Childhood Obesity: a Study of Group Treatment Targeting Parents Behaviour
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|ClinicalTrials.gov Identifier: NCT00842777|
Recruitment Status : Completed
First Posted : February 12, 2009
Last Update Posted : July 28, 2016
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:
- 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.
- 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.
- Reduction in BMI will correlate with increased quality of life, reduced number and severity of mental health problems, and increased self-concept.
|Condition or disease||Intervention/treatment||Phase|
|Childhood Obesity||Behavioral: Parent manualized group treatment Behavioral: Parent self-help groups||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Childhood Obesity; a Randomized Controlled Study of Group Treatment Targeting Parents Behaviour|
|Study Start Date :||October 2004|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00842777
|St Olav University Hospital, Department of Pediatrics|
|Trondheim. Olav Kyrres gt 17, Trondheim, Norway, 7006|
|Principal Investigator:||Ronnaug A Odegard, MD, PhD||St. Olavs Hospital|