OverweightNCT00277420
Trial of a Culturally-Appropriate Weight Loss Intervention for Overweight Latino Children
A study testing Comprehensive weight management in people with Overweight, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This project aims to conduct a unique, community-based intervention consisting of a randomized trial of a culturally-appropriate weight loss intervention for overweight Latino children in Milwaukee. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Overweight
- What is being tested?
- Comprehensive weight management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Aug 2008
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children must be of Latino descent
- At risk for becoming overweight or is overweight
- 6-17 years old.
Who cannot join
- Age > 17 years old
- Not overweight or at risk for becoming overweight
- Non-Latino ethnicity/race.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Advancement of Underserved Children (CAUC), Department of Pediatrics, Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: A Randomized Controlled Trial of a Culturally-Appropriate Weight Loss Intervention for Overweight Latino Children
This project aims to conduct a unique, community-based intervention consisting of a randomized trial of a culturally-appropriate weight loss intervention for overweight Latino children in Milwaukee. The intervention promotes lifestyle changes through a low weight loss regimen, one or more physical activities ranging from soccer to hip-hop dance, and dietary counseling including cooking classes for parents. In addition to weight reduction for overweight Latino children, the project has the potential to reduce missed school days and improve self-esteem and quality of life.
- Conditions
- Overweight
- Being tested
- Comprehensive weight management
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive weight managementBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
change in body mass index (BMI) z-score
Secondary outcomes (13)
height, weight, and BMI
percent body fat
physical activity
sedentary activity
dietary habits
the child's quality of life
self-esteem
physical fitness
selected health and use of health services measures (missed school days, parental missed work days, and number of healthcare provider visits for illness by child)
the parents' BMI
the child's satisfaction with opportunities to lose weight and increase physical activity in the past year
the parents' satisfaction with opportunities for the child to lose weight and increase physical activity in the past year
costs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2006 (estimated)
- Study startAug 2005
- Study completionAug 2008 (estimated)
Why it stopped: PI has left institution after losing funding for this PI-initiated study
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 Medical College of WisconsinThe 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- United Community Center, Milwaukee SCORES, Milwaukee Kickers Soccer Club
- Investigators
- Glenn Flores, MD, Study director, Center for Advancement of Underserved Children (CAUC), Department of Pediatrics, Medical College of WisconsinJane Brotanek, MD, Principal investigator, Assistant Professor of Pediatrics, Department of Pediatrics, Medical College of WisconsinJulio C Maldonado, BA, Principal investigator, Project Coordinator II, Center for Advancement of Underserved Children (CAUC), Department of Pediatrics, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277420
- Sponsor's protocol ID
- #CHW 05/75, HRRC 214-05
- Status last verified
- Aug 2015
- First submitted
- 12 Jan 2006
- Last updated
- 25 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Culturally-Appropriate Weight Loss Intervention for Overweight Latino Children
- ClinicalTrials.gov ID
- NCT00277420
- Acronym / sponsor ID
- #CHW 05/75, HRRC 214-05
- Conditions
- Overweight
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI has left institution after losing funding for this PI-initiated study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- United Community Center, Milwaukee SCORES, Milwaukee Kickers Soccer Club
- Study start
- Aug 2005
- Study completion
- Aug 2008 (estimated)
- First posted
- 16 Jan 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 aims to conduct a unique, community-based intervention consisting of a randomized trial of a culturally-appropriate weight loss intervention for overweight Latino children in Milwaukee. The intervention promotes lifestyle changes through a low weight loss regimen, one or more physical activities ranging from soccer to hip-hop dance, and dietary counseling including cooking classes for parents. In addition to weight reduction for overweight Latino children, the project has the potential to reduce missed school days and improve self-esteem and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children must be of Latino descent
- At risk for becoming overweight or is overweight
- 6-17 years old.
Key exclusion criteria (3 listed)
- Age > 17 years old
- Not overweight or at risk for becoming overweight
- Non-Latino ethnicity/race.
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 |
|---|---|---|
| Comprehensive weight management | Behavioural | – |
Primary outcome
change in body mass index (BMI) z-score
13 secondary outcomes
height, weight, and BMI
percent body fat
physical activity
sedentary activity
dietary habits
the child's quality of life
self-esteem
physical fitness
selected health and use of health services measures (missed school days, parental missed work days, and number of healthcare provider visits for illness by child)
the parents' BMI
the child's satisfaction with opportunities to lose weight and increase physical activity in the past year
the parents' satisfaction with opportunities for the child to lose weight and increase physical activity in the past year
costs
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 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.
Glenn Flores, MD study director
Center for Advancement of Underserved Children (CAUC), Department of Pediatrics, Medical College of Wisconsin
Jane Brotanek, MD principal investigator
Assistant Professor of Pediatrics, Department of Pediatrics, Medical College of Wisconsin
Julio C Maldonado, BA principal investigator
Project Coordinator II, Center for Advancement of Underserved Children (CAUC), Department of Pediatrics, Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive weight management in people with Overweight, run by Medical College of Wisconsin at 1 site 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 3 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: withdrawn, as of the sponsor's last update on 25 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
change in body mass index (BMI) z-score. 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 25 Aug 2015.