ObesityPhase 1NCT00125580
Healthy Sleeping and Feeding During Infancy
A Phase 1 study testing Infant sleep instruction in people with Obesity, run by Penn State University at 2 sites in United States.
Trial summary
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 from 1999 to 2002, 10.3% of children ages 2 to 5 were overweight, an increase from 7% in 1994. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Infant sleep instruction
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2005to Dec 2006
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ≥37 weeks gestation
- Primiparous mother (first pregnancy)
- Singleton
- Breast or bottle-fed
- Birth weight ≥2500 grams
Who cannot join
- <37 weeks gestation
- Multiparous mother {see above comment}
- Twin or multiple infant
- Birth weight <2500 grams
- Maternal conditions causing prolonged hospital stay or "non-routine" postpartum follow-up (except for diabetes mellitus: type 1, 2, or gestational)
- Infants with chronic illnesses or anomalies that require non-routine care or follow-up
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Penn State University
University Park, Pennsylvania, 16802
About this study
Official title: Healthy Sleeping and Feeding During Infancy: Pilot Study for the Primary Prevention of Obesity in Primary Care
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 from 1999 to 2002, 10.3% of children ages 2 to 5 were overweight, an increase from 7% in 1994. Epidemiologic evidence is now emerging that suggests obesity in childhood and adulthood may often originate from accelerated weight gain during infancy. Further data are accumulating that link short sleep duration with obesity during childhood and later life. Prospective data are lacking that demonstrate whether the accelerated weight gain during infancy can be prevented and whether interventions to improve sleep early in life can prevent childhood obesity.
Key Objectives:
Read more
The key objectives are:
- To adapt a procedure aimed at prolonging sleep duration during infancy that is effective in experimental settings to the clinical setting of primary care; and
- To evaluate, in the primary care setting, the effect of a simple training procedure on overnight sleep duration and rate of weight gain during the first four months of life.
Read the detailed description
The objective of this proposal is to test, in a primary care setting, the effect of an established intervention designed to promote healthy feeding and sleeping behaviors early in life on risk factors for subsequent obesity. Because nocturnal feeding of infants, short sleep duration, and childhood obesity are linked, the procedure is designed to prevent short sleep duration and subsequently accelerated weight gain during infancy, two emerging risk factors for obesity in childhood and adulthood. In this study, 40 participants will be randomized to receive either an intervention that teaches infants to sleep through the night by 8 weeks of age or standard care. The procedure instructs parents to offer a "focal feed" before bedtime, avoid feeding as the first alternative to infant waking and distress, and carry out environmental control measures that emphasize day/night differences. In assessing the impact of the intervention, night wakening, and rate of weight gain will be assessed between birth and 4 months of age. The current proposal will test the feasibility of delivering this proven intervention in the primary care setting, an environment that must be included in primary preventive strategies for childhood obesity.
Aim 1: To adapt a procedure aimed at prolonging sleep duration during infancy that is effective in experimental settings to the clinical setting of primary care.
This procedure, which instructs parents to offer a "focal feed" before bedtime, avoid feeding as the first alternative to infant waking and distress, and carry out environmental control measures that emphasize day/night differences has been successful at prolonging sleep duration in experimental settings. By demonstrating that subjects can be recruited from the newborn nursery, be taught the procedure at a primary care visit, and followed for four months, the feasibility of a larger study will be more apparent to external funding agencies.
Aim 2: To evaluate, in the primary care setting, the effect of a simple training procedure on overnight sleep duration and rate of weight gain during the first four months of life.
