Adipocytokine levels in obese children before and after lifestyle intervention

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN71948313
• Date of registration: 10/09/2015
• Prospective Registration: No
• Primary sponsor: Regional Hospital Viborg
• Public title: Adipocytokine levels in obese children before and after lifestyle intervention
• Scientific title: Investigations of levels of adiponectin, leptin, and CRP in a cohort of 11-13-years old children before and after a lifestyle intervention program.
• Date of first enrolment: 01/09/2009
• Target sample size: 30
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN71948313
• Study type: Interventional
• Study design: Interventional multidisciplinary study. (Treatment)

Countries of recruitment

Denmark

Contacts

• Name: Charlotte Eggertsen

Key inclusion & exclusion criteria

Inclusion criteria: 1. Aged between 11-13 years
2. BMI = 22 (this value at the age of 12 years old correlates to BMI of 25 in an adult)
Exclusion criteria: Considerable comorbidity which would make participation in structural physical activity impossible.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Obesity
Nutritional, Metabolic, Endocrine
Obesity

Intervention(s)

The children and their families are followed at the out-patient clinic at the Pediatric Department at 7 consultations during one year. Three visits are individual and included physical examination by pediatrician. Six visits included motivational behavioral therapy individually (2 visits) or in small groups (4 visits) leaded by child psychologist, pediatrician and pediatric nurse.
The exercise program is organized by two health workers and performed two times a week, including 60 minutes of physical exercise. The children and their families receive three individual nutritional guidance sessions by a clinical dietitian in addition to six cooking arrangements during the intervention program.
One year after the intervention ended the children and their families are re-invited to a follow-up examination conducted by a pediatric nurse in the out-patients clinic.

Primary Outcome(s)

1. The degree of weight loss and weight changes. Weight, height and BMI was registrated every third month during the intervention period.
2. Changes in adiponectin, leptin and c-reactive protein (CRP) are measured before and after the intervention. Adiponectin (mg/l) is determined by a validated in-house time-resolved immunofluorometric assay based on two monoclonal antibodies and recombinant human adiponectin (obtained from R&D Systems, Abingdon, UK). Leptin (µg/l) is determined by a validated in-house time-resolved immunofluorometric assay based on commercial available monoclonal antibodies and recombinant human leptin (R&D Systems, Abingdon, UK). CRP levels are determined by a high sensitive CRP (hsCRP) TRIFMA assay based on commercial available monoclonal antibodies (R&D systems).

Secondary Outcome(s)

1. Waist circumference, measured every third month during the intervention.
2. Hip circumference, measured every third month during the intervention.
3. Blood pressure, measured every third month during the intervention.

Secondary ID(s)

N/A

Source(s) of Monetary Support

Department of Pediatrics, Regional Hospital Viborg, Council of Sport, Municipality of Viborg