Body Composition, BeneficialNCT01386190
Impact of Exercise on Body Composition in Premature Infants
A study testing Exercise/Social Behavioral in people with Body Composition, Beneficial, run by University of California, Irvine at 1 site in United States.
Trial summary
This research consists of a novel intervention designed to increase physical activity of premature babies in their first year of life. The potential beneficial impact of augmented physical activity on: 1. Body composition 2. Associated biochemical and cellular mechanisms of growth and inflammation 3. Read more about this study
- Who is it for?
- Ages 29 to 34 weeks
- Conditions the study is for
- Body Composition, Beneficial
- What is being tested?
- Exercise/Social Behavioral
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jun 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 29 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Infant Inclusion criteria:
- Infant is a healthy, growing NICU inpatient.
- Caregiver ≥18 years of age
- Infant gestational age at birth <29weeks
- Infant gestational age at time of study recruitment >34 wks, on full feeds and nearing discharge
Infant Exclusion criteria:
- Significant lung disease of prematurity requiring supplemental oxygen or corticosteroids at discharge
- Significant intraventricular hemorrhage, grade III -IV
- Necrotizing entrocolitis
- Tracheostomy
- Bone Diseases
- Osteogenesis Imperfecta
- Hip or knee joint anomalies
- Arthrogryposis
- Fractures
- Skin disorders (e.g., Erythematus Bullosis)
- Symptomatic congestive heart disease
- Any other conditions or congenital anomalies likely to severely impact the ability of the premature baby and caregiver to participate in a demanding study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine Douglas Hospital
Orange, California, 92868
About this study
Official title: Impact of Exercise on Body Composition in Premature Infants: New Approaches
This research consists of a novel intervention designed to increase physical activity of premature babies in their first year of life. The potential beneficial impact of augmented physical activity on:
- Body composition
- Associated biochemical and cellular mechanisms of growth and inflammation
- Quality of maternal care will be measured
Read the detailed description
Premature birth is recognized as the single most important health problem in maternal child health in the US. Paradoxically, both failure to thrive and obesity are now known to be associated with prematurity, as are osteopenia (a condition where bone mineral density is lower than normal) and increased risk of fracture, and increased risk of cardiovascular disease later in life. We lack cohesive approaches to mitigate these profound threats to health. Despite promising new research demonstrating that physical activity can stimulate the growth of muscle and bone even during intrauterine life (perhaps through metabolic programming), there have been very few attempts to implement and study physical activity interventions in the premature baby.
The challenges are substantial and include:
- measuring body composition
- assessing physical activity
- engaging caregivers as partners in the intervention
- identifying plausible and testable biological mechanisms
- designing interventions that actually increase physical activity and match the rapid pace of motor development early in life
A developmentally dynamic physical activity intervention has been designed and pilot tested-one that engages the caregiver as a partner. Using techniques and tools as far-ranging as Dual X-ray Absorbiometry (DXA), smart phones, doubly labeled water, and lightweight, wireless accelerometers developed specifically for this purpose, the working hypothesis is that the one-year intervention will augment lean body mass (primary outcome variable) and improve bone mineralization and the ratio of lean to fat tissue (secondary outcome variables). The study will gauge the impact of the physical activity intervention on the balance between circulating anabolic mediators (insulin-like growth factor-I and growth hormone binding protein) and inflammation-associated cytokines (interleukin-6, and interleukin-1 receptor antagonist), which antagonize muscle and bone growth.
We will additionally:
- begin to explore how physical activity influences circulating endothelial progenitor cells, which are increasingly viewed as markers of vascular health very early in life
- take advantage of this prospective, interventional study to explore potential genetic determinants of growth in babies born prematurely.
- Finally, any study involving the premature infant and the data associated with it must be viewed in light of the critical relationship between the mother and baby.
The potential broad impact of early life interventions has been recently demonstrated by the success of the "Back-To-Sleep" campaign in mitigating sudden infant death syndrome. Should the positive effects of augmented exercise on body composition be supported, we would then anticipate widespread benefit in preventing long-term health consequences of prematurity at relatively low cost.
