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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
Contemporary Clinical Trials
|November 22, 2011
Summary
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.
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