ObesityNCT00397865
A Primary Care Educational Intervention for Families of Overweight Children
A study testing Educational booklet in people with Obesity, run by University of Wisconsin, Madison at 4 sites in United States.
Trial summary
The purpose of the research is to find out if an educational booklet is helpful to families with overweight children. The educational booklet contains information for parents about nutritious eating, physical activity, and strategies for healthy living. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Educational booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2006to Aug 2007
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Body mass index greater than or equal to the 95th percentile for age and gender
- Presenting to pediatrician for a health maintenance visit
Who cannot join
- Genetic conditions known to predispose to overweight
- Endocrine conditions associated with overweight
- Chronic steroid therapy
- Current enrollment in a professional weight management program
Trial locations and contacts
4 sites in 1 country.
United States4 sites
UW East Towne Pediatric Clinic
Madison, Wisconsin, 53704
Associated Physicians Pediatric Clinic
Madison, Wisconsin, 53705
Boys & Girls Club of Dane County
Madison, Wisconsin, 53715
UW West Pediatric Clinic
Madison, Wisconsin, 53717
About this study
The purpose of the research is to find out if an educational booklet is helpful to families with overweight children. The educational booklet contains information for parents about nutritious eating, physical activity, and strategies for healthy living.
Read the detailed description
The prevalence of overweight among children has at least doubled in the past 25 years. In the year 2004, 18.8% of children ages 6-11 were overweight. Being overweight as a child is clearly associated with adulthood obesity. In addition, complications once prevalent only in adults are now being seen in overweight children and adolescents. These include hypertension, hypercholesterolemia, and type II diabetes which are well known risk factors for cardiovascular disease. Obesity is also associated with low self-esteem among some groups of overweight adolescents.
Primary care providers are in a unique position to combat this epidemic. However, a recent survey found that only 12% of pediatricians felt highly effective in their ability to treat obesity. Furthermore, physicians reported that low self-efficacy in treating obesity was associated with a lack of patient educational materials. Few written resources for families of overweight children have been tested in the primary care setting. Much of the research on childhood overweight has been conducted in specialty obesity clinics where the resources and patient population may differ from those of primary care offices.
Kid STRIDE is an educational booklet designed for parents of overweight children. It includes information about nutrition, physical activity, and strategies for healthy living. It is hypothesized that the booklet will be distributed to and used by parents of children who are overweight or at risk for overweight. This study will analyze parents' perceptions of this booklet in order to improve its potential value. Information obtained from this pilot study will be used to prepare for a future study to determine the effectiveness of this intervention.
The purpose of this study is:
Aim 1 is to determine the distribution rate and uptake rate of an educational booklet for parents of children between the ages of 8 and 12 who are overweight.
Aim 2 is to describe parents' perceptions of the educational booklet.
Aim 3 is to assess the impact of the intervention on BMI as measured by change in BMI z-score.
- Conditions
- Obesity
- Being tested
- Educational booklet
- Keywords
- Obesity, Overweight
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational bookletBehavioural
Parental perception of educational booklet and evaluating any change in child's weight.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Behavioral: Educational booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe parents' perceptions of the educational booklet
Measured: one year
Determine the uptake rate of an educational booklet for parents of overweight children between the ages of 7 and 12
Measured: 6 months
Assess the impact of the intervention on BMI as measured by change in BMI z-score
Measured: 6 months
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 startOct 2006
- Study completionAug 2007
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen R Wald, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397865
- Sponsor's protocol ID
- M-2006-1259
- Status last verified
- Jul 2010
- First submitted
- 8 Nov 2006
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Whitlock EP, Williams SB, Gold R, Smith PR, Shipman SA. Screening and interventions for childhood overweight: a summary of evidence for the US Preventive Services Task Force. Pediatrics. 2005 Jul;116(1):e125-44. doi: 10.1542/peds.2005-0242.
PubMed 15995013Ogden CL, Flegal KM, Carroll MD, Johnson CL. Prevalence and trends in overweight among US children and adolescents, 1999-2000. JAMA. 2002 Oct 9;288(14):1728-32. doi: 10.1001/jama.288.14.1728.
PubMed 12365956Guo SS, Roche AF, Chumlea WC, Gardner JD, Siervogel RM. The predictive value of childhood body mass index values for overweight at age 35 y. Am J Clin Nutr. 1994 Apr;59(4):810-9. doi: 10.1093/ajcn/59.4.810.
PubMed 8147324Freedman DS, Dietz WH, Srinivasan SR, Berenson GS. The relation of overweight to cardiovascular risk factors among children and adolescents: the Bogalusa Heart Study. Pediatrics. 1999 Jun;103(6 Pt 1):1175-82. doi: 10.1542/peds.103.6.1175.
PubMed 10353925Strauss RS. Childhood obesity and self-esteem. Pediatrics. 2000 Jan;105(1):e15. doi: 10.1542/peds.105.1.e15.
PubMed 10617752Perrin EM, Flower KB, Garrett J, Ammerman AS. Preventing and treating obesity: pediatricians' self-efficacy, barriers, resources, and advocacy. Ambul Pediatr. 2005 May-Jun;5(3):150-6. doi: 10.1367/A04-104R.1.
