Pediatric ObesityPhase 1/2LAUNCHNCT01018121
Behavioral Rx & Nutrition in Pediatric Chronic Disease
A Phase 1/2 study testing LAUNCH and Pediatrician Counseling in people with Pediatric 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 for modifying the diet and physical activity patterns of overweight preschool children through improved parenting and nutritional education(LAUNCH). Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- LAUNCH and Pediatrician Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Sep 2009
- Phase
- Phase 1/2
- 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
- child age between 2- 5 years;
- child > 95th percentile BMI for age and sex 12, but not more than 100% above the mean BMI;
- medical clearance from pediatrician; and
- at least one parent with a BMI > 25. -
Who cannot join
- non-English speaking;
- living more than 50 miles from the medical center;
- a disability/illness that would preclude engagement in at least moderate physical activity;
- medical condition/medication associated with weight gain; or 5) enrolled in another weight control 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 for modifying the diet and physical activity patterns of overweight preschool children through improved parenting and nutritional education(LAUNCH). This intervention will be compared to standard of care for preschool overweight in the primary care setting using a randomized clinical trial design (RCT. The results of this pilot RCT will provide data integral to estimating the effect size for a more definitive RCT of the intervention in the future. The primary hypothesis is:
H1: LAUNCH will result in a significantly greater decrease in BMI z score compared to the standard of care at 12 months post-treatment.
- Conditions
- Pediatric Obesity
- Being tested
- LAUNCH, Pediatrician Counseling
- Keywords
- Behavioral Treatment, Preschool Children, Obesity Treatment
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAUNCHBehavioural
A 6-month intervention consisting of two phases: Phase I (Intensive Intervention), 12 weekly sessions that alternated between group-based clinic sessions (parent and child concurrent groups) and individual home visits and Phase II (Maintenance), 12 weeks of every other week sessions, alternating between group sessions in-clinic and home sessions. Targeted 3 components: 1) Dietary education with age-specific caloric targets, healthy eating recommendations for children following the AAP guidelines used in the PC session; 2) Physical Activity education with age-specific activities for children and families; and 3) Parenting skills to achieve the diet and physical activity goals using behavioral management skills and parent modeling of eating and activity.
Pediatrician CounselingOther
A one time 45-minute visit with a board certified pediatrician for each family that focused on the AAP guidelines for eating and physical activity for children
| Study group | Role | What they receive |
|---|---|---|
| Clinic and Home Behavioral Intervention | Experimental | Not described Receives: Behavioral: LAUNCH |
| Pediatrician Counseling | Active comparator | Not described Receives: Other: Pediatrician Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI z score
Measured: Baseline, 6 months, 12 months
Secondary outcomes (5)
Parent weight loss
Measured: baseline, 24 weeks, 48 weeks
Child caloric intake
Measured: baseline, 6 months, 12 months
Home food and activity environment
Measured: baseline, 6 months, 12 months
Child physical activity
Measured: baseline, 6 motnhs, 12 months
Parent-child mealtime interactions
Measured: baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startNov 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 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)
- Investigators
- Lori J Stark, Ph.D., Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018121
- Sponsor's protocol ID
- 103254
- Other IDs
- K24DK059492
- Acronym
- LAUNCH
- Status last verified
- Nov 2009
- First submitted
- 19 Nov 2009
- Last updated
- 23 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2009. 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
- NCT01018121
- Acronym / sponsor ID
- LAUNCH / 103254
- Conditions
- Pediatric Obesity
- Keywords
- Behavioral Treatment, Preschool Children, Obesity Treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 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
- Nov 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 23 Nov 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 objective of this project is to pilot test a behavioral intervention for modifying the diet and physical activity patterns of overweight preschool children through improved parenting and nutritional education(LAUNCH). This intervention will be compared to standard of care for preschool overweight in the primary care setting using a randomized clinical trial design (RCT. The results of this pilot RCT will provide data integral to estimating the effect size for a more definitive RCT of the intervention in the future. The primary hypothesis is:
H1: LAUNCH will result in a significantly greater decrease in BMI z score compared to the standard of care at 12 months post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinic and Home Behavioral Intervention | Experimental | Behavioral: LAUNCH |
| Pediatrician Counseling | Active comparator | Other: Pediatrician Counseling |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- child age between 2- 5 years;
- child > 95th percentile BMI for age and sex 12, but not more than 100% above the mean BMI;
- medical clearance from pediatrician; and
- at least one parent with a BMI > 25. -
Key exclusion criteria (4 listed)
- non-English speaking;
- living more than 50 miles from the medical center;
- a disability/illness that would preclude engagement in at least moderate physical activity;
- medical condition/medication associated with weight gain; or 5) enrolled in another weight control 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 |
|---|---|---|
| LAUNCHA 6-month intervention consisting of two phases: Phase I (Intensive Intervention), 12 weekly sessions that alternated between group-based clinic sessions (parent and child concurrent groups) and individual home visits and Phase II (Maintenance), 12 weeks of every other week sessions, alternating between group sessions in-clinic and home sessions. Targeted 3 components: 1) Dietary education with age-specific caloric targets, healthy eating recommendations for children following the AAP guidelines used in the PC session; 2) Physical Activity education with age-specific activities for children and families; and 3) Parenting skills to achieve the diet and physical activity goals using behavioral management skills and parent modeling of eating and activity. | Behavioural | Clinic and Home Behavioral Intervention |
| Pediatrician CounselingA one time 45-minute visit with a board certified pediatrician for each family that focused on the AAP guidelines for eating and physical activity for children | Other | Pediatrician Counseling |
Primary outcome
BMI z score
Time frame: Baseline, 6 months, 12 months
5 secondary outcomes
Parent weight loss
Time frame: baseline, 24 weeks, 48 weeks
Child caloric intake
Time frame: baseline, 6 months, 12 months
Home food and activity environment
Time frame: baseline, 6 months, 12 months
Child physical activity
Time frame: baseline, 6 motnhs, 12 months
Parent-child mealtime interactions
Time frame: baseline, 6 months, 12 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 23 Nov 2009.
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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 1/2 study testing LAUNCH and Pediatrician Counseling in people with Pediatric 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 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 23 Nov 2009. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
BMI z score (time frame: Baseline, 6 months, 12 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 23 Nov 2009.