- Conditions
- Body Composition, Beneficial
- Being tested
- Exercise/Social Behavioral
- Keywords
- preterm infant, body composition, exercise
- Medical subject headings
- Glucocorticoid Receptor Deficiency, Premature Birth, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise/Social BehavioralOther
Both the control and the intervention groups will be guided in implementing structured social interaction. In the intervention group, the structured interaction will incorporate augmented physical activities, while in the control group, the structured interaction will consist of predominantly social activities such as the caregiver reading or singing to the baby. The duration of the structured activities for both groups will be the same.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Caregivers will be taught progressive exercises to use with their infants from hospital discharge to 1 year of age. Receives: Other: Exercise/Social Behavioral |
| Control | Active comparator | Both the control and the intervention groups will be guided in implementing structured social interaction.In the control group, the structured interaction will consist of predominantly social activities such as the caregiver reading or singing to the baby. The duration of the structured activities for both groups will be the same. Receives: Other: Exercise/Social Behavioral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lean Body Mass (LBM) as assessed by Dual X-ray Absorbiometry(DXA) at age 34-40 weeks gestational age and 86-92 weeks of age
LBM (lean body mass) will be measured and compared at the UCI Institute for Clinical and Translational Science. Dual X-ray Absorbiometry (DXA) scan to measure lean mass will be done using a whole body fan-beam scanner (Hologic QDR Discovery-A Hologic Inc., Bedford MA)at age 34-40 weeks gestational age and again at 86-92 weeks of age
Measured: ages: 34-40 weeks gestational age and 86 - 92 weeks of age
Secondary outcomes (6)
Blood sample
Blood sample (IGF-I)insulin-like growth factor-I , (GHBP)growth hormone binding protein, (IL-1ra)interleukin-1 receptor antagonist,(IL-6)interleukin-6, (EPCs)Epithelial Progenitor Cells. Inflammatory/Stress and growth factors will be measured from infant blood. A blood sample will be obtained from the NICU before discharge. A second blood sample will be obtained (venous) from the infant at 1 year.The Enzyme-linked immunosorbent assay (ELISAs) for IGF-I, IL-6, GHBP, and IL-1ra are available and routinely performed in our laboratory.
Measured: ages: 34-40 weeks gestational age and 86 - 92 weeks of age
Energy Expenditure 1 Accelerometer three time points in the study
Accelerometers provide robust, high fidelity logging of observed limb acceleration. The devices are worn in a canonical and identical orientation relative to the anatomy of each infant. Sleep/wake cycles of the babies will be synchronized to assure that comparable activity.
Measured: ages: 34-40 weeks gestational age, 52-68 weeks and 86 - 92 weeks of age
Energy expenditure 2 Total Energy Expenditure as assessed by Doubly Labeled Water
A study a subset of 100 of our enrollees will have total energy expenditure assessed by DLW. DLW measurements in children will be sent to our subcontract William Wong at Baylor University
Measured: age: 86-92 weeks
Diet Assessments
Parents will be called at two random days during the week of the assessment, thereby making sure that the recall interviews capture 1 weekday and 1 weekend day. Information on infant nutrition will also be obtained by three 24-h dietary recall interviews with the primary caregiver. Each interview will take approximately 20-30 minutes.
Measured: ages: 34-40 weeks gestational age, 52-68 weeks and 86 - 92 weeks of age
Quality of Caregiver-Child Interaction
A standardized laboratory protocol developed for the National Institute of Child Health and Human Development (NICHD) Study of Early Child Care and Youth Development and used currently by our group of researchers will be administered to determine quality of maternal infant interaction. For this protocol, observations are made during semi-structured play.
Measured: ages: 34-40 weeks gestational age and 86 to 92 weeks of age
TIMP/AIMS
TIMP(Test of Infant Motor Performance)/AIMS(Alberta Infant Motor Scale) The AIMS (Alberta Infant Motor Scale) is a reliable norm-referenced observational motor assessment. The AIMS measures qualitative aspects of movement and it is sensitive to changes in infant's motor performance. We also plan a test of motor development (TIMP, Test of Infant Motor Performance) that was developed specifically for newborns, overlaps well with the AIMS, and can be used to guide our exercise intervention in the first months of life.
Measured: ages: 34-40 weeks gestational age and 86 to 92 weeks of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: Non applicable clinical trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Composition, BeneficialStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan M. Cooper, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386190
- Sponsor's protocol ID
- R01H110163-01A1 [2011-8156]
- Other IDs
- HS # 2011-8156
- Status last verified
- Jan 2021
- First submitted
- 21 Jun 2011
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Exercise on Body Composition in Premature Infants: New Approaches
- ClinicalTrials.gov ID
- NCT01386190
- Acronym / sponsor ID
- R01H110163-01A1 [2011-8156]
- Conditions
- Body Composition, Beneficial
- Keywords
- preterm infant, body composition, exercise
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Non applicable clinical trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 30 Jun 2011 (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 research consists of a novel intervention designed to increase physical activity of premature babies in their first year of life. The potential beneficial impact of augmented physical activity on:
- Body composition
- Associated biochemical and cellular mechanisms of growth and inflammation
- Quality of maternal care will be measured
Detailed description
Premature birth is recognized as the single most important health problem in maternal child health in the US. Paradoxically, both failure to thrive and obesity are now known to be associated with prematurity, as are osteopenia (a condition where bone mineral density is lower than normal) and increased risk of fracture, and increased risk of cardiovascular disease later in life. We lack cohesive approaches to mitigate these profound threats to health. Despite promising new research demonstrating that physical activity can stimulate the growth of muscle and bone even during intrauterine life (perhaps through metabolic programming), there have been very few attempts to implement and study physical activity interventions in the premature baby.
