OverweightNCT00993434
The Impact of Educational Materials on Family Behavior
A study testing Booklet on nutrition and physical activity. and Safety Booklet in people with Overweight and Obesity, run by University of Wisconsin, Madison at 4 sites in United States.
Trial summary
The purpose of the research is to learn whether written materials or handouts that are given to parents are helpful in changing knowledge or behavior. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Booklet on nutrition and physical activity. and Safety Booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2009to Aug 2012
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with a BMI greater than or equal to 85% along with a parent.
- All subjects must speak English.
Who cannot join
- Genetic conditions associated with 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
GHC Capitol Pediatric Clinic
Madison, Wisconsin, 53703
UW Health East Towne Pediatrics
Madison, Wisconsin, 53704
UW Health West Towne Pediatrics
Madison, Wisconsin, 53717
UW Health Park Street Pediatrics
Madison, Wisconsin, 53792
About this study
The purpose of the research is to learn whether written materials or handouts that are given to parents are helpful in changing knowledge or behavior.
Read the detailed description
Few written resources for families have been tested in the primary care setting. Kid STRIDE (STRiving to Improve Diet \& Exercise) is an educational booklet designed for parents of overweight children. We hypothesize that this booklet will benefit a small percentage of the overweight and obese population of children as a first-tiered approach to treatment of overweight and obese children.
- Conditions
- Overweight, Obesity
- Being tested
- Booklet on nutrition and physical activity., Safety Booklet
- Keywords
- Child
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Booklet on nutrition and physical activity.Behavioural
Parents will be asked to read the booklet and complete a pre- and post-questionnaire.
Safety BookletBehavioural
Parents will be asked to read a safety booklet and complete a pre- and post-questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Kid STRIDE Booklet | Active comparator | Not described Receives: Behavioral: Booklet on nutrition and physical activity. |
| Safety Booklet | Placebo comparator | Not described Receives: Behavioral: Safety Booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the effectiveness of written materials on changing knowledge and behavior regarding diet, exercise, and other weight factors.
Measured: 3 months
Secondary outcomes (1)
Assess the impact of the intervention on height and weight as reflected in a change in BMI z-score.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 95 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 Dept of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993434
- Sponsor's protocol ID
- M-2009-1162
- Status last verified
- Nov 2012
- First submitted
- 8 Oct 2009
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
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
- The Impact of Educational Materials on Family Behavior
- ClinicalTrials.gov ID
- NCT00993434
- Acronym / sponsor ID
- M-2009-1162
- Conditions
- Overweight, Obesity
- Keywords
- Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 12 Oct 2009 (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 learn whether written materials or handouts that are given to parents are helpful in changing knowledge or behavior.
Detailed description
Few written resources for families have been tested in the primary care setting. Kid STRIDE (STRiving to Improve Diet \& Exercise) is an educational booklet designed for parents of overweight children. We hypothesize that this booklet will benefit a small percentage of the overweight and obese population of children as a first-tiered approach to treatment of overweight and obese children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kid STRIDE Booklet | Active comparator | Behavioral: Booklet on nutrition and physical activity. |
| Safety Booklet | Placebo comparator | Behavioral: Safety Booklet |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with a BMI greater than or equal to 85% along with a parent.
- All subjects must speak English.
Key exclusion criteria (4 listed)
- Genetic conditions associated with 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 |
|---|---|---|
| Booklet on nutrition and physical activity.Parents will be asked to read the booklet and complete a pre- and post-questionnaire. | Behavioural | Kid STRIDE Booklet |
| Safety BookletParents will be asked to read a safety booklet and complete a pre- and post-questionnaire. | Behavioural | Safety Booklet |
Primary outcome
Assess the effectiveness of written materials on changing knowledge and behavior regarding diet, exercise, and other weight factors.
Time frame: 3 months
1 secondary outcome
Assess the impact of the intervention on height and weight as reflected in a change in BMI z-score.
Time frame: 3 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 2 Oct 2015.
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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 Dept of Pediatrics
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Booklet on nutrition and physical activity. and Safety Booklet in people with Overweight and 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 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 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. Some participants in this study may receive a placebo. 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?
Assess the effectiveness of written materials on changing knowledge and behavior regarding diet, exercise, and other weight factors. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.