Wen, L. M., Baur, L. A., Simpson, J. M., Rissel, C., Wardle, K., & Flood, V. M. (2012). Effectiveness of home based early intervention on children's BMI at age 2: Randomised controlled trial. BMJ, 344, e3732. https://doi.org/10.1136/bmj.e3732
Model(s) Reviewed:
Healthy Beginnings
| Screening decision | Screening conclusion | HomVEE procedures and standards version |
|---|---|---|
| Passes screens | Eligible for review | Version 1 |
| Rating | Design | Attrition | Baseline equivalence | Compromised randomization | Confounding factors | Valid, reliable measure(s) |
|---|---|---|---|---|---|---|
| Moderate | Randomized controlled trial | Low | Established on SES for full sample; not established on race; outcome measures are not assessable at baseline for children; not established on outcome measures at baseline for mothers. | No | No | Not assessed in manuscripts reviewed before 2021 |
Notes:
In 2020, HomVEE updated this review to move measures of food used as reward and TV during meals concept from the Positive Parenting Practices domain to the Child Health domain because because ACF determined that HomVEE should place all child feeding outcomes under the Child Health domain.
This randomized controlled trial had low attrition, no confounding factors, and no reassignment; it qualifies for a moderate rating in the HomVEE review. A high rating requires that authors statistically control for any baseline differences in race/ethnicity, socioeconomic status (SES), or measures of the outcome. Because the study authors do not indicate that they assessed race/ethnicity of the study sample, nor do they indicate that their analysis controls for this or any other variables, moderate is the highest possible rating for the study.
| Study participants | Evaluators randomly assigned pregnant women receiving prenatal care through two hospitals to intervention or control groups (with women from each hospital in each study group). The study enrolled 337 women in the intervention group and 330 women in the control group. Most women were assessed and randomized before giving birth (61 percent); however, the remaining cases were assessed and randomized shortly after giving birth. Evaluators examined outcomes 24 months after the child's birth. The analytic sample focused on 497 women (255 intervention, 242 control) and their children.Among the original randomized sample, the plurality of women (42 percent) were younger than age 25; most (54 percent) were either employed or on maternity leave, and most (55 percent) had a high school or technical diploma before the study began. Among these women, about one-third earned less than $40,000 annually; one-third earned $40,000 to $79,999; and one-third earned $80,000 or more. Authors did not report collecting race/ethnicity data but stated that 64 percent of women in the study were born in Australia. |
|---|---|
| Setting | The study was conducted in southwestern Sydney, Australia, through Liverpool and Campbelltown Hospitals, and enrolled women in the study in 2007 and 2008. |
| Intervention services | The intervention group received up to eight visits starting at 30 to 36 weeks of pregnancy (if recruited at that time) and 1, 3, 5, 9, 12, 18, and 24 months after birth. Each visit lasted about 1 to 2 hours. Working with the mother and infant, the nurse addressed infant feeding practices, nutrition and play/activity (of both child and family), and social support. Using a checklist, nurses followed a protocol for service delivery, including discussion points and resources. The authors reference an appendix for additional details on the protocol. |
| Comparison conditions | The control group received the usual services provided in Australia, which includes home visiting from a childhood nursing service within one month of the child's birth. The study provided home safety promotion materials at 6 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). Subgroups are not listed for manuscripts reviewed before 2021. |
| Funding sources | The study was funded by the Australian National Health and Medical Research Council (ID number: 393112) as part of the Healthy Beginnings Trial. |
| Author affiliation | The authors are affiliated with the University of Sydney and the University of Wollongong. The first authors are also affiliated with the Health Promotion Service, which sponsors the Healthy Beginnings Trial model. |
| Peer reviewed | Peer reviewed status is not listed for manuscripts reviewed before 2021. |
Study Registration:
Clinicaltrials.gov Identifier: None found; listed as Australian Clinical Trial Registry No. 12607000168459. Study registration was assessed by HomVEE beginning with the 2014 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Moderate | Child outdoor play >=120 minutes/day-Complete Case Analysis | FavorableUnfavorable or ambiguousNo Effect |
Sydney, Australia Healthy Beginnings Trial | 24 months | 484 children | Unadjusted mean = 0.62 | Unadjusted mean = 0.61 | Mean difference = 0.01 | HomVEE calculated = 0.01 | Not statistically significant, p = 0.90 |
| Rating | Outcome measure | Effect | Sample | Timing of follow-up | Sample size | Intervention group | Comparison group | Group difference | Effect size | Statistical significance | Notes |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Moderate | BMI-Complete Case Analysis | FavorableUnfavorable or ambiguousNo Effect |
Sydney, Australia Healthy Beginnings Trial | 24 months | 483 children | Unadjusted mean = 16.49 | Unadjusted mean = 16.87 | Mean difference = -0.38 | HomVEE calculated = -0.22 | Statistically significant, p = 0.01 |
Authors indicated that negative effect favors the treatment group.
