ObesityHKHNCT00994084
Healthy Kids-Houston: A Community Childhood Obesity Intervention Program
A study testing Healthy Kids-Houston program in people with Obesity, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The collaborative study is to determine the effectiveness of an after-school community-based program to prevent obesity among minority children. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Healthy Kids-Houston program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,094 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Aug 2013
- 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 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Live in close proximity of the community centers
Who cannot join
- Medical or physical conditions that prevent the child from participating in the physical activities
Trial locations and contacts
1 site in 1 country.
United States1 site
Houston Parks and Recreation Department Community Centers
Houston, Texas, 77023
About this study
Official title: Healthy Kids-Houston: An Integrated Community Program for the Prevention of Obesity Among Minority Children
The collaborative study is to determine the effectiveness of an after-school community-based program to prevent obesity among minority children.
Read the detailed description
Childhood obesity is a major health issue in the United States, particularly among minority children. An integrated after-school program that offers structured and fun physical activities with nutrition and behavior lessons in community centers operated by the Houston Parks and Recreation Department might prevent obesity among minority children who live in the neighborhood.
- Conditions
- Obesity
- Being tested
- Healthy Kids-Houston program, Control
- Keywords
- Obesity, Minority children, Community intervention program, Lifestyle changes, Physical activities, Nutrition lessons, Behavior modification
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Kids-Houston programBehavioural
Also called Healthy Kids-Houston curriculum
Children receive 90 minutes of after-school structured physical activities and 30 minutes of nutrition and behavior lessons twice a week during three 6-week sessions at the community centers. The 6-week sessions take place once in the fall, once in early spring and once in late spring.
ControlBehavioural
Children do not receive the Healthy Kids-Houston behavior modification program but will participate in the regular after-school enrichment programs offered by the community centers.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle modification | Active comparator | This arm receives the intervention program that includes structured physical activities and nutrition and behavior lessons Receives: Behavioral: Healthy Kids-Houston program |
| Control | Placebo comparator | This arm receives no intervention Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
Measured: One school year
Secondary outcomes (5)
Agility
Measured: One school year
Muscular strength and endurance
Measured: One school year
Self esteem
Measured: One school year
Physical activity level
Measured: One school year
Flexibility
Measured: One school year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2013
- Study completionAug 2013
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 Baylor College of MedicineThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,094 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Wong, Baylor College of Medicine
- Investigators
- William W Wong, PhD, Study director, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994084
- Sponsor's protocol ID
- 26490-1
- Other IDs
- 2008-55215-18875, 2008
- Acronym
- HKH
- Status last verified
- Jan 2015
- First submitted
- 13 Oct 2009
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wong WW, Mikhail C, Ortiz CL, Lathan D, Moore LA, Konzelmann KL, Smith EO. Body weight has no impact on self-esteem of minority children living in inner city, low-income neighborhoods: a cross-sectional study. BMC Pediatr. 2014 Jan 24;14:19. doi: 10.1186/1471-2431-14-19.
PubMed 24456638Wong WW, Ortiz CL, Lathan D, Moore LA, Konzelmann KL, Adolph AL, Smith EO, Butte NF. Sleep duration of underserved minority children in a cross-sectional study. BMC Public Health. 2013 Jul 12;13:648. doi: 10.1186/1471-2458-13-648.
PubMed 23849231Wong WW, Ortiz CL, Stuff JE, Mikhail C, Lathan D, Moore LA, Alejandro ME, Butte NF, Smith EO. A Community-based Healthy Living Promotion Program Improved Self-esteem Among Minority Children. J Pediatr Gastroenterol Nutr. 2016 Jul;63(1):106-12. doi: 10.1097/MPG.0000000000001088.
PubMed 27336592
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Kids-Houston: An Integrated Community Program for the Prevention of Obesity Among Minority Children
- ClinicalTrials.gov ID
- NCT00994084
- Acronym / sponsor ID
- HKH / 26490-1
- Conditions
- Obesity
- Keywords
- Obesity, Minority children, Community intervention program, Lifestyle changes, Physical activities, Nutrition lessons, Behavior modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,094 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 14 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 collaborative study is to determine the effectiveness of an after-school community-based program to prevent obesity among minority children.
Detailed description
Childhood obesity is a major health issue in the United States, particularly among minority children. An integrated after-school program that offers structured and fun physical activities with nutrition and behavior lessons in community centers operated by the Houston Parks and Recreation Department might prevent obesity among minority children who live in the neighborhood.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle modification | Active comparator | Behavioral: Healthy Kids-Houston programThis arm receives the intervention program that includes structured physical activities and nutrition and behavior lessons |
| Control | Placebo comparator | Behavioral: ControlThis arm receives no intervention |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Live in close proximity of the community centers
Key exclusion criteria (1 listed)
- Medical or physical conditions that prevent the child from participating in the physical activities
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 |
|---|---|---|
| Healthy Kids-Houston programAlso: Healthy Kids-Houston curriculumChildren receive 90 minutes of after-school structured physical activities and 30 minutes of nutrition and behavior lessons twice a week during three 6-week sessions at the community centers. The 6-week sessions take place once in the fall, once in early spring and once in late spring. | Behavioural | Lifestyle modification |
| ControlChildren do not receive the Healthy Kids-Houston behavior modification program but will participate in the regular after-school enrichment programs offered by the community centers. | Behavioural | Control |
Primary outcome
Body mass index
Time frame: One school year
5 secondary outcomes
Agility
Time frame: One school year
Muscular strength and endurance
Time frame: One school year
Self esteem
Time frame: One school year
Physical activity level
Time frame: One school year
Flexibility
Time frame: One school year
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 28 Jan 2015.
- Background: PubMed 24456638Wong WW, Mikhail C, Ortiz CL, Lathan D, Moore LA, Konzelmann KL, Smith EO. Body weight has no impact on self-esteem of minority children living in inner city, low-income neighborhoods: a cross-sectional study. BMC Pediatr. 2014 Jan 24;14:19. doi: 10.1186/1471-2431-14-19.
- Results publication: PubMed 23849231Wong WW, Ortiz CL, Lathan D, Moore LA, Konzelmann KL, Adolph AL, Smith EO, Butte NF. Sleep duration of underserved minority children in a cross-sectional study. BMC Public Health. 2013 Jul 12;13:648. doi: 10.1186/1471-2458-13-648.
- Derived from this study: PubMed 27336592Wong WW, Ortiz CL, Stuff JE, Mikhail C, Lathan D, Moore LA, Alejandro ME, Butte NF, Smith EO. A Community-based Healthy Living Promotion Program Improved Self-esteem Among Minority Children. J Pediatr Gastroenterol Nutr. 2016 Jul;63(1):106-12. doi: 10.1097/MPG.0000000000001088.
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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.
William W Wong, PhD study director
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Kids-Houston program in people with Obesity, run by Baylor College of Medicine 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 1 inclusion and 1 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 28 Jan 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. 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?
Body mass index (time frame: One school year). 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 NCT00994084, 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 28 Jan 2015.