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Completed

NCT Number: NCT00961740

Childhood Obesity- Characteristics and Treatment

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.

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Key information

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bergen

Bergen, Hordaland, 5020, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Cognitive Behavioural Therapy

Behavioral

See summary

Waitlist condition

Other

See Summary

Other names: 12-week waitlist condition, before CBT as in arm 1

Primary outcomes

  1. Body Mass Index

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

Secondary outcomes

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

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

  2. Waist circumference

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

  3. Child Behavior Checklist (CBCL)

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

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

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

  5. Physical activity actigraphy and self-report

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

  6. Food diary

    Time frame: (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)

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

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Collaborators

  • Helse Vest
  • The Royal Norwegian Ministry of Health

Registry information

Official study title

Cognitive Behavioural Treatment for Childhood Obesity- A Clinical Trial.

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 19, 2009
Registry last updated
May 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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