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The Odense Overweight Intervention Study (OOIS)

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ClinicalTrials.gov Identifier: NCT01574352
Recruitment Status : Active, not recruiting
First Posted : April 10, 2012
Results First Posted : November 19, 2020
Last Update Posted : November 19, 2020
Sponsor:
Collaborator:
TrygFonden, Denmark
Information provided by (Responsible Party):
Lars Bo Andersen, University of Southern Denmark

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Prevention
Conditions Children
Overweight
Obesity
Metabolic Syndrome
Interventions Behavioral: Small intervention
Behavioral: Intervention camp
Enrollment 115
Recruitment Details  
Pre-assignment Details Due to practical circumstances, it was not possible to conduct baseline measurements before randomization. Consequently, 9 participants dropped out before baseline measurements toke place.
Arm/Group Title Intervention Camp Standard Intervention
Hide Arm/Group Description

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: 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.
Period Title: Overall Study
Started 55 [1] 51 [2]
Completed 48 [3] 38 [3]
Not Completed 7 13
Reason Not Completed
Withdrawal by Subject             6             13
Injury in non-camp related sport             1             0
[1]
59 participants where randomized, but 4 dropped out prior to baseline measurements.
[2]
56 participants where randomized, but 5 dropped out prior to baseline measurements.
[3]
Participated in the last follow up measurement.
Arm/Group Title Intervention Camp Standard Intervention Total
Hide Arm/Group Description

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: 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 of all reporting groups
Overall Number of Baseline Participants 55 51 106
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 51 participants 106 participants
12.04  (0.38) 11.95  (0.46) 12.00  (0.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 51 participants 106 participants
Female
29
  52.7%
30
  58.8%
59
  55.7%
Male
26
  47.3%
21
  41.2%
47
  44.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 55 participants 51 participants 106 participants
Danish 34 36 70
Non-Danish 21 15 36
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Denmark Number Analyzed 55 participants 51 participants 106 participants
55 51 106
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 55 participants 51 participants 106 participants
25.00  (2.80) 24.52  (3.01) 24.78  (2.89)
[1]
Measure Description: The BMI is calculated as kg/m^2.
Standardized BMI Z-score   [1] 
Mean (Standard Deviation)
Unit of measure:  Standardized BMI Z-score
Number Analyzed 55 participants 51 participants 106 participants
1.64  (0.37) 1.54  (0.42) 1.59  (0.40)
[1]
Measure Description:

Based on the International Obesity Task Force (IOTF) 2000 definitions of age and sex adjusted weight status (Cole TJ., 2012).

According to the IOTF-2000 cut points the body mass index (BMI) of 21.22 kg/m2 at age 12.0 corresponds to a BMI of 25 kg/m2 at age 18.0 for males. The corresponding BMI for females is 21.68 at age 12.0.

An IOTF Z-score from -1.014 to 1.310 corresponds to normal weight for any given age. Values above are indicative of being overweight. Values below are indicative of being underweight.

Socio-economic status (SES)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 55 participants 51 participants 106 participants
SES level 1 15 10 25
SES level 2 24 15 39
SES level 3 13 22 35
[1]
Measure Description:

Based on the mothers highest education level. Data were not available for all participants.

SES level 1 corresponds to basic school no more than 10 years. SES level 2 corresponds to high school or non-university vocational programs. SES level 3 corresponds to college or university degrees.

Weight status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 55 participants 51 participants 106 participants
Normal weight 3 6 9
Overweight 36 31 67
Obese 16 14 30
[1]
Measure Description:

Based on the International Obesity Task Force 2000 definitions of age and sex adjusted weight status. The child was initially invited to participate if he/she was overweight or obese at the screening assessments.

Some participants had lost weight after the screening and before the baseline measurements, which explains why 9 individuals are normal weight at baseline measurements.

Systolic blood pressure   [1] 
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 55 participants 51 participants 106 participants
106.64  (7.64) 103.90  (8.52) 105.35  (8.14)
[1]
Measure Description: Measured after 10 minutes in a seated position and calm environment.
1.Primary Outcome
Title Change in BMI From Baseline to 12 Months Follow up.
Hide Description

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.

Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Only children that participated in both the baseline and the follow up measurements were included in the results.
Arm/Group Title Intervention Camp Standard Intervention
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 48 38
Mean (95% Confidence Interval)
Unit of Measure: BMI (kg/m^2)
-1.1
(-1.7 to -0.6)
0.1
(-0.4 to 0.6)
2.Secondary Outcome
Title Change in Cognitive Function From Baseline to 12 Months Follow up.
Hide Description 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.
Time Frame 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.
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Change in Motor Skills From Baseline to 12 Months Follow up.
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Only children that participated in both the baseline and the follow up measurements were included in the results.
Arm/Group Title Intervention Camp Standard Intervention
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 46 36
Mean (95% Confidence Interval)
Unit of Measure: Percentile score on a scale
6.4
(-0.5 to 13.3)
22.6
(13.2 to 32.0)
4.Secondary Outcome
Title Change in Body Composition From Baseline to 12 Months Follow up.
Hide Description Measurements of fat mass and lean tissue mass using dual-energy X-ray absorptiometry.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Camp Standard Intervention
Hide Arm/Group Description:

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: 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 Number of Participants Analyzed 47 39
Mean (95% Confidence Interval)
Unit of Measure: Change in percent body fat
-3.8
(-5.1 to -2.6)
-2.0
(-3.4 to -0.7)
5.Secondary Outcome
Title Change From Baseline in Brain-derived Neurotrophic Factor (BDNF) at 12 Months.
Hide Description The chronic level of serum brain-derived neurotrophic factor (BDNF) is assessed in fasting blood samples.
Time Frame 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.
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Change From Baseline in Blood Pressure at 12 Months.
Hide Description 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.
Time Frame 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.
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Change From Baseline in Subclinical Atherosclerosis Using B-mode Ultrasound: Carotid Intima Media Thickness and Carotid Elasticity at 12 Months.
Hide Description 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.
Time Frame 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.
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Change From Baseline in Cardio-respiratory Fitness at 12 Months.
Hide Description 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).
Time Frame 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.
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Change From Baseline in Insulin Level at 12 Months.
Hide Description The level of insulin is assessed in fasting blood samples.
Time Frame 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.
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Change From Baseline in Glucose Level at 12 Months.
Hide Description The level of glucose is assessed in fasting blood samples.
Time Frame 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.
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Change From Baseline in Blood Lipids at 12 Months.
Hide Description The levels of lipids are assessed in fasting blood samples.
Time Frame 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.
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Change From Baseline in C-Reactive Protein at 12 Months.
Hide Description The level of c-reactive-protein is assessed in fasting blood samples.
Time Frame 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.
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Change From Baseline in Waist/Hip Circumference at 12 Months.
Hide Description 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.
Time Frame 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.
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Change in Clustered Cardiovascular Disease (CVD) Risk Factor
Hide Description 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.
Time Frame 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.
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Change From Baseline in Physical Strength at 12 Months.
Hide Description Will be measured by hand grip and Sargent vertical jump.
Time Frame 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.
Outcome Measure Data Not Reported
Time Frame During the 48 weeks following the intervention. Monitoring were non-systematic.
Adverse Event Reporting Description 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.
 
Arm/Group Title Camp Intervention Standard Internvention
Hide Arm/Group Description

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.

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.
All-Cause Mortality
Camp Intervention Standard Internvention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)      0/51 (0.00%)    
Hide Serious Adverse Events
Camp Intervention Standard Internvention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/55 (0.00%)      0/51 (0.00%)    
Psychiatric disorders     
Eating disorder * [1]  0/55 (0.00%)  0 0/51 (0.00%)  0
Self harm * [2]  0/55 (0.00%)  0 0/51 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
School nurses were observant, although in a non-systematic manner, whether any of the children showed signs of eating disorder during the 48 week family-based intervention period.
[2]
School nurses were observant, although in a non-systematic manner, whether any of the children showed signs of self harm during the 48 week family-based intervention period.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Camp Intervention Standard Internvention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/55 (0.00%)      0/51 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: professor Lars Bo Andersen
Organization: USouthernDenmark
Phone: +45 60114380
EMail: lars.bo.andersen@hvl.no
Layout table for additonal information
Responsible Party: Lars Bo Andersen, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01574352    
Other Study ID Numbers: S20120015
First Submitted: March 26, 2012
First Posted: April 10, 2012
Results First Submitted: October 24, 2017
Results First Posted: November 19, 2020
Last Update Posted: November 19, 2020