ObesityPhase 3NCT00398359
Treatment of Childhood Obesity in Primary Care
A Phase 3 study testing Motivational Interviewing (physicians) and Behavior Modification (families) in people with Obesity, run by University of Wisconsin, Madison at 6 sites in United States.
Trial summary
This project will apply the concepts from the Chronic Care Model to the problem of pediatric obesity and proposes: 1) to assess the effectiveness of teaching primary care providers (in diverse practice settings) to use specific communication strategies with parents of overweight and obese children to help them take… Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Motivational Interviewing (physicians) and Behavior Modification (families)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 6 sitesUnited States
- Study dates
- May 2006to Dec 2010
- Phase
- Phase 3
- 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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- >95% BMI
- developmentally normal
- referred by primary care provider
Who cannot join
- currently involved in an organized weight control program
- Preexisting high blood pressure
- Preexisting high lipids
- Preexisting diabetes due to obesity
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Group Health East Pediatrics
Madison, Wisconsin, 53704
UW East Pediatric Clinic
Madison, Wisconsin, 53704
University Station Pediatrics
Madison, Wisconsin, 53705
UW Pediatrics-Park St.
Madison, Wisconsin, 53713
UW West Towne Pediatrics
Madison, Wisconsin, 53717
Dean Pediatric Clinic
Sun Prairie, Wisconsin, 53590
About this study
This project will apply the concepts from the Chronic Care Model to the problem of pediatric obesity and proposes: 1) to assess the effectiveness of teaching primary care providers (in diverse practice settings) to use specific communication strategies with parents of overweight and obese children to help them take steps with their child toward healthy behavior change; 2) to offer core components of an efficacious evidence-based pediatric obesity treatment within the pediatric primary care setting to determine if participating children will achieve clinically meaningful weight loss (assessed as weight and BMI percentile changes at the end of treatment and at a six month follow-up); and 3) to assess the ability of trained, behavioral psychologists to offer the treatment so that desired child outcomes are achieved. The primary project outcomes will include: 1) increase in self-reported physician confidence in use of counseling skills related to pediatric overweight; and 2) change in child's diet, physical activity, weight and BMI percentile at the end of treatment and at 6-month follow-up.
Read the detailed description
Overweight in children, adolescents and adults has increased dramatically during the last two decades in developed and developing nations, leading to a global epidemic. Current trends in childhood overweight are a function of both poor nutrition and an increase in sedentary activities.
Pediatric health care providers are ideally situated to address this problem, especially since children are seen frequently for preventive care during the early years when intervention may be more likely to yield long-term change. However, most pediatric providers do not have the needed training to manage obesity effectively. This project will use the chronic care model to foster the effectiveness of an office-based intervention aimed at altering dietary intake and physical activity for children whose BMI reflects overweight and their parents. With the support of the health care system (through new reimbursement strategies), office redesign (assignment of tasks to the health assistant, physician and behavioral interventionist), self-management techniques (patient training) and enhanced community resources, a successful program for improved nutrition and physical activity will be built.
Specific Aim 1 of this study is to increase physician use of counseling techniques that are effective in promoting positive behavior change regarding nutrition and physical activity in the pediatric primary care setting. This aim will be accomplished by offering a training intervention for primary care pediatricians and health assistants. The intervention will:
- Increase physician recognition of risk factors for overweight.
- Teach physicians to use brief motivational strategies with parents and children that will assist them in taking steps toward healthier behavior as it relates to nutrition and physical activities, including but not limited to enrolling in a group behavioral treatment program.
Specific Aim 2 is to assess the effectiveness of implementing a pediatric primary care office-based nutrition/physical activity behavioral intervention for overweight and obese children and their parents.
In specific aim 2 we will employ trained behavioral interventionists to offer a family-based behavioral intervention targeting healthy eating and decreased sedentary behavior/increased physical activity to overweight/obese children ages 9-12 and their parents; and to evaluate parent and child adherence to attendance and behavioral intervention factors. Self-monitoring reports of the child's behavioral changes (e.g., decrease in number of "red foods"[foods high in calories and fat] consumed weekly and decreased time spent each week watching TV, using the computer, and playing video games) will be described, as will any changes in BMI.
