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Completed

NCT Number: NCT01012206

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

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.

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umeå university

Umeå, SE-901 87, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention regarding food habits and physical activity.

Behavioral

Children in the intervention group participated in an intervention program regarding food habits and physical activity.

Primary outcomes

  1. Body Mass Index

    Time frame: Two years

Secondary outcomes

  1. Food intake

    Time frame: Two years

  2. Physical activity

    Time frame: Two years

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Acronym: SELFH

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Nov 11, 2009
Registry last updated
Sep 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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