Overweighed Children´s Health - Studies of the Effect of Lifestyle and Food Habits

Obesity Clinical Trial

— SELFH  

Official title:

Overweighed Children´s Health - Studies of the Effect of Lifestyle and Food Habits

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01012206
• Other study ID #: 05-088M
• Status: Completed
• Phase: N/A
• First received: November 10, 2009
• Last updated: September 2, 2016
• Start date: August 2006
• Est. completion date: June 2009

Study information

• Verified date: September 2016
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish National Council on Medical Ethics
• Study type: Interventional

Clinical Trial Summary

The aim is to investigate the development of overweight and obesity from infancy to school age, and to evaluate an intervention to prevent further development of overweight and obesity among children.

A follow-up study will be conducted on 267 children and will allow comparison between children that developed overweight with the ones who did not. Subjects will be requited at 10 years of age from a previous project. These children have been studied when they were 6-18 months old and a follow-up was conducted at 4 years of age. Sixteen percent of the children were overweight at 4 years of age and retrospective data of e.g. food intake, blood lipids and anthropometric measurements exists. In the present follow-up data regarding food and physical activity habits, anthropometric measurements and blood samples of e.g. blood lipids, IGF1 will be collected.

An intervention study will be conducted on 80-120 overweight children that will be randomized into one intervention and one control group. An intervention during two years will encourage long term healthy habits regarding diet and physical activity through group meetings and supervision. Information about food habits will be collected through questionnaires, interviews and diaries. Measurement of physical activity and energy expenditure will be made with Sense Wear and double labeled water, and will be used to validate reported food intake. Further, anthropometric measurements and blood samples will be collected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria for SELFH intervention study:

• age and gender adjusted body mass index (BMI) > 25

• born in 1995-1998

• living in or nearby the northern city of Umea, Sweden

Exclusion Criteria for SELFH intervention study:

• no chronic disease that could influence metabolic parameters

• no attention deficit disorders

• no access to internet

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Intervention regarding food habits and physical activity.
Children in the intervention group participated in an intervention program regarding food habits and physical activity.

Locations

Country	Name	City	State
Sweden	Umeå university	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Waling MU, Larsson CL. Energy intake of Swedish overweight and obese children is underestimated using a diet history interview. J Nutr. 2009 Mar;139(3):522-7. doi: 10.3945/jn.108.101311. Epub 2009 Jan 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index		Two years	No
Secondary	Food intake		Two years	No
Secondary	Physical activity		Two years	No

External Links

•   SELFH project