Childhood ObesityFYCSNCT00756626
Feeding Young Children Study: Bottle Weaning Intervention
A study testing Bottle Weaning Intervention in people with Childhood Obesity, run by Montefiore Medical Center at 1 site in United States.
Trial summary
This Integrated Project (Research + Extension) aims to reduce the risk of early childhood overweight through changing bottle-feeding behavior. Excess bottles of whole milk and sweet beverages beyond the advised weaning age of 12 months, "inappropriate bottle-feeding," has been linked to overweight. Read more about this study
- Who is it for?
- Ages 12 to 13 months
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Bottle Weaning Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Dec 2011
- 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 12 to 13 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 12 month olds using 2 bottles a day of non-water liquids.
Who cannot join
- Health or developmental conditions that may affect the child's health or weight.
- On chronic medications that may affect the child's appetite or growth rate.
- Medical conditions that may affect the child's appetite or growth rate.
- Neurological or muscular conditions that affect the child's ability to feed themselves.
- Steroid treatments such as prednisone that may affect the growth rate of the child.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feeding Young Children Study (FYCS)- a Randomized Control Trial of a Bottle Weaning Intervention Aimed at Reducing the Risk of Overweight in Low Income Multi-ethnic Toddlers.
This Integrated Project (Research + Extension) aims to reduce the risk of early childhood overweight through changing bottle-feeding behavior. Excess bottles of whole milk and sweet beverages beyond the advised weaning age of 12 months, "inappropriate bottle-feeding," has been linked to overweight. Our pilot of this intervention reduced bottle use.
COMPONENTS OF THE 'FEEDING YOUNG CHILDREN STUDY' (FYCS):
- Randomized Controlled Trial (RCT)- of a bottle-weaning intervention in low-income multi-ethnic toddlers, will enroll n=464 12 month olds using >2 bottles/day from two WIC sites. Bottle use, anthropometrics, dietary intake, and nutrient density outcomes will be assessed at Baseline, and 4 times over a 12 month follow-up.
- Observational Study- nested within the RCT, will describe dietary intake and nutrient density data (24 hour recalls) for this period of feeding transitions. FYCS fills a gap in knowledge about this population's dietary habits, and their relationship to bottle use.
- Extension- our Marketing Department will produce: a 5-8 minute 'infomercial' and nutritionist and client guides (freely downloadable) at WIC, maternal/child health, and pediatric websites, and; a public TV segment. We will disseminate findings through a) the National WIC Association, b) nutrition \& pediatric journals, and; c) lay print, media, and websites with assistance from our Public Relations Department.
Read the detailed description
Mounting evidence finds that obesity tracks with age, even from infancy.1-10 Excess bottles of whole milk and sweet beverages beyond the advised weaning age of 12 months- inappropriate bottle-feeding- is linked to overweight. Inappropriate bottle use as used herein refers to children > 12 months drinking > 2 bottle-type containers/day. In our prior work inappropriate bottle use was associated with overweight in local WIC centers and national survey data. And,a February 2007 publication from a national study found that "taking a bottle to bed" was a major predictor of 3 year olds' being overweight or obese. Our pilot of the proposed intervention reduced daily bottle use.
The Feeding Young Children Study (FYCS) is a randomized controlled trial (RCT) of a bottle-weaning intervention aimed at reducing the risk of overweight in low-income multi-ethnic toddlers in WIC.
Aim #1: To reduce inappropriate bottle-feeding practices (RCT)
1.The Intervention group will reduce inappropriate feeding practices, as measured by: absolute weaning; # of bottles; ounces consumed from bottles; and content, pattern \& timing of bottles.
Aim#2: To decrease the risk of overweight in children (RCT)
- The Intervention group will see a decrease in the percentage of children >85th percentile weight-for-length, and > 95th % ile weight-for-length over the 12 month follow-up.
- The Intervention group will have lower age- and sex-adjusted weight-for-length z scores; and a decreased weight gain velocity over the 12 month follow-up, compared with Controls.
Aim #3: To understand dietary intake \& nutrient density (Observational Study)
- We will describe beverage and food intakes and nutrient density at baseline and over time in relation to bottle use patterns and anthropometrics, for the sample and by treatment group.
Aim #4: To produce sustainable products and widely disseminate findings (Extension)
- We will produce a 5-8 minute bottle-weaning infomercial, and nutritionist and client guides for download from WIC,15 maternal/child health16,17 and pediatric18 websites-- as well as a segment for "Keeping Kids Healthy," a nationally syndicated, Emmy award winning TV show.
