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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Childhood Obesity
- 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 group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Other | 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. Receives: Behavioral: Cognitive Behavioural Therapy; Other: Waitlist condition |
| 12-weeks waitlist condition | Other | 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. 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.
Body Mass Index
Measured: (pre-treatment), 4-months after starting treatment, 12-months after ending intensive phase of treatment
Secondary outcomes (7)
Self-perception Profile for Children (Harter, 1985)
Measured: (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
Waist circumference
Measured: (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
Child Behavior Checklist (CBCL)
Measured: (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
Children's Depression Inventory (CDI) (Kovacs)
Measured: (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
Physical activity actigraphy and self-report
Measured: (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
Food diary
Measured: (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
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.
- First posted19 Aug 2009 (estimated)
- Study startFeb 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Vest, The Royal Norwegian Ministry of Health
- Responsible party
- Principal investigator, Yngvild Sørebø Danielsen, University of Bergen
- Investigators
- Yngvild S Danielsen, Principal investigator, University of Bergen
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 18055651Cole 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 10797032Harter, 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 4089116Zametkin 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
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioural Treatment for Childhood Obesity- A Clinical Trial.
- ClinicalTrials.gov ID
- NCT00961740
- Acronym / sponsor ID
- 911180- Helse Vest
- Conditions
- Childhood Obesity
- Keywords
- Childhood Obesity, CBT, Family, Lifestyle change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Helse Vest, The Royal Norwegian Ministry of Health
- Study start
- Feb 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 19 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Other | Behavioral: Cognitive Behavioural Therapy, Other: Waitlist conditionDesign: 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. |
| 12-weeks waitlist condition | Other | Behavioral: Cognitive Behavioural Therapy, Other: Waitlist conditionAfter 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. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- obese status, according to Cole et al.'s (2000) international criteria.
Key exclusion criteria (3 listed)
- serious somatic or metal health problems
- diabetes
- cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioural TherapySee summary | Behavioural | 12-weeks waitlist condition, Cognitive Behavioral Therapy |
| Waitlist conditionAlso: 12-week waitlist condition, before CBT as in arm 1See Summary | Other | 12-weeks waitlist condition, Cognitive Behavioral Therapy |
Primary outcome
Body Mass Index
Time frame: (pre-treatment), 4-months after starting treatment, 12-months after ending intensive phase of treatment
7 secondary outcomes
Self-perception Profile for Children (Harter, 1985)
Time frame: (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
Waist circumference
Time frame: (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
Child Behavior Checklist (CBCL)
Time frame: (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
Children's Depression Inventory (CDI) (Kovacs)
Time frame: (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
Physical activity actigraphy and self-report
Time frame: (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
Food diary
Time frame: (pre-treatment), 4 months after starting treatment, 12 months after ending intensive phase of treatment
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
- BackgroundAchenbach, T. M. Integrative Guide to the 1991 CBCL/4-18, YSR, and TRF Profiles. Burlington, VT: University of Vermont, Department of Psychology 1991.
- Background: PubMed 18055651Barlow 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.
- Background: PubMed 10797032Cole 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.
- BackgroundHarter, S. Manual for the self-perception profile for children. Denver, CO: University of Denver, 1985.
- Background: PubMed 4089116Kovacs M. The Children's Depression, Inventory (CDI). Psychopharmacol Bull. 1985;21(4):995-8. No abstract available.
- Background: PubMed 14726719Zametkin 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.
Related trials for Childhood Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yngvild S Danielsen principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
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.