARD_DEVIATION 10.7 • n=73 Participants • Missing data due to refusal of blood pressure measurements or malfunction of the blood pressure device.
|
109.8 mmHg
STANDARD_DEVIATION 10.31 • n=68 Participants • Missing data due to refusal of blood pressure measurements or malfunction of the blood pressure device.
|
109.2 mmHg
STANDARD_DEVIATION 9.1 • n=23 Participants • Missing data due to refusal of blood pressure measurements or malfunction of the blood pressure device.
|
110.5 mmHg
STANDARD_DEVIATION 10.5 • n=164 Participants • Missing data due to refusal of blood pressure measurements or malfunction of the blood pressure device.
|
|
Blood pressure (diastolic)
|
70.2 mmHg
STANDARD_DEVIATION 6.4 • n=73 Participants • Missing data due to refusal of blood pressure measurements or malfunction of the blood pressure device.
|
72.5 mmHg
STANDARD_DEVIATION 8.7 • n=68 Participants • Missing data due to refusal of blood pressure measurements or malfunction of the blood pressure device.
|
71.7 mmHg
STANDARD_DEVIATION 5.1 • n=23 Participants • Missing data due to refusal of blood pressure measurements or malfunction of the blood pressure device.
|
71.3 mmHg
STANDARD_DEVIATION 7.7 • n=164 Participants • Missing data due to refusal of blood pressure measurements or malfunction of the blood pressure device.
|
|
Total cholesterol
|
3.9 mmol/L
STANDARD_DEVIATION 0.7 • n=33 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
4.3 mmol/L
STANDARD_DEVIATION 0.7 • n=44 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
4.0 mmol/L
STANDARD_DEVIATION 0.8 • n=11 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
4.2 mmol/L
STANDARD_DEVIATION 0.7 • n=88 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
|
HDL cholesterol
|
1.2 mmol/L
STANDARD_DEVIATION 0.3 • n=33 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
1.2 mmol/L
STANDARD_DEVIATION 0.2 • n=44 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
1.2 mmol/L
STANDARD_DEVIATION 0.3 • n=11 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
1.2 mmol/L
STANDARD_DEVIATION 0.2 • n=88 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
|
LDL cholesterol
|
2.2 mmol/L
STANDARD_DEVIATION 0.6 • n=33 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
2.5 mmol/L
STANDARD_DEVIATION 0.6 • n=40 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
2.2 mmol/L
STANDARD_DEVIATION 0.6 • n=11 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
2.4 mmol/L
STANDARD_DEVIATION 0.6 • n=84 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
|
Triglyceride
|
1.3 mmol/L
n=33 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
1.3 mmol/L
n=44 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
1.3 mmol/L
n=11 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
1.3 mmol/L
n=88 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
|
ALAT
|
22 units/L
n=33 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
22.5 units/L
n=44 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
20 units/L
n=11 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
22 units/L
n=88 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
|
ASAT
|
24 units/L
n=33 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
23 units/L
n=44 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
16 units/L
n=11 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
23 units/L
n=88 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
|
GGT
|
16 units/L
n=33 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
16 units/L
n=44 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
15 units/L
n=11 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
16 units/L
n=88 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
|
Basic phosphatase
|
297 units/L
STANDARD_DEVIATION 84 • n=33 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
274 units/L
STANDARD_DEVIATION 90 • n=44 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
251 units/L
STANDARD_DEVIATION 77 • n=11 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
284 units/L
STANDARD_DEVIATION 87 • n=88 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
|
P-glucose
|
5.9 mmol/L
STANDARD_DEVIATION 0.4 • n=33 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
5.9 mmol/L
STANDARD_DEVIATION 0.3 • n=44 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
5.9 mmol/L
STANDARD_DEVIATION 0.4 • n=11 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
5.9 mmol/L
STANDARD_DEVIATION 0.3 • n=88 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
|
Albumin
|
42.0 g/L
STANDARD_DEVIATION 2.4 • n=33 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
42.8 g/L
STANDARD_DEVIATION 2.4 • n=44 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
43 g/L
STANDARD_DEVIATION 1.9 • n=11 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
42.4 g/L
STANDARD_DEVIATION 2.4 • n=88 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
|
CD163
|
2.4 mg/L
n=33 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
2.6 mg/L
n=44 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
2.1 mg/L
n=11 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
2.5 mg/L
n=88 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
|
Platelets
|
314 units/L
STANDARD_DEVIATION 64 • n=33 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
310 units/L
STANDARD_DEVIATION 61 • n=44 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
295 units/L
STANDARD_DEVIATION 29 • n=11 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
312 units/L
STANDARD_DEVIATION 62 • n=88 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
|
Uric acid
|
0.31 mmol/L
STANDARD_DEVIATION 0.0 • n=33 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
0.32 mmol/L
STANDARD_DEVIATION 0.1 • n=44 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
0.33 mmol/L
STANDARD_DEVIATION 0.1 • n=11 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
0.31 mmol/L
STANDARD_DEVIATION 0.1 • n=88 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
|
HbA1c
|
34.9 mmol/mol
STANDARD_DEVIATION 2.5 • n=33 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
35.0 mmol/mol
STANDARD_DEVIATION 2.1 • n=44 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
35 mmol/mol
STANDARD_DEVIATION 2.8 • n=11 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
34.9 mmol/mol
STANDARD_DEVIATION 2.3 • n=88 Participants • Blood samples were voluntary for all participants; therefore, only a subsample of participants had blood samples collected.
