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Wen, L. M., Baur, L. A., Simpson, J. M., Rissel, C., & Flood, V. M. (2011). Effectiveness of an early intervention on infant feeding practices and "tummy time": A randomized controlled trial. Archives of Pediatrics & Adolescent Medicine, 165(8), 701-707.

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 Not established on race or SES; no outcome measures assessable at baseline. No No
Notes:

In 2020, HomVEE updated this review to move measures of bottle at bedtime and food used as reward concept from the Positive Parenting Practices domain to the Child Health domain because ACF determined that HomVEE should place all child feeding outcomes under the Child Health domain.

footnote208

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 6 and 12 months after the child's birth. At 6 months, the authors analyzed 561 women (278 intervention, 283 control); at the 12-month follow-up, they analyzed 527 women (268 intervention, 259 control).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 six visits in the first year: at 30 to 36 weeks of pregnancy (if recruited at that time); and 1, 3, 5, 9, and 12 months after birth. (A later study by these authors reports a subsequent 24-month visit). 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, with discussion points and resources.
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.
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

Child development and school readiness
Rating Outcome measure Effect Sample Timing of follow-up Sample size Intervention group Comparison group Group difference Effect size Statistical significance Notes
Moderate Child use of cup
FavorableUnfavorable or ambiguousNo Effect
Sydney, Australia Healthy Beginnings Trial 12 months 527 mothers Unadjusted mean = 0.92 Unadjusted mean = 0.85 Mean difference = 0.07 HomeVEE calculated = 0.43 Statistically significant,
p = 0.01
Child health
Rating Outcome measure Effect Sample Timing of follow-up Sample size Intervention group Comparison group Group difference Effect size Statistical significance Notes
Moderate Bottle at bedtime
FavorableUnfavorable or ambiguousNo Effect
Sydney, Australia Healthy Beginnings Trial 12 months 527 mothers Unadjusted mean = 0.35 Unadjusted mean = 0.44 Mean difference = -0.09 HomeVEE calculated = -0.23 Statistically significant,
p = 0.04

footnote209

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

Authors indicated that negative effect favors the treatment group.

Moderate Breastfeeding (yes/no)-Chi-square 12 months
FavorableUnfavorable or ambiguousNo Effect
Sydney, Australia Healthy Beginnings Trial 12 months 527 mothers Unadjusted mean = 0.21 Unadjusted mean = 0.15 Mean difference = 0.06 HomeVEE calculated = 0.25 Statistically significant,
p < 0.05
Moderate Breastfeeding (yes/no)-Chi-square 6 months
FavorableUnfavorable or ambiguousNo Effect
Sydney, Australia Healthy Beginnings Trial 6 months 561 mothers Unadjusted mean = 0.42 Unadjusted mean = 0.32 Mean difference = 0.10 HomeVEE calculated = 0.26 Not statistically significant,
p = <0.05
Moderate Breastfeeding duration (weeks)-12 months
FavorableUnfavorable or ambiguousNo Effect
Sydney, Australia Healthy Beginnings Trial 12 months 527 mothers Unadjusted mean = 0.17 Unadjusted mean = 0.13 Mean difference = 0.04 Not available Statistically significant,
p = 0.03
Moderate Breastfeeding exclusive (yes/no)-6 months
FavorableUnfavorable or ambiguousNo Effect
Sydney, Australia Healthy Beginnings Trial 6 months 561 mothers Unadjusted mean = 0.04 Unadjusted mean = 0.02 Mean difference = 0.02 HomeVEE calculated = 0.45 Not statistically significant,
p = 0.14
Moderate Food used as reward
FavorableUnfavorable or ambiguousNo Effect
Sydney, Australia Healthy Beginnings Trial 12 months 527 mothers Unadjusted mean = 0.18 Unadjusted mean = 0.25 Mean difference = -0.07 HomeVEE calculated = -0.27 Statistically significant,
p = 0.04

footnote209

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

Authors indicated that negative effect favors the treatment group.

Moderate Introduction of solids (4 months or younger)
FavorableUnfavorable or ambiguousNo Effect
Sydney, Australia Healthy Beginnings Trial 6 months 561 mothers Unadjusted mean = 0.18 Unadjusted mean = 0.26 Mean difference = -0.08 HomeVEE calculated = -0.30 Statistically significant,
p = 0.00

footnote209

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

Authors indicated that negative effect favors the treatment group.

Moderate Introduction of solids (5 months)
FavorableUnfavorable or ambiguousNo Effect
Sydney, Australia Healthy Beginnings Trial 6 months 561 mothers Unadjusted mean = 0.44 Unadjusted mean = 0.48 Mean difference = -0.04 HomeVEE calculated = -0.10 Statistically significant,
p = 0.00

footnote209

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

Authors indicated that negative effect favors the treatment group.

