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Completed

NCT Number: NCT01110096

Family Based Intervention in Childhood obesitY

The study compares the effect on BMI of two different treatment options for obesity in childhood. Families with at least one obese child and parent are invited to join the project. The hypothesis is that family camp gives an additional reduction in BMI compared to a less intensive family lifestyle school.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Olavs Hospital, Trondheim, Norway

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About this study

Participants are randomised to two intervention groups:

A): Two weeks family camp and two years follow-up as a cooperation with primary health care, private rehabilitation center and specialist health care.

B): Four days lifestyle school with two years follow-up as a cooperation with primary health care and specialist health care

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • age 7 to 12 years
  • BMI > iso-BMI 30 (Coles index)

Exclusion criteria

  • syndromatic obesity
  • obesity related to diseases
  • local community not involved
  • child has present follow-up because of obesity in secondary health care
  • parent has present/planned follow-up because of obesity in secondary health care

Treatment and study plan

Parent Management Training - Oregon (PMTO)

Behavioral

Method to help parents and caregivers manage the behavior of the children they are responsible for.

Motivational Interviewing

Behavioral

Communication method to facilitate behavioral change and empower the parents.

Dynamic group therapy

Behavioral

Focuses on individual experiences within families and/or parents/children, and that the participants are their own experts.

Primary outcomes

  1. BMI-SDS

    Time frame: After 2 years

    Primary Outcome Measure is body mass index-standard deviation score. Reduced values from baseline to endpoint means reduced overweight.

Secondary outcomes

  1. Quality of life

    Time frame: After 2 years

    Questionnaire for children and parent

  2. Physical fitness

    Time frame: After 2 years

    Six minutes walk test for children and parents.

  3. Behaviour

    Time frame: After 2 years

    Evaluating effect of intervention on risk for psyciatric disorders.

  4. Blood samples

    Time frame: After 2 years

    Improvement in spesific blood tests with relevance to metabolic syndrome after 2 years intervention? Blood is biobanked at baseline and after 2 years.

Sponsors and collaborators

Lead sponsor

Sykehuset i Vestfold HF

Other

Collaborators

  • Evjeklinikken
  • Gjensidigestiftelsen
  • Organisasjonen Voksne for Barn
  • Oslo University Hospital
  • Røros Rehabiliteringssenter
  • St. Olavs Hospital
  • Stiftelsen Helse og Rehabilitering

Registry information

Official study title

Randomised Controlled Clinical Trial Comparing Two Family Interventions to Treat Obesity in Children Between 7 and 12 Years.

Important dates

Study start
2010
Primary completion
2013
Study completion
2020
First posted
Apr 26, 2010
Registry last updated
Apr 15, 2020

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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