Manuscript Details

Source

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

Moderate rating
Model(s) Reviewed
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.

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.

Study Design

Design Attrition Baseline equivalence Confounding factors Valid, reliable measures?
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
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.

Home Visiting 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.

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.

Home Visiting 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.

Findings that rate moderate or high in this manuscript

Child health
Outcome measure Timing of follow-up Rating Direction of Effect Effect size (absolute value) Stastical significance Sample size Sample description
BMI-Complete Case Analysis 24 months Moderate
0.22 Statistically significant,
p = 0.01
483 children Sydney, Australia Healthy Beginnings Trial
Food used as a reward-Complete Case Analysis 24 months Moderate
0.25 Statistically significant,
p = 0.03
493 children Sydney, Australia Healthy Beginnings Trial
TV on during meal-Complete Case Analysis 24 months Moderate
0.29 Statistically significant,
p = 0.02
496 children Sydney, Australia Healthy Beginnings Trial
Child eat dinner in front of TV-Complete Case Analysis 24 months Moderate
0.31 Statistically significant,
p = 0.01
494 children Sydney, Australia Healthy Beginnings Trial
Weight-Complete Case Analysis 24 months Moderate
Not statistically significant,
p = 0.24
483 children Sydney, Australia Healthy Beginnings Trial
Length-Complete Case Analysis 24 months Moderate
Not statistically significant,
p = 0.35
483 children Sydney, Australia Healthy Beginnings Trial
Child vegetable >= 1 serving/day-Complete Case Analysis 24 months Moderate
0.35 Statistically significant,
p = 0.03
497 children Sydney, Australia Healthy Beginnings Trial
Child fruit >= 1 serving/day-Complete Case Analysis 24 months Moderate
0.18 Not statistically significant,
p = 0.43
497 children Sydney, Australia Healthy Beginnings Trial
Child water >3 cups/day-Complete Case Analysis 24 months Moderate
0.21 Not statistically significant,
p = 0.12
496 children Sydney, Australia Healthy Beginnings Trial
Child eat french fries-Complete Case Analysis 24 months Moderate
0.09 Not statistically significant,
p = 0.65
496 children Sydney, Australia Healthy Beginnings Trial
Child eat salty snack-Complete Case Analysis 24 months Moderate
0.12 Not statistically significant,
p = 0.29
496 children Sydney, Australia Healthy Beginnings Trial
Child eat sweet snack everyday-Complete Case Analysis 24 months Moderate
0.13 Not statistically significant,
p = 0.31
497 children Sydney, Australia Healthy Beginnings Trial
Child drink soft drink-Complete Case Analysis 24 months Moderate
0.09 Not statistically significant,
p = 0.48
495 children Sydney, Australia Healthy Beginnings Trial
Effect rating key
Favorable finding / Statistically significant
UnFavorable finding / Statistically significant
Ambiguous finding / Statistically significant
No effect / Not statistically significant
Positive parenting practices
Outcome measure Timing of follow-up Rating Direction of Effect Effect size (absolute value) Stastical significance Sample size Sample description
Child watch TV >60 minutes/day-Complete Case Analysis 24 months Moderate
0.35 Statistically significant,
p = 0.02
434 children Sydney, Australia Healthy Beginnings Trial
Effect rating key
Favorable finding / Statistically significant
UnFavorable finding / Statistically significant
Ambiguous finding / Statistically significant
No effect / Not statistically significant
Maternal health
Outcome measure Timing of follow-up Rating Direction of Effect Effect size (absolute value) Stastical significance Sample size Sample description
Mother eat processed meat-Complete Case Analysis 24 months Moderate
0.28 Statistically significant,
p = 0.03
495 mothers Sydney, Australia Healthy Beginnings Trial
Mother vegetable >2 servings/day-Complete Case Analysis 24 months Moderate
0.41 Statistically significant,
p = 0.00
496 mothers Sydney, Australia Healthy Beginnings Trial
Mother fruit >2 serving/day-Complete Case Analysis 24 months Moderate
0.16 Not statistically significant,
p = 0.25
497 mothers Sydney, Australia Healthy Beginnings Trial
Mother water >=8 cups/day-Complete Case Analysis 24 months Moderate
0.00 Not statistically significant,
p = 0.99
497 mothers Sydney, Australia Healthy Beginnings Trial
Mother drink soft drink-Complete Case Analysis 24 months Moderate
0.19 Not statistically significant,
p = 0.08
497 mothers Sydney, Australia Healthy Beginnings Trial
Mother eat french fries-Complete Case Analysis 24 months Moderate
0.25 Not statistically significant,
p = 0.09
497 mothers Sydney, Australia Healthy Beginnings Trial
Mother eat fast food-Complete Case Analysis 24 months Moderate
0.15 Not statistically significant,
p = 0.33
497 mothers Sydney, Australia Healthy Beginnings Trial
Mother activity time >=150 minutes/week-Complete Case Analysis 24 months Moderate
0.24 Statistically significant,
p = 0.04
458 children Sydney, Australia Healthy Beginnings Trial
Mother watch TV >=120 minutes/day-Complete Case Analysis 24 months Moderate
0.02 Not statistically significant,
p = 0.84
496 children Sydney, Australia Healthy Beginnings Trial
Effect rating key
Favorable finding / Statistically significant
UnFavorable finding / Statistically significant
Ambiguous finding / Statistically significant
No effect / Not statistically significant
Child development and school readiness
Outcome measure Timing of follow-up Rating Direction of Effect Effect size (absolute value) Stastical significance Sample size Sample description
Child outdoor play >=120 minutes/day-Complete Case Analysis 24 months Moderate
0.01 Not statistically significant,
p = 0.90
484 children Sydney, Australia Healthy Beginnings Trial
Effect rating key
Favorable finding / Statistically significant
UnFavorable finding / Statistically significant
Ambiguous finding / Statistically significant
No effect / Not statistically significant