Moderate Introduction of solids (6 months)
FavorableUnfavorable or ambiguousNo Effect
Sydney, Australia Healthy Beginnings Trial 6 months 561 mothers Unadjusted mean = 0.39 Unadjusted mean = 0.26 Mean difference = 0.13 HomeVEE calculated = 0.35 Statistically significant,
p = 0.00
Moderate Introduction of solids (before 6 months)
FavorableUnfavorable or ambiguousNo Effect
Sydney, Australia Healthy Beginnings Trial 6 months 561 mothers Unadjusted mean = 0.62 Unadjusted mean = 0.74 Mean difference = -0.12 HomeVEE calculated = -0.34 Statistically significant,
p = 0.00

footnote209

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

Authors indicated that negative effect favors the treatment group.

Positive parenting practices
Rating Outcome measure Effect Sample Timing of follow-up Sample size Intervention group Comparison group Group difference Effect size Statistical significance Notes
Moderate Tummy time-age started (4 to 8 weeks)
FavorableUnfavorable or ambiguousNo Effect
Sydney, Australia Healthy Beginnings Trial 6 months 561 mothers Unadjusted mean = 0.22 Unadjusted mean = 0.26 Mean difference = -0.04 HomeVEE calculated = -0.12 Statistically significant,
p = 0.03

footnote209

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

Authors indicated that negative effect favors the treatment group.

Moderate Tummy time-age started (later than 8 weeks)
FavorableUnfavorable or ambiguousNo Effect
Sydney, Australia Healthy Beginnings Trial 6 months 561 mothers Unadjusted mean = 0.19 Unadjusted mean = 0.25 Mean difference = -0.06 HomeVEE calculated = -0.20 Statistically significant,
p = 0.03

footnote209

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

Authors indicated that negative effect favors the treatment group.

Moderate Tummy time-age started (less than 4 weeks)
FavorableUnfavorable or ambiguousNo Effect
Sydney, Australia Healthy Beginnings Trial 6 months 561 mothers Unadjusted mean = 0.58 Unadjusted mean = 0.49 Mean difference = 0.09 HomeVEE calculated = 0.22 Statistically significant,
p = 0.03
Moderate Tummy time-if daily
FavorableUnfavorable or ambiguousNo Effect
Sydney, Australia Healthy Beginnings Trial 6 months 561 mothers Unadjusted mean = 0.83 Unadjusted mean = 0.76 Mean difference = 0.07 HomeVEE calculated = 0.25 Statistically significant,
p = 0.05

Outcome measure summary

Child development and school readiness
Outcome measure Description of measure Data collection method Properties of measure

Child use of cup

Percentage of mothers reporting the child used a cup Mother report

Not applicable

Child health
Outcome measure Description of measure Data collection method Properties of measure

Bottle at bedtime

Percentage of mothers who put the child to bed with a bottle at 12 months

Mother report

Not applicable

Breastfeeding (yes/no)-Chi-square 12 months

Percentage of mothers who were breastfeeding 12 months after the child's birth Mother report

Not applicable

Breastfeeding (yes/no)-Chi-square 6 months

Percentage of mothers who were breastfeeding 6 months after the child's birth Mother report

Not applicable

Breastfeeding duration (weeks)-12 months

The number of weeks the mother breastfed her child Mother report

Not applicable

Breastfeeding exclusive (yes/no)-6 months

Whether the mother was exclusively breastfeeding (no other liquids or solid foods) at 6 months Mother report

Not applicable

Food used as reward

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

Mother report

Not applicable

Introduction of solids (4 months or younger)

The percentage of mothers who introduced solid foods when the child was 4 months or younger Mother report

Not applicable

Introduction of solids (5 months)

The percentage of mothers who introduced solid foods when the child was 5 months old Mother report

Not applicable

Introduction of solids (6 months)

The percentage of mothers who introduced solid foods when the child was 6 months old Mother report

Not applicable

Introduction of solids (before 6 months)

The percentage of mothers who introduced solid foods prior to child turning 6 months of age Mother report

Not applicable

Positive parenting practices
Outcome measure Description of measure Data collection method Properties of measure

Tummy time-age started (4 to 8 weeks)

Percentage of mothers who had the child spend time on his/her tummy when child was between 4 and 8 weeks old Mother report

Not applicable

Tummy time-age started (later than 8 weeks)

Percentage of mothers who had the child spend time on his/her tummy when child was older than 8 weeks old Mother report

Not applicable

Tummy time-age started (less than 4 weeks)

Percentage of mothers who had the child spend time on his/her tummy when child was less than 4 weeks old Mother report

Not applicable

Tummy time-if daily

Percentage of mothers who had the child spend time daily on his/her tummy Mother report

Not applicable