Impact of Exercise on Body Composition in Premature Infants
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ClinicalTrials.gov Identifier: NCT01386190 |
Recruitment Status
: Unknown
Verified July 2011 by University of California, Irvine.
Recruitment status was: Recruiting
First Posted
: June 30, 2011
Last Update Posted
: July 6, 2011
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Tracking Information | ||||
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First Submitted Date ICMJE | June 21, 2011 | |||
First Posted Date ICMJE | June 30, 2011 | |||
Last Update Posted Date | July 6, 2011 | |||
Study Start Date ICMJE | June 2011 | |||
Estimated Primary Completion Date | August 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE |
Change in Lean Body Mass (LBM) as assessed by 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. DXA (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
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Change History | Complete list of historical versions of study NCT01386190 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Impact of Exercise on Body Composition in Premature Infants | |||
Official Title ICMJE | Impact of Exercise on Body Composition in Premature Infants: New Approaches | |||
Brief 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:
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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:
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:
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. |
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Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Investigator) Primary Purpose: Prevention |
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Condition ICMJE | Body Composition, Beneficial | |||
Intervention ICMJE | Other: Exercise/Social Behavioral
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. |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
200 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date | August 2016 | |||
Estimated Primary Completion Date | August 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Infant Inclusion criteria:
Infant Exclusion criteria:
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Sex/Gender |
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Ages | 29 Weeks to 34 Weeks (Child) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01386190 | |||
Other Study ID Numbers ICMJE | R01HL110163-01A1( U.S. NIH Grant/Contract ) HS # 2011-8156 ( Other Identifier: IRB # ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Dan M. Cooper, University of California, Irvine | |||
Study Sponsor ICMJE | University of California, Irvine | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | University of California, Irvine | |||
Verification Date | July 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |