Weight GainPhase 1NCT00359242
The SLeeping and Intake Methods Taught to Infants and Mothers Early in Life (SLIMTIME) Project
A Phase 1 study testing Infant Sleeping and Soothing and Repeated Food Exposure in people with Weight Gain and Obesity, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
Childhood obesity has reached epidemic proportions and its prevalence continues to rise, even among very young children. Because the current evidence base regarding potentially effective early intervention components to prevent obesity is so incomplete, it is logical to initiate obesity prevention intervention… Read more about this study
- Who is it for?
- Ages 1 day to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Weight Gain, Obesity
- What is being tested?
- Infant Sleeping and Soothing and Repeated Food Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Dec 2009
- 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 1 day to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- > 34 0/7 weeks gestational age
- Discharged from the newborn nursery or neonatal intensive care unit (NICU) without significant neonatal morbidity
- Singleton infant
- Nursery or NICU stay of 7 days or less
- Primiparous mother
- Maternity stay of 7 days or less
Show all 9Show fewer
- Pediatric primary care provider from one of 3 University-affiliated pediatric practices or University-affiliated family medicine practices
- Feeding human milk (breast milk) during the maternity/newborn stay with intent to continue to breastfeed after discharge
- English speaking mother.
Who cannot join
- Newborn nursery, NICU, or maternity stay > 7 days
- Exclusive formula feeding in the nursery or NICU
- Multiparous mother
- Any metabolic condition that requires feedings at precise intervals
- Gestational age of 33 6/7 weeks or less
- Presence of a congenital anomaly or neonatal condition that significantly affects a newborn's feeding (e.g. cleft lip or cleft palate) or sleeping (hyperexplexia - exaggerated startle reflex)
- Non-singleton newborn
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
About this study
Official title: Primary Prevention of Obesity Through Infancy Interventions
Childhood obesity has reached epidemic proportions and its prevalence continues to rise, even among very young children. Because the current evidence base regarding potentially effective early intervention components to prevent obesity is so incomplete, it is logical to initiate obesity prevention intervention research during infancy, focusing on the two major components of the infant lifestyle, sleeping and feeding.
Read the detailed description
Rationale: Childhood obesity has reached epidemic proportions and its prevalence continues to rise, even among very young children. A recent report from the National Health and Nutrition Examination Survey (NHANES) revealed that between 2003-2004, a staggering 26.2% of children aged 2 to 5 years were already overweight or at-risk for overweight. As such, in the summary of the "Conference on Preventing Childhood Obesity," it was remarked that researchers should particularly consider the youngest of children when planning obesity related interventions. Because the current evidence base regarding potentially effective early intervention components is so incomplete, it is logical to initiate obesity prevention intervention research during infancy, focusing on the two major components of the infant lifestyle, sleeping and feeding.
Key Objectives:
Aim 1: To evaluate the effect of simple procedures, taught to parents in the home environment by visiting nurses, that trains parents to calm their infants and increase their nocturnal sleep duration, thereby influencing sleep duration, nocturnal feeding frequency, and weight gain during infancy.
Aim 2: To evaluate a simple training procedure for parents, taught in the home environment by visiting nurses, that promotes infants' acceptance of nutritious, developmentally appropriate weaning foods.
Aim 3: To evaluate the delivery of these behavioral interventions to parents by community based home health nurses.
Aim 4: To examine the effect of a soothing intervention designed to increase sleep duration on overall maternal regulation of emotion, self-regulation of emotion, and weight gain.
Study Population: 160 newborns and mothers that demonstrate intent to breastfeed during the newborn nursery stay will be recruited during the maternity hospitalization. Approximately 25-50 physicians from the university affiliated pediatric and family practices.
- Conditions
- Weight Gain, Obesity
- Being tested
- Infant Sleeping and Soothing, Repeated Food Exposure
- Keywords
- Infant Sleep, Infant Diet, Infant Temperament, Rapid Infant weight gain, Infant Development, Parenting Competence, infant weight gain
- Medical subject headings
- Weight Gain, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant Sleeping and SoothingBehavioural
Soothing and Calming instructions given to parents at a home visit when their infant is approximately 2 weeks old.
Repeated Food ExposureBehavioural
Instructions given to parents on introduction of solid foods and repeated exposure when the infant is approximately 4 to 6 months of age.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Soothing and Calming instructions given at 2 weeks of life Receives: Behavioral: Infant Sleeping and Soothing |
| 2 | Experimental | Repeated food exposure instructions given between 4 and 6 months of life Receives: Behavioral: Repeated Food Exposure |
| 3 | Experimental | Receive both interventions: Soothing and Calming and Repeated food exposure Receives: Behavioral: Infant Sleeping and Soothing; Behavioral: Repeated Food Exposure |
| 4 | No intervention | Group receiving neither of the interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of infants sleeping 5 consecutive hours at night at 2 months of age
Measured: 2.5 years
Secondary outcomes (9)
Duration breastfed
Measured: 2 years
Rate of weight gain
Measured: 2.5 years
Self-regulation of emotion
Measured: 3 years
Timing of introduction of solids
Measured: 3 years
Infant dietary variety
Measured: 3 years
Maternal feeding style
Measured: 3 years
Infant temperament
Measured: 3 years
Body Composition
Measured: 3 years
Lab evaluation
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2006 (estimated)
- Study startJun 2006
- Primary completionNov 2008
- Study completionDec 2009
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 Weight GainStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Gerber Products Company
- Responsible party
- Principal investigator, Ian M. Paul, MD, Milton S. Hershey Medical Center
- Investigators
- Leann Birch, PhD, Principal investigator, Penn State UniversityIan M Paul, MD, MSc, Study director, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00359242
- Sponsor's protocol ID
- 22165EP
- Other IDs
- Grant Number: R56DK072996
- Status last verified
- Jul 2017
- First submitted
- 28 Jul 2006
- Last updated
- 28 Jul 2017
- Results posted
- No
Publications
Paul IM, Savage JS, Anzman SL, Beiler JS, Marini ME, Stokes JL, Birch LL. Preventing obesity during infancy: a pilot study. Obesity (Silver Spring). 2011 Feb;19(2):353-61. doi: 10.1038/oby.2010.182. Epub 2010 Aug 19.
