Trial Outcomes & Findings for The Odense Overweight Intervention Study (NCT NCT01574352)
NCT ID: NCT01574352
Last Updated: 2020-11-19
Results Overview
Change in Body Mass Index (BMI) for each intervention arm from baseline (4-6 weeks prior to intervention) to 12 months follow up. BMI is defined as kg/m\^2. Although three measurements have been conducted, we only report the first and last.
UNKNOWN
NA
115 participants
Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions.
2020-11-19
Participant Flow
Due to practical circumstances, it was not possible to conduct baseline measurements before randomization. Consequently, 9 participants dropped out before baseline measurements toke place.
Participant milestones
| Measure |
Intervention Camp
Children's behavior were controlled each week day for six weeks, and participated in three hours of physical activity every day.
Intervention camp: The children were participating in a 6 week day camp. The camp contained social activities, physical activity training, usual school classes and health education. All meals (healthy food) were consumed during the camp day.
A subsequent 46 weeks family based intervention took place after the camp was completed.
|
Standard Intervention
Standard intervention: The children were offered a weekly 1 hour training and/or activity session during six weeks. This includes one session where the parents also were invited to get information about diet and exercise.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
51
|
|
Overall Study
COMPLETED
|
48
|
38
|
|
Overall Study
NOT COMPLETED
|
7
|
13
|
Reasons for withdrawal
| Measure |
Intervention Camp
Children's behavior were controlled each week day for six weeks, and participated in three hours of physical activity every day.
Intervention camp: The children were participating in a 6 week day camp. The camp contained social activities, physical activity training, usual school classes and health education. All meals (healthy food) were consumed during the camp day.
A subsequent 46 weeks family based intervention took place after the camp was completed.
|
Standard Intervention
Standard intervention: The children were offered a weekly 1 hour training and/or activity session during six weeks. This includes one session where the parents also were invited to get information about diet and exercise.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
13
|
|
Overall Study
Injury in non-camp related sport
|
1
|
0
|
Baseline Characteristics
The Odense Overweight Intervention Study
Baseline characteristics by cohort
| Measure |
Intervention Camp
n=55 Participants
Children's behavior were controlled each week day for six weeks, and participated in three hours of physical activity every day.
Intervention camp: The children were participating in a 6 week day camp. The camp contained social activities, physical activity training, usual school classes and health education. All meals (healthy food) were consumed during the camp day.
A subsequent 46 weeks family based intervention took place after the camp was completed.
|
Standard Intervention
n=51 Participants
Standard intervention: The children were offered a weekly 1 hour training and/or activity session during six weeks. This includes one session where the parents also were invited to get information about diet and exercise.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.04 years
STANDARD_DEVIATION 0.38 • n=5 Participants
|
11.95 years
STANDARD_DEVIATION 0.46 • n=7 Participants
|
12.00 years
STANDARD_DEVIATION 0.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Danish
|
34 participants
n=5 Participants
|
36 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Danish
|
21 participants
n=5 Participants
|
15 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
55 participants
n=5 Participants
|
51 participants
n=7 Participants
|
106 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
25.00 kg/m^2
STANDARD_DEVIATION 2.80 • n=5 Participants
|
24.52 kg/m^2
STANDARD_DEVIATION 3.01 • n=7 Participants
|
24.78 kg/m^2
STANDARD_DEVIATION 2.89 • n=5 Participants
|
|
Standardized BMI Z-score
|
1.64 Standardized BMI Z-score
STANDARD_DEVIATION 0.37 • n=5 Participants
|
1.54 Standardized BMI Z-score
STANDARD_DEVIATION 0.42 • n=7 Participants
|
1.59 Standardized BMI Z-score
STANDARD_DEVIATION 0.40 • n=5 Participants
|
|
Socio-economic status (SES)
SES level 1
|
15 participants
n=5 Participants
|
10 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Socio-economic status (SES)
SES level 2
|
24 participants
n=5 Participants
|
15 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Socio-economic status (SES)
SES level 3
|
13 participants
n=5 Participants
|
22 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Weight status
Normal weight
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Weight status
Overweight
|
36 participants
n=5 Participants
|
31 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Weight status
Obese
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Systolic blood pressure
|
106.64 mmHg
STANDARD_DEVIATION 7.64 • n=5 Participants
|
103.90 mmHg
STANDARD_DEVIATION 8.52 • n=7 Participants
|
105.35 mmHg
STANDARD_DEVIATION 8.14 • n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions.Population: Only children that participated in both the baseline and the follow up measurements were included in the results.
