ObesityNCT00365807
Examination of a Treatment Program for Overweight Children, Adolescents, and Their Families
A study testing Positively Fit and Brief Family Intervention (Primarily education) in people with Obesity, run by University of Kansas at 2 sites in United States.
Trial summary
The current study examined the effectiveness of a behaviorally-based group intervention for overweight children and their families. The target intervention was compared to an enhanced standard of care treatment. The impact of both treatment programs on numerous outcomes was explored. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Obesity
- What is being tested?
- Positively Fit and Brief Family Intervention (Primarily education)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2006to May 2010
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child between ages 7 and 17 (inclusive)
- Child BMI at or above the 85th percentile based on norms provided for age and gender
- Child's parent/guardian provides informed consent for treatment of the child as well as consent for study participation
- Child's parent/caregiver is willing to participate with the child in the program
Who cannot join
- Presence of serious mental illnesses or significant developmental delay that would reasonably predict altered ability to adhere to the treatment protocol
- Current physical illness or hospitalization of the child that would interfere with group attendance or protocol adherence
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Kansas
Lawrence, Kansas, 66045
About this study
Official title: Effectiveness of a Treatment Program for Pediatric Obesity
The current study examined the effectiveness of a behaviorally-based group intervention for overweight children and their families. The target intervention was compared to an enhanced standard of care treatment. The impact of both treatment programs on numerous outcomes was explored.
Read the detailed description
The primary objective of the present investigation was to determine the effectiveness of an empirically supported intervention for pediatric overweight in two outpatient clinical settings. A number of previous randomized clinical trials have demonstrated the efficacy of behaviorally-based group interventions for overweight children and their families. As called for by Kazdin and Weisz (1998) and Chambless and Hollon (1998) the proposed investigation was designed to demonstrate the effectiveness of such a treatment in a clinical setting, and to examine the effects of the intervention on children's quality of life (QOL). Because the clinical impact of empirically supported interventions is mitigated by economic and consumer variables, a secondary aim of the proposed investigation was to examine (1) the cost-effectiveness of an outpatient group intervention for pediatric obesity, and (2) the consumer satisfaction with the proposed intervention. Finally, an additional exploratory aim was to examine predictors of adherence to treatment for the intervention.
- Conditions
- Obesity
- Being tested
- Positively Fit, Brief Family Intervention (Primarily education)
- Keywords
- Obesity, Overweight, Behavioral treatment, Family involvement
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positively FitBehavioural
12-week group intervention for children with obesity and their parents/caregivers
Brief Family Intervention (Primarily education)Other
3 hours of contact with registered dietician for education and nutritional counseling.
| Study group | Role | What they receive |
|---|---|---|
| Brief Family Intervention (Primarily education) | Active comparator | Behaviorally based family group intervention using standard education and nutrition counseling. Three hours of client contact Receives: Other: Brief Family Intervention (Primarily education) |
| Positively Fit | Experimental | 12 week (90 minute per session) behavioral group intervention for children and their parents. Children and parent attend parallel group with identical (but developmentally appropriate) information presented. Receives: Behavioral: Positively Fit |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI Percentile Change
Measured: Treatment completion, 1 year follow up
Secondary outcomes (4)
Quality of Life - The PedsQL™ (version 4.0;Varni et al., 2001)
Measured: treatment completion, one year follow up
Child Psychosocial Adjustment -- the Behavioral Assessment System for Children- Parent report form (BASC-PRF) and the BASC-Child Self Report (BASC-CSR; Reynolds & Kamphaus, 2002)
Measured: Treatment completion, one year follow up
Cost-effectiveness
Measured: Treatment completion, one year follow up
Consumer Satisfaction
Measured: Treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionDec 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ric G Steele, Ph.D., Principal investigator, University of KansasAnn M. Davis, Ph.D., Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365807
- Sponsor's protocol ID
- R40MC06631-01-00
- Status last verified
- Nov 2012
- First submitted
- 17 Aug 2006
- Last updated
- 5 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Steele RG, Aylward BS, Jensen CD, Cushing CC, Davis AM, Bovaird JA. Comparison of a family-based group intervention for youths with obesity to a brief individual family intervention: a practical clinical trial of positively fit. J Pediatr Psychol. 2012 Jan-Feb;37(1):53-63. doi: 10.1093/jpepsy/jsr057. Epub 2011 Aug 18.
