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Childhood Obesity- Characteristics and Treatment

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy
Waitlist condition
Sponsored by
University of Bergen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Obesity focused on measuring Childhood Obesity, CBT, Family, Lifestyle change

Eligibility Criteria

8 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • obese status, according to Cole et al.'s (2000) international criteria.

Exclusion Criteria:

  • serious somatic or metal health problems
  • diabetes
  • cardiovascular disease

Sites / Locations

  • University of Bergen

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Cognitive Behavioral Therapy

12-weeks waitlist condition

Arm Description

Design: 49 children (aged 8-12)with obesity was recruited, the children were randomly assigned to a group that started a cognitive behavioural intervention immediately after recruitment, and another group that received the same treatment after a 12-week wait list condition. For further description of the treatment, see summary. Arm 1 (this arm) started receiving a cognitive behavioural intervention immediately after randomization.

After an initial pre-assessment no contact were made before assessment after 12-weeks and start of intervention after this assessment. After the 12-week waitlist condition the families were offered the same familibased cognitive behavioral intervention as in arm one.

Outcomes

Primary Outcome Measures

Body Mass Index

Secondary Outcome Measures

Self-perception Profile for Children (Harter, 1985)
Waist circumference
Child Behavior Checklist (CBCL)
Children's Depression Inventory (CDI) (Kovacs)
Physical activity actigraphy and self-report
Food diary
Blood measures (cholesterol, triglyceride, insulin, glucose, HbA1c, lipoprotein A)

Full Information

First Posted
August 17, 2009
Last Updated
May 25, 2014
Sponsor
University of Bergen
Collaborators
Helse Vest, The Royal Norwegian Ministry of Health
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1. Study Identification

Unique Protocol Identification Number
NCT00961740
Brief Title
Childhood Obesity- Characteristics and Treatment
Official Title
Cognitive Behavioural Treatment for Childhood Obesity- A Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bergen
Collaborators
Helse Vest, The Royal Norwegian Ministry of Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study is evaluating the effect of a 14-session cognitive behavioural treatment for childhood obesity. The treatment is family based and 49 families with children with obesity, aged 8-12, will be recruited. Outcome measures are: BMI, waist circumference, self-esteem, social- and psychological functioning, cholesterol, glucose and insulin values, activity level (actigraphs) and a measure of food intake.
Detailed Description
Aim of the study: Evaluating a manualized treatment program for childhood obesity. Participants: 49 families with children with obesity, aged 8-12. The participants will be recruited through referrals from medical doctors or nurses in primary health care or through ads in newspapers. Inclusion criteria: age between 8 and 12 and satisfying the criteria for obesity according to Coles indexes for BMI for the given gender and age group (Cole et al, 2000). Exclusion criteria are cardiovascular disease, diabetes and severe psychopathology. Before inclusion the child will go through a medical examination by a pediatrician as well as an interview by a psychologist. Procedure/treatment program: The manualized treatment is based on principles from cognitive behavioural therapy and is family based. The treatment consists of 14 sessions (60 minutes), where a clinical psychologist meet the family together. The first 12 sessions are given at a weekly basis, the last two sessions are administered half a year and one year after the more intensive part of the treatment. The treatment program includes elements such as: 1) general overview of the treatment plan, 2) basic information about nutrition, physical activity and metabolism, 3) keeping a food and activity diary, 4) a behavioral modification plan aimed at changing habits such as watching TV, video and PC causing sedentary behavior, 5) a behavioral modification plan aimed at changing eating patterns and level of physical activity 6) a module consisting of identifying and avoiding risk factors associated with unhealthy and/or excessive eating and sedentary behavior, 7) a module focusing upon parent counseling 8)modules focusing on problem solving skills, reactions in stressful situations and automatic thoughts 9) modules discussing bullying and self-esteem 10)home work assignments between sessions(Barlow & Dietz, 1998; Zametkin et al, 2004). In all, 20 subjects will be randomized to immediate treatment (12 weeks) while the other half of the subjects will randomized to a waiting-list control group. The waiting-list control group will receive treatment. Instruments measuring the results of the treatment: Behavioural change: Daily logs on activity and nutrition will be kept by the subjects for one week prior to and one week following the intensive phase of the treatment (12-sessions), as well as after one year. In the same periods actigraphs will be used in order to obtain objective data on physical activity levels. Self-report measures: The Self-Perception Profile for Children (SPPC) (Harter, 1985)is a well recognized self-report measure that assesses general and dimensional (cognitive, social, and physical) self-esteem in children and adolescents. The Children's Depression Inventory (CDI) a commonly used screening device for pediatric depression containing a 27-item, symptom-oriented scale (Kovacs, 1985). Child Behavior Check-list (CBCL,a well recognized parent-report measure, measuring children's social competence and behavioral problems(Achenbach,1991). Physiological measures: Fasting plasma insulin, glucose and triglyceride, cholesterol (total, HDL, LDL), HbA1c and lipoprotein A. Physical measures: Weight, BMI, waist circumference, blood pressure. All measures will be administered pre-treatment (and pre-wait-list for the control group), after 12-sessions of treatment and after one year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Childhood Obesity, CBT, Family, Lifestyle change