Experienced behavioral interventionists will be trained in behavioral theory principles fundamental to the intervention that involve helping children and their parents to change behavior and maintain the changes by Dr. Ewing (Co-Investigator). Dr Ewing, who has completed Human Subjects and HIPAA training at the University of Pittsburgh will come to Madison, Wisconsin to do a training session for the behavioral interventionists and study coordinator. In addition, she will provide instruction in principles of weight management, the role of healthy eating and physical activity in maintaining a healthy weight, and the empirical support for the intervention that will be offered. Finally, the interventionists will receive training to conduct each of the individual sessions.
The American Academy of Pediatrics (AAP) recommends that overweight children be screened for fasting blood glucose, fasting blood insulin, and serum lipids. Pre and post lab values that are available for participating children will be recorded.
- Conditions
- Obesity
- Being tested
- Motivational Interviewing (physicians), Behavior Modification (families)
- Keywords
- Obesity, Overweight, Children, Behavioral, Motivational, Family, Primary care
- Medical subject headings
- Obesity, Overweight, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing (physicians)Behavioural
Identifying and referring children with BMI >93%.
Behavior Modification (families)Behavioural
Group meetings and individual family meetings based on behavior modification for healthy lifestyle changes.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Motivational Interviewing (physicians); Behavioral: Behavior Modification (families) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of primary care physicians who discuss the child's BMI with parents
Measured: 6/2007 - ongoing
Secondary outcomes (3)
Basic descriptive data analysis
Measured: two years
Statistical testing of the primary hypothesis of each aim
Measured: two years
Statistical modeling to better understand the relationship between the outcome of interest and the intervention
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2006 (estimated)
- Study startMay 2006
- Primary completionJun 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Ellen R. Wald, M.D., Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398359
- Sponsor's protocol ID
- M-2006-1018
- Status last verified
- Dec 2011
- First submitted
- 8 Nov 2006
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Koletzko B, Girardet JP, Klish W, Tabacco O. Obesity in children and adolescents worldwide: current views and future directions--Working Group Report of the First World Congress of Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. 2002;35 Suppl 2:S205-12. doi: 10.1097/00005176-200208002-00019. No abstract available.
PubMed 12192190Miller WR, Rollnick S. Motivational Interviewing: Preparing People for Change. 2nd edition. New York: Guilford Press; 2002.
Rollnick S, Mason P, Butler C. Health Behavior Change: A guide for practitioners. Edinburgh: Churchill Livingstone; 1999.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Childhood Obesity in Primary Care
- ClinicalTrials.gov ID
- NCT00398359
- Acronym / sponsor ID
- M-2006-1018
- Conditions
- Obesity
- Keywords
- Obesity, Overweight, Children, Behavioral, Motivational, Family, Primary care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- May 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 10 Nov 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.
This project will apply the concepts from the Chronic Care Model to the problem of pediatric obesity and proposes: 1) to assess the effectiveness of teaching primary care providers (in diverse practice settings) to use specific communication strategies with parents of overweight and obese children to help them take steps with their child toward healthy behavior change; 2) to offer core components of an efficacious evidence-based pediatric obesity treatment within the pediatric primary care setting to determine if participating children will achieve clinically meaningful weight loss (assessed as weight and BMI percentile changes at the end of treatment and at a six month follow-up); and 3) to assess the ability of trained, behavioral psychologists to offer the treatment so that desired child outcomes are achieved. The primary project outcomes will include: 1) increase in self-reported physician confidence in use of counseling skills related to pediatric overweight; and 2) change in child's diet, physical activity, weight and BMI percentile at the end of treatment and at 6-month follow-up.
Detailed description
Overweight in children, adolescents and adults has increased dramatically during the last two decades in developed and developing nations, leading to a global epidemic. Current trends in childhood overweight are a function of both poor nutrition and an increase in sedentary activities.
Pediatric health care providers are ideally situated to address this problem, especially since children are seen frequently for preventive care during the early years when intervention may be more likely to yield long-term change. However, most pediatric providers do not have the needed training to manage obesity effectively. This project will use the chronic care model to foster the effectiveness of an office-based intervention aimed at altering dietary intake and physical activity for children whose BMI reflects overweight and their parents. With the support of the health care system (through new reimbursement strategies), office redesign (assignment of tasks to the health assistant, physician and behavioral interventionist), self-management techniques (patient training) and enhanced community resources, a successful program for improved nutrition and physical activity will be built.
