Childhood ObesityENRICHNCT02739334
PALS-CATCH Intervention for Obesity Prevention Among At-risk Toddlers
A study testing ENRICH in people with Childhood Obesity, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to learn whether a combination of two research-proven programs, a responsive caregiving parenting program and a childhood obesity prevention program, will have an effect on toddlers' healthy nutrition and physical activity behaviors. Read more about this study
- Who is it for?
- Ages 24 to 48 months
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- ENRICH
- 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
- Mar 2016to Jun 2017
- 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 24 to 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child is 2 - 3 years at the time of enrollment
- child is >85th percentile for BMI
- ability of the parents to speak and read in English at the 4th grade level
- provide primarily in-home care for the children at the time of enrollment
- child is Medicaid eligible
Who cannot join
- acute secondary complications of obesity for child (e.g., severe respiratory insufficiency)
- child with endocrine abnormalities
- child with severe obesity (>99.5th BMI percentile)
- children who have participated in an obesity treatment program within the past year
- parent with significant sensory impairments (e.g. deaf, blind)
- parent with BMI >40.0
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Shreela Sharma, PhD, RD, 713-500-9344, Shreela.V.Sharma@uth.tmc.edu
About this study
The purpose of this study is to learn whether a combination of two research-proven programs, a responsive caregiving parenting program and a childhood obesity prevention program, will have an effect on toddlers' healthy nutrition and physical activity behaviors. Investigators hypothesize that the children participating in the intervention will have significantly lower BMI z-scores, lower intake of sugar sweetened beverages, and increased number of servings of fruits and vegetables, and minutes of physical activity.
- Conditions
- Childhood Obesity
- Being tested
- ENRICH, Control - monthly handouts
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENRICHBehavioural
The intervention, called ENRICH (Encouraging Nurturing Responsiveness to Improve Child Health), is a 10-week home-based parent-centered curriculum designed to facilitate parents' mastery of skills for interacting with their toddler to increase opportunities for healthy eating and activity. Each weekly session is a 60 minute session implemented by a trained coach.
Control - monthly handoutsBehavioural
The control group receives monthly handouts (one per month) for 3 months that provides information on various topics including child cognitive and language development and child behaviors as it pertains to 2 and 3 year old children.
| Study group | Role | What they receive |
|---|---|---|
| ENRICH | Experimental | The intervention will integrate the Play and Learning Strategies (PALS) program, a 10-week home-based parent-centered curriculum designed to facilitate parents' mastery of skills for interacting with their toddler with Coordinated Approach To Child Health (CATCH), a behaviorally-based school health promotion program based on Social Cognitive Theory (SCT) to increase opportunities for healthy eating and activity. Receives: Behavioral: ENRICH |
| Control - monthly handouts | Active comparator | The control group receives monthly handouts (one per month) for 3 months that provides information on various topics including child cognitive and language development and child behaviors as it pertains to 2 and 3 year old children. Receives: Behavioral: Control - monthly handouts |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in child Body Mass Index
Measured: baseline and 10 weeks
Secondary outcomes (3)
change in intake of servings of sugar sweetened beverages for the child as assessed using 24 hour parent-reported recalls
investigators will assess intake of sugar sweetened beverages per day as collected using multiple 24 hour recalls with the parents conducted by trained interviewers.
Measured: baseline and 10 weeks
change in total intake of servings fruits and vegetables for the child as assessed using 24 hour parent-reported recalls
investigators will assess total intake of servings of fruit and vegetable per day as collected using multiple 24 hour recalls with the parents conducted by trained interviewers.
Measured: baseline and 10 weeks
change in daily minutes of physical activity for the child as assessed using accelerometers
Measured: baseline and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shreela V Sharma, The University of Texas Health Science Center, Houston
- Investigators
- Shreela Sharma, PhD, RD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739334
- Sponsor's protocol ID
- HSC-MS-15-0293
- Acronym
- ENRICH
- Status last verified
- Apr 2016
- First submitted
- 24 Mar 2016
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PALS-CATCH Intervention for Obesity Prevention Among At-risk Toddlers
- ClinicalTrials.gov ID
- NCT02739334
- Acronym / sponsor ID
- ENRICH / HSC-MS-15-0293
- Conditions
- Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jun 2017 (estimated)
- First posted
- 15 Apr 2016 (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 this study is to learn whether a combination of two research-proven programs, a responsive caregiving parenting program and a childhood obesity prevention program, will have an effect on toddlers' healthy nutrition and physical activity behaviors. Investigators hypothesize that the children participating in the intervention will have significantly lower BMI z-scores, lower intake of sugar sweetened beverages, and increased number of servings of fruits and vegetables, and minutes of physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENRICH | Experimental | Behavioral: ENRICHThe intervention will integrate the Play and Learning Strategies (PALS) program, a 10-week home-based parent-centered curriculum designed to facilitate parents' mastery of skills for interacting with their toddler with Coordinated Approach To Child Health (CATCH), a behaviorally-based school health promotion program based on Social Cognitive Theory (SCT) to increase opportunities for healthy eating and activity. |
| Control - monthly handouts | Active comparator | Behavioral: Control - monthly handoutsThe control group receives monthly handouts (one per month) for 3 months that provides information on various topics including child cognitive and language development and child behaviors as it pertains to 2 and 3 year old children. |
Who may qualify
- Ages
- 24 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- child is 2 - 3 years at the time of enrollment
- child is >85th percentile for BMI
- ability of the parents to speak and read in English at the 4th grade level
- provide primarily in-home care for the children at the time of enrollment
- child is Medicaid eligible
Key exclusion criteria (6 listed)
- acute secondary complications of obesity for child (e.g., severe respiratory insufficiency)
- child with endocrine abnormalities
- child with severe obesity (>99.5th BMI percentile)
- children who have participated in an obesity treatment program within the past year
- parent with significant sensory impairments (e.g. deaf, blind)
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 |
|---|---|---|
| ENRICHThe intervention, called ENRICH (Encouraging Nurturing Responsiveness to Improve Child Health), is a 10-week home-based parent-centered curriculum designed to facilitate parents' mastery of skills for interacting with their toddler to increase opportunities for healthy eating and activity. Each weekly session is a 60 minute session implemented by a trained coach. | Behavioural | ENRICH |
| Control - monthly handoutsThe control group receives monthly handouts (one per month) for 3 months that provides information on various topics including child cognitive and language development and child behaviors as it pertains to 2 and 3 year old children. | Behavioural | Control - monthly handouts |
Primary outcome
change in child Body Mass Index
Time frame: baseline and 10 weeks
3 secondary outcomes
change in intake of servings of sugar sweetened beverages for the child as assessed using 24 hour parent-reported recalls
Time frame: baseline and 10 weeks
change in total intake of servings fruits and vegetables for the child as assessed using 24 hour parent-reported recalls
Time frame: baseline and 10 weeks
change in daily minutes of physical activity for the child as assessed using accelerometers
Time frame: baseline and 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
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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.
Shreela Sharma, PhD, RD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENRICH in people with Childhood Obesity, run by The University of Texas Health Science Center, Houston 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Apr 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shreela Sharma, PhD, RD (713-500-9244, Shreela.v.sharma@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in child Body Mass Index (time frame: baseline and 10 weeks). 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 15 Apr 2016.