ObesityPhase 1NCT01419951
Launch II: A Pilot Randomized Control Trial of a Clinic and Clinic Plus Home Intervention for Preschool Obesity
A Phase 1 study testing Clinic + Home Behavioral Intervention, Pediatrician Counseling and Clinic Only Behavioral Intervention in people with Obesity, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The objective of this project is to pilot test a behavioral intervention that includes a home visit component compared to a clinic only and standard of care for the treatment of obesity in preschool age children. The results of this study will inform the design of a larger randomized control trial. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Clinic + Home Behavioral Intervention, Pediatrician Counseling and Clinic Only Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Oct 2014
- Phase
- Phase 1
- 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 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 2 years 0 months to 5 years 11 months of age
- at or above the 95th percentile BMI for age and sex
- have at least one parent with a BMI at or greater than 25
- medical clearance from pediatrician
Who cannot join
- non-English speaking
- living greater than 50 miles from medical center
- a disability or illness that would preclude engagement in moderate activity
- medical condition/medication associated with weight
- enrolled in another weight management program
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: LAUNCH II: Learning About Activity and Understanding Nutrition for Better Child Health
The objective of this project is to pilot test a behavioral intervention that includes a home visit component compared to a clinic only and standard of care for the treatment of obesity in preschool age children. The results of this study will inform the design of a larger randomized control trial.
H1: The clinic + home intervention will result in a significantly greater decrease in BMIz compared to the in clinic only intervention or pediatric standard of care at 6 months post-treatment.
- Conditions
- Obesity
- Being tested
- Clinic + Home Behavioral Intervention, Pediatrician Counseling, Clinic Only Behavioral Intervention
- Keywords
- Behavioral treatment, Preschool aged children, Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinic + Home Behavioral InterventionBehavioural
A 6 month intervention consisting of two phases: Phase I Intensive intervention is 12 weekly sessions that alternate between a group-based clinic session (concurrent parent and child groups) and individual home visits. Phase II Maintenance is 12 weeks of every other week visits alternating between clinic and home. Treatment targets 3 components: Dietary education, physical activity and parenting training.
Pediatrician CounselingOther
A one-time 45 minute visit with a board certified pediatrician that focuses on the AAP guidelines for eating and physical activity for preschool aged children.
Clinic Only Behavioral InterventionBehavioural
A 6 month intervention consisting of two phases: Phase I Intensive intervention is 6 sessions delivered in a group-based format in clinic (concurrent parent and child groups) every other week. Phase II Maintenance is 3 monthly clinic visits. Treatment targets 3 components: Dietary education, physical activity and parenting training.
| Study group | Role | What they receive |
|---|---|---|
| Clinic Only Behavioral Intervention | Active comparator | A 6 month intervention consisting of two phases: Phase I Intensive intervention is 6 sessions delivered in a group-based format in clinic (concurrent parent and child groups) every other week. Phase II Maintenance is 3 monthly clinic visits. Treatment targets 3 components: Dietary education, physical activity and parenting training. Receives: Behavioral: Clinic Only Behavioral Intervention |
| Pediatrician Counseling | Active comparator | A one-time 45 minute visit with a board certified pediatrician that focuses on the AAP guidelines for eating and physical activity for preschool aged children. Receives: Other: Pediatrician Counseling |
| Clinic + Home Behavioral Intervention | Experimental | A 6 month intervention consisting of two phases: Phase I Intensive intervention is 12 weekly sessions that alternate between a group-based clinic session (concurrent parent and child groups) and individual home visits. Phase II Maintenance is 12 weeks of every other week visits alternating between clinic and home. Treatment targets 3 components: Dietary education, physical activity and parenting training. Receives: Behavioral: Clinic + Home Behavioral Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI z score
Body mass index z score
Measured: Change from Baseline to 6 months
Secondary outcomes (6)
Change in Parent weight loss
Measured: Change from baseline to 6 months
Change in Child caloric intake
Measured: Change from baseline to 6 months
Change in Home food and activity environment
Measured: Change from baseline to 6 months
Change in Child physical activity
Measured: Change from baseline to 6 months
Change in Parent-child mealtime interactions
Measured: Change from baseline to 6 months
Change in Health related quality of life
Measured: Change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study startMay 2009
- Primary completionOct 2011
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Center for Research Resources (NCRR)
- Responsible party
- Sponsor
- Investigators
- Lori J Stark, Ph.D., Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419951
- Sponsor's protocol ID
- 2008-0666
- Other IDs
- K24DK059492
- Status last verified
- Oct 2014
- First submitted
- 5 Aug 2011
- Last updated
- 22 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LAUNCH II: Learning About Activity and Understanding Nutrition for Better Child Health
- ClinicalTrials.gov ID
- NCT01419951
- Acronym / sponsor ID
- 2008-0666
- Conditions
- Obesity
- Keywords
- Behavioral treatment, Preschool aged children, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Center for Research Resources (NCRR)
- Study start
- May 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 18 Aug 2011 (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 objective of this project is to pilot test a behavioral intervention that includes a home visit component compared to a clinic only and standard of care for the treatment of obesity in preschool age children. The results of this study will inform the design of a larger randomized control trial.
