Wen, L. M., Baur, L. A., Simpson, J. M., Xu, H., Hayes, A. J., Hardy, L. L., Williams, M., & Rissel, C. (2015). Sustainability of effects of an early childhood obesity prevention trial over time: A further 3-year follow-up of the Healthy Beginnings trial. JAMA Pediatrics, 169(6), 543–551. https:// doi:10.1001/jamapediatrics.2015.0258
| Screening decision | Screening conclusion | HomVEE procedures and standards version |
|---|---|---|
| Passes screens | Eligible for review | Version 2 |
| Rating | Design | Attrition | Baseline equivalence | Compromised randomization | Confounding factors | Valid, reliable measure(s) |
|---|---|---|---|---|---|---|
| High | Randomized controlled trial | Low | Not assessed for randomized controlled trials with low attrition |
No | No |
Yes |
All child and maternal outcomes assessed when children were age 5 received a low rating because they had high attrition and did not satisfy the baseline equivalence requirement. Some findings on children’s dietary behaviors and TV-watching behaviors when they were age 3.5 received an indeterminate rating because HomVEE was not able to confirm measure reliability.
| Study participants | The Healthy Beginnings Trial (HBT) was a randomized controlled trial that recruited first-time mothers receiving prenatal care in one of two hospitals. The study began in 2007 and assigned 337 families to the Healthy Beginnings home visiting intervention—received in the first two years of a child’s life—and 330 families to the comparison group. The HBT Phase 2 study began in 2011 with a goal of investigating the long-term effects of the home visiting intervention when children were ages 3.5 and 5. Of those originally assigned, 465 (236 intervention, 229 comparison) agreed to participate in the Phase 2 study, and 369 (191 intervention, 178 comparison) remained in the study when their children were age 5. Fifty-five percent of enrolled children in the follow-up study were male, and 46 percent were female. More than half of the women (57 percent) were employed or on paid or unpaid parental leave. Twenty-five percent of households had an annual income of less than $40,000; 31 percent had an annual income of between $40,000 and $79,999; and 43 percent had an annual income of more than $80,000. Authors did not report collecting data on race or ethnicity but did say that 63 percent of women in the study were born in Australia. |
|---|---|
| Setting | The study took place in socially and economically disadvantaged areas of South Western Sydney, Australia. |
| Intervention services | The Healthy Beginnings intervention was designed to improve family and behavioral risk factors for childhood obesity. The intervention consisted of eight home visits from community nurses delivering a staged home-based intervention, with one visit in the antenatal period and seven visits at one, three, five, nine, 12, 18, and 24 months after birth. Each visit lasted about one to two hours. Working with the mother and infant, the nurse addressed infant feeding practices, nutrition, play and activity (of both child and family), and social support. |
| Comparison conditions | Families assigned to the comparison group were not eligible to receive Healthy Beginnings. The comparison group was eligible to receive typical antenatal services provided in Australia, which included at least one nurse visit for general support at home. The study provided materials promoting home safety at six and 12 months. |
| Subgroups examined |
This field lists subgroups examined in the manuscript (even if they were not replicated in other samples and not reported on the summary page for this model’s report). There were no subgroups reported in this manuscript. |
| Funding sources | This research was supported by grants from the Australian National Health and Medical Research Council (ID numbers 393112 and 1003780). One of the co-authors was supported by a grant from the Australian National Health and Medical Research Council (ID number 571372). |
| Author affiliation | The authors are affiliated with the Sydney School of Public Health and Sydney Medical School at the University of Sydney, the Department of Endocrinology and Metabolism at the University of Tongji, and the Discipline of Pediatrics and Child Health, Sydney Medical School at the University of Sydney. The authors were involved in designing the Healthy Beginnings demonstration project. |
| Peer reviewed | Yes |
Clinicaltrials.gov Identifier: None found. SocialScienceRegistry.org Identifier: None found. Registry of Efficacy and Effectiveness Studies Identifier: None found. Study registration was assessed by HomVEE for Clinicaltrials.gov beginning with the 2014 review, and for other registries beginning with the 2021 review.