- We will extend findings through a) lay print, media, and web outlets via Public Relations; b) the National WIC association; and c) nutrition \& pediatric journal papers.
We will enroll n=464 12 month olds who are drinking >2 (non-water) bottles or sippy cups/day, from 2 Bronx WIC sites. Bottle/sippy cup use, anthropometrics, and dietary intake will be assessed at Baseline, and again at 15, 18, 21, and 24 months of age. FYCS nutritionists (blinded to group assignment) will collect two 24 h recalls of all beverage and solid intake, and enter it into the Windows-based Nutrition Data Systems for Research software, the premiere dietary data collection and nutrient density calculation tool. WIC nutritionists will administer the Intervention at Baseline, and (blinded to outcomes) as needed at follow-ups.
- Conditions
- Childhood Obesity
- Being tested
- Bottle Weaning Intervention
- Keywords
- Bottle Weaning, Bottle Feeding, Overweight in toddlers, Bottle use, excess weight for length
- Medical subject headings
- Pediatric Obesity, Bottle Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bottle Weaning InterventionBehavioural
WIC Nutritionist will deliver bottle weaning intervention education with participants in intervention group at 12 month baseline and at 15, 18, 21, and 24 month follow-up as needed
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intervention group receives bottle weaning intervention from WIC nutritionist Receives: Behavioral: Bottle Weaning Intervention |
| 2 | No intervention | Control standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bottle use frequency
Measured: Beverage container assessment done at 12,15,18,21 and 24 months
Secondary outcomes (2)
Anthropometric measurements, age and sex specific weight-for-length.
Measured: Assessed at 12, 15,18, 21 and 24 months
Dietary intake and nutrient density
Measured: Assessment at 12 month baseline and 7 to 10 day follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Principal investigator, Karen Bonuck, Montefiore Medical Center
- Investigators
- Karen A. Bonuck, PhD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756626
- Sponsor's protocol ID
- 03-11-295E
- Other IDs
- USDA 2007-004556
- Acronym
- FYCS
- Status last verified
- May 2018
- First submitted
- 19 Sep 2008
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Bonuck K, Avraham SB, Lo Y, Kahn R, Hyden C. Bottle-weaning intervention and toddler overweight. J Pediatr. 2014 Feb;164(2):306-12.e1-2. doi: 10.1016/j.jpeds.2013.09.029. Epub 2013 Oct 31.
PubMed 24183206
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feeding Young Children Study (FYCS)- a Randomized Control Trial of a Bottle Weaning Intervention Aimed at Reducing the Risk of Overweight in Low Income Multi-ethnic Toddlers.
- ClinicalTrials.gov ID
- NCT00756626
- Acronym / sponsor ID
- FYCS / 03-11-295E
- Conditions
- Childhood Obesity
- Keywords
- Bottle Weaning, Bottle Feeding, Overweight in toddlers, Bottle use, excess weight for length
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- Oct 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 22 Sep 2008 (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 Integrated Project (Research + Extension) aims to reduce the risk of early childhood overweight through changing bottle-feeding behavior. Excess bottles of whole milk and sweet beverages beyond the advised weaning age of 12 months, "inappropriate bottle-feeding," has been linked to overweight. Our pilot of this intervention reduced bottle use.
COMPONENTS OF THE 'FEEDING YOUNG CHILDREN STUDY' (FYCS):
- Randomized Controlled Trial (RCT)- of a bottle-weaning intervention in low-income multi-ethnic toddlers, will enroll n=464 12 month olds using >2 bottles/day from two WIC sites. Bottle use, anthropometrics, dietary intake, and nutrient density outcomes will be assessed at Baseline, and 4 times over a 12 month follow-up.
- Observational Study- nested within the RCT, will describe dietary intake and nutrient density data (24 hour recalls) for this period of feeding transitions. FYCS fills a gap in knowledge about this population's dietary habits, and their relationship to bottle use.
- Extension- our Marketing Department will produce: a 5-8 minute 'infomercial' and nutritionist and client guides (freely downloadable) at WIC, maternal/child health, and pediatric websites, and; a public TV segment. We will disseminate findings through a) the National WIC Association, b) nutrition \& pediatric journals, and; c) lay print, media, and websites with assistance from our Public Relations Department.
