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

U

Umeå University

Status

Completed

Conditions

Overweight
Obesity

Treatments

Behavioral: Intervention regarding food habits and physical activity.

Study type

Interventional

Funder types

Other

Identifiers

NCT01012206
05-088M

Details and patient eligibility

About

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.

Enrollment

105 patients

Sex

All

Ages

8 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

105 participants in 2 patient groups

Control group
No Intervention group
Description:
Children in control group obtained no lifestyle counseling (intervention).
Intervention group
Active Comparator group
Description:
Children in the intervention group and their parents were given lifestyle counseling and participated in an intervention program regarding food habits and physical activity.
Treatment:
Behavioral: Intervention regarding food habits and physical activity.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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