The Odense Overweight Intervention Study
NCT01574352, Not applicable, Unknown, University of Southern Denmark; results first posted 2020-11-19
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Odense Overweight Intervention Study | ClinicalTrials.gov |
| NCT number | NCT01574352 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 115 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of Southern Denmark | ClinicalTrials.gov |
| Conditions | Children, Overweight, Obesity, Metabolic Syndrome | ClinicalTrials.gov |
| Interventions | Small intervention, Intervention camp | ClinicalTrials.gov |
| First posted | 2012-04-10 | ClinicalTrials.gov |
| Last updated | 2020-11-19 | ClinicalTrials.gov |
| Results first posted | 2020-11-19 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in BMI From Baseline to 12 Months Follow up. | 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. | 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. | ClinicalTrials.gov |
| Secondary | Change in Cognitive Function From Baseline to 12 Months Follow up. | 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. | ClinicalTrials.gov |
| Secondary | Change in Motor Skills From Baseline to 12 Months Follow up. | 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 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. | ClinicalTrials.gov |
| Secondary | Change in Body Composition From Baseline to 12 Months Follow up. | 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. | Measurements of fat mass and lean tissue mass using dual-energy X-ray absorptiometry. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Brain-derived Neurotrophic Factor (BDNF) at 12 Months. | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Blood Pressure at 12 Months. | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Subclinical Atherosclerosis Using B-mode Ultrasound: Carotid Intima Media Thickness and Carotid Elasticity at 12 Months. | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Cardio-respiratory Fitness at 12 Months. | 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). | ClinicalTrials.gov |
| Secondary | Change From Baseline in Insulin Level at 12 Months. | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Glucose Level at 12 Months. | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Blood Lipids at 12 Months. | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in C-Reactive Protein at 12 Months. | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Waist/Hip Circumference at 12 Months. | 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. | ClinicalTrials.gov |
| Secondary | Change in Clustered Cardiovascular Disease (CVD) Risk Factor | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Physical Strength at 12 Months. | 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. | ClinicalTrials.gov |
Outcomes 15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Change in BMI From Baseline to 12 Months Follow up. | 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. | Only children that participated in both the baseline and the follow up measurements were included in the results. | BMI (kg/m^2) | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Cognitive Function From Baseline to 12 Months Follow up. | 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. | ClinicalTrials.gov | |||
| SECONDARY | Change in Motor Skills From Baseline to 12 Months Follow up. | 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. | Only children that participated in both the baseline and the follow up measurements were included in the results. | Percentile score on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Body Composition From Baseline to 12 Months Follow up. | 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. | 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. | Change in percent body fat | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Brain-derived Neurotrophic Factor (BDNF) at 12 Months. | 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. | ClinicalTrials.gov | |||
| SECONDARY | Change From Baseline in Blood Pressure at 12 Months. | 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. | ClinicalTrials.gov | |||
| SECONDARY | Change From Baseline in Subclinical Atherosclerosis Using B-mode Ultrasound: Carotid Intima Media Thickness and Carotid Elasticity at 12 Months. | 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. | ClinicalTrials.gov | |||
| SECONDARY | Change From Baseline in Cardio-respiratory Fitness at 12 Months. | 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. | ClinicalTrials.gov | |||
| SECONDARY | Change From Baseline in Insulin Level at 12 Months. | 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. | ClinicalTrials.gov | |||
| SECONDARY | Change From Baseline in Glucose Level at 12 Months. | 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. | ClinicalTrials.gov | |||
| SECONDARY | Change From Baseline in Blood Lipids at 12 Months. | 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. | ClinicalTrials.gov | |||
| SECONDARY | Change From Baseline in C-Reactive Protein at 12 Months. | 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. | ClinicalTrials.gov | |||
| SECONDARY | Change From Baseline in Waist/Hip Circumference at 12 Months. | 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. | ClinicalTrials.gov | |||
| SECONDARY | Change in Clustered Cardiovascular Disease (CVD) Risk Factor | 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. | ClinicalTrials.gov | |||
| SECONDARY | Change From Baseline in Physical Strength at 12 Months. | 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. | ClinicalTrials.gov |
Results by group 6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Change in BMI From Baseline to 12 Months Follow up. | Intervention Camp | -1.1 | 95% Confidence Interval -1.7 to -0.6 | BMI (kg/m^2) | ClinicalTrials.gov | |
| Change in BMI From Baseline to 12 Months Follow up. | Standard Intervention | 0.1 | 95% Confidence Interval -0.4 to 0.6 | BMI (kg/m^2) | ClinicalTrials.gov | |
| Change in Motor Skills From Baseline to 12 Months Follow up. | Intervention Camp | 6.4 | 95% Confidence Interval -0.5 to 13.3 | Percentile score on a scale | ClinicalTrials.gov | |
| Change in Motor Skills From Baseline to 12 Months Follow up. | Standard Intervention | 22.6 | 95% Confidence Interval 13.2 to 32.0 | Percentile score on a scale | ClinicalTrials.gov | |
| Change in Body Composition From Baseline to 12 Months Follow up. | Intervention Camp | -3.8 | 95% Confidence Interval -5.1 to -2.6 | Change in percent body fat | ClinicalTrials.gov | |
| Change in Body Composition From Baseline to 12 Months Follow up. | Standard Intervention | -2.0 | 95% Confidence Interval -3.4 to -0.7 | Change in percent body fat | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Intervention Camp | 55 | ClinicalTrials.gov | |
| Overall Study | STARTED | Standard Intervention | 51 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Intervention Camp | 48 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Standard Intervention | 38 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Intervention Camp | 7 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Standard Intervention | 13 | ClinicalTrials.gov |
Adverse events 4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| serious | Eating disorder | Psychiatric disorders | Camp Intervention | 0 | 55 | 0 | ClinicalTrials.gov |
| serious | Eating disorder | Psychiatric disorders | Standard Internvention | 0 | 51 | 0 | ClinicalTrials.gov |
| serious | Self harm | Psychiatric disorders | Camp Intervention | 0 | 55 | 0 | ClinicalTrials.gov |
| serious | Self harm | Psychiatric disorders | Standard Internvention | 0 | 51 | 0 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Camp Intervention | 0 | 55 | ClinicalTrials.gov |
| Total, all-cause mortality | Standard Internvention | 0 | 51 | ClinicalTrials.gov |
| Total, other adverse events | Camp Intervention | 0 | 55 | ClinicalTrials.gov |
| Total, other adverse events | Standard Internvention | 0 | 51 | ClinicalTrials.gov |
| Total, serious adverse events | Camp Intervention | 0 | 55 | ClinicalTrials.gov |
| Total, serious adverse events | Standard Internvention | 0 | 51 | ClinicalTrials.gov |
Papers 3
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Camp Intervention vs Standard Internvention: deaths from any cause | Trial comparisons |
| Camp Intervention vs Standard Internvention: serious adverse events | Trial comparisons |
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Complex Figure Copy and Recall | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)