Manuscript Details

Source

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

Rating
High
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.

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.

Home Visiting Services

INSIGHT consisted of home visits conducted when infants were 3 to 4, 16, 28, and 40 weeks old, followed by annual clinic-based visits at 1, 2, and 3 years old. The curriculum taught parents to respond promptly and in developmentally appropriate ways to infant cues across four behavioral states (drowsy, sleepy, fussy, and alert/calm). Research nurses provided parents with developmentally appropriate sleep guidance during each visit. The guidance addressed bedtime routines, sleep location, and night waking. During and between visits, caregivers were provided with information and resources on responsive feeding, lactation support, soothing practices, and home safety (including crib safety and choking hazards). When infants were 2 weeks old, participants received a mailed packet with information on infant feeding.

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)

Findings that rate moderate or high in this manuscript

Child health
Outcome measure Timing of follow-up Rating Effect size Stastical significance Sample size Sample description

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

Percent overweight

3 years old

High -0.41

Not statistically significant, p= 0.07

232 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

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 percentile

2 years old

High -0.15

Not statistically significant, p= 0.26

243 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 obese

2 years old

High -1.47

Statistically significant, p= 0.01

243 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

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

Conditional weight gain

28 weeks old

High

Statistically significant, p <.01

262 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

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

BMI

4 weeks old

High -0.43

Statistically significant, p <.01

279 children

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

28 weeks old

High -0.39

Statistically significant, p <.01

262 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

1 year old

High -0.28

Statistically significant, p = 0.02

253 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

3 years old

High -0.32

Statistically significant, p = 0.02

232 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
3.20%
Black or African American
6.10%
Hispanic or Latino
6.81%
Native Hawaiian or Pacific Islander
0.36%
White
89.20%
Unknown
1.10%

Maternal Education

Some college or Associate's degree
26.20%
Bachelor's degree or higher
62.40%
Unknown
11.40%

Other Characteristics

Indigenous population
0.36%