Manuscript Details

Peer reviewed?
Yes

Paul, I. M., Savage, J. S., Anzman-Frasca, S., Marini, M. E., Beiler, J. S., Hess, L. B., ... & Birch, L. L. (2018). Effect of a responsive parenting educational intervention on childhood weight outcomes at 3 years of age: the INSIGHT randomized clinical trial. JAMA, 320(5), 461-468. https://doi.org/10.1001/jama.2018.9432

High rating
Study reviewed under: Handbook of Procedures and Standards, Version 2
Screening Conclusion

Eligible for review

Model(s) Reviewed
Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT)
Study Registration
ClinicalTrials.gov
Author Affiliation

The authors are affiliated with several universities, including Pennsylvania State University, and are developers of the INSIGHT program.

Funding Sources

This research was supported by Award Numbers R01DK088244 and UL1TR000127 from the National Institutes of Health and 2011-67001-30117 from the U.S. Department of Agriculture. The research was also supported by the Children’s Miracle Network at Penn State Health Children's Hospital and the Penn State Clinical and Translational Science Institute.

Study Design
Design Attrition Baseline equivalence Confounding factors Valid, reliable measures?
Randomized controlled trial Low

Not assessed for randomized controlled trials with low attrition

No

Yes, details reported below for findings on valid, reliable outcomes that otherwise rate at least moderate
Notes

Information on sample sizes and details about findings on body-mass index were based on correspondence with the author. The authors reported several findings that are not eligible for review because they do not examine the impact of the intervention on an eligible outcome.

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
Accelerated weight gain 1 year old High
0.05 Not statistically significant, p= 0.97 253 children INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample
Accelerated weight gain 16 weeks old High
0.19 Not statistically significant, p= 0.44 269 infants INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample
BMI 16 weeks old High
0.27 Statistically significant, p = 0.03 269 children INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample
BMI 1 year old High
0.28 Statistically significant, p = 0.02 253 children INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample
BMI 4 weeks old High
0.43 Statistically significant, p <.01 279 children INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample
BMI 40 weeks old High
0.33 Statistically significant, p = 0.01 259 children INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample
BMI 3 years old High
0.32 Statistically significant, p = 0.02 232 children INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample
BMI 28 weeks old High
0.39 Statistically significant, p <.01 262 children INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample
BMI 2 years old High
0.21 Not statistically significant, p = 0.10 243 children INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample
BMI (in standardized units) 2 years old High
0.21 Not statistically significant, p= 0.10 243 children INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample
BMI (in standardized units) 3 years old High
0.28 Statistically significant, p= 0.04 232 children INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample
BMI percentile 3 years old High
0.24 Not statistically significant, p= 0.07 232 children INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample
BMI percentile 2 years old High
0.15 Not statistically significant, p= 0.26 243 children INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample
Conditional weight gain 28 weeks old High
Statistically significant, p <.01 262 children INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample
Downward crossing of 2 major percentile lines for height and weight 3 years old High
0.32 Not statistically significant, p = 0.47 279 children INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample
Percent obese 2 years old High
1.47 Statistically significant, p= 0.01 243 children INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample
Percent obese 3 years old High
0.70 Not statistically significant, p= 0.08 232 children INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample
Percent overweight 2 years old High
0.43 Statistically significant, p= 0.04 243 children INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample
Percent overweight 3 years old High
0.41 Not statistically significant, p= 0.07 232 children INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample
Weight-for-age below 5th percentile 3 years old High
0.39 Not statistically significant, p = 0.22 279 children INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample
Effect rating key
Favorable finding / Statistically significant
Unfavorable finding / Statistically significant
Ambiguous finding / Statistically significant
No effect / Not statistically significant

This study included participants with the following characteristics at enrollment:

Race/Ethnicity

The race and ethnicity categories may sum to more than 100 percent if Hispanic ethnicity was reported separately or respondents could select two or more race or ethnicity categories.

Asian
3%
Black or African American
6%
Hispanic or Latino
7%
Native Hawaiian or Pacific Islander
<1%
White
89%
Unknown
1%

Maternal Education

Some college or Associate's degree
26%
Bachelor's degree or higher
62%
Unknown
11%

Other Characteristics

Indigenous population
<1%

This study included participants from the following locations:

  • Pennsylvania
Study Participants

Study participants were mother and infant dyads recruited after delivery in one Pennsylvania hospital. To be eligible, dyads had to include full-term, singleton births, with infants of normal birth weight. Mothers were English-speaking, primiparous, and at least 20 years old. A total of 291 dyads were randomly assigned to either the Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) intervention (145 dyads) or a comparison intervention (146 dyads). Mother–infant dyads were randomly assigned to the INSIGHT intervention or the comparison intervention two weeks after birth, and outcomes were measured until the children’s third birthday. In the study, 89 percent of mothers were White, 6 percent were Black, 3 percent were Asian, and 1 percent reported another race. Seven percent of mothers reported Hispanic ethnicity.

Setting

The study took place in Hershey, Pennsylvania.

Intervention condition
Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT)

Note: Navigate to the model page for more information about the home visiting model. See the source manuscript for more information about how the model was implemented in this study.

Comparison Conditions

Families assigned to the comparison condition were not eligible to receive intervention services through the INSIGHT program. However, these families received a similar number of home visits as the INSIGHT group (when infants were 3 to 4, 16, 28, and 40 weeks old) and annual clinic-based visits at 1, 2, and 3 years old. The home visits focused solely on home safety topics, including crib safety. When infants were 2 weeks old, participants received a mailed packet with information on infant feeding.

Were any subgroups examined?
No
Subgroups examined

• Boys • Girls • Intended feeding mode (breastfeeding) • Intended feeding mode (formula)