Childhood Obesity: a Study of Group Treatment Targeting Parents Behaviour
Childhood Obesity; a Randomized Controlled Study of Group Treatment Targeting Parents Behaviour
1 other identifier
interventional
99
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2004
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 11, 2009
CompletedFirst Posted
Study publicly available on registry
February 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedJuly 28, 2016
July 1, 2016
5.5 years
February 11, 2009
July 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline, 6 months and 24 months
Study Arms (2)
Parent group treatment
EXPERIMENTALManualized group treatment of parents. Allocation of 4-6 parental couples of children with similar age.
Parent self-help groups
ACTIVE COMPARATORProfessionals initiate and organize the self-help groups initially. The groups will not receive any teaching or counseling concerning eating and physical activity.
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- Age 7-12 years
- Body Mass Index \> 2SDS (age adjusted BMI)
- no known medical cause of obesity
You may not qualify if:
- pervasive developmental disorders
- serious psychopathology
- parental drug abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian University of Science and Technologylead
- St. Olavs Hospitalcollaborator
Study Sites (1)
St Olav University Hospital, Department of Pediatrics
Trondheim. Olav Kyrres Gt 17, Trondheim, 7006, Norway
Related Publications (1)
Hystad HT, Steinsbekk S, Odegard R, Wichstrom L, Gudbrandsen OA. A randomised study on the effectiveness of therapist-led v. self-help parental intervention for treating childhood obesity. Br J Nutr. 2013 Sep 28;110(6):1143-50. doi: 10.1017/S0007114513000056. Epub 2013 Feb 6.
PMID: 23388524RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronnaug A Odegard, MD, PhD
St. Olavs Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2009
First Posted
February 12, 2009
Study Start
October 1, 2004
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
July 28, 2016
Record last verified: 2016-07