"Fit For Kids"-Copenhagen

NCT01660789 | Completed DMC

• 1 other identifier: H-2-2011-132
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of a 40- week multifactorial intervention against overweight, obesity and physical inactivity in Danish children. The investigators wish to examine 40 children before and after the "Fit for Kids" intervention with basic anthropometric measures such as body mass indexi (BMI), waist/hip ratio, systolic- and diastolic blood pressure, level of physical fitness and Total Body fat mass. Furthermore the investigators wish to examine the more specific inflammatory, metabolic and hormonal effect of the intervention with a more extensive examination programme. The tests include a DXA-scan, cardio-respiratory fitness, accelerometer monitoring, pedometer monitoring, cognitive testing, Continuous Glucose Monitoring System, different metabolic and inflammatory markers and an oral glucose tolerance test. The study will take place at Centre of Inflammation and Metabolism, Rigshospitalet, Copenhagen. The study is a randomised controlled trial with a gradual rollout. The 40 children will be randomised. Twenty children will start the intervention at baseline and 20 children will start after the first 20 weeks of intervention, thus providing a control group. The investigators expect to find a significant reduction in BMI, total body fat mass and systolic blood pressure after the intervention. As for the more extensive tests, the data approach is explorative, as the investigators look at more statistical dependent variables. The contribution of this project is a further description on the effect of intervention against overweight and physical inactivity on the metabolic and inflammatory response.

Conditions

Obesity

Keywords

Obesity; Diabetes; Physical activity

Outcome Measures

Primary Outcomes (1)

• BMI

  One year

Study Arms (1)

Lifestyle intervention

OTHER

Lifestyle intervention.

Behavioral: Physical activity, dietary counseling, coaching

Interventions

Physical activity, dietary counseling, coaching BEHAVIORAL

Physical activity, dietary counseling, coaching

Lifestyle intervention

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Obese children

You may not qualify if:

• Other chronic medical conditions
• Medical intake

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Centre of Inflammation and Metabolism, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Harder-Lauridsen NM, Birk NM, Ried-Larsen M, Juul A, Andersen LB, Pedersen BK, Krogh-Madsen R. A randomized controlled trial on a multicomponent intervention for overweight school-aged children - Copenhagen, Denmark. BMC Pediatr. 2014 Oct 21;14:273. doi: 10.1186/1471-2431-14-273.

  PMID: 25330848 DERIVED

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Motor Activity

Interventions

Exercise; Nutrition Assessment

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Nina Marie Birk Eriksen, MD

  Centre of Inflammation and Metabolism

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Administrator

Study Record Dates

• First Submitted: April 2, 2012
• First Posted: August 9, 2012
• Study Start: January 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 31, 2012

Record last verified: 2012-08

Locations

DK (1)