PubMed 20725058
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Prevention of Obesity Through Infancy Interventions
- ClinicalTrials.gov ID
- NCT00359242
- Acronym / sponsor ID
- 22165EP
- Conditions
- Weight Gain, Obesity
- Keywords
- Infant Sleep, Infant Diet, Infant Temperament, Rapid Infant weight gain, Infant Development, Parenting Competence, infant weight gain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Gerber Products Company
- Study start
- Jun 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 1 Aug 2006 (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.
Childhood obesity has reached epidemic proportions and its prevalence continues to rise, even among very young children. Because the current evidence base regarding potentially effective early intervention components to prevent obesity is so incomplete, it is logical to initiate obesity prevention intervention research during infancy, focusing on the two major components of the infant lifestyle, sleeping and feeding.
Detailed description
Rationale: Childhood obesity has reached epidemic proportions and its prevalence continues to rise, even among very young children. A recent report from the National Health and Nutrition Examination Survey (NHANES) revealed that between 2003-2004, a staggering 26.2% of children aged 2 to 5 years were already overweight or at-risk for overweight. As such, in the summary of the "Conference on Preventing Childhood Obesity," it was remarked that researchers should particularly consider the youngest of children when planning obesity related interventions. Because the current evidence base regarding potentially effective early intervention components is so incomplete, it is logical to initiate obesity prevention intervention research during infancy, focusing on the two major components of the infant lifestyle, sleeping and feeding.
Key Objectives:
Aim 1: To evaluate the effect of simple procedures, taught to parents in the home environment by visiting nurses, that trains parents to calm their infants and increase their nocturnal sleep duration, thereby influencing sleep duration, nocturnal feeding frequency, and weight gain during infancy.
Aim 2: To evaluate a simple training procedure for parents, taught in the home environment by visiting nurses, that promotes infants' acceptance of nutritious, developmentally appropriate weaning foods.
Aim 3: To evaluate the delivery of these behavioral interventions to parents by community based home health nurses.
Aim 4: To examine the effect of a soothing intervention designed to increase sleep duration on overall maternal regulation of emotion, self-regulation of emotion, and weight gain.
Study Population: 160 newborns and mothers that demonstrate intent to breastfeed during the newborn nursery stay will be recruited during the maternity hospitalization. Approximately 25-50 physicians from the university affiliated pediatric and family practices.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Infant Sleeping and SoothingSoothing and Calming instructions given at 2 weeks of life |
| 2 | Experimental | Behavioral: Repeated Food ExposureRepeated food exposure instructions given between 4 and 6 months of life |
| 3 | Experimental | Behavioral: Infant Sleeping and Soothing, Behavioral: Repeated Food ExposureReceive both interventions: Soothing and Calming and Repeated food exposure |
| 4 | No intervention | –Group receiving neither of the interventions. |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- > 34 0/7 weeks gestational age
- Discharged from the newborn nursery or neonatal intensive care unit (NICU) without significant neonatal morbidity
- Singleton infant
- Nursery or NICU stay of 7 days or less
- Primiparous mother
Key exclusion criteria (7 listed)
- Newborn nursery, NICU, or maternity stay > 7 days
- Exclusive formula feeding in the nursery or NICU
- Multiparous mother
- Any metabolic condition that requires feedings at precise intervals
- Gestational age of 33 6/7 weeks or less
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 |
|---|---|---|
| Infant Sleeping and SoothingSoothing and Calming instructions given to parents at a home visit when their infant is approximately 2 weeks old. | Behavioural | 1, 3 |
| Repeated Food ExposureInstructions given to parents on introduction of solid foods and repeated exposure when the infant is approximately 4 to 6 months of age. | Behavioural | 2, 3 |
Primary outcome
Percent of infants sleeping 5 consecutive hours at night at 2 months of age
Time frame: 2.5 years
9 secondary outcomes
Duration breastfed
Time frame: 2 years
Rate of weight gain
Time frame: 2.5 years
Self-regulation of emotion
Time frame: 3 years
Timing of introduction of solids
Time frame: 3 years
Infant dietary variety
Time frame: 3 years
Maternal feeding style
Time frame: 3 years
Infant temperament
Time frame: 3 years
Body Composition
Time frame: 3 years
Lab evaluation
Time frame: 5 years
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 Jul 2017.
- Derived from this study: PubMed 20725058Paul IM, Savage JS, Anzman SL, Beiler JS, Marini ME, Stokes JL, Birch LL. Preventing obesity during infancy: a pilot study. Obesity (Silver Spring). 2011 Feb;19(2):353-61. doi: 10.1038/oby.2010.182. Epub 2010 Aug 19.
- Penn State Milton S. Hershey Children's Hospital Pediatric Clinical Research OfficeLink provided by the sponsor.
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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.
Leann Birch, PhD principal investigator
Penn State University
Ian M Paul, MD, MSc study director
Milton S. Hershey Medical Center
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 Infant Sleeping and Soothing and Repeated Food Exposure in people with Weight Gain and Obesity, run by Milton S. Hershey 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 9 inclusion and 7 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 Jul 2017. 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?
Percent of infants sleeping 5 consecutive hours at night at 2 months of age (time frame: 2.5 years). 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 NCT00359242, 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 28 Jul 2017.