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Childhood Obesity: a Study of Group Treatment Targeting Parents Behaviour

This study has been completed.
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00842777
First received: February 11, 2009
Last updated: January 5, 2012
Last verified: January 2012
History of Changes
  Purpose

Long term effects of treatment of childhood obesity are not well documented but there is growing evidence that parental involvement and behavioral changes are strong predictors of children weight loss. However, which form and content of parental involvement are most effective is not studied. In the present randomized controlled study we compare the effect of parent manualized group treatment ("experimental group") to the effect of parent self-help groups on changes in children Body Mass Index, food intake, physical activity, quality of life and self esteem. We pose the following hypotheses:

  1. Parents participating in the experimental group will have children who achieve a larger reduction in BMI than children with their parents in the control group.
  2. This treatment effect will be mediated by changes in one of several elements of parents' cognition: outcome expectancies, perceived control, perceived value of outcome, self-efficacy, perceived reduction in barriers, and subjective norms.
  3. Reduction in BMI will correlate with increased quality of life, reduced number and severity of mental health problems, and increased self-concept.

Condition Intervention Phase
Childhood Obesity
 Behavioral: Parent manualized group treatment
Behavioral: Parent self-help groups
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Childhood Obesity; a Randomized Controlled Study of Group Treatment Targeting Parents Behaviour

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Body Mass Index, lean body mass, waist circumference, energy intake, physical activity, physical fitness, quality of life, self-esteem, Parental body mass index, parental eating behaviour, parental levels of physical activity. [ Time Frame: Baseline, 6 months and 24 months ] [ Designated as safety issue: No ]

Enrollment: 99
Study Start Date: October 2004
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Parent group treatment
Manualized group treatment of parents. Allocation of 4-6 parental couples of children with similar age.
 Behavioral: Parent manualized group treatment

Parent manualized group treatment in childhood obesity; 10 manualized group treatment over a 6 months period.

Ten sessions will be conducted with the following content: 1) Expectancies and goal setting,; 2) Taking to the child about overweight; 3) Daily physical activity; 4) Everyday meals and nutrition; 5) Mastery and motivation; 6) Guidance and limit setting; 7) Who should join the team? The role of siblings and the social network; 8) Parents' history of eating and physical activity; 9) Self-concept and body image; and 10) Vacations and parties.

Thereafter booster-meetings every third month over 1,5 years, in all 2 years treatment
Active Comparator: Parent self-help groups
Professionals initiate and organize the self-help groups initially. The groups will not receive any teaching or counseling concerning eating and physical activity.
 Behavioral: Parent self-help groups
Professionals initiate and organize the self-help groups initially and attend the two first meetings. Their role will be to organize group and facilitate group rules governing group behaviors to be formed. The sharing of experiences, feelings, and thoughts concerning being a parent to an overweight child is encouraged, in addition to sharing tips and advices concerning managing their child's behavior. The groups will not receive any teaching or counseling concerning eating and physical activity.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 7-12 years
  • Body Mass Index > 2SDS (age adjusted BMI)
  • no known medical cause of obesity

Exclusion Criteria:

  • pervasive developmental disorders
  • serious psychopathology
  • parental drug abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00842777

Locations
Norway
St Olav University Hospital, Department of Pediatrics
Trondheim. Olav Kyrres gt 17, Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Principal Investigator: Ronnaug A Odegard, MD, PhD St. Olavs Hospital
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00842777     History of Changes
Other Study ID Numbers: 17188
Study First Received: February 11, 2009
Last Updated: January 5, 2012
Health Authority: Norway: Data Protection Authority

Keywords provided by Norwegian University of Science and Technology:
Childhood obesity
Quality of life
Self-esteem
 BMI
parental group treatment
Body image

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

ClinicalTrials.gov processed this record on May 16, 2013