NCT00842777

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. 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. 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. 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

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2004

Longer than P75 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

July 28, 2016

Status Verified

July 1, 2016

Enrollment Period

5.5 years

First QC Date

February 11, 2009

Last Update Submit

July 27, 2016

Conditions

Keywords

Childhood obesityQuality of lifeSelf-esteemBMIparental group treatmentBody image

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

EXPERIMENTAL

Manualized group treatment of parents. Allocation of 4-6 parental couples of children with similar age.

Behavioral: Parent manualized group treatment

Parent self-help groups

ACTIVE COMPARATOR

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

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

Parent group 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.

Parent self-help groups

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Study Sites (1)

St Olav University Hospital, Department of Pediatrics

Trondheim. Olav Kyrres Gt 17, Trondheim, 7006, Norway

Location

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.

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ronnaug A Odegard, MD, PhD

    St. Olavs Hospital

    PRINCIPAL INVESTIGATOR

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

Locations