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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.

Model(s) Reviewed: Healthy Beginnings
Manuscript Screening Details
Screening Decision Screening Conclusion
Passes screens Eligible for review
Study Design Details
Rating Design Attrition Baseline Equivalence Reassignment Confounding Factors
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
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.

footnote210

Submitted by user on Fri, 03/15/2019 - 14:29

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 Characteristics
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.
Staff Characteristics and Training Home visiting staff were community nurses. They received training on the intervention by health promotion practitioners. No additional information is provided on the characteristics or training. The authors reference an appendix for details on the protocol.
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.
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 Details

Outcome Domain: Maternal Health
Rating Outcome Measure Effect Sample Timing of Follow-Up Sample Size Intervention Group Comparison Group Group Difference Effect Size Statistical Significance Outcome Type 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 HomeVEE calculated = 0.24 Statistically significant,
p = 0.04
Secondary
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 HomeVEE calculated = -0.19 Not statistically significant,
p = 0.08
Secondary
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 HomeVEE calculated = -0.15 Not statistically significant,
p = 0.33
Secondary
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 HomeVEE calculated = -0.25 Not statistically significant,
p = 0.09
Secondary
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 HomeVEE calculated = -0.28 Statistically significant,
p = 0.03
Secondary

footnote209

Submitted by user on Fri, 03/15/2019 - 14:29

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 HomeVEE calculated = 0.16 Not statistically significant,
p = 0.25
Secondary
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 HomeVEE calculated = 0.41 Statistically significant,
p = 0.00
Secondary
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 HomeVEE calculated = 0.02 Not statistically significant,
p = 0.84
Secondary
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 HomeVEE calculated = 0.00 Not statistically significant,
p = 0.99
Secondary
Outcome Domain: Child Health
Rating Outcome Measure Effect Sample Timing of Follow-Up Sample Size Intervention Group Comparison Group Group Difference Effect Size Statistical Significance Outcome Type 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 HomeVEE calculated = -0.22 Statistically significant,
p = 0.01
Primary

footnote209

Submitted by user on Fri, 03/15/2019 - 14:29

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 HomeVEE calculated = -0.09 Not statistically significant,
p = 0.48
Secondary
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 HomeVEE calculated = -0.31 Statistically significant,
p = 0.01
Secondary

footnote209

Submitted by user on Fri, 03/15/2019 - 14:29

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 HomeVEE calculated = -0.09 Not statistically significant,
p = 0.65
Secondary
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 HomeVEE calculated = -0.12 Not statistically significant,
p = 0.29
Secondary
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 HomeVEE calculated = -0.13 Not statistically significant,
p = 0.31
Secondary
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 HomeVEE calculated = -0.18 Not statistically significant,
p = 0.43
Secondary
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 HomeVEE calculated = 0.01 Not statistically significant,
p = 0.90
Secondary
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 HomeVEE calculated = 0.35 Statistically significant,
p = 0.03
Secondary
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 HomeVEE calculated = 0.21 Not statistically significant,
p = 0.12
Secondary
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 HomeVEE calculated = -0.25 Statistically significant,
p = 0.03
Secondary

footnote209

Submitted by user on Fri, 03/15/2019 - 14:29

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
Primary
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 HomeVEE calculated = -0.29 Statistically significant,
p = 0.02
Secondary

footnote209

Submitted by user on Fri, 03/15/2019 - 14:29

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
Primary
Outcome Domain: Positive Parenting Practices
Rating Outcome Measure Effect Sample Timing of Follow-Up Sample Size Intervention Group Comparison Group Group Difference Effect Size Statistical Significance Outcome Type 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 HomeVEE calculated = -0.35 Statistically significant,
p = 0.02
Secondary

footnote209

Submitted by user on Fri, 03/15/2019 - 14:29

Authors indicated that negative effect favors the treatment group.