Change in Body Mass Index (BMI) for each intervention arm from baseline (4-6 weeks prior to intervention) to 12 months follow up. BMI is defined as kg/m\^2. Although three measurements have been conducted, we only report the first and last.
Outcome measures
| Measure |
Intervention Camp
n=48 Participants
Children's behavior were controlled each week day for six weeks, and participated in three hours of physical activity every day.
Intervention camp: The children were participating in a 6 week day camp. The camp contained social activities, physical activity training, usual school classes and health education. All meals (healthy food) were consumed during the camp day.
A subsequent 46 weeks family based intervention took place after the camp was completed.
|
Standard Intervention
n=38 Participants
Standard intervention: The children were offered a weekly 1 hour training and/or activity session during six weeks. This includes one session where the parents also were invited to get information about diet and exercise.
|
|---|---|---|
|
Change in BMI From Baseline to 12 Months Follow up.
|
-1.1 BMI (kg/m^2)
Interval -1.7 to -0.6
|
0.1 BMI (kg/m^2)
Interval -0.4 to 0.6
|
SECONDARY outcome
Timeframe: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions.To assess cognitive function the following test are used: The Stroop Color and word test; Trail making test (part A and B); Rey complex figure test and recognition trial; Symbol digit modalities Test; Behavior rating inventory of executive function.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions.Population: Only children that participated in both the baseline and the follow up measurements were included in the results.
To assess motor skills, the Movement Assesment Battery for Children 2 (Movement ABC-2) test for 11-16 year olds was applied. The battery allows for recording a number of different aspects of a child's movement skills in a systematic way. In this study we only used the quantitative part of the test (it also includes a qualitative part). This includes 3 tests for hand skills (fine motor skills), 2 tests for throwing and catching balls, and 3 tests for balance skills. Each subtest returns a score, which is summarized and then equivalent to a percentile score (based on norm data from a standard population in a table from the Movement ABC-2 compendium). The percentile score is reported as the overall motor skills. The scale is from 0.1 to 99.9 (normal distributed with an average of 50) and higher scores mean better motor skills.
Outcome measures
| Measure |
Intervention Camp
n=46 Participants
Children's behavior were controlled each week day for six weeks, and participated in three hours of physical activity every day.
Intervention camp: The children were participating in a 6 week day camp. The camp contained social activities, physical activity training, usual school classes and health education. All meals (healthy food) were consumed during the camp day.
A subsequent 46 weeks family based intervention took place after the camp was completed.
|
Standard Intervention
n=36 Participants
Standard intervention: The children were offered a weekly 1 hour training and/or activity session during six weeks. This includes one session where the parents also were invited to get information about diet and exercise.
|
|---|---|---|
|
Change in Motor Skills From Baseline to 12 Months Follow up.
|
6.4 Percentile score on a scale
Interval -0.5 to 13.3
|
22.6 Percentile score on a scale
Interval 13.2 to 32.0
|
SECONDARY outcome
Timeframe: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions.Population: Only children that participated in both the baseline and the follow up measurements were included in the results. As this test took place on a different time and location than most other tests, the number of participants differs from many other tests.
Measurements of fat mass and lean tissue mass using dual-energy X-ray absorptiometry.
Outcome measures
| Measure |
Intervention Camp
n=47 Participants
Children's behavior were controlled each week day for six weeks, and participated in three hours of physical activity every day.
Intervention camp: The children were participating in a 6 week day camp. The camp contained social activities, physical activity training, usual school classes and health education. All meals (healthy food) were consumed during the camp day.
