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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.

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

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)
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

Other trials in United States

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:

  1. Increase physician recognition of risk factors for overweight.
  2. 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 groups in NCT00398359
Study groupRoleWhat they receive
1ExperimentalNot 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.

  1. Proportion of primary care physicians who discuss the child's BMI with parents

    Measured: 6/2007 - ongoing

Secondary outcomes (3)
  1. Basic descriptive data analysis

    Measured: two years

  2. Statistical testing of the primary hypothesis of each aim

    Measured: two years

  3. 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.

  1. First posted10 Nov 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionJun 2010
  4. Study completionDec 2010

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
145 participants (actual)
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 12192190
  • Miller 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.

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.

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