Findings that rate moderate or high
| Rating | Outcome measure | Effect | Sample | Timing of follow-up | Sample size | Intervention group | Comparison group | Group difference | Effect size | Statistical significance | Notes |
|---|---|---|---|---|---|---|---|---|---|---|---|
| High | Child physical activity: Outdoor play at least 120 min/day |
FavorableUnfavorable or ambiguousNo Effect |
HBT Phase 2 vs. comparison RCT, Sydney, Australia, 2011-2014, full sample |
3.5 years old |
415 children | Unadjusted proportion = 0.66 | Unadjusted proportion = 0.68 | Mean difference = -0.02 | HomVEE calculated = -0.05 | Not statistically significant, p= 0.65 |
| Rating | Outcome measure | Effect | Sample | Timing of follow-up | Sample size | Intervention group | Comparison group | Group difference | Effect size | Statistical significance | Notes |
|---|---|---|---|---|---|---|---|---|---|---|---|
| High | Child BMI |
FavorableUnfavorable or ambiguousNo Effect |
HBT Phase 2 vs. comparison RCT, Sydney, Australia, 2011-2014, full sample |
3.5 years old |
415 children | Unadjusted mean = 16.74 | Unadjusted mean = 16.80 | Mean difference = -0.06 | HomVEE calculated = -0.03 | Not statistically significant, p = 0.73 |
Statistical significance is based on HomVEE calculations. |
| High | Child BMI |
FavorableUnfavorable or ambiguousNo Effect |
HBT Phase 2 vs. comparison RCT, Sydney, Australia, 2011-2014, full sample |
2 years old |
465 children | Unadjusted mean = 16.57 | Unadjusted mean = 16.98 | Mean difference = -0.41 | HomVEE calculated = -0.25 | Statistically significant, p = 0.01 |
Statistical significance is based on HomVEE calculations. |
| High | Child BMI (standardized units) |
FavorableUnfavorable or ambiguousNo Effect |
HBT Phase 2 vs. comparison RCT, Sydney, Australia, 2011-2014, full sample |
2 years old |
465 children | Unadjusted mean = 0.55 | Unadjusted mean = 0.84 | Mean difference = -0.29 | HomVEE calculated = -0.26 | Statistically significant, p = 0.01 |
Statistical significance is based on HomVEE calculations. |
| High | Child BMI (standardized units) |
FavorableUnfavorable or ambiguousNo Effect |
HBT Phase 2 vs. comparison RCT, Sydney, Australia, 2011-2014, full sample |
3.5 years old |
415 children | Unadjusted mean = 0.89 | Unadjusted mean = 0.97 | Mean difference = -0.08 | HomVEE calculated = -0.07 | Not statistically significant, p = 0.49 |
Statistical significance is based on HomVEE calculations. |
| High | Child dietary behaviors: At least 2 servings per day of fruit |
FavorableUnfavorable or ambiguousNo Effect |
HBT Phase 2 vs. comparison RCT, Sydney, Australia, 2011-2014, full sample |
3.5 years old |
415 children | Unadjusted proportion = 0.70 | Unadjusted proportion = 0.69 | Mean difference = 0.01 | HomVEE calculated = 0.03 | Not statistically significant, p= 0.82 |
|
| High | Child dietary behaviors: At least 2 servings per day of vegetables |
FavorableUnfavorable or ambiguousNo Effect |
HBT Phase 2 vs. comparison RCT, Sydney, Australia, 2011-2014, full sample |
3.5 years old |
415 children | Unadjusted proportion = 0.45 | Unadjusted proportion = 0.45 | Mean difference = 0.00 | HomVEE calculated = 0.00 | Not statistically significant, p= 0.95 |
| Rating | Outcome measure | Effect | Sample | Timing of follow-up | Sample size | Intervention group | Comparison group | Group difference | Effect size | Statistical significance | Notes |
|---|---|---|---|---|---|---|---|---|---|---|---|