|
| Moderate | Child drink soft drink-Complete Case Analysis | FavorableUnfavorable or ambiguousNo Effect |
Sydney, Australia Healthy Beginnings Trial | 24 months | 495 children | Unadjusted mean = 0.24 | Unadjusted mean = 0.26 | Mean difference = -0.03 | HomVEE calculated = -0.09 | Not statistically significant, p = 0.48 |
|
| Moderate | Child eat dinner in front of TV-Complete Case Analysis | FavorableUnfavorable or ambiguousNo Effect |
Sydney, Australia Healthy Beginnings Trial | 24 months | 494 children | Unadjusted mean = 0.56 | Unadjusted mean = 0.68 | Mean difference = -0.12 | HomVEE calculated = -0.31 | Statistically significant, p = 0.01 |
Authors indicated that negative effect favors the treatment group.
|
| Moderate | Child eat french fries-Complete Case Analysis | FavorableUnfavorable or ambiguousNo Effect |
Sydney, Australia Healthy Beginnings Trial | 24 months | 496 children | Unadjusted mean = 0.86 | Unadjusted mean = 0.88 | Mean difference = -0.02 | HomVEE calculated = -0.09 | Not statistically significant, p = 0.65 |
|
| Moderate | Child eat salty snack-Complete Case Analysis | FavorableUnfavorable or ambiguousNo Effect |
Sydney, Australia Healthy Beginnings Trial | 24 months | 496 children | Unadjusted mean = 0.65 | Unadjusted mean = 0.70 | Mean difference = -0.04 | HomVEE calculated = -0.12 | Not statistically significant, p = 0.29 |
|
| Moderate | Child eat sweet snack everyday-Complete Case Analysis | FavorableUnfavorable or ambiguousNo Effect |
Sydney, Australia Healthy Beginnings Trial | 24 months | 497 children | Unadjusted mean = 0.73 | Unadjusted mean = 0.77 | Mean difference = -0.04 | HomVEE calculated = -0.13 | Not statistically significant, p = 0.31 |
|
| Moderate | Child fruit >= 1 serving/day-Complete Case Analysis | FavorableUnfavorable or ambiguousNo Effect |
Sydney, Australia Healthy Beginnings Trial | 24 months | 497 children | Unadjusted mean = 0.90 | Unadjusted mean = 0.93 | Mean difference = -0.02 | HomVEE calculated = -0.18 | Not statistically significant, p = 0.43 |
|
| Moderate | Child vegetable >= 1 serving/day-Complete Case Analysis | FavorableUnfavorable or ambiguousNo Effect |
Sydney, Australia Healthy Beginnings Trial | 24 months | 497 children | Unadjusted mean = 0.89 | Unadjusted mean = 0.83 | Mean difference = 0.07 | HomVEE calculated = 0.35 | Statistically significant, p = 0.03 |
|
| Moderate | Child water >3 cups/day-Complete Case Analysis | FavorableUnfavorable or ambiguousNo Effect |
Sydney, Australia Healthy Beginnings Trial | 24 months | 496 children | Unadjusted mean = 0.24 | Unadjusted mean = 0.19 | Mean difference = 0.06 | HomVEE calculated = 0.21 | Not statistically significant, p = 0.12 |
|
| Moderate | Food used as a reward-Complete Case Analysis | FavorableUnfavorable or ambiguousNo Effect |
Sydney, Australia Healthy Beginnings Trial | 24 months | 493 children | Unadjusted mean = 0.62 | Unadjusted mean = 0.72 | Mean difference = -0.09 | HomVEE calculated = -0.25 | Statistically significant, p = 0.03 |
Authors indicated that negative effect favors the treatment group.
|
| Moderate | Length-Complete Case Analysis | FavorableUnfavorable or ambiguousNo Effect |
Sydney, Australia Healthy Beginnings Trial | 24 months | 483 children | Unadjusted mean = 88.73 | Unadjusted mean = 88.42 | Mean difference = 0.31 | Not available | Not statistically significant, p = 0.35 |
|
| Moderate | TV on during meal-Complete Case Analysis | FavorableUnfavorable or ambiguousNo Effect |
Sydney, Australia Healthy Beginnings Trial | 24 months | 496 children | Unadjusted mean = 0.66 | Unadjusted mean = 0.76 | Mean difference = -0.10 | HomVEE calculated = -0.29 | Statistically significant, p = 0.02 |
Authors indicated that negative effect favors the treatment group.
