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Childhood ObesityNCT00961740

Childhood Obesity- Characteristics and Treatment

A study testing Cognitive Behavioural Therapy and Waitlist condition in people with Childhood Obesity, run by University of Bergen at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 13 yearsHealthy volunteers can take part
Conditions the study is for
Childhood Obesity
What is being tested?
Cognitive Behavioural Therapy and Waitlist condition
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteNorway
Study dates
Feb 2007to Dec 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 13 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Norway1 site
  • University of Bergen

    Bergen, Hordaland, 5020

Other trials in Norway

About this study

Official title: Cognitive Behavioural Treatment for Childhood Obesity- A Clinical Trial.

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.

Read the 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.

Being tested
Cognitive Behavioural Therapy, Waitlist condition
Keywords
Childhood Obesity, CBT, Family, Lifestyle change
Medical subject headings
Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioural TherapyBehavioural

    See summary

  • Waitlist conditionOther

    Also called 12-week waitlist condition, before CBT as in arm 1

    See Summary

Study groups in NCT00961740
Study groupRoleWhat they receive
Cognitive Behavioral TherapyOtherDesign: 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.
Receives: Behavioral: Cognitive Behavioural Therapy; Other: Waitlist condition
12-weeks waitlist conditionOtherAfter 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.
Receives: Behavioral: Cognitive Behavioural Therapy; Other: Waitlist condition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Mass Index

    Measured: (pre-treatment), 4-months after starting treatment, 12-months after ending intensive phase of treatment

Secondary outcomes (7)
  1. Self-perception Profile for Children (Harter, 1985)

    Measured: (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment

  2. Waist circumference

    Measured: (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment

  3. Child Behavior Checklist (CBCL)

    Measured: (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment

  4. Children's Depression Inventory (CDI) (Kovacs)

    Measured: (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment

  5. Physical activity actigraphy and self-report

    Measured: (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment

  6. Food diary

    Measured: (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment

  7. Blood measures (cholesterol, triglyceride, insulin, glucose, HbA1c, lipoprotein A)

    Measured: (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2009 (estimated)
  2. Study startFeb 2007
  3. Primary completionDec 2009
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00961740
Sponsor's protocol ID
911180- Helse Vest
Other IDs
15792- NSD, 241.06-REK Vest, 1244-Biobankregisteret, ShDir
Status last verified
May 2014
First submitted
17 Aug 2009
Last updated
28 May 2014
Results posted
No
Data monitoring committee
No

Publications

  • Achenbach, T. M. Integrative Guide to the 1991 CBCL/4-18, YSR, and TRF Profiles. Burlington, VT: University of Vermont, Department of Psychology 1991.

  • 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.

    PubMed 18055651
  • 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.

    PubMed 10797032
  • Harter, S. Manual for the self-perception profile for children. Denver, CO: University of Denver, 1985.

  • Kovacs M. The Children's Depression, Inventory (CDI). Psychopharmacol Bull. 1985;21(4):995-8. No abstract available.

    PubMed 4089116
  • 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.

    PubMed 14726719

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioural Therapy and Waitlist condition in people with Childhood Obesity, run by University of Bergen at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Mass Index (time frame: (pre-treatment), 4-months after starting treatment, 12-months after ending intensive phase of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00961740, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2014.

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