| High | Maternal dietary behaviors: At least 2 servings per day of fruit |
FavorableUnfavorable or ambiguousNo Effect |
HBT Phase 2 vs. comparison RCT, Sydney, Australia, 2011-2014, full sample |
3.5 years old |
369 mothers | Unadjusted proportion = 0.52 | Unadjusted proportion = 0.48 | Mean difference = 0.04 | HomVEE calculated = 0.10 | Not statistically significant, p= 0.49 |
|
| High | Maternal dietary behaviors: At least 2 servings per day of vegetables |
FavorableUnfavorable or ambiguousNo Effect |
HBT Phase 2 vs. comparison RCT, Sydney, Australia, 2011-2014, full sample |
3.5 years old |
369 mothers | Unadjusted proportion = 0.63 | Unadjusted proportion = 0.71 | Mean difference = -0.08 | HomVEE calculated = -0.22 | Not statistically significant, p= 0.08 |
|
| High | Maternal dietary behaviors: Fast food |
FavorableUnfavorable or ambiguousNo Effect |
HBT Phase 2 vs. comparison RCT, Sydney, Australia, 2011-2014, full sample |
3.5 years old |
369 mothers | Unadjusted proportion = 0.78 | Unadjusted proportion = 0.85 | Mean difference = -0.07 | HomVEE calculated = -0.28 | Not statistically significant, p= 0.06 |
Negative effect is favorable to the intervention. |
| High | Maternal dietary behaviors: Processed meat more than 3 times per week |
FavorableUnfavorable or ambiguousNo Effect |
HBT Phase 2 vs. comparison RCT, Sydney, Australia, 2011-2014, full sample |
3.5 years old |
369 mothers | Unadjusted proportion = 0.24 | Unadjusted proportion = 0.22 | Mean difference = 0.02 | HomVEE calculated = 0.07 | Not statistically significant, p= 0.69 |
|
| High | Maternal dietary behaviors: Soft drinks, more than 7 cups per week |
FavorableUnfavorable or ambiguousNo Effect |
HBT Phase 2 vs. comparison RCT, Sydney, Australia, 2011-2014, full sample |
3.5 years old |
369 mothers | Unadjusted proportion = 0.31 | Unadjusted proportion = 0.34 | Mean difference = -0.03 | HomVEE calculated = -0.08 | Not statistically significant, p= 0.51 |
Negative effect is favorable to the intervention. |
| High | Maternal physical activity: Total physical activity time at least 150 min/week |
FavorableUnfavorable or ambiguousNo Effect |
HBT Phase 2 vs. comparison RCT, Sydney, Australia, 2011-2014, full sample |
3.5 years old |
369 mothers | Unadjusted proportion = 0.44 | Unadjusted proportion = 0.47 | Mean difference = -0.03 | HomVEE calculated = -0.07 | Not statistically significant, p= 0.59 |
|
| High | Maternal TV watching: Watching TV less than 120 min/day |
FavorableUnfavorable or ambiguousNo Effect |
HBT Phase 2 vs. comparison RCT, Sydney, Australia, 2011-2014, full sample |
3.5 years old |
369 mothers | Unadjusted proportion = 0.63 | Unadjusted proportion = 0.68 | Mean difference = -0.05 | HomVEE calculated = -0.13 | Not statistically significant, p= 0.32 |
| Rating | Outcome measure | Effect | Sample | Timing of follow-up | Sample size | Intervention group | Comparison group | Group difference | Effect size | Statistical significance | Notes |
|---|---|---|---|---|---|---|---|---|---|---|---|
| High | Child TV watching: TV viewing time less than 60 min/day |
FavorableUnfavorable or ambiguousNo Effect |
HBT Phase 2 vs. comparison RCT, Sydney, Australia, 2011-2014, full sample |
3.5 years old |
415 children | Unadjusted proportion = 0.11 | Unadjusted proportion = 0.06 | Mean difference = 0.05 | HomVEE calculated = 0.40 | Not statistically significant, p= 0.07 |
Negative effect is favorable to the intervention. |