Manuscript Details

Rosenstock, S., Ingalls, A., Cuddy, R. F., Neault, N., Littlepage, S., Cohoe, L., Nelson, L., Shephard-Yazzie, K., Yazzie, S., Alikhani, A., Reid, R., Kenney, A., & Barlow, A. (2021). Effect of a home-visiting intervention to reduce early childhood obesity among Native American children: A randomized clinical trial. JAMA Pediatrics, 175(2), 133–142. https://doi.org10.1001/jamapediatrics.2020.3557

Peer Reviewed

Model(s): Family Spirit®
Study Registration: ClinicalTrials.gov

This manuscript describes findings for an enhanced model, Family Spirit Nurture. For more information about Family Spirit Nurture, see the Tailored services and enhanced models section of Family Spirit's model page.

High rating
This manuscript received a rating of high because it is a randomized-controlled trial with low-attrition.

Study reviewed under: Handbook of Procedures and Standards, Version 2.3
Child Health
Outcome Measure Timing of Follow-Up Rating Direction of Effect Effect Size (Absolute Value) Statistical Significance Sample Size Sample Description
Age (in months) infant given first complementary food 12 months old High
0.38 Statistically significant, p= 0.04 126 children Family Spirit Nurture vs. comparison, Shiprock, New Mexico, Navajo Nation, 2017-2019, full sample
Age (months) when sugar-sweetened beverage first given 12 months old High
Not available Not statistically significant, p= 0.59 122 children Family Spirit Nurture vs. comparison, Shiprock, New Mexico, Navajo Nation, 2017-2019, full sample
Ever introduced sugar-sweetened beverage 6 months old High
0.03 Not statistically significant, p= 0.94 128 children Family Spirit Nurture vs. comparison, Shiprock, New Mexico, Navajo Nation, 2017-2019, full sample
Ever introduced sugar-sweetened beverage 9 months old High
0.08 Not statistically significant, p= 0.67 128 children Family Spirit Nurture vs. comparison, Shiprock, New Mexico, Navajo Nation, 2017-2019, full sample
Ever introduced sugar-sweetened beverage 12 months old High
0.14 Not statistically significant, p= 0.34 128 children Family Spirit Nurture vs. comparison, Shiprock, New Mexico, Navajo Nation, 2017-2019, full sample
Infant sugar-sweetened beverage consumption, cups per week 12 months old High
1.01 Statistically significant, p< 0.01 122 children Family Spirit Nurture vs. comparison, Shiprock, New Mexico, Navajo Nation, 2017-2019, full sample
Introduced complementary food at 6 months postpartum or later 12 months old High
0.48 Statistically significant, p= 0.04 126 children Family Spirit Nurture vs. comparison, Shiprock, New Mexico, Navajo Nation, 2017-2019, 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.

American Indian or Alaska Native
100%

Maternal Education

Less than a high school diploma
16%
Some college or Associate's degree
49%
Unknown
35%

Other Characteristics

Indigenous population
100%
Enrollment in means-tested programs
74%

This study included participants from the following locations:

  • New Mexico
Study Participants
  • Study participants were Navajo mothers ages 13 and older who had infants younger than 14 weeks. Researchers recruited participants through a pediatric clinic, the local Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), and word of mouth. 
  • After the baseline assessment, 134 mothers were randomly assigned to the intervention group (68 mothers) or the comparison group (66 mothers). 
  • Outcomes were measured starting at six months postpartum and ending at 12 months postpartum. 
  • At enrollment, the average age of mothers was 27, and the average age of infants was around 2 months. About 84 percent of mothers were unemployed, and 81 percent were unmarried. In addition, about 35 percent of the families lacked reliable access to safe drinking water.
Setting

The study took place in Shiprock, New Mexico, on the Navajo Nation.

Intervention condition
Comparison Conditions
  • Families in the comparison group did not receive Family Spirit. Instead, they received three lessons at three, four, and five months after birth on injury prevention, including childproofing, safe travel with an infant, and preventing abuse and neglect. 
  • All families in both groups also received deliveries of safe drinking water for a period lasting from six to nine months after birth.
Author Affiliation

Most authors were affiliated with the Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland, where Family Spirit Nurture was developed.

Funding Sources

This research was supported by Healthy Eating Research, a national program of the Robert Wood Johnson Foundation (grant 74132); the Navajo Area Indian Health Service (grants HHSI245201501072P and HHSI245201801201P); the Osprey Foundation (grant 132271); the McCune Charitable Foundation; and a private donor.

Study design characteristics contributing to rating
Design Random assignment compromised? Attrition Baseline equivalence Confounding factors? Valid, reliable measures?
Randomized controlled trial No Low

Not assessed for randomized controlled trials with low attrition

No

Yes

Notes from the review of this manuscript

Findings on infant body mass index (BMI) at ages 6, 9, and 12 months were not eligible for review because HomVEE does not review BMI outcomes measured before age 24 months. Findings on responsive feeding at ages 6, 9, and 12 months received a low rating because the measure did not meet HomVEE’s reliability standards. The internal consistency values reported for those time points were below HomVEE’s minimum threshold. Findings on infants’ sugar-sweetened drink intake at ages 6 and 9 months also received a low rating because they had high attrition and did not meet the baseline equivalence requirement. Information on measure reliability and baseline equivalence was obtained through correspondence with one of the study authors.