Abstract：
BACKGROUND:In 2007, we commenced the Healthy Beginnings Trial (HBT) Phase 1 study, which is the first randomised controlled trial (RCT) to test the effectiveness of an early childhood obesity intervention in children aged up to 2 years. The results were promising with significant improvements in infant feeding practices and a lower mean body mass index (BMI). The aims of this proposed Phase 2 study are to determine if the early intervention will lead to a lower mean BMI, lower screen time, improved dietary behaviours and demonstrated cost-effectiveness of the intervention, in children aged 3½ and 5 years. METHODS/DESIGN:In Phase 1 of HBT 667 families participated in the RCT. No further intervention will be carried out in HBT Phase 2. In this study the intervention and control groups will be compared for children's outcomes at ages 3½ and 5 years. Primary outcome measures will be 1) BMI, 2) selected dietary measures using a validated survey tool, and 3) physical activity and screen time using a new generation of tri-axial accelerometers. Intention to treat principles will be used in the analysis. Multiple imputation will be used to impute outcomes for subjects lost to follow-up. A cost-effectiveness analysis (CEA) and cost-utility analysis for both HBT Phase 1 and 2 will also be conducted. DISCUSSION:This is the first time that a home-based early intervention strategy has been implemented to prevent the development of childhood obesity and obesity-conducive behaviours. The results of this trial will ascertain whether early intervention during the first 2 years of life is effective and cost-effective in preventing childhood overweight and obesity at 3½ and 5 years old.
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
Wen LM,Baur LA,Rissel C,Flood V,Simpson JM,Hayes A,Hardy LL,Wardle Kdoi
10.1016/j.cct.2011.11.008subject
Has Abstractpub_date
2012-03-01 00:00:00pages
396-401issue
2eissn
1551-7144issn
1559-2030pii
S1551-7144(11)00274-6journal_volume
33pub_type
杂志文章,多中心研究,随机对照试验abstract：:Traumatic brain injury (TBI) often leads to immediate and chronic functional impairments that affect care partners, or those providing physical and/or emotional support to individuals with TBI. The many challenges associated with being a care partner often lead to caregiver burden and can compromise the well-being and...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
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abstract：:We report here on the use of interactive telephone technology for collecting longitudinal data in a large randomized non-blinded parallel trial. Data were primarily collected via an automated interactive telephone system which enabled data to be downloaded by researchers periodically via a secure website. Alternative ...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1016/j.cct.2011.10.012
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journal_title：Contemporary clinical trials
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journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
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journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
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journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2013.06.017
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journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2016.07.004
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journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
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journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
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journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2016.06.005
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journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2009.01.010
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journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2016.07.012
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journal_title：Contemporary clinical trials
pub_type： 杂志文章,meta分析
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journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
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pub_type： 杂志文章,随机对照试验
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pub_type： 杂志文章
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journal_title：Contemporary clinical trials
pub_type： 杂志文章,多中心研究,随机对照试验
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pub_type： 更正并重新发布的文章,已发布勘误
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journal_title：Contemporary clinical trials
pub_type： 杂志文章,评审
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pub_type： 杂志文章,meta分析
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journal_title：Contemporary clinical trials
pub_type： 杂志文章
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pub_type： 杂志文章
doi：10.1016/j.cct.2010.06.002
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pub_type： 杂志文章,评审
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journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
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pub_type： 杂志文章,随机对照试验
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journal_title：Contemporary clinical trials
pub_type： 杂志文章,多中心研究,随机对照试验
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journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
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更新日期：2017-06-01 00:00:00
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journal_title：Contemporary clinical trials
pub_type： 杂志文章
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