Specific Aim 1 of this study is to increase physician use of counseling techniques that are effective in promoting positive behavior change regarding nutrition and physical activity in the pediatric primary care setting. This aim will be accomplished by offering a training intervention for primary care pediatricians and health assistants. The intervention will:
- Increase physician recognition of risk factors for overweight.
- Teach physicians to use brief motivational strategies with parents and children that will assist them in taking steps toward healthier behavior as it relates to nutrition and physical activities, including but not limited to enrolling in a group behavioral treatment program.
Specific Aim 2 is to assess the effectiveness of implementing a pediatric primary care office-based nutrition/physical activity behavioral intervention for overweight and obese children and their parents.
In specific aim 2 we will employ trained behavioral interventionists to offer a family-based behavioral intervention targeting healthy eating and decreased sedentary behavior/increased physical activity to overweight/obese children ages 9-12 and their parents; and to evaluate parent and child adherence to attendance and behavioral intervention factors. Self-monitoring reports of the child's behavioral changes (e.g., decrease in number of "red foods"[foods high in calories and fat] consumed weekly and decreased time spent each week watching TV, using the computer, and playing video games) will be described, as will any changes in BMI.
Experienced behavioral interventionists will be trained in behavioral theory principles fundamental to the intervention that involve helping children and their parents to change behavior and maintain the changes by Dr. Ewing (Co-Investigator). Dr Ewing, who has completed Human Subjects and HIPAA training at the University of Pittsburgh will come to Madison, Wisconsin to do a training session for the behavioral interventionists and study coordinator. In addition, she will provide instruction in principles of weight management, the role of healthy eating and physical activity in maintaining a healthy weight, and the empirical support for the intervention that will be offered. Finally, the interventionists will receive training to conduct each of the individual sessions.
The American Academy of Pediatrics (AAP) recommends that overweight children be screened for fasting blood glucose, fasting blood insulin, and serum lipids. Pre and post lab values that are available for participating children will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Motivational Interviewing (physicians), Behavioral: Behavior Modification (families) |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- >95% BMI
- developmentally normal
- referred by primary care provider
Key exclusion criteria (4 listed)
- currently involved in an organized weight control program
- Preexisting high blood pressure
- Preexisting high lipids
- Preexisting diabetes due to obesity
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 |
|---|---|---|
| Motivational Interviewing (physicians)Identifying and referring children with BMI >93%. | Behavioural | 1 |
| Behavior Modification (families)Group meetings and individual family meetings based on behavior modification for healthy lifestyle changes. | Behavioural | 1 |
Primary outcome
Proportion of primary care physicians who discuss the child's BMI with parents
Time frame: 6/2007 - ongoing
3 secondary outcomes
Basic descriptive data analysis
Time frame: two years
Statistical testing of the primary hypothesis of each aim
Time frame: two years
Statistical modeling to better understand the relationship between the outcome of interest and the intervention
Time frame: two years
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 2 Oct 2015.
- Background: PubMed 12192190Koletzko B, Girardet JP, Klish W, Tabacco O. Obesity in children and adolescents worldwide: current views and future directions--Working Group Report of the First World Congress of Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. 2002;35 Suppl 2:S205-12. doi: 10.1097/00005176-200208002-00019. No abstract available.
- BackgroundMiller WR, Rollnick S. Motivational Interviewing: Preparing People for Change. 2nd edition. New York: Guilford Press; 2002.
- BackgroundRollnick S, Mason P, Butler C. Health Behavior Change: A guide for practitioners. Edinburgh: Churchill Livingstone; 1999.
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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.
Ellen R. Wald, M.D. principal investigator
University of Wisconsin, Madison
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Motivational Interviewing (physicians) and Behavior Modification (families) in people with Obesity, run by University of Wisconsin, Madison at 6 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 3 inclusion and 4 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 2 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Proportion of primary care physicians who discuss the child's BMI with parents (time frame: 6/2007 - ongoing). 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 NCT00398359, which also lists 3 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 2 Oct 2015.