Project Summary
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
Health literacy refers to patients’ ability to understand basic health information to make health decisions. Parents with low health literacy may have trouble learning steps to promote healthy weight gain in their babies and prevent childhood obesity. For example, parents may not know the benefits of breastfeeding, how to mix formula correctly, or how to interpret food labels. They may not know that gaining too much weight quickly as a baby can cause health problems later in life.
In this study, the research team is comparing two ways to promote healthy weight gain and help prevent obesity. The first way is a program called Greenlight. Greenlight targets parents with low health literacy but is designed to help families of all literacy levels. At regular office check-ups, doctors trained in the program review health education booklets with parents. The booklets focus on breastfeeding, diet, physical activity, and parenting. Doctors help parents set goals around these behaviors.
The second way is called Greenlight Plus. In Greenlight Plus, parents receive the Greenlight program plus information to reinforce healthy behaviors between doctor visits. For example, parents get access to the Greenlight website and regular text messages on setting and reaching behavior goals that promote healthy weight gain for babies.
Who can this research help?
Results may help clinics when considering ways to help parents raise healthy children.
What is the research team doing?
The research team is recruiting 900 English- and Spanish-speaking parent-infant pairs from six primary care clinics. The team is assigning the pairs by chance to receive either Greenlight or Greenlight Plus for two years. At the start of the study and throughout the child’s first two years of life, the team is interviewing families and reviewing medical records to see how each baby is growing. The team wants to know how Greenlight and Greenlight Plus compare in promoting healthy weight gain for different groups based on language, race, ethnicity, and health literacy.
Families, clinicians, and experts in health communication helped design the Greenlight program. They are also helping to plan and conduct the study.
Research methods at a glance
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 900 parent-infant dyads |
| Interventions/ Comparators |
|
| Outcomes |
Primary: weight-for-length trajectory Secondary: body mass index z-score trajectory, weight-for-length z-score trajectory, overweight and/or obesity, family-reported beliefs and behaviors, family satisfaction with care, perception of health communication quality |
| Timeframe | 2-year follow-up for primary outcome |
COVID-19-Related Study
Exploring How COVID-19 Affects Families with Low Incomes
Results Summary
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
What was this COVID-19 study about?
The COVID-19 pandemic has had a profound impact on families with low incomes and those who are Black or Hispanic. Learning more about the pandemic’s effects on families may help with plans for recovery.
In this study, the research team interviewed and surveyed parents with infants up to age 2 about their experiences at two time points:
- Before COVID-19 vaccines became available, from July to September 2020
- After vaccines became available to adults, from December 2020 to February 2021
What were the results?
July–September 2020. Parents said they felt afraid and socially isolated due to trying to protect their infants from COVID-19. Parents with older children said their normal routines were disrupted. But 86 percent of parents responded that the pandemic made it “a lot” or “a little” easier to care for their infants.
Parents reported using less in-person health care due to fear of COVID-19. Some parents found telehealth convenient. Others said that not having a physical exam resulted in worse care.
Parents said they didn’t know which sources of COVID-19 information they could trust. Spanish-speaking families reported problems accessing virtual school for their children and support programs like Medicaid or food stamps.
December 2020–February 2021. When asked about the COVID-19 vaccine:
- 58 percent of parents said they received it or planned to get it.
- 16 percent didn’t plan to get it.
- 26 percent weren’t sure.
When asked about plans to vaccinate their children:
- 34 percent planned to vaccinate.
- 14 percent didn’t plan to vaccinate.
- 44 percent weren’t sure.
Some parents felt that the COVID-19 vaccine was safe and effective. They also saw the benefits of the vaccine like getting back to normal life and protecting others. Other parents didn’t trust the vaccine and how safe it would be for children. Parents who had severe illness or loss from COVID-19 strongly supported the vaccine.
What did the research team do?
The research team interviewed and surveyed two groups of parents of infants up to age 2 by Zoom or telephone in English or Spanish. Parents were part of an ongoing study at six locations in five states across the United States.
The first group included 72 parents. Of these, 46 percent were Hispanic, 21 percent were non-Hispanic Black, and 19 percent were non-Hispanic White. The average age was 29.
The second group included a separate set 50 parents. Of these, 64 percent were Hispanic, 16 percent were non-Hispanic White, 14 percent were non-Hispanic Black, and 6 percent marked race as other. The average age was 32. Almost all parents in both groups were mothers. Nearly half of parents had yearly household incomes below $35,000.