A subsequent 46 weeks family based intervention took place after the camp was completed.
|
Standard Intervention
n=39 Participants
Standard intervention: The children were offered a weekly 1 hour training and/or activity session during six weeks. This includes one session where the parents also were invited to get information about diet and exercise.
|
|---|---|---|
|
Change in Body Composition From Baseline to 12 Months Follow up.
|
-3.8 Change in percent body fat
Interval -5.1 to -2.6
|
-2.0 Change in percent body fat
Interval -3.4 to -0.7
|
SECONDARY outcome
Timeframe: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions.The chronic level of serum brain-derived neurotrophic factor (BDNF) is assessed in fasting blood samples.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions.Blood pressure will be measured in up-right sitting position after resting supine for ten minutes. A minimum of five measurements will be conducted with one minute intervals.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions.The Carotid Intima Media and Carotid Elasticity are measured on 2 sites (posterior and lateral) of the far wall 1 cm proximal to the bifurcation on both sides of the common carotid artery.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions.Cardio-respiratory fitness will be assessed using a progressive bicycle ergometer protocol after a 5 minutes warm-up by means of indirect calorimetry (Innovision, Odense, Denmark).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions.The level of insulin is assessed in fasting blood samples.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions.The level of glucose is assessed in fasting blood samples.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions.The levels of lipids are assessed in fasting blood samples.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions.The level of c-reactive-protein is assessed in fasting blood samples.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions.Hip circumference will be measured at the level of the great trochanter. Waist circumference will be measured between the lower costal margin and the iliac crest.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions.The CVD risk factor is the mutual presence of five different health outcomes based on the Metabolic Syndrome. It is calculated by creating a composite risk score (mean of z-scores) of: 1) Insulin resistance (Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)), 2) Systolic blood pressure, 3) triglyceride, 4) total cholesterol/HDL ratio, 5) Abdominal fatness (by Dual-energy X-ray absorptiometry (DXA)), and 6) aerobic fitness.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions.Will be measured by hand grip and Sargent vertical jump.
Outcome measures
Outcome data not reported
Adverse Events
Camp Intervention
Standard Internvention
Serious adverse events
| Measure |
Camp Intervention
n=55 participants at risk
The intervention camp consisted of a six-week multi-component day camp including increased physical activity, healthy diet and health education followed by 46 weeks of family-based habitual intervention.
The standard care arm was offered two weekly hours of physical activity training for six weeks.
|
Standard Internvention
n=51 participants at risk
In the Standard intervention children were offered a weekly 1-hour training and/or activity session during six weeks. This includes one session where the parents also were invited to get information about diet and exercise.
|
|---|---|---|
|
Psychiatric disorders
Eating disorder
|
0.00%
0/55 • During the 48 weeks following the intervention. Monitoring were non-systematic.
Health professionals (school nurses) met families that choose to participate in the following meetings throughout the 48 weeks following the intervention. If any of the children showed signs of eating disorders or self harm, they would react appropriately. The screening were non-systematic.
|
0.00%
0/51 • During the 48 weeks following the intervention. Monitoring were non-systematic.
Health professionals (school nurses) met families that choose to participate in the following meetings throughout the 48 weeks following the intervention. If any of the children showed signs of eating disorders or self harm, they would react appropriately. The screening were non-systematic.
|
|
Psychiatric disorders
Self harm
|
0.00%
0/55 • During the 48 weeks following the intervention. Monitoring were non-systematic.
Health professionals (school nurses) met families that choose to participate in the following meetings throughout the 48 weeks following the intervention. If any of the children showed signs of eating disorders or self harm, they would react appropriately. The screening were non-systematic.
|
0.00%
0/51 • During the 48 weeks following the intervention. Monitoring were non-systematic.
Health professionals (school nurses) met families that choose to participate in the following meetings throughout the 48 weeks following the intervention. If any of the children showed signs of eating disorders or self harm, they would react appropriately. The screening were non-systematic.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place