The Odense Overweight Intervention Study

NCT01574352 | Unknown Results

• 1 other identifier: S20120015
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 2

Brief Summary

Strong and consistent evidence have shown that overweight, including obesity, is an important risk factor for the development of cardiovascular disease (CVD) in adults. Several studies have found an association between overweight in childhood and increased risk of morbidity and mortality later in life. The prevalence of overweight in children and adolescents has increased in recent years, and consequently it is important to identify effective approaches in the prevention and treatment of overweight in young individuals. Approaches such as resident weight loss camps have shown promising results. A residential camp setting provides an opportunity to increase and control exposure to, for instance, particular foodstuffs, beverages and physical activity opportunities. However, well-designed studies with sufficient participants are still needed on the reversal of overweight in childhood with increased focus on documenting predictors of behavior changes associated with decreases in overweight. This study is carried through as a randomized controlled trial which investigates the effect of participating in a 6 week health promoting resident for overweight fifth grade children camp followed by 46 weeks of family support. The study hypothesis is that participating in a 6 week resident camp and a following period of 46 weeks of child and family support will induce a reduction in body mass index (BMI). In addition it is expected that the intensity and duration intervention program is sufficient to cause changes in physiological parameters related to a reduced risk of lifestyle diseases.

Conditions

Children; Overweight; Obesity; Metabolic Syndrome

Keywords

Children; Overweight; Obesity; BMI; Physical activity; Cognitive function; Intervention study; Randomized controlled trial; Day camp; Risk factors

Outcome Measures

Primary Outcomes (1)

• Change in BMI From Baseline to 12 Months Follow up.

  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.

  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.

Secondary Outcomes (14)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Intervention camp

EXPERIMENTAL

Children's behavior are controlled each week day for six weeks, and children participate in three hours of physical activity every day

Behavioral: Intervention camp

Small intervention

EXPERIMENTAL

Children are only informed of healthy behavior

Behavioral: Small intervention

Interventions

Small intervention BEHAVIORAL

The control group are offered a weekly 1 hour training or activity session during six weeks. Furthermore two sessions where the parents are invited to participate in information about diet and exercise.

Also known as: control group

Small intervention

Intervention camp BEHAVIORAL

The children are participating in a 6 week day camp. The camp contains social activities, physical activity training, usual school classes and health education. All meals (healthy food) are consumed during the camp day.

Also known as: Behavioral intervention, Camp intervention, Physical activity intervention

Intervention camp

Eligibility Criteria

• Age: 10 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children in the municipality of Odense, Denmark
• Overweight or obese (BMI) according to the International Obesity Task Force

You may not qualify if:

• Children who are participating in other research based intervention programmes related to risk factors of heart diseases.
• Children who are following a special school programme.
• Use of weight reducing medicine within 3 months before the baseline measurements
• Children with a motor skill determined handicap of such complexity that it hinders them from participating in the intervention.

Sponsors & Collaborators

• University of Southern Denmark: lead
• TrygFonden, Denmark: collaborator

Study Sites (2)

Odense University Hospital

Odense, Funen, 5000, Denmark

Location

University of Southern Denmark

Odense, Funen, 5230, Denmark

Location

Related Publications (3)

• Thomsen CF, Goharian TS, Larsen KT, Goetze JP, Andersen LB, Jeppesen JL. Intensive Lifestyle Intervention Increases Plasma Midregional Proatrial Natriuretic Peptide Concentrations in Overweight Children. J Am Heart Assoc. 2021 Jul 6;10(13):e020676. doi: 10.1161/JAHA.121.020676. Epub 2021 Jun 28.

  PMID: 34180245 DERIVED

• Larsen KT, Huang T, Larsen LR, Olesen LG, Andersen LB, Moller NC. The effect of a multi-component camp-based weight-loss program on children's motor skills and physical fitness: a randomized controlled trial. BMC Pediatr. 2016 Jul 15;16:91. doi: 10.1186/s12887-016-0627-5.

  PMID: 27416906 DERIVED

• Larsen KT, Huang T, Moller NC, Andersen LB, Ried-Larsen M. Effectiveness of a one-year multi-component day-camp intervention for overweight children: study protocol of the Odense overweight intervention study (OOIS). BMC Public Health. 2014 Apr 5;14:313. doi: 10.1186/1471-2458-14-313.

  PMID: 24708676 DERIVED

Related Links

• Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark

MeSH Terms

Conditions

Overweight; Obesity; Metabolic Syndrome; Motor Activity

Interventions

Control Groups; Behavior Therapy

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: professor Lars Bo Andersen
• Organization: USouthernDenmark

lars.bo.andersen@hvl.no

+45 60114380

Study Officials

• Lars Bo Andersen, Professor

  Center of Research in Childhood Health (RICH), University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 26, 2012
• First Posted: April 10, 2012
• Study Start: April 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2021
• Last Updated: November 19, 2020
• Results First Posted: November 19, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: After August 2016
• Access Criteria: 1. Data can only be used for scientific and statistical aims and reporting of aggregated information. Not for investigating affairs of private individuals or organisations. 2. Data can under any circumstances be passed on to a third party, but only be utilized by the user(s) from the project application. 3. Data can only be used for the purposes stated in the project application for the Danish National Archives. 4. Considerable changes of the aim will require a new application. 5. Any publication using the data from the project must bibliographically correct credit the Danish National Archives as well as the principal investigator. Publications must be send to the mailbox og the Danish National Archives attached as a file. The Danish National Archives will forward a copy to the principal investigator. 6. After utilization of the data it must be deleted or returned to the Danish National Archives.

Locations

DK (2)