Families, doctors, and community members gave input throughout the study.
What were the limits of the study?
The research team couldn’t look at differences between racial and ethnic groups because of the small number of people in the study.
How can people use the results?
Health systems can consider the results when planning care for young families with low incomes and those who are Black or Hispanic.
Professional Abstract
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
Background
In the United States, the COVID-19 pandemic has disproportionally affected families with low incomes and those who are Black or Hispanic. Characterizing the full impact of the pandemic and developing strategies for recovery requires understanding its effects on multiple aspects of family health and healthcare access.
Objective
To learn how the COVID-19 pandemic has changed social, emotional, and healthcare needs among families with low incomes and those who are Black or Hispanic
Study Design
| Design Element | Description |
|---|---|
| Design | Survey, in-depth interviews |
| Population | 72 adult parents of infants ages 0–2 years (wave 1), 50 adult parents of infants ages 0–2 years (wave 2); families were participants in a randomized controlled trial about early childhood obesity in North Carolina, New York, Florida, California, and Tennessee |
| Outcomes | COVID-19 exposure and impact on families’ health behaviors, healthcare access, and beliefs about COVID-19 vaccination |
| Data Collection Timeframe | July–September 2020 (wave 1), December 2020–February 2021 (wave 2) |
This mixed-methods study examined how the COVID-19 pandemic affected parents enrolled in an ongoing randomized controlled trial at six sites in five states.
Researchers interviewed and surveyed parents via Zoom or telephone in English or Spanish in two waves. The first wave occurred before COVID-19 vaccines became available and included 72 parents. The second wave occurred after and included a separate set of 50 parents. Parents answered questions about the impact of COVID-19 on their families and their vaccination beliefs.
Among wave 1 parents, 46% were Hispanic, 21% were non-Hispanic Black, and 19% were non-Hispanic White. The average age was 29, and 99% were female. Among wave 2 parents, 64% were Hispanic, 16% were non-Hispanic White, 14% were non-Hispanic Black; 6% marked race as other. The average age was 32, and 98% were female. Also, 43% of parents in wave 1 and 48% in wave 2 reported annual household incomes below $35,000.
Families, clinicians, and community members provided input throughout the study.
Results
Wave 1. Parents reported heightened fear and social isolation because of efforts to protect their infants from COVID-19. Many parents also had older children and reported high levels of disruption to normal routines. However, 86% of parents indicated that the pandemic made it “a lot” or “a little” easier to care for their infants.
Parents reported using less in-person health care due to fear of COVID-19 exposure. Parents’ experiences of telehealth varied. Some found it convenient; others felt that a lack of physical examination led to inferior care.
Parents reported difficulty knowing which sources of information about COVID-19 were trustworthy. Spanish-speaking families reported challenges accessing government safety-net programs and online platforms to support virtual school for their children.
Wave 2. When asked about the COVID-19 vaccine, 58% of parents had received or planned to receive it, 16% did not plan to, and 26% were undecided. Also, 34% planned to vaccinate their children, 14% did not, and 44% were undecided. Some parents were confident in the COVID-19 vaccine’s efficacy, safety, and perceived benefits of returning to normalcy and protecting loved ones. Others expressed distrust in the vaccine’s efficacy and safety and highlighted the lack of clarity about the benefits of the vaccine for children. Parents who experienced severe illness or loss from COVID-19 strongly endorsed the vaccine.
Limitations
Because of the limited sample size, the research team could not compare differences between racial or ethnic groups.
Conclusions and Relevance
This study identified ways that COVID-19 has affected parents of infants including social and emotional challenges and changes in healthcare use, needs, and access.
Peer Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers asked for more detail about how patients and other stakeholders contributed to elements of the study. The researchers added text in the section on patient and stakeholder engagement describing how patients were involved in the study and how stakeholders were identified and recruited to participate.
- Reviewers noted that the study completed three waves of data collection, but results were only included for waves 1 and 2. The researchers revised their report to explain that they did not have time to include wave 3 results in this report.
- The reviewers requested that the researchers explain the larger study which encompassed this COVID-19-specific work. The researchers added information describing the Greenlight Plus Trial, which had not yet concluded.
Final Enhancement Report
View this COVID-19 study's final enhancement report.
DOI - Digital Object Identifier: 10.25302/01.2023.AD.2018C111238_C19
Journal Citations
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Conflict of Interest Disclosures
Project Information
Key Dates
Study Registration Information
^Russell Rothman, MD, MPA was the original Principal Investigator on the project.