CI

At a glance

ClinicalIndex Comparison Record
N/AUnknown· 115 enrolled
Drug / intervention
Small intervention +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01574352
NCT01574352N/AUnknown

The Odense Overweight Intervention Study (OOIS): A Randomized Controlled Trial on Overweight Prevention in Children.

University of Southern Denmark·interventional·Posted Apr 10, 2012·Updated Nov 19, 2020

In Brief

A clinical study evaluating Small intervention and Intervention camp for Children and 3 related conditions. Targeting 115 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark
CollaboratorsTrygFonden, Denmark

Timeline

N/AUnknownOverdue
201220132014201520162017201820192020202120222023202420252026
First PostedApr 10, 2012
Enrollment StartApr 1, 2012
Primary CompletionJul 1, 2014
Study CompletionJul 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.2 years ago

Interventions

Small interventionbehavioral

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.

Intervention campbehavioral

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.