NCT01012206

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2009

Completed
Last Updated

September 5, 2016

Status Verified

September 1, 2016

Enrollment Period

2.8 years

First QC Date

November 10, 2009

Last Update Submit

September 2, 2016

Conditions

OverweightObesity

Keywords

ChildrenOverweightObesityFood habitsDietary assessmentPhysical activity

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index

    Two years

Secondary Outcomes (2)

  • Food intake

    Two years

  • Physical activity

    Two years

Study Arms (2)

Control group

NO INTERVENTION

Children in control group obtained no lifestyle counseling (intervention).

Intervention group

ACTIVE COMPARATOR

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.

Interventions

Intervention regarding food habits and physical activity.BEHAVIORAL

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

Intervention group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • age and gender adjusted body mass index (BMI) \> 25
  • born in 1995-1998
  • living in or nearby the northern city of Umea, Sweden

You may not qualify if:

  • no chronic disease that could influence metabolic parameters
  • no attention deficit disorders
  • no access to internet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umeå university

Umeå, SE-901 87, Sweden

Location

Related 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.

    PMID: 19158227RESULT

MeSH Terms

Conditions

OverweightObesityFeeding BehaviorMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Christel Larsson, PhD

    Department of Food and Nutrition, Umeå university.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 10, 2009

First Posted

November 11, 2009

Study Start

August 1, 2006

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

September 5, 2016

Record last verified: 2016-09

Locations

SE(1)