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Lee, E., Mitchell-Herzfeld, S., Lowenfels, A. A., Greene, R., Dorabawila, V., & DuMont, K. A. (2009). Reducing low birth weight through home visitation: A randomized controlled trial. American Journal of Preventive Medicine, 36(2), 154–160.

Manuscript screening details
Screening decision Screening conclusion HomVEE procedures and standards version
Passes screens Eligible for review Version 1
Study design details
Rating Design Attrition Baseline equivalence Compromised randomization Confounding factors Valid, reliable measure(s)
High Randomized controlled trial Low Established on race/ethnicity and SES; outcomes not feasible to assess at baseline. None None Not assessed in manuscripts reviewed before 2021
Notes:

footnote249

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

Two outcomes, frequency of prenatal care visits and whether the mother has a primary care provider, received a rating of moderate because the study demonstrates baseline equivalence for socioeconomic status but not for race and ethnicity. In addition, baseline measures of the primary care provider outcome were measurable at baseline and baseline equivalence was not demonstrated for this outcome.

Study characteristics
Study participants Potential participants at three Healthy Families New York sites (Healthy Families America program) were screened for socioeconomic risk factors and administered the family stress checklist. Eligible participants lived at or under 200 percent of the federal poverty level and were pregnant or had given birth within three months of enrollment. In total, 1,297 pregnant mothers or mothers who had recently given birth were eligible and agreed to participate in the study and were randomized to either a Healthy Families New York group or a comparison group. This study focused on the subsample of mothers who were randomized at 30 or fewer weeks of gestation and who had a single birth. Within this subsample, 264 mothers were randomized to the intervention group and 291 to the comparison group. Among the total 501 mothers in the study, 44.9 percent were black, 22.4 percent were Hispanic, and 30.1 percent were white; 21.8 percent were below the age of 18, 23.2 percent participated in the Temporary Assistance for Needy Families (TANF) program, 26.9 percent had smoked while pregnant, and 56.3 percent were first-time mothers.
Setting The study took place within three Healthy Families of New York sites: Erie, Rensselaer, and Ulster counties.
Intervention services Mothers assigned to the Healthy Families of New York (based on Healthy Families America) group received bi-weekly visits. On average, home visits were an hour in duration. The home visits focused on improving the mothers' social support, providing prenatal education, and linking the mothers to other community services. Home visitors discussed preparedness for motherhood, helped the mothers develop problem-solving skills and healthy prenatal behaviors, encouraged mothers to follow all medical advice and attend all medical appointments, and helped the mothers obtain a health care provider and connect with other services, such as the Supplemental Nutrition Assistance Program (SNAP) and the Special Supplemental Nutrition Program for Women, Infants and Children (WIC).
Comparison conditions Members of the comparison group received information about and referrals to other community services.
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).
Subgroups are not listed for manuscripts reviewed before 2021.
Staff characteristics and training Home visitors were “indigenous to the community,” and had the same language and “cultural background” as the women participating in the program. The home visitors were a median age of 38 years old and typically had experience working with infants and young children. About half of the home visitors had at least some college education. The home visitors were trained by certified Healthy Families of America trainers and were supervised weekly.
Funding sources Not reported
Author affiliation Center for Human Services Research, School of Social Welfare, University of Albany, State University of New York; and the Bureau of Evaluation and Research, New York State Office of Children and Family Services.
Peer reviewed Peer reviewed status is not listed for manuscripts reviewed before 2021.
Study Registration:
Clinicaltrials.gov Identifier: None found. Study registration was assessed by HomVEE beginning with the 2014 review.

Findings details

Child health
Rating Outcome measure Effect Sample Timing of follow-up Sample size Intervention group Comparison group Group difference Effect size Statistical significance Notes
High Low birth weight
FavorableUnfavorable or ambiguousNo Effect
Full sample At birth 501 Adjusted proportion = 0.05 Adjusted proportion = 0.10 OR = 0.43 HomeVEE calculated = -0.51 Statistically significant, p = 0.02

footnote162

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

Negative value is favorable to the intervention.

High Preterm birth
FavorableUnfavorable or ambiguousNo Effect
Full sample At birth 501 Not reported Not reported Not reported Not available Not statistically significant, p ≥ 0.05
Maternal health
Rating Outcome measure Effect Sample Timing of follow-up Sample size Intervention group Comparison group Group difference Effect size Statistical significance Notes
Moderate Frequency of prenatal care visits during third trimester
FavorableUnfavorable or ambiguousNo Effect
Full sample At birth 456 Not reported Not reported Not reported Not available Statistically significant, p<0.051
Moderate Mother has primary care provider
FavorableUnfavorable or ambiguousNo Effect
Full sample At birth 461 Unadjusted proportion = 0.94 Unadjusted proportion = 0.88 Not reported Not available Statistically significant, p<0.05

footnote250

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

<abbr title="Home Visiting Evidence of Effectiveness">HomVEE</abbr> reported p value.

Outcome measure summary

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

Low birth weight

The study considered a baby born weighing less than 2,500 grams as low birth weight. The study determined birth weight using birth certificates. Birth certificate

Not applicable

Preterm birth

The study considered a baby born after 37 or fewer weeks of gestation as a preterm birth. New York State Department of Health birth records

Not applicable

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

Frequency of prenatal care visits during third trimester

Mother was asked about the frequency of prenatal care visits during third trimester. Maternal interview

Not reported

Mother has primary care provider

Mother was asked if had primary care provider. Maternal interview

Not reported