It is hypothesized that the positive effect of the procedure in an experimental setting will be replicated in a randomized controlled trial in the primary care setting. By definition, teaching infants to sleep through the night will be manifest in longer sleep duration, which has been shown to be protective for childhood obesity in epidemiological studies. Sleeping through the night is hypothesized to promote protective factors for childhood obesity by supporting
- Conditions
- Obesity
- Being tested
- Infant sleep instruction
- Keywords
- Obesity, Childhood Obesity, Infant Sleep, Infant growth, Infant feeding
- Medical subject headings
- Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant sleep instructionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of sleeping through the night at 8 weeks of age between treatment groups (intervention versus standard treatment)
Secondary outcomes (1)
Across the study period, infant weight gain will be measured to study differences between treatment groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionDec 2006
- Study completionDec 2006
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 Penn State UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian Paul, MD, MSc, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125580
- Sponsor's protocol ID
- 20970EP
- Status last verified
- Nov 2017
- First submitted
- 29 Jul 2005
- Last updated
- 24 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Sleeping and Feeding During Infancy: Pilot Study for the Primary Prevention of Obesity in Primary Care
- ClinicalTrials.gov ID
- NCT00125580
- Acronym / sponsor ID
- 20970EP
- Conditions
- Obesity
- Keywords
- Obesity, Childhood Obesity, Infant Sleep, Infant growth, Infant feeding
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 1 Aug 2005 (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. A recent report from the National Health and Nutrition Examination Survey (NHANES) revealed that from 1999 to 2002, 10.3% of children ages 2 to 5 were overweight, an increase from 7% in 1994. Epidemiologic evidence is now emerging that suggests obesity in childhood and adulthood may often originate from accelerated weight gain during infancy. Further data are accumulating that link short sleep duration with obesity during childhood and later life. Prospective data are lacking that demonstrate whether the accelerated weight gain during infancy can be prevented and whether interventions to improve sleep early in life can prevent childhood obesity.
Key Objectives:
The key objectives are:
- To adapt a procedure aimed at prolonging sleep duration during infancy that is effective in experimental settings to the clinical setting of primary care; and
- To evaluate, in the primary care setting, the effect of a simple training procedure on overnight sleep duration and rate of weight gain during the first four months of life.
Detailed description
The objective of this proposal is to test, in a primary care setting, the effect of an established intervention designed to promote healthy feeding and sleeping behaviors early in life on risk factors for subsequent obesity. Because nocturnal feeding of infants, short sleep duration, and childhood obesity are linked, the procedure is designed to prevent short sleep duration and subsequently accelerated weight gain during infancy, two emerging risk factors for obesity in childhood and adulthood. In this study, 40 participants will be randomized to receive either an intervention that teaches infants to sleep through the night by 8 weeks of age or standard care. The procedure instructs parents to offer a "focal feed" before bedtime, avoid feeding as the first alternative to infant waking and distress, and carry out environmental control measures that emphasize day/night differences. In assessing the impact of the intervention, night wakening, and rate of weight gain will be assessed between birth and 4 months of age. The current proposal will test the feasibility of delivering this proven intervention in the primary care setting, an environment that must be included in primary preventive strategies for childhood obesity.
Aim 1: To adapt a procedure aimed at prolonging sleep duration during infancy that is effective in experimental settings to the clinical setting of primary care.
This procedure, which instructs parents to offer a "focal feed" before bedtime, avoid feeding as the first alternative to infant waking and distress, and carry out environmental control measures that emphasize day/night differences has been successful at prolonging sleep duration in experimental settings. By demonstrating that subjects can be recruited from the newborn nursery, be taught the procedure at a primary care visit, and followed for four months, the feasibility of a larger study will be more apparent to external funding agencies.
Aim 2: To evaluate, in the primary care setting, the effect of a simple training procedure on overnight sleep duration and rate of weight gain during the first four months of life.
It is hypothesized that the positive effect of the procedure in an experimental setting will be replicated in a randomized controlled trial in the primary care setting. By definition, teaching infants to sleep through the night will be manifest in longer sleep duration, which has been shown to be protective for childhood obesity in epidemiological studies. Sleeping through the night is hypothesized to promote protective factors for childhood obesity by supporting
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- ≥37 weeks gestation
- Primiparous mother (first pregnancy)
- Singleton
- Breast or bottle-fed
- Birth weight ≥2500 grams
Key exclusion criteria (6 listed)
- <37 weeks gestation
- Multiparous mother {see above comment}
- Twin or multiple infant
- Birth weight <2500 grams
- Maternal conditions causing prolonged hospital stay or "non-routine" postpartum follow-up (except for diabetes mellitus: type 1, 2, or gestational)
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 sleep instruction | Behavioural | – |
Primary outcome
The rate of sleeping through the night at 8 weeks of age between treatment groups (intervention versus standard treatment)
1 secondary outcome
Across the study period, infant weight gain will be measured to study differences between treatment groups.
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 24 Nov 2017.
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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.
Ian Paul, MD, MSc principal investigator
Milton S. Hershey Medical Center
2 sites 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 sleep instruction in people with Obesity, run by Penn State University at 2 sites 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: finished, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The rate of sleeping through the night at 8 weeks of age between treatment groups (intervention versus standard treatment). 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 24 Nov 2017.