Outcome Measure Summary

Outcome Domain: Maternal Health
Rating Outcome Measure Description of Measure Data Collection Method Properties of Measure Outcome Type Link to delete Content
Moderate

Mother activity time >=150 minutes/week-Complete Case Analysis

Percentage of mothers who engage in 150 minutes or more of activity in a week Mother report

Not applicable

Secondary
Moderate

Mother drink soft drink-Complete Case Analysis

Percentage of mothers who drink soft drinks Mother report

Not applicable

Secondary
Moderate

Mother eat fast food-Complete Case Analysis

Percentage of mothers who eat fast food Mother report

Not applicable

Secondary
Moderate

Mother eat french fries-Complete Case Analysis

Percentage of mothers who eat french fries Mother report

Not applicable

Secondary
Moderate

Mother eat processed meat-Complete Case Analysis

Percentage of mothers who eat processed meat Mother report

Not applicable

Secondary
Moderate

Mother fruit >2 serving/day-Complete Case Analysis

Percentage of mothers consuming more than 2 servings per day of fruit Mother report

Not applicable

Secondary
Moderate

Mother vegetable >2 servings/day-Complete Case Analysis

Percentage of mothers consuming more than 2 servings per day of vegetables Mother report

Not applicable

Secondary
Moderate

Mother watch TV >=120 minutes/day-Complete Case Analysis

Percentage of mothers who watch 120 minutes or more of TV a day Mother report

Not applicable

Secondary
Moderate

Mother water >=8 cups/day-Complete Case Analysis

Percentage of mothers drinking 8 or more cups of water per day Mother report

Not applicable

Secondary
Outcome Domain: Child Health
Rating Outcome Measure Description of Measure Data Collection Method Properties of Measure Outcome Type Link to delete Content
Moderate

BMI-Complete Case Analysis

Body Mass Index based on direct measures of height and weight Direct Measurement

Not applicable

Primary
Moderate

Child drink soft drink-Complete Case Analysis

Percentage of children who drink soft drinks Mother report

Not applicable

Secondary
Moderate

Child eat dinner in front of TV-Complete Case Analysis

Percentage of children who eat dinner in front of the TV

Mother report

Not applicable

Secondary
Moderate

Child eat french fries-Complete Case Analysis

Percentage of children who ate french fries Mother report

Not applicable

Secondary
Moderate

Child eat salty snack-Complete Case Analysis

Percentage of children who eat salty snacks Mother report

Not applicable

Secondary
Moderate

Child eat sweet snack everyday-Complete Case Analysis

Percentage of children who eat sweet snacks Mother report

Not applicable

Secondary
Moderate

Child fruit >= 1 serving/day-Complete Case Analysis

Percentage of children consuming one or more servings of fruit a day Mother report

Not applicable

Secondary
Moderate

Child outdoor play >=120 minutes/day-Complete Case Analysis

Percentage of children who played outside for 120 minutes or more per day Mother report

Not applicable

Secondary
Moderate

Child vegetable >= 1 serving/day-Complete Case Analysis

Percentage of children consuming one or more servings of vegetable a day Mother report

Not applicable

Secondary
Moderate

Child water >3 cups/day-Complete Case Analysis

Percentage of children drinking more than 3 cups of water per day Mother report

Not applicable

Secondary
Moderate

Food used as a reward-Complete Case Analysis

Percentage of mothers reporting they used food as a reward with child

Mother report

Not applicable

Secondary
Moderate

Length-Complete Case Analysis

Child length (cm) Direct Measurement

Not applicable

Primary
Moderate

TV on during meal-Complete Case Analysis

Percentage of mothers reporting the TV is on during meals

Mother report

Not applicable

Secondary
Moderate

Weight-Complete Case Analysis

Child weight (kg) Direct Measurement

Not applicable

Primary
Outcome Domain: Positive Parenting Practices
Rating Outcome Measure Description of Measure Data Collection Method Properties of Measure Outcome Type Link to delete Content
Moderate

Child watch TV >60 minutes/day-Complete Case Analysis

Percentage of children watching TV for more than 60 minutes per day Mother report

Not applicable

Secondary