H1: The clinic + home intervention will result in a significantly greater decrease in BMIz compared to the in clinic only intervention or pediatric standard of care at 6 months post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinic Only Behavioral Intervention | Active comparator | Behavioral: Clinic Only Behavioral InterventionA 6 month intervention consisting of two phases: Phase I Intensive intervention is 6 sessions delivered in a group-based format in clinic (concurrent parent and child groups) every other week. Phase II Maintenance is 3 monthly clinic visits. Treatment targets 3 components: Dietary education, physical activity and parenting training. |
| Pediatrician Counseling | Active comparator | Other: Pediatrician CounselingA one-time 45 minute visit with a board certified pediatrician that focuses on the AAP guidelines for eating and physical activity for preschool aged children. |
| Clinic + Home Behavioral Intervention | Experimental | Behavioral: Clinic + Home Behavioral InterventionA 6 month intervention consisting of two phases: Phase I Intensive intervention is 12 weekly sessions that alternate between a group-based clinic session (concurrent parent and child groups) and individual home visits. Phase II Maintenance is 12 weeks of every other week visits alternating between clinic and home. Treatment targets 3 components: Dietary education, physical activity and parenting training. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 2 years 0 months to 5 years 11 months of age
- at or above the 95th percentile BMI for age and sex
- have at least one parent with a BMI at or greater than 25
- medical clearance from pediatrician
Key exclusion criteria (5 listed)
- non-English speaking
- living greater than 50 miles from medical center
- a disability or illness that would preclude engagement in moderate activity
- medical condition/medication associated with weight
- enrolled in another 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 |
|---|---|---|
| Clinic + Home Behavioral InterventionA 6 month intervention consisting of two phases: Phase I Intensive intervention is 12 weekly sessions that alternate between a group-based clinic session (concurrent parent and child groups) and individual home visits. Phase II Maintenance is 12 weeks of every other week visits alternating between clinic and home. Treatment targets 3 components: Dietary education, physical activity and parenting training. | Behavioural | Clinic + Home Behavioral Intervention |
| Pediatrician CounselingA one-time 45 minute visit with a board certified pediatrician that focuses on the AAP guidelines for eating and physical activity for preschool aged children. | Other | Pediatrician Counseling |
| Clinic Only Behavioral InterventionA 6 month intervention consisting of two phases: Phase I Intensive intervention is 6 sessions delivered in a group-based format in clinic (concurrent parent and child groups) every other week. Phase II Maintenance is 3 monthly clinic visits. Treatment targets 3 components: Dietary education, physical activity and parenting training. | Behavioural | Clinic Only Behavioral Intervention |
Primary outcome
Change in BMI z score
Time frame: Change from Baseline to 6 months
Body mass index z score
6 secondary outcomes
Change in Parent weight loss
Time frame: Change from baseline to 6 months
Change in Child caloric intake
Time frame: Change from baseline to 6 months
Change in Home food and activity environment
Time frame: Change from baseline to 6 months
Change in Child physical activity
Time frame: Change from baseline to 6 months
Change in Parent-child mealtime interactions
Time frame: Change from baseline to 6 months
Change in Health related quality of life
Time frame: Change from baseline to 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 22 Oct 2014.
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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.
Lori J Stark, Ph.D. principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Clinic + Home Behavioral Intervention, Pediatrician Counseling and Clinic Only Behavioral Intervention in people with Obesity, run by Children's Hospital Medical Center, Cincinnati 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 4 inclusion and 5 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 22 Oct 2014. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change in BMI z score (time frame: Change from Baseline to 6 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 22 Oct 2014.