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Healthy Beginnings Trial Phase 2 study: follow-up and cost-effectiveness analysis
Li Ming Wen1, Louise A Baur, Chris Rissel
1School of Public Health, Sydney Medical School, University of Sydney, 2006, Australia. lmwen@email.cs.nsw.gov.au
Insights
The Healthy Beginnings Trial (HBT) Phase 2 investigates an early childhood obesity intervention. This study assesses if the intervention effectively reduces body mass index (BMI) and improves behaviors up to age 5.
Area of Science:
- Pediatrics
- Public Health
- Obesity Prevention
Background:
- The Healthy Beginnings Trial (HBT) Phase 1 was the first randomized controlled trial (RCT) for early childhood obesity intervention up to age 2.
- Phase 1 showed promising results, including improved infant feeding and lower mean body mass index (BMI).
Purpose of the Study:
- To determine if the early intervention leads to lower mean BMI in children at ages 3½ and 5 years.
- To assess the intervention's impact on screen time, dietary behaviors, and cost-effectiveness.
- To ascertain the long-term effectiveness of a home-based strategy for preventing childhood obesity.
Main Methods:
- Phase 2 compares intervention and control groups from Phase 1 at ages 3½ and 5 years.
- Primary outcomes include BMI, dietary measures (validated survey), and physical activity/screen time (accelerometers).
- Intention-to-treat analysis with multiple imputation for lost subjects; cost-effectiveness and cost-utility analyses will be conducted.
Main Results:
- Phase 1 demonstrated significant improvements in infant feeding practices.
- Phase 1 showed a lower mean body mass index (BMI) in the intervention group.
- Phase 2 aims to confirm these benefits and assess cost-effectiveness at later ages.
Conclusions:
- This study is the first to implement and evaluate a home-based early intervention for preventing childhood obesity.
- Results will determine the effectiveness and cost-effectiveness of early intervention in the first two years of life.
- The findings will inform strategies for preventing childhood overweight and obesity.
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.
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