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy
Arm Type
Other
Arm Description
Design: 49 children (aged 8-12)with obesity was recruited, the children were randomly assigned to a group that started a cognitive behavioural intervention immediately after recruitment, and another group that received the same treatment after a 12-week wait list condition. For further description of the treatment, see summary. Arm 1 (this arm) started receiving a cognitive behavioural intervention immediately after randomization.
Arm Title
12-weeks waitlist condition
Arm Type
Other
Arm Description
After an initial pre-assessment no contact were made before assessment after 12-weeks and start of intervention after this assessment. After the 12-week waitlist condition the families were offered the same familibased cognitive behavioral intervention as in arm one.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy
Intervention Description
See summary
Intervention Type
Other
Intervention Name(s)
Waitlist condition
Other Intervention Name(s)
12-week waitlist condition, before CBT as in arm 1
Intervention Description
See Summary
Primary Outcome Measure Information:
Title
Body Mass Index
Time Frame
(pre-treatment), 4-months after starting treatment, 12-months after ending intensive phase of treatment
Secondary Outcome Measure Information:
Title
Self-perception Profile for Children (Harter, 1985)
Time Frame
(pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
Title
Waist circumference
Time Frame
(pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
Title
Child Behavior Checklist (CBCL)
Time Frame
(pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
Title
Children's Depression Inventory (CDI) (Kovacs)
Time Frame
(pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
Title
Physical activity actigraphy and self-report
Time Frame
(pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
Title
Food diary
Time Frame
(pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
Title
Blood measures (cholesterol, triglyceride, insulin, glucose, HbA1c, lipoprotein A)
Time Frame
(pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: obese status, according to Cole et al.'s (2000) international criteria. Exclusion Criteria: serious somatic or metal health problems diabetes cardiovascular disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yngvild S Danielsen
Organizational Affiliation
University of Bergen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bergen
City
Bergen
State/Province
Hordaland
ZIP/Postal Code
5020
Country
Norway

12. IPD Sharing Statement

Citations:
Citation
Achenbach, T. M. Integrative Guide to the 1991 CBCL/4-18, YSR, and TRF Profiles. Burlington, VT: University of Vermont, Department of Psychology 1991.
Results Reference
background
PubMed Identifier
18055651
Citation
Barlow SE; Expert Committee. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics. 2007 Dec;120 Suppl 4:S164-92. doi: 10.1542/peds.2007-2329C.
Results Reference
background
PubMed Identifier
10797032
Citation
Cole TJ, Bellizzi MC, Flegal KM, Dietz WH. Establishing a standard definition for child overweight and obesity worldwide: international survey. BMJ. 2000 May 6;320(7244):1240-3. doi: 10.1136/bmj.320.7244.1240.
Results Reference
background
Citation
Harter, S. Manual for the self-perception profile for children. Denver, CO: University of Denver, 1985.
Results Reference
background
PubMed Identifier
4089116
Citation
Kovacs M. The Children's Depression, Inventory (CDI). Psychopharmacol Bull. 1985;21(4):995-8. No abstract available.
Results Reference
background
PubMed Identifier
14726719
Citation
Zametkin AJ, Zoon CK, Klein HW, Munson S. Psychiatric aspects of child and adolescent obesity: a review of the past 10 years. J Am Acad Child Adolesc Psychiatry. 2004 Feb;43(2):134-50. doi: 10.1097/00004583-200402000-00008.
Results Reference
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Childhood Obesity- Characteristics and Treatment

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