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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christel Larsson, Umeå University
ClinicalTrials.gov Identifier:
NCT01012206
First received: November 10, 2009
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Overweight
Obesity
Behavioral: Intervention regarding food habits and physical activity.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Overweighed Children´s Health - Studies of the Effect of Lifestyle and Food Habits

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Body Mass Index [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Food intake [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • Physical activity [ Time Frame: Two years ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: August 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Children in control group obtained no lifestyle counseling (intervention).
Active Comparator: Intervention group
Children in the intervention group and their parents were given lifestyle counseling and participated in an intervention program regarding food habits and physical activity.
Behavioral: Intervention regarding food habits and physical activity.
Children in the intervention group participated in an intervention program regarding food habits and physical activity.

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01012206

Locations
Sweden
Umeå university
Umeå, Sweden, SE-901 87
Sponsors and Collaborators
Umeå University
Investigators
Principal Investigator: Christel Larsson, PhD Department of Food and Nutrition, Umeå university.
  More Information

Additional Information:
Publications:
Responsible Party: Christel Larsson, Professor, Umeå University
ClinicalTrials.gov Identifier: NCT01012206     History of Changes
Other Study ID Numbers: 05-088M
Study First Received: November 10, 2009
Last Updated: August 14, 2014
Health Authority: Sweden: Swedish National Council on Medical Ethics

Keywords provided by Umeå University:
Children
Overweight
Obesity
Food habits
Dietary assessment
Physical activity

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 25, 2014