Anzman-Frasca, S., Paul, I. M., Moding, K. J., Savage, J. S., Hohman, E. E., & Birch, L. L. (2018). Effects of the INSIGHT obesity preventive intervention on reported and observed infant temperament. Journal of Developmental and Behavioral Pediatrics: JDBP, 39(9), 736-743. https://doi.org/10.1097/DBP.0000000000000597
| Screening decision | Screening conclusion | HomVEE procedures and standards version |
|---|---|---|
| Passes screens | Eligible for review | Version 2 |
| 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 |
Information on sample sizes was obtained from Paul et al. (2014). Information on reliability of outcome measures was 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 first birthday. In the study, 93 percent of mothers were White, 3 percent were Black, 3 percent were Asian, and 1 percent reported another race. Five percent of mothers were Hispanic or Latino. One-third had a high school diploma or some college education, and two-thirds were college graduates. |
|---|---|
| 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 were 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). • Boys • Girls |
| 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. |
| Author affiliation | The authors are affiliated with several universities—including the University of Buffalo and Pennsylvania State University—and are developers of the INSIGHT program. |
| Peer reviewed | Yes |
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.
| Rating | Outcome measure | Effect | Sample | Timing of follow-up | Sample size | Intervention group | Comparison group | Group difference | Effect size | Statistical significance | Notes |
|---|---|---|---|---|---|---|---|---|---|---|---|
| High | Infant Behavior Questionnaire-Revised (IBQ-R): Distress to limitations |
FavorableUnfavorable or ambiguousNo Effect |
INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
1 year old |
240 children | Unadjusted mean = 3.85 | Unadjusted mean = 4.08 | Mean difference = -0.23 | HomVEE calculated = -0.33 | Statistically significant, p <.05 |
Negative effect is favorableNegative effect is favorable to the intervention. |
| High | Infant Behavior Questionnaire-Revised (IBQ-R): Falling reactivity |
FavorableUnfavorable or ambiguousNo Effect |
INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
1 year old |
240 children | Unadjusted mean = 2.60 | Unadjusted mean = 2.85 | Mean difference = -0.25 | HomVEE calculated = -0.36 | Statistically significant, p <.01 |
Negative effect is favorableNegative effect is favorable to the intervention. |
| High | Infant Behavior Questionnaire-Revised (IBQ-R): Fear |
FavorableUnfavorable or ambiguousNo Effect |
INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
1 year old |
240 children | Unadjusted mean = 2.97 | Unadjusted mean = 2.95 | Mean difference = 0.02 | HomVEE calculated = 0.02 | Not statistically significant, p= 0.86 |
Negative effect is favorableNegative effect is favorable to the intervention. |
| High | Infant Behavior Questionnaire-Revised (IBQ-R): Negativity |
FavorableUnfavorable or ambiguousNo Effect |
INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
1 year old |
240 children | Unadjusted mean = 3.16 | Unadjusted mean = 3.30 | Mean difference = -0.14 | HomVEE calculated = -0.26 | Statistically significant, p <.05 |
Negative effect is favorableNegative effect is favorable to the intervention. |
| High | Infant Behavior Questionnaire-Revised (IBQ-R): Negativity |
FavorableUnfavorable or ambiguousNo Effect |
INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
16 weeks old |
230 children | Unadjusted mean = 3.25 | Unadjusted mean = 3.46 | Mean difference = -0.21 | HomVEE calculated = -0.24 | Not statistically significant, p <.10 |
Negative effect is favorableNegative effect is favorable to the intervention. |
| High | Infant Behavior Questionnaire-Revised (IBQ-R): Regulation |
FavorableUnfavorable or ambiguousNo Effect |
INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
1 year old |
240 children | Unadjusted mean = 4.73 | Unadjusted mean = 4.79 | Mean difference = -0.06 | HomVEE calculated = -0.11 | Not statistically significant, p= 0.39 |
|
| High | Infant Behavior Questionnaire-Revised (IBQ-R): Regulation |
FavorableUnfavorable or ambiguousNo Effect |
INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
16 weeks old |
230 children | Unadjusted mean = 5.42 | Unadjusted mean = 5.37 | Mean difference = 0.05 | HomVEE calculated = 0.07 | Not statistically significant, p = 0.58 |
|
| High | Infant Behavior Questionnaire-Revised (IBQ-R): Sadness |
FavorableUnfavorable or ambiguousNo Effect |
INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
1 year old |
240 children | Unadjusted mean = 3.22 | Unadjusted mean = 3.32 | Mean difference = -0.10 | HomVEE calculated = -0.13 | Not statistically significant, p= 0.29 |
Negative effect is favorableNegative effect is favorable to the intervention. |
| High | Negativity score during toy removal (toy removal frustration task) |
FavorableUnfavorable or ambiguousNo Effect |
INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
1 year old |
230 children | Unadjusted mean = 0.67 | Unadjusted mean = 0.67 | Mean difference = 0.00 | HomVEE calculated = 0.00 | Not statistically significant, p= 0.99 |
Negative effect is favorableNegative effect is favorable to the intervention. |
| High | Negativity score during toy return (toy removal frustration task) |
FavorableUnfavorable or ambiguousNo Effect |
INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
1 year old |
230 children | Unadjusted mean = 0.41 | Unadjusted mean = 0.41 | Mean difference = 0.00 | HomVEE calculated = 0.00 | Not statistically significant, p= 0.96 |
Negative effect is favorableNegative effect is favorable to the intervention. |
| High | Other regulation during toy removal (toy removal frustration task) |
FavorableUnfavorable or ambiguousNo Effect |
INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
1 year old |
230 children | Unadjusted mean = 64.70 | Unadjusted mean = 66.80 | Mean difference = -2.10 | HomVEE calculated = -0.12 | Not statistically significant, p= 0.36 |
|
| High | Other regulation during toy return (toy removal frustration task) |
FavorableUnfavorable or ambiguousNo Effect |
INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
1 year old |
230 children | Unadjusted mean = 89.70 | Unadjusted mean = 92.30 | Mean difference = -2.60 | HomVEE calculated = -0.17 | Not statistically significant, p= 0.22 |
|
| High | Self-soothing by orienting (toy removal frustration task) |
FavorableUnfavorable or ambiguousNo Effect |
INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
1 year old |
230 children | Unadjusted mean = 8.00 | Unadjusted mean = 7.40 | Mean difference = 0.60 | HomVEE calculated = 0.07 | Not statistically significant, p= 0.39 |
|
| High | Self-soothing by self-comforting (toy removal frustration task) |
FavorableUnfavorable or ambiguousNo Effect |
INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
1 year old |
230 children | Unadjusted mean = 12.00 | Unadjusted mean = 7.80 | Mean difference = 4.20 | HomVEE calculated = 0.28 | Statistically significant, p <.05 |
|
| High | Self-soothing strategy (any) during toy removal (toy removal frustration task) |
FavorableUnfavorable or ambiguousNo Effect |
INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
1 year old |
230 children | Unadjusted mean = 41.90 | Unadjusted mean = 41.90 | Mean difference = 0.00 | HomVEE calculated = 0.00 | Not statistically significant, p= 1.00 |
|
| High | Self-soothing strategy (any) during toy return (toy removal frustration task) |
FavorableUnfavorable or ambiguousNo Effect |
INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
1 year old |
230 children | Unadjusted mean = 18.80 | Unadjusted mean = 13.90 | Mean difference = 4.90 | HomVEE calculated = 0.30 | Statistically significant, p <.05 |