Detailed description
Mounting evidence finds that obesity tracks with age, even from infancy.1-10 Excess bottles of whole milk and sweet beverages beyond the advised weaning age of 12 months- inappropriate bottle-feeding- is linked to overweight. Inappropriate bottle use as used herein refers to children > 12 months drinking > 2 bottle-type containers/day. In our prior work inappropriate bottle use was associated with overweight in local WIC centers and national survey data. And,a February 2007 publication from a national study found that "taking a bottle to bed" was a major predictor of 3 year olds' being overweight or obese. Our pilot of the proposed intervention reduced daily bottle use.
The Feeding Young Children Study (FYCS) is a randomized controlled trial (RCT) of a bottle-weaning intervention aimed at reducing the risk of overweight in low-income multi-ethnic toddlers in WIC.
Aim #1: To reduce inappropriate bottle-feeding practices (RCT)
1.The Intervention group will reduce inappropriate feeding practices, as measured by: absolute weaning; # of bottles; ounces consumed from bottles; and content, pattern \& timing of bottles.
Aim#2: To decrease the risk of overweight in children (RCT)
- The Intervention group will see a decrease in the percentage of children >85th percentile weight-for-length, and > 95th % ile weight-for-length over the 12 month follow-up.
- The Intervention group will have lower age- and sex-adjusted weight-for-length z scores; and a decreased weight gain velocity over the 12 month follow-up, compared with Controls.
Aim #3: To understand dietary intake \& nutrient density (Observational Study)
- We will describe beverage and food intakes and nutrient density at baseline and over time in relation to bottle use patterns and anthropometrics, for the sample and by treatment group.
Aim #4: To produce sustainable products and widely disseminate findings (Extension)
- We will produce a 5-8 minute bottle-weaning infomercial, and nutritionist and client guides for download from WIC,15 maternal/child health16,17 and pediatric18 websites-- as well as a segment for "Keeping Kids Healthy," a nationally syndicated, Emmy award winning TV show.
- We will extend findings through a) lay print, media, and web outlets via Public Relations; b) the National WIC association; and c) nutrition \& pediatric journal papers.
We will enroll n=464 12 month olds who are drinking >2 (non-water) bottles or sippy cups/day, from 2 Bronx WIC sites. Bottle/sippy cup use, anthropometrics, and dietary intake will be assessed at Baseline, and again at 15, 18, 21, and 24 months of age. FYCS nutritionists (blinded to group assignment) will collect two 24 h recalls of all beverage and solid intake, and enter it into the Windows-based Nutrition Data Systems for Research software, the premiere dietary data collection and nutrient density calculation tool. WIC nutritionists will administer the Intervention at Baseline, and (blinded to outcomes) as needed at follow-ups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Bottle Weaning InterventionIntervention group receives bottle weaning intervention from WIC nutritionist |
| 2 | No intervention | –Control standard of care |
Who may qualify
- Ages
- 12 to 13 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 12 month olds using 2 bottles a day of non-water liquids.
Key exclusion criteria (5 listed)
- Health or developmental conditions that may affect the child's health or weight.
- On chronic medications that may affect the child's appetite or growth rate.
- Medical conditions that may affect the child's appetite or growth rate.
- Neurological or muscular conditions that affect the child's ability to feed themselves.
- Steroid treatments such as prednisone that may affect the growth rate of the child.
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 |
|---|---|---|
| Bottle Weaning InterventionWIC Nutritionist will deliver bottle weaning intervention education with participants in intervention group at 12 month baseline and at 15, 18, 21, and 24 month follow-up as needed | Behavioural | 1 |
Primary outcome
Bottle use frequency
Time frame: Beverage container assessment done at 12,15,18,21 and 24 months
2 secondary outcomes
Anthropometric measurements, age and sex specific weight-for-length.
Time frame: Assessed at 12, 15,18, 21 and 24 months
Dietary intake and nutrient density
Time frame: Assessment at 12 month baseline and 7 to 10 day follow up
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 4 Jun 2018.
- Derived from this study: PubMed 24183206Bonuck K, Avraham SB, Lo Y, Kahn R, Hyden C. Bottle-weaning intervention and toddler overweight. J Pediatr. 2014 Feb;164(2):306-12.e1-2. doi: 10.1016/j.jpeds.2013.09.029. Epub 2013 Oct 31.
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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.
Karen A. Bonuck, PhD principal investigator
Albert Einstein 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 Bottle Weaning Intervention in people with Childhood Obesity, run by Montefiore Medical Center 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 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 4 Jun 2018. 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 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?
Bottle use frequency (time frame: Beverage container assessment done at 12,15,18,21 and 24 months). 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 NCT00756626, which also lists 1 linked publication.
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 4 Jun 2018.