The challenges are substantial and include:
- measuring body composition
- assessing physical activity
- engaging caregivers as partners in the intervention
- identifying plausible and testable biological mechanisms
- designing interventions that actually increase physical activity and match the rapid pace of motor development early in life
A developmentally dynamic physical activity intervention has been designed and pilot tested-one that engages the caregiver as a partner. Using techniques and tools as far-ranging as Dual X-ray Absorbiometry (DXA), smart phones, doubly labeled water, and lightweight, wireless accelerometers developed specifically for this purpose, the working hypothesis is that the one-year intervention will augment lean body mass (primary outcome variable) and improve bone mineralization and the ratio of lean to fat tissue (secondary outcome variables). The study will gauge the impact of the physical activity intervention on the balance between circulating anabolic mediators (insulin-like growth factor-I and growth hormone binding protein) and inflammation-associated cytokines (interleukin-6, and interleukin-1 receptor antagonist), which antagonize muscle and bone growth.
We will additionally:
- begin to explore how physical activity influences circulating endothelial progenitor cells, which are increasingly viewed as markers of vascular health very early in life
- take advantage of this prospective, interventional study to explore potential genetic determinants of growth in babies born prematurely.
- Finally, any study involving the premature infant and the data associated with it must be viewed in light of the critical relationship between the mother and baby.
The potential broad impact of early life interventions has been recently demonstrated by the success of the "Back-To-Sleep" campaign in mitigating sudden infant death syndrome. Should the positive effects of augmented exercise on body composition be supported, we would then anticipate widespread benefit in preventing long-term health consequences of prematurity at relatively low cost.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: Exercise/Social BehavioralCaregivers will be taught progressive exercises to use with their infants from hospital discharge to 1 year of age. |
| Control | Active comparator | Other: Exercise/Social BehavioralBoth the control and the intervention groups will be guided in implementing structured social interaction.In the control group, the structured interaction will consist of predominantly social activities such as the caregiver reading or singing to the baby. The duration of the structured activities for both groups will be the same. |
Who may qualify
- Ages
- 29 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| Exercise/Social BehavioralBoth the control and the intervention groups will be guided in implementing structured social interaction. In the intervention group, the structured interaction will incorporate augmented physical activities, while in the control group, the structured interaction will consist of predominantly social activities such as the caregiver reading or singing to the baby. The duration of the structured activities for both groups will be the same. | Other | Control, Exercise Group |
Primary outcome
Change in Lean Body Mass (LBM) as assessed by Dual X-ray Absorbiometry(DXA) at age 34-40 weeks gestational age and 86-92 weeks of age
Time frame: ages: 34-40 weeks gestational age and 86 - 92 weeks of age
LBM (lean body mass) will be measured and compared at the UCI Institute for Clinical and Translational Science. Dual X-ray Absorbiometry (DXA) scan to measure lean mass will be done using a whole body fan-beam scanner (Hologic QDR Discovery-A Hologic Inc., Bedford MA)at age 34-40 weeks gestational age and again at 86-92 weeks of age
6 secondary outcomes
Blood sample
Time frame: ages: 34-40 weeks gestational age and 86 - 92 weeks of age
Energy Expenditure 1 Accelerometer three time points in the study
Time frame: ages: 34-40 weeks gestational age, 52-68 weeks and 86 - 92 weeks of age
Energy expenditure 2 Total Energy Expenditure as assessed by Doubly Labeled Water
Time frame: age: 86-92 weeks
Diet Assessments
Time frame: ages: 34-40 weeks gestational age, 52-68 weeks and 86 - 92 weeks of age
Quality of Caregiver-Child Interaction
Time frame: ages: 34-40 weeks gestational age and 86 to 92 weeks of age
TIMP/AIMS
Time frame: ages: 34-40 weeks gestational age and 86 to 92 weeks of age
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
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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.
Dan M. Cooper, MD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise/Social Behavioral in people with Body Composition, Beneficial, run by University of California, Irvine 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?
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: withdrawn, as of the sponsor's last update on 25 Jan 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Lean Body Mass (LBM) as assessed by Dual X-ray Absorbiometry(DXA) at age 34-40 weeks gestational age and 86-92 weeks of age (time frame: ages: 34-40 weeks gestational age and 86 - 92 weeks of age). 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 25 Jan 2021.