PubMed 21852343
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Treatment Program for Pediatric Obesity
- ClinicalTrials.gov ID
- NCT00365807
- Acronym / sponsor ID
- R40MC06631-01-00
- Conditions
- Obesity
- Keywords
- Obesity, Overweight, Behavioral treatment, Family involvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 18 Aug 2006 (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 current study examined the effectiveness of a behaviorally-based group intervention for overweight children and their families. The target intervention was compared to an enhanced standard of care treatment. The impact of both treatment programs on numerous outcomes was explored.
Detailed description
The primary objective of the present investigation was to determine the effectiveness of an empirically supported intervention for pediatric overweight in two outpatient clinical settings. A number of previous randomized clinical trials have demonstrated the efficacy of behaviorally-based group interventions for overweight children and their families. As called for by Kazdin and Weisz (1998) and Chambless and Hollon (1998) the proposed investigation was designed to demonstrate the effectiveness of such a treatment in a clinical setting, and to examine the effects of the intervention on children's quality of life (QOL). Because the clinical impact of empirically supported interventions is mitigated by economic and consumer variables, a secondary aim of the proposed investigation was to examine (1) the cost-effectiveness of an outpatient group intervention for pediatric obesity, and (2) the consumer satisfaction with the proposed intervention. Finally, an additional exploratory aim was to examine predictors of adherence to treatment for the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Family Intervention (Primarily education) | Active comparator | Other: Brief Family Intervention (Primarily education)Behaviorally based family group intervention using standard education and nutrition counseling. Three hours of client contact |
| Positively Fit | Experimental | Behavioral: Positively Fit12 week (90 minute per session) behavioral group intervention for children and their parents. Children and parent attend parallel group with identical (but developmentally appropriate) information presented. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Child between ages 7 and 17 (inclusive)
- Child BMI at or above the 85th percentile based on norms provided for age and gender
- Child's parent/guardian provides informed consent for treatment of the child as well as consent for study participation
- Child's parent/caregiver is willing to participate with the child in the program
Key exclusion criteria (2 listed)
- Presence of serious mental illnesses or significant developmental delay that would reasonably predict altered ability to adhere to the treatment protocol
- Current physical illness or hospitalization of the child that would interfere with group attendance or protocol adherence
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 |
|---|---|---|
| Positively Fit12-week group intervention for children with obesity and their parents/caregivers | Behavioural | Positively Fit |
| Brief Family Intervention (Primarily education)3 hours of contact with registered dietician for education and nutritional counseling. | Other | Brief Family Intervention (Primarily education) |
Primary outcome
BMI Percentile Change
Time frame: Treatment completion, 1 year follow up
4 secondary outcomes
Quality of Life - The PedsQL™ (version 4.0;Varni et al., 2001)
Time frame: treatment completion, one year follow up
Child Psychosocial Adjustment -- the Behavioral Assessment System for Children- Parent report form (BASC-PRF) and the BASC-Child Self Report (BASC-CSR; Reynolds & Kamphaus, 2002)
Time frame: Treatment completion, one year follow up
Cost-effectiveness
Time frame: Treatment completion, one year follow up
Consumer Satisfaction
Time frame: Treatment completion
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 5 Nov 2012.
- Results publication: PubMed 21852343Steele RG, Aylward BS, Jensen CD, Cushing CC, Davis AM, Bovaird JA. Comparison of a family-based group intervention for youths with obesity to a brief individual family intervention: a practical clinical trial of positively fit. J Pediatr Psychol. 2012 Jan-Feb;37(1):53-63. doi: 10.1093/jpepsy/jsr057. Epub 2011 Aug 18.
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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.
Ric G Steele, Ph.D. principal investigator
University of Kansas
Ann M. Davis, Ph.D. principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positively Fit and Brief Family Intervention (Primarily education) in people with Obesity, run by University of Kansas at 2 sites in United States.
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 4 inclusion and 2 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 5 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
BMI Percentile Change (time frame: Treatment completion, 1 year follow up). 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 NCT00365807, which also lists 1 linked publication.
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 5 Nov 2012.