|
PRIMARY outcome
Timeframe: Mean changes from baseline to 10-weeks (post camp intervention)Population: The COVID-19 pandemic forced a lockdown from December 2020 to February 2021. All children affected by the COVID-19 lockdown (The SARS CoV-group) were sent home for five weeks with no control of dietary intake and physical. Only a subsample of participants had bloodsamples collected.
BMI-SDS was calculated using World Health Organization Anthro-Plus software.
Outcome measures
| Measure |
Control Group
n=71 Participants
In the control group, no changes were. This group received a standard care lifestyle camp for 10-weeks.
|
Intervention Group
n=74 Participants
In the intervention group, the aim was to replace carbohydrates-rich foods at breakfast and two in-between meals with naturally protein-containing foods (e.g., dairy products, nuts, egg, meat-products) to increase the amount of protein from \~ 10-15E% to \~ 25E% per day with minimal changes in total caloric intake.
|
SARS CoV-group
n=34 Participants
The SARS CoV-group were affected by the COVID-19 lockdown of the camps.Thus, they were sent home for five weeks with no control of dietary intake and physical activity. They received standard care during their stay at camp.
|
|---|---|---|---|
|
Body Mass Index Standard Deviation Score (BMI-SDS)
|
-0.54 Standard deviation score
Interval -0.63 to -0.45
|
-0.61 Standard deviation score
Interval -0.68 to -0.53
|
-0.70 Standard deviation score
Interval -0.84 to -0.55
|
PRIMARY outcome
Timeframe: Mean changes from baseline to 10-weeks (post camp intervention)Population: The COVID-19 pandemic forced a lockdown from December 2020 to February 2021. All children affected by the COVID-19 lockdown (The SARS CoV-group) were sent home for five weeks with no control of dietary intake and physical. Only a subsample of participants had bloodsamples collected.
Body weight (kg) was measured in light clothing without shoes using a Bioelectric impedance (InBody model 270, Hopkins Medical Products, Grand Rapids, MI, USA).
Outcome measures
| Measure |
Control Group
n=71 Participants
In the control group, no changes were. This group received a standard care lifestyle camp for 10-weeks.
|
Intervention Group
n=74 Participants
In the intervention group, the aim was to replace carbohydrates-rich foods at breakfast and two in-between meals with naturally protein-containing foods (e.g., dairy products, nuts, egg, meat-products) to increase the amount of protein from \~ 10-15E% to \~ 25E% per day with minimal changes in total caloric intake.
|
SARS CoV-group
n=34 Participants
The SARS CoV-group were affected by the COVID-19 lockdown of the camps.Thus, they were sent home for five weeks with no control of dietary intake and physical activity. They received standard care during their stay at camp.
|
|---|---|---|---|
|
Body Weight (kg)
|
-6.25 kilogram
Interval -7.54 to -4.96
|
-6.62 kilogram
Interval -7.87 to -5.37
|
-7.64 kilogram
Interval -9.47 to -5.81
|
PRIMARY outcome
Timeframe: Mean changes from baseline to 10-weeks (post camp intervention)Population: The COVID-19 pandemic forced a lockdown from December 2020 to February 2021. All children affected by the COVID-19 lockdown (The SARS CoV-group) were sent home for five weeks with no control of dietary intake and physical. Only a subsample of participants had bloodsamples collected.