PubMed 15913408
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Primary Care Educational Intervention for Families of Overweight Children
- ClinicalTrials.gov ID
- NCT00397865
- Acronym / sponsor ID
- M-2006-1259
- Conditions
- Obesity
- Keywords
- Obesity, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Oct 2006
- Study completion
- Aug 2007 (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.
The purpose of the research is to find out if an educational booklet is helpful to families with overweight children. The educational booklet contains information for parents about nutritious eating, physical activity, and strategies for healthy living.
Detailed description
The prevalence of overweight among children has at least doubled in the past 25 years. In the year 2004, 18.8% of children ages 6-11 were overweight. Being overweight as a child is clearly associated with adulthood obesity. In addition, complications once prevalent only in adults are now being seen in overweight children and adolescents. These include hypertension, hypercholesterolemia, and type II diabetes which are well known risk factors for cardiovascular disease. Obesity is also associated with low self-esteem among some groups of overweight adolescents.
Primary care providers are in a unique position to combat this epidemic. However, a recent survey found that only 12% of pediatricians felt highly effective in their ability to treat obesity. Furthermore, physicians reported that low self-efficacy in treating obesity was associated with a lack of patient educational materials. Few written resources for families of overweight children have been tested in the primary care setting. Much of the research on childhood overweight has been conducted in specialty obesity clinics where the resources and patient population may differ from those of primary care offices.
Kid STRIDE is an educational booklet designed for parents of overweight children. It includes information about nutrition, physical activity, and strategies for healthy living. It is hypothesized that the booklet will be distributed to and used by parents of children who are overweight or at risk for overweight. This study will analyze parents' perceptions of this booklet in order to improve its potential value. Information obtained from this pilot study will be used to prepare for a future study to determine the effectiveness of this intervention.
The purpose of this study is:
Aim 1 is to determine the distribution rate and uptake rate of an educational booklet for parents of children between the ages of 8 and 12 who are overweight.
Aim 2 is to describe parents' perceptions of the educational booklet.
Aim 3 is to assess the impact of the intervention on BMI as measured by change in BMI z-score.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Educational booklet |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Body mass index greater than or equal to the 95th percentile for age and gender
- Presenting to pediatrician for a health maintenance visit
Key exclusion criteria (4 listed)
- Genetic conditions known to predispose to overweight
- Endocrine conditions associated with overweight
- Chronic steroid therapy
- Current enrollment in a professional weight management program
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 |
|---|---|---|
| Educational bookletParental perception of educational booklet and evaluating any change in child's weight. | Behavioural | A |
Primary outcome
Describe parents' perceptions of the educational booklet
Time frame: one year
Determine the uptake rate of an educational booklet for parents of overweight children between the ages of 7 and 12
Time frame: 6 months
Assess the impact of the intervention on BMI as measured by change in BMI z-score
Time frame: 6 months
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 Oct 2015.
- Background: PubMed 15995013Whitlock EP, Williams SB, Gold R, Smith PR, Shipman SA. Screening and interventions for childhood overweight: a summary of evidence for the US Preventive Services Task Force. Pediatrics. 2005 Jul;116(1):e125-44. doi: 10.1542/peds.2005-0242.
- Background: PubMed 12365956Ogden CL, Flegal KM, Carroll MD, Johnson CL. Prevalence and trends in overweight among US children and adolescents, 1999-2000. JAMA. 2002 Oct 9;288(14):1728-32. doi: 10.1001/jama.288.14.1728.
- Background: PubMed 8147324Guo SS, Roche AF, Chumlea WC, Gardner JD, Siervogel RM. The predictive value of childhood body mass index values for overweight at age 35 y. Am J Clin Nutr. 1994 Apr;59(4):810-9. doi: 10.1093/ajcn/59.4.810.
- Background: PubMed 10353925Freedman DS, Dietz WH, Srinivasan SR, Berenson GS. The relation of overweight to cardiovascular risk factors among children and adolescents: the Bogalusa Heart Study. Pediatrics. 1999 Jun;103(6 Pt 1):1175-82. doi: 10.1542/peds.103.6.1175.
- Background: PubMed 10617752Strauss RS. Childhood obesity and self-esteem. Pediatrics. 2000 Jan;105(1):e15. doi: 10.1542/peds.105.1.e15.
- Background: PubMed 15913408Perrin EM, Flower KB, Garrett J, Ammerman AS. Preventing and treating obesity: pediatricians' self-efficacy, barriers, resources, and advocacy. Ambul Pediatr. 2005 May-Jun;5(3):150-6. doi: 10.1367/A04-104R.1.
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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, MD principal investigator
University of Wisconsin, Madison
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational booklet in people with Obesity, run by University of Wisconsin, Madison at 4 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 2 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 5 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 4 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?
Describe parents' perceptions of the educational booklet (time frame: one year). The study lists 3 primary outcomes in all. 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 NCT00397865, 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 5 Oct 2015.