Manuscript Detail | Home Visiting Evidence of Effectiveness

Adams, E. L., Marini, M. E., Brick, T. R., Paul, I. M., Birch, L. L., & Savage, J. S. (2019). Ecological momentary assessment of using food to soothe during infancy in the INSIGHT trial. International Journal of Behavioral Nutrition and Physical Activity, 16(1), 1-11. https://doi.org/10.1186/s12966-019-0837-y

Manuscript screening details
Screening decision	Screening conclusion	HomVEE procedures and standards version
Passes screens	Eligible for review	Version 2

Study design details
Rating	Design	Attrition	Baseline equivalence	Compromised randomization	Confounding factors	Valid, reliable measure(s)
High	Randomized controlled trial	Low	Not assessed for randomized controlled trials with low attrition	No	No	Yes, details reported below for findings on valid, reliable outcomes that otherwise rate at least moderate

Notes:

Information on sample sizes was based on correspondence with the author. The authors report findings in the manuscript that are ineligible for review because they do not examine the impact of the intervention on an eligible outcome (for example, descriptions of infant fusses and feeds and descriptions of soothing strategies).

Study characteristics
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); 157 of the dyads were included in the analyses in this manuscript (81 in the intervention group and 76 in the comparison group). Mother–infant dyads were randomly assigned to the INSIGHT intervention or the comparison intervention two weeks after birth. Outcomes were measured when children were 3 weeks and 8 weeks old. In the study, 89 percent of mothers were White, 7 percent were Black, 2 percent were Asian, and 2 percent reported another race. Most mothers (62 percent) had annual household incomes between $25,000 and $99,000; 10 percent had annual household incomes below $25,000. Ninety percent of mothers were college educated.
Setting	The study took place in Hershey, Pennsylvania.
Intervention 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.
Subgroups examined	This field lists subgroups examined in the manuscript (even if they were not replicated in other samples and not reported on the summary page for this model’s report). There were no subgroups reported in this manuscript.
Funding sources	This research was supported by Award Number R01DK088244 from the National Institute of Diabetes and Digestive and Kidney Diseases. It was also supported by the Children's Miracle Network at Penn State Health Children’s Hospital and the U.S. Department of Agriculture Childhood Obesity Prevention Training Program.
Author affiliation	The authors are affiliated with several universities, including Pennsylvania State University, and are developers of the INSIGHT program.
Peer reviewed	Yes

Study Registration:

Clinicaltrials.gov Identifier: NCT01167270. SocialScienceRegistry.org Identifier: None found. Registry of Efficacy and Effectiveness Studies Identifier: None found. Study registration was assessed by HomVEE for Clinicaltrials.gov beginning with the 2014 review, and for other registries beginning with the 2021 review.

Findings that rate moderate or high

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
High	Mother used a responsive parenting practice (for example, rub or pat) to address infant fussing	FavorableUnfavorable or ambiguousNo Effect	INSIGHT vs comparison, Pennsylvania 2012-2014, full sample	3 weeks old	152 mother/child dyads	Adjusted proportion = 0.58	Adjusted proportion = 0.42	Mean difference = 0.16	HomVEE calculated = 0.40	Statistically significant, p <.01
High	Mother used a responsive parenting practice (for example, rub or pat) to address infant fussing	FavorableUnfavorable or ambiguousNo Effect	INSIGHT vs comparison, Pennsylvania 2012-2014, full sample	8 weeks old	142 mother/child dyads	Adjusted proportion = 0.57	Adjusted proportion = 0.43	Mean difference = 0.14	HomVEE calculated = 0.35	Statistically significant, p <.01
High	Mother's first response to infant fussing is to feed	FavorableUnfavorable or ambiguousNo Effect	INSIGHT vs comparison, Pennsylvania 2012-2014, full sample	8 weeks old	144 mother/child dyads	Not reported	Not reported	Odds ratio = 1.40	HomVEE calculated = 0.20	Not statistically significant, p=.053	Submitted by user on Fri, 03/15/2019 - 14:29 Negative effect is favorable to the intervention. Submitted by barbara on Fri, 04/12/2019 - 18:55 HomVEE calculated the effect size based on the study-reported odds ratio.
High	Mother's first response to infant fussing is to feed	FavorableUnfavorable or ambiguousNo Effect	INSIGHT vs comparison, Pennsylvania 2012-2014, full sample	3 weeks old	153 mother/child dyads	Not reported	Not reported	Odds ratio = 1.90	HomVEE calculated = 0.39	Statistically significant, p <.01	Submitted by user on Fri, 03/15/2019 - 14:29 Negative effect is favorable to the intervention. Submitted by barbara on Fri, 04/12/2019 - 18:55 HomVEE calculated the effect size based on the study-reported odds ratio.