Body fat (%) was measured in light clothing without shoes using a Bioelectric impedance (InBody model 270, Hopkins Medical Products, Grand Rapids, MI, USA).
Outcome measures
| Measure |
Control Group
n=71 Participants
In the control group, no changes were. This group received a standard care lifestyle camp for 10-weeks.
|
Intervention Group
n=74 Participants
In the intervention group, the aim was to replace carbohydrates-rich foods at breakfast and two in-between meals with naturally protein-containing foods (e.g., dairy products, nuts, egg, meat-products) to increase the amount of protein from \~ 10-15E% to \~ 25E% per day with minimal changes in total caloric intake.
|
SARS CoV-group
n=34 Participants
The SARS CoV-group were affected by the COVID-19 lockdown of the camps.Thus, they were sent home for five weeks with no control of dietary intake and physical activity. They received standard care during their stay at camp.
|
|---|---|---|---|
|
Body Fat (%)
|
-5.77 Percentage (%)
Interval -6.94 to -4.6
|
-6.06 Percentage (%)
Interval -7.14 to -4.99
|
-7.44 Percentage (%)
Interval -9.35 to -5.53
|
PRIMARY outcome
Timeframe: Mean changes from baseline to 10-weeks (post camp intervention)Population: The COVID-19 pandemic forced a lockdown from December 2020 to February 2021. All children affected by the COVID-19 lockdown (The SARS CoV-group) were sent home for five weeks with no control of dietary intake and physical. Only a subsample of participants had bloodsamples collected.
Skeletal muscle mass (kg) was measured in light clothing without shoes using a Bioelectric impedance (InBody model 270, Hopkins Medical Products, Grand Rapids, MI, USA).
Outcome measures
| Measure |
Control Group
n=71 Participants
In the control group, no changes were. This group received a standard care lifestyle camp for 10-weeks.
|
Intervention Group
n=74 Participants
In the intervention group, the aim was to replace carbohydrates-rich foods at breakfast and two in-between meals with naturally protein-containing foods (e.g., dairy products, nuts, egg, meat-products) to increase the amount of protein from \~ 10-15E% to \~ 25E% per day with minimal changes in total caloric intake.
|
SARS CoV-group
n=34 Participants
The SARS CoV-group were affected by the COVID-19 lockdown of the camps.Thus, they were sent home for five weeks with no control of dietary intake and physical activity. They received standard care during their stay at camp.
|
|---|---|---|---|
|
Skeletal Muscle Mass (kg)
|
0.22 Kilogram
Interval -0.17 to 0.61
|
-0.003 Kilogram
Interval -0.42 to 0.41
|
0.49 Kilogram
Interval -0.1 to 1.09
|
SECONDARY outcome
Timeframe: Mean changes from baseline to 10-weeks (post camp intervention)Population: The COVID-19 pandemic forced a lockdown from December 2020 to February 2021. All children affected by the COVID-19 lockdown (The SARS CoV-group) were sent home for five weeks with no control of dietary intake and physical. Only a subsample of participants had bloodsamples collected.
Height (m) was measured using a fixed wall measuring tape.
Outcome measures
| Measure |
Control Group
n=71 Participants
In the control group, no changes were. This group received a standard care lifestyle camp for 10-weeks.
|
Intervention Group
n=74 Participants
In the intervention group, the aim was to replace carbohydrates-rich foods at breakfast and two in-between meals with naturally protein-containing foods (e.g., dairy products, nuts, egg, meat-products) to increase the amount of protein from \~ 10-15E% to \~ 25E% per day with minimal changes in total caloric intake.
|
SARS CoV-group
n=34 Participants
The SARS CoV-group were affected by the COVID-19 lockdown of the camps.Thus, they were sent home for five weeks with no control of dietary intake and physical activity. They received standard care during their stay at camp.
|
|---|---|---|---|
|
Body Height (m)
|
0.01 Meter
Interval 0.01 to 0.02
|
0.02 Meter
Interval 0.01 to 0.02
|
0.02 Meter
Interval 0.01 to 0.03
|
SECONDARY outcome
Timeframe: Mean changes from baseline to 10-weeks (post camp intervention)Population: The COVID-19 pandemic forced a lockdown from December 2020 to February 2021. All children affected by the COVID-19 lockdown (The SARS CoV-group) were sent home for five weeks with no control of dietary intake and physical. Only a subsample of participants had bloodsamples collected.