|
| Moderate | Weight-Complete Case Analysis | FavorableUnfavorable or ambiguousNo Effect |
Sydney, Australia Healthy Beginnings Trial | 24 months | 483 children | Unadjusted mean = 12.98 | Unadjusted mean = 13.15 | Mean difference = -0.17 | Not available | Not statistically significant, p = 0.24 |
| Rating | Outcome measure | Effect | Sample | Timing of follow-up | Sample size | Intervention group | Comparison group | Group difference | Effect size | Statistical significance | Notes |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Moderate | Mother activity time >=150 minutes/week-Complete Case Analysis | FavorableUnfavorable or ambiguousNo Effect |
Sydney, Australia Healthy Beginnings Trial | 24 months | 458 children | Unadjusted mean = 0.48 | Unadjusted mean = 0.38 | Mean difference = 0.10 | HomVEE calculated = 0.24 | Statistically significant, p = 0.04 |
|
| Moderate | Mother drink soft drink-Complete Case Analysis | FavorableUnfavorable or ambiguousNo Effect |
Sydney, Australia Healthy Beginnings Trial | 24 months | 497 mothers | Unadjusted mean = 0.44 | Unadjusted mean = 0.52 | Mean difference = -0.08 | HomVEE calculated = -0.19 | Not statistically significant, p = 0.08 |
|
| Moderate | Mother eat fast food-Complete Case Analysis | FavorableUnfavorable or ambiguousNo Effect |
Sydney, Australia Healthy Beginnings Trial | 24 months | 497 mothers | Unadjusted mean = 0.83 | Unadjusted mean = 0.86 | Mean difference = -0.03 | HomVEE calculated = -0.15 | Not statistically significant, p = 0.33 |
|
| Moderate | Mother eat french fries-Complete Case Analysis | FavorableUnfavorable or ambiguousNo Effect |
Sydney, Australia Healthy Beginnings Trial | 24 months | 497 mothers | Unadjusted mean = 0.81 | Unadjusted mean = 0.86 | Mean difference = -0.06 | HomVEE calculated = -0.25 | Not statistically significant, p = 0.09 |
|
| Moderate | Mother eat processed meat-Complete Case Analysis | FavorableUnfavorable or ambiguousNo Effect |
Sydney, Australia Healthy Beginnings Trial | 24 months | 495 mothers | Unadjusted mean = 0.20 | Unadjusted mean = 0.28 | Mean difference = -0.08 | HomVEE calculated = -0.28 | Statistically significant, p = 0.03 |
Authors indicated that negative effect favors the treatment group.
|
| Moderate | Mother fruit >2 serving/day-Complete Case Analysis | FavorableUnfavorable or ambiguousNo Effect |
Sydney, Australia Healthy Beginnings Trial | 24 months | 497 mothers | Unadjusted mean = 0.22 | Unadjusted mean = 0.18 | Mean difference = 0.04 | HomVEE calculated = 0.16 | Not statistically significant, p = 0.25 |
|
| Moderate | Mother vegetable >2 servings/day-Complete Case Analysis | FavorableUnfavorable or ambiguousNo Effect |
Sydney, Australia Healthy Beginnings Trial | 24 months | 496 mothers | Unadjusted mean = 0.52 | Unadjusted mean = 0.36 | Mean difference = 0.16 | HomVEE calculated = 0.41 | Statistically significant, p = 0.00 |
|
| Moderate | Mother watch TV >=120 minutes/day-Complete Case Analysis | FavorableUnfavorable or ambiguousNo Effect |
Sydney, Australia Healthy Beginnings Trial | 24 months | 496 children | Unadjusted mean = 0.65 | Unadjusted mean = 0.64 | Mean difference = 0.01 | HomVEE calculated = 0.02 | Not statistically significant, p = 0.84 |
|
| Moderate | Mother water >=8 cups/day-Complete Case Analysis | FavorableUnfavorable or ambiguousNo Effect |
Sydney, Australia Healthy Beginnings Trial | 24 months | 497 mothers | Unadjusted mean = 0.16 | Unadjusted mean = 0.17 | Mean difference = 0.00 | HomVEE calculated = 0.00 | Not statistically significant, p = 0.99 |
| Rating | Outcome measure | Effect | Sample | Timing of follow-up | Sample size | Intervention group | Comparison group | Group difference | Effect size | Statistical significance | Notes |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Moderate | Child watch TV >60 minutes/day-Complete Case Analysis | FavorableUnfavorable or ambiguousNo Effect |
Sydney, Australia Healthy Beginnings Trial | 24 months | 434 children | Unadjusted mean = 0.14 | Unadjusted mean = 0.22 | Mean difference = -0.08 | HomVEE calculated = -0.35 | Statistically significant, p = 0.02 |
Authors indicated that negative effect favors the treatment group.
|