Blood pressure was measured with the right arm placed at heart level using an automatic non-invasive blood pressure monitor (Omron M3, Kyoto, Japan).
Outcome measures
| Measure |
Control Group
n=71 Participants
In the control group, no changes were. This group received a standard care lifestyle camp for 10-weeks.
|
Intervention Group
n=74 Participants
In the intervention group, the aim was to replace carbohydrates-rich foods at breakfast and two in-between meals with naturally protein-containing foods (e.g., dairy products, nuts, egg, meat-products) to increase the amount of protein from \~ 10-15E% to \~ 25E% per day with minimal changes in total caloric intake.
|
SARS CoV-group
n=32 Participants
The SARS CoV-group were affected by the COVID-19 lockdown of the camps.Thus, they were sent home for five weeks with no control of dietary intake and physical activity. They received standard care during their stay at camp.
|
|---|---|---|---|
|
Systolic Blood Pressure
|
-4.39 mmHg
Interval -6.68 to -2.09
|
-3.32 mmHg
Interval -5.97 to -0.67
|
-4.38 mmHg
Interval -8.53 to -0.23
|
SECONDARY outcome
Timeframe: Mean changes from baseline to 10-weeks (post camp intervention)Population: The COVID-19 pandemic forced a lockdown from December 2020 to February 2021. All children affected by the COVID-19 lockdown (The SARS CoV-group) were sent home for five weeks with no control of dietary intake and physical. Only a subsample of participants had bloodsamples collected.
Blood pressure was measured with the right arm placed at heart level using an automatic non-invasive blood pressure monitor (Omron M3, Kyoto, Japan).
Outcome measures
| Measure |
Control Group
n=71 Participants
In the control group, no changes were. This group received a standard care lifestyle camp for 10-weeks.
|
Intervention Group
n=74 Participants
In the intervention group, the aim was to replace carbohydrates-rich foods at breakfast and two in-between meals with naturally protein-containing foods (e.g., dairy products, nuts, egg, meat-products) to increase the amount of protein from \~ 10-15E% to \~ 25E% per day with minimal changes in total caloric intake.
|
SARS CoV-group
n=32 Participants
The SARS CoV-group were affected by the COVID-19 lockdown of the camps.Thus, they were sent home for five weeks with no control of dietary intake and physical activity. They received standard care during their stay at camp.
|
|---|---|---|---|
|
Diastolic Blood Pressure
|
-2.97 mmHg
Interval -4.5 to -1.43
|
-4.28 mmHg
Interval -6.42 to -2.13
|
-5.24 mmHg
Interval -8.36 to -2.11
|
SECONDARY outcome
Timeframe: Mean changes from baseline to 10-weeks (post camp intervention)Population: The COVID-19 pandemic forced a lockdown from December 2020 to February 2021. All children affected by the COVID-19 lockdown (The SARS CoV-group) were sent home for five weeks with no control of dietary intake and physical. Only a subsample of participants had bloodsamples collected.
Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
Outcome measures
| Measure |
Control Group
n=33 Participants
In the control group, no changes were. This group received a standard care lifestyle camp for 10-weeks.
|
Intervention Group
n=42 Participants
In the intervention group, the aim was to replace carbohydrates-rich foods at breakfast and two in-between meals with naturally protein-containing foods (e.g., dairy products, nuts, egg, meat-products) to increase the amount of protein from \~ 10-15E% to \~ 25E% per day with minimal changes in total caloric intake.
|
SARS CoV-group
n=11 Participants
The SARS CoV-group were affected by the COVID-19 lockdown of the camps.Thus, they were sent home for five weeks with no control of dietary intake and physical activity. They received standard care during their stay at camp.
|
|---|---|---|---|
|
P-cholesterol
|
-0.39 mmol/L
Interval -0.58 to -0.21
|
-0.55 mmol/L
Interval -0.75 to -0.35
|
-0.63 mmol/L
Interval -0.9 to -0.35
|
SECONDARY outcome
Timeframe: Mean changes from baseline to 10-weeks (post camp intervention)Population: The COVID-19 pandemic forced a lockdown from December 2020 to February 2021. All children affected by the COVID-19 lockdown (The SARS CoV-group) were sent home for five weeks with no control of dietary intake and physical. Only a subsample of participants had bloodsamples collected.
Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
Outcome measures
| Measure |
Control Group
n=33 Participants
In the control group, no changes were. This group received a standard care lifestyle camp for 10-weeks.
|
Intervention Group
n=42 Participants
In the intervention group, the aim was to replace carbohydrates-rich foods at breakfast and two in-between meals with naturally protein-containing foods (e.g., dairy products, nuts, egg, meat-products) to increase the amount of protein from \~ 10-15E% to \~ 25E% per day with minimal changes in total caloric intake.
|
SARS CoV-group
n=11 Participants
The SARS CoV-group were affected by the COVID-19 lockdown of the camps.Thus, they were sent home for five weeks with no control of dietary intake and physical activity. They received standard care during their stay at camp.
|
|---|---|---|---|
|
HDL Cholesterol
|
-0.03 mmol/L
Interval -0.09 to 0.04
|
-0.04 mmol/L
Interval -0.11 to 0.02
|
-0.10 mmol/L
Interval -0.23 to 0.03
|
SECONDARY outcome
Timeframe: Mean changes from baseline to 10-weeks (post camp intervention)Population: The COVID-19 pandemic forced a lockdown from December 2020 to February 2021. All children affected by the COVID-19 lockdown (The SARS CoV-group) were sent home for five weeks with no control of dietary intake and physical. Only a subsample of participants had bloodsamples collected.
Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
Outcome measures
| Measure |
Control Group
n=33 Participants
In the control group, no changes were. This group received a standard care lifestyle camp for 10-weeks.
|
Intervention Group
n=42 Participants
In the intervention group, the aim was to replace carbohydrates-rich foods at breakfast and two in-between meals with naturally protein-containing foods (e.g., dairy products, nuts, egg, meat-products) to increase the amount of protein from \~ 10-15E% to \~ 25E% per day with minimal changes in total caloric intake.
|
SARS CoV-group
n=11 Participants
The SARS CoV-group were affected by the COVID-19 lockdown of the camps.Thus, they were sent home for five weeks with no control of dietary intake and physical activity. They received standard care during their stay at camp.
|
|---|---|---|---|
|
LDL Cholesterol
|
-0.25 mmol/L
Interval -0.42 to -0.09
|
-0.43 mmol/L
Interval -0.6 to -0.26
|
-0.34 mmol/L
Interval -0.56 to -0.12
|
SECONDARY outcome
Timeframe: Mean changes from baseline to 10-weeks (post camp intervention)Population: The COVID-19 pandemic forced a lockdown from December 2020 to February 2021. All children affected by the COVID-19 lockdown (The SARS CoV-group) were sent home for five weeks with no control of dietary intake and physical. Only a subsample of participants had bloodsamples collected.
Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
Outcome measures
| Measure |
Control Group
n=33 Participants
In the control group, no changes were. This group received a standard care lifestyle camp for 10-weeks.
|
Intervention Group
n=42 Participants
In the intervention group, the aim was to replace carbohydrates-rich foods at breakfast and two in-between meals with naturally protein-containing foods (e.g., dairy products, nuts, egg, meat-products) to increase the amount of protein from \~ 10-15E% to \~ 25E% per day with minimal changes in total caloric intake.
|
SARS CoV-group
n=11 Participants
The SARS CoV-group were affected by the COVID-19 lockdown of the camps.Thus, they were sent home for five weeks with no control of dietary intake and physical activity. They received standard care during their stay at camp.
|
|---|---|---|---|
|
P-tryglyceride
|
-0.18 mmol/L
Interval -0.35 to -0.01
|
-0.20 mmol/L
Interval -0.37 to -0.03
|
-0.35 mmol/L
Interval -0.65 to -0.05
|
SECONDARY outcome
Timeframe: Mean changes from baseline to 10-weeks (post camp intervention)Population: The COVID-19 pandemic forced a lockdown from December 2020 to February 2021. All children affected by the COVID-19 lockdown (The SARS CoV-group) were sent home for five weeks with no control of dietary intake and physical. Only a subsample of participants had bloodsamples collected.
Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
Outcome measures
| Measure |
Control Group
n=33 Participants
In the control group, no changes were. This group received a standard care lifestyle camp for 10-weeks.
|
Intervention Group
n=42 Participants
In the intervention group, the aim was to replace carbohydrates-rich foods at breakfast and two in-between meals with naturally protein-containing foods (e.g., dairy products, nuts, egg, meat-products) to increase the amount of protein from \~ 10-15E% to \~ 25E% per day with minimal changes in total caloric intake.
|
SARS CoV-group
n=11 Participants
The SARS CoV-group were affected by the COVID-19 lockdown of the camps.Thus, they were sent home for five weeks with no control of dietary intake and physical activity. They received standard care during their stay at camp.
|
|---|---|---|---|
|
ALAT
|
-0.14 units/L
Interval -0.25 to -0.03
|
-0.28 units/L
Interval -0.43 to -0.13
|
0.13 units/L
Interval -0.1 to 0.37
|
SECONDARY outcome
Timeframe: Mean changes from baseline to 10-weeks (post camp intervention)Population: The COVID-19 pandemic forced a lockdown from December 2020 to February 2021. All children affected by the COVID-19 lockdown (The SARS CoV-group) were sent home for five weeks with no control of dietary intake and physical. Only a subsample of participants had bloodsamples collected.
Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
Outcome measures
| Measure |
Control Group
n=33 Participants
In the control group, no changes were. This group received a standard care lifestyle camp for 10-weeks.
|
Intervention Group
n=42 Participants
In the intervention group, the aim was to replace carbohydrates-rich foods at breakfast and two in-between meals with naturally protein-containing foods (e.g., dairy products, nuts, egg, meat-products) to increase the amount of protein from \~ 10-15E% to \~ 25E% per day with minimal changes in total caloric intake.
|
SARS CoV-group
n=11 Participants
The SARS CoV-group were affected by the COVID-19 lockdown of the camps.Thus, they were sent home for five weeks with no control of dietary intake and physical activity. They received standard care during their stay at camp.
|
|---|---|---|---|
|
ASAT
|
-0.04 units/L
Interval -0.14 to 0.06
|
-0.16 units/L
Interval -0.27 to -0.04
|
0.18 units/L
Interval 0.06 to 0.29
|
SECONDARY outcome
Timeframe: Mean changes from baseline to 10-weeks (post camp intervention)Population: The COVID-19 pandemic forced a lockdown from December 2020 to February 2021. All children affected by the COVID-19 lockdown (The SARS CoV-group) were sent home for five weeks with no control of dietary intake and physical. Only a subsample of participants had bloodsamples collected.
Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
Outcome measures
| Measure |
Control Group
n=33 Participants
In the control group, no changes were. This group received a standard care lifestyle camp for 10-weeks.
|
Intervention Group
n=42 Participants
In the intervention group, the aim was to replace carbohydrates-rich foods at breakfast and two in-between meals with naturally protein-containing foods (e.g., dairy products, nuts, egg, meat-products) to increase the amount of protein from \~ 10-15E% to \~ 25E% per day with minimal changes in total caloric intake.
|
SARS CoV-group
n=11 Participants
The SARS CoV-group were affected by the COVID-19 lockdown of the camps.Thus, they were sent home for five weeks with no control of dietary intake and physical activity. They received standard care during their stay at camp.
|
|---|---|---|---|
|
GGT
|
-0.16 units/L
Interval -0.25 to -0.07
|
-0.22 units/L
Interval -0.36 to -0.09
|
-0.24 units/L
Interval -0.38 to -0.1
|
SECONDARY outcome
Timeframe: Mean changes from baseline to 10-weeks (post camp intervention)Population: The COVID-19 pandemic forced a lockdown from December 2020 to February 2021. All children affected by the COVID-19 lockdown (The SARS CoV-group) were sent home for five weeks with no control of dietary intake and physical. Only a subsample of participants had bloodsamples collected.
Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
Outcome measures
| Measure |
Control Group
n=33 Participants
In the control group, no changes were. This group received a standard care lifestyle camp for 10-weeks.
|
Intervention Group
n=42 Participants
In the intervention group, the aim was to replace carbohydrates-rich foods at breakfast and two in-between meals with naturally protein-containing foods (e.g., dairy products, nuts, egg, meat-products) to increase the amount of protein from \~ 10-15E% to \~ 25E% per day with minimal changes in total caloric intake.
|
SARS CoV-group
n=11 Participants
The SARS CoV-group were affected by the COVID-19 lockdown of the camps.Thus, they were sent home for five weeks with no control of dietary intake and physical activity. They received standard care during their stay at camp.
|
|---|---|---|---|
|
Basic Phosphatase
|
-15.47 units/L
Interval -36.22 to 5.29
|
-3.69 units/L
Interval -25.26 to 17.88
|
-22.62 units/L
Interval -45.46 to 0.23
|
SECONDARY outcome
Timeframe: Mean changes from baseline to 10-weeks (post camp intervention)Population: The COVID-19 pandemic forced a lockdown from December 2020 to February 2021. All children affected by the COVID-19 lockdown (The SARS CoV-group) were sent home for five weeks with no control of dietary intake and physical. Only a subsample of participants had bloodsamples collected.
Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
Outcome measures
| Measure |
Control Group
n=33 Participants
In the control group, no changes were. This group received a standard care lifestyle camp for 10-weeks.
|
Intervention Group
n=42 Participants
In the intervention group, the aim was to replace carbohydrates-rich foods at breakfast and two in-between meals with naturally protein-containing foods (e.g., dairy products, nuts, egg, meat-products) to increase the amount of protein from \~ 10-15E% to \~ 25E% per day with minimal changes in total caloric intake.
|
SARS CoV-group
n=11 Participants
The SARS CoV-group were affected by the COVID-19 lockdown of the camps.Thus, they were sent home for five weeks with no control of dietary intake and physical activity. They received standard care during their stay at camp.
|
|---|---|---|---|
|
HbA1c
|
-0.46 mmol/mol
Interval -1.24 to 0.31
|
-0.21 mmol/mol
Interval -0.82 to 0.41
|
-0.23 mmol/mol
Interval -0.97 to 0.51
|
SECONDARY outcome
Timeframe: Mean changes from baseline to 10-weeks (post camp intervention)Population: The COVID-19 pandemic forced a lockdown from December 2020 to February 2021. All children affected by the COVID-19 lockdown (The SARS CoV-group) were sent home for five weeks with no control of dietary intake and physical. Only a subsample of participants had bloodsamples collected.
Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
Outcome measures
| Measure |
Control Group
n=33 Participants
In the control group, no changes were. This group received a standard care lifestyle camp for 10-weeks.
|
Intervention Group
n=42 Participants
In the intervention group, the aim was to replace carbohydrates-rich foods at breakfast and two in-between meals with naturally protein-containing foods (e.g., dairy products, nuts, egg, meat-products) to increase the amount of protein from \~ 10-15E% to \~ 25E% per day with minimal changes in total caloric intake.
|
SARS CoV-group
n=11 Participants
The SARS CoV-group were affected by the COVID-19 lockdown of the camps.Thus, they were sent home for five weeks with no control of dietary intake and physical activity. They received standard care during their stay at camp.
|
|---|---|---|---|
|
P-glucose
|
-0.07 mmol/L
Interval -0.18 to 0.04
|
-0.02 mmol/L
Interval -0.11 to 0.07
|
-0.01 mmol/L
Interval -0.12 to 0.09
|
SECONDARY outcome
Timeframe: Mean changes from baseline to 10-weeks (post camp intervention)Population: The COVID-19 pandemic forced a lockdown from December 2020 to February 2021. All children affected by the COVID-19 lockdown (The SARS CoV-group) were sent home for five weeks with no control of dietary intake and physical. Only a subsample of participants had bloodsamples collected.
Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
Outcome measures
| Measure |
Control Group
n=33 Participants
In the control group, no changes were. This group received a standard care lifestyle camp for 10-weeks.
|
Intervention Group
n=42 Participants
In the intervention group, the aim was to replace carbohydrates-rich foods at breakfast and two in-between meals with naturally protein-containing foods (e.g., dairy products, nuts, egg, meat-products) to increase the amount of protein from \~ 10-15E% to \~ 25E% per day with minimal changes in total caloric intake.
|
SARS CoV-group
n=11 Participants
The SARS CoV-group were affected by the COVID-19 lockdown of the camps.Thus, they were sent home for five weeks with no control of dietary intake and physical activity. They received standard care during their stay at camp.
|
|---|---|---|---|
|
Albumin
|
-0.51 g/L
Interval -1.29 to 0.26
|
-0.14 g/L
Interval -0.94 to 0.66
|
-2.33 g/L
Interval -3.37 to -1.29
|
SECONDARY outcome
Timeframe: Mean changes from baseline to 10-weeks (post camp intervention)Population: The COVID-19 pandemic forced a lockdown from December 2020 to February 2021. All children affected by the COVID-19 lockdown (The SARS CoV-group) were sent home for five weeks with no control of dietary intake and physical. Only a subsample of participants had bloodsamples collected.
Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
Outcome measures
| Measure |
Control Group
n=33 Participants
In the control group, no changes were. This group received a standard care lifestyle camp for 10-weeks.
|
Intervention Group
n=42 Participants
In the intervention group, the aim was to replace carbohydrates-rich foods at breakfast and two in-between meals with naturally protein-containing foods (e.g., dairy products, nuts, egg, meat-products) to increase the amount of protein from \~ 10-15E% to \~ 25E% per day with minimal changes in total caloric intake.
|
SARS CoV-group
n=11 Participants
The SARS CoV-group were affected by the COVID-19 lockdown of the camps.Thus, they were sent home for five weeks with no control of dietary intake and physical activity. They received standard care during their stay at camp.
|
|---|---|---|---|
|
CD163
|
0.01 mg/L
Interval -0.08 to 0.09
|
-0.08 mg/L
Interval -0.17 to 0.01
|
-0.12 mg/L
Interval -0.24 to 0.01
|
SECONDARY outcome
Timeframe: Mean changes from baseline to 10-weeks (post camp intervention)Population: The COVID-19 pandemic forced a lockdown from December 2020 to February 2021. All children affected by the COVID-19 lockdown (The SARS CoV-group) were sent home for five weeks with no control of dietary intake and physical. Only a subsample of participants had bloodsamples collected. .
Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
Outcome measures
| Measure |
Control Group
n=33 Participants
In the control group, no changes were. This group received a standard care lifestyle camp for 10-weeks.
|
Intervention Group
n=42 Participants
In the intervention group, the aim was to replace carbohydrates-rich foods at breakfast and two in-between meals with naturally protein-containing foods (e.g., dairy products, nuts, egg, meat-products) to increase the amount of protein from \~ 10-15E% to \~ 25E% per day with minimal changes in total caloric intake.
|
SARS CoV-group
n=11 Participants
The SARS CoV-group were affected by the COVID-19 lockdown of the camps.Thus, they were sent home for five weeks with no control of dietary intake and physical activity. They received standard care during their stay at camp.
|
|---|---|---|---|
|
Platelets
|
-0.14 Units/L
Interval -0.18 to -0.1
|
-0.10 Units/L
Interval -0.14 to -0.06
|
-0.14 Units/L
Interval -0.21 to -0.06
|
SECONDARY outcome
Timeframe: Mean changes from baseline to 10-weeks (post camp intervention)Population: The COVID-19 pandemic forced a lockdown from December 2020 to February 2021. All children affected by the COVID-19 lockdown (The SARS CoV-group) were sent home for five weeks with no control of dietary intake and physical. Only a subsample of participants had bloodsamples collected.
Educated bio-analysts were responsible for collecting blood samples in a subsample of children.
Outcome measures
| Measure |
Control Group
n=33 Participants
In the control group, no changes were. This group received a standard care lifestyle camp for 10-weeks.
|
Intervention Group
n=42 Participants
In the intervention group, the aim was to replace carbohydrates-rich foods at breakfast and two in-between meals with naturally protein-containing foods (e.g., dairy products, nuts, egg, meat-products) to increase the amount of protein from \~ 10-15E% to \~ 25E% per day with minimal changes in total caloric intake.
|
SARS CoV-group
n=11 Participants
The SARS CoV-group were affected by the COVID-19 lockdown of the camps.Thus, they were sent home for five weeks with no control of dietary intake and physical activity. They received standard care during their stay at camp.
|
|---|---|---|---|
|
Uric Acid
|
-0.04 mmol/L
Interval -0.05 to -0.02
|
-0.03 mmol/L
Interval -0.04 to -0.02
|
-0.02 mmol/L
Interval -0.05 to 0.007
|
Adverse Events
All Arms
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
Dorthe Dalstrup Pauls
Department of Clinical Medicine, Aarhus University / Steno Diabetes Center Aarhus, Aarhus University Hospital
Phone: +45 28256406
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place