NHLBI Supporting Statement A

The major modifiable risk factors for cardiovascular disease (CVD)—overweight/obesity, high blood cholesterol, high blood pressure, diabetes, and physical inactivity—once considered only threats to adults, are being seen in rising numbers among US children. The evidence is clear that cardiovascular health (CVH) promotion begins with practices learned early by children, and that CVD in adulthood relates directly to the presence of these and other risk factors—even in the first decade of life.

In 2009, the National Heart, Lung, and Blood Institute (NHLBI) will publish the first clinical guidelines for physicians to address the known CVD risk factors as part of routine pediatric care. Coinciding with the release of the Integrated Pediatric Cardiovascular Risk Reduction Guidelines (Pediatric Guidelines), NHLBI will conduct a national public awareness campaign targeted to parents to help them understand that risk for CVD begins in childhood, and to encourage healthy habits in their children to promote CV health and reduce their children’s CVD risk now and as they grow.

Currently, little is known about parental knowledge, attitudes, and behaviors related to heart health in children – the research question that the NHLBI seeks to answer as a result of the proposed study and the subject of this request for Office of Management and Budget (OMB) clearance. Some research with parents has been done about individual CVD risk factors or about general health behaviors, but little research exits about awareness or knowledge among parents of cardiovascular health in children. For example, a study released in 2008 by the University of Michigan reveals that obesity is the number one health concern of parents. But it is not heart disease that parents worry about as obesity’s major consequence; it is bullying, indicating that some parents may not connect obesity with heart disease. At the same time, most parents believe they are doing the right thing to keep their children healthy and try to do so, but barriers such as lack of time, motivation, and money keep them from following through. A 2005 Yankelovich Youth Monitor study reveals that 90% of parents say they know families should eat healthy and exercise regularly, but only 50% do these things.

The NHLBI’s objectives are to increase number of parents who know that CVD risk begins in childhood and that risk prevention should start early in life; increase the number of parents who know how to promote children’s heart health; and increase the number of parents who know the risk factors for CVD, and how to recognize and reduce risk factors in children when present. Serving as a baseline for evaluation of NHLBI’s outreach activities related to these objectives, the proposed data collection will elucidate how much parents are thinking about this health issue, their level of knowledge and efficacy related to their children’s heart health, and what they currently are doing to promote their children’s cardiovascular health. As a result of the research, NHLBI will be better able to determine what information and support the campaign can provide to parents to help them take action on their children’s cardiovascular health.

This project is authorized under US Code Title 42, Chapter 6a, Subchapter III, Part C, Subpart 2 § 285b-2, National Heart, Lung, and Blood Institute Information and Education.

A.2. Purpose and Use of the Information

The NHLBI, as demonstrated by the attached survey (Attachment 1), seeks to learn the following through this study proposal: a) parents’ awareness of cardiovascular disease risk factors in children and knowledge of what to do for risk reduction, b) parents’ level of efficacy toward taking action to promote cardiovascular health and reduce risk factors, and c) parents’ behaviors related to cardiovascular health. The Program will use the information for planning (development of content/messages, materials, and partnerships) and evaluation. Results of the information collection will enable NHLBI to identify the gaps in knowledge and awareness and target specific information in communications with parents. NHLBI will also be able to determine parents’ efficacy related to the actions needed to promote their children’s heart health, allocating resources for the campaign to provide support to overcome perceived barriers. Without this information, NHLBI risks the possibility of inefficiently and ineffectively implementing outreach activities.

A.3. Use of Information Technology and Burden Reduction

In order to maximize efficiency and reduce burden, NHLBI proposes conducting a quantitative on-line survey among the key target audience for this campaign—parents/caregivers of children ages 0-7 (see Attachment 1 for the sample survey). Completed at a secure Web site, the survey will be structured for easy respondent use, allowing the automatic administration of skip patterns while maintaining a simple, seamless navigation. The use of a Web-based survey offers many advantages, including:

All responses are automatically recorded, allowing for rapid tabulation and analysis of findings.
Online surveys create time and cost efficiencies because respondents complete them during a much shorter window of time than other survey methods, and at a substantially reduced cost (e.g., less labor is involved than in the case of telephone or in-person surveys, and because no postage is required as would be the case for mail-based surveys).
Online surveys allow for a great deal of geographic and regional diversity.
Parents with younger children are more likely to agree to an on-line survey, which can be taken at their convenience and in a setting where they feel comfortable and at ease (e.g., at home).
In many cases, respondents do not have to travel or make an extra trip to a specific location, such as a focus group facility, in order to participate in the research.

The on-line methodology is a more effective way to reach the target audience for this study and will provide NHLBI with the rapid, rich, and detailed feedback from a geographically diverse sample of parents that the campaign needs to implement effective outreach. In addition, we will be able to effectively reach lower-income families; according to 2007 Census data, families with a household income of $30-50K have Internet penetration of 77 percent.

A Privacy Impact Assessment will be conducted on the database that will collect the respondent information.

A.4. Efforts to Identify Duplication and Use of Similar Information

The NHLBI has taken steps to ensure that the proposed data collection does not duplicate ongoing efforts and that no existing data sets would address the proposed study questions. NHLBI has searched existing Federal health studies (e.g., NHANES, BRFSS), studies from other prominent research institutions (e.g., Kaiser Family Foundation), and other government agencies that focus on this topic (e.g., National Institute on Child Health and Human Development) to confirm that information on parental awareness and knowledge of pediatric cardiovascular risk is not being collected currently.

NHLBI completed a comprehensive review of the literature by examining several large periodical journal databases as well as specific journals. The following search terms were used: pediatric cardiovascular health, child heart health, cardiovascular disease risk factors in childhood, awareness of cardiovascular risk in children, preventing heart disease early, heart healthy habits for children, caregiver awareness of pediatric heart disease risk factors, awareness studies on pediatric heart health, mother awareness of heart healthy behavior in children, child obesity awareness, and heart disease risk factors in children. Searches were also performed on several Internet search engines, including Google, Yahoo, and High Beam Research. Marketing databases that provide information on parental opinions and beliefs were also examined for relevant/related information. These include Yankelovich, Roper, and Mediamark Research & Intelligence.

NHLBI conducted a comprehensive audience analysis of parents of children ages 0-7 that synthesized publicly available data, research, and trend reports to profile this parent audience in terms of: demographics; knowledge, attitudes, and behaviors; lifestyle and psychographic factors; and communications channels and media use. While research on related topics, such as parental awareness of a child’s overweight status exists, none of the existing literature spoke to the topic of parental knowledge and awareness of pediatric cardiovascular risk or contained specific measures of parents’ behaviors related to these risks. The existing research does not adequately answer the questions this study seeks to answer.

A.5. Impact on Small Businesses or Other Small Entities

The information collection does not impact small businesses or other small entities.

A.6. Consequences of Not Collecting the Information or Collecting Less Frequently

The proposed information collection is necessary for the NHLBI to identify gaps in parental knowledge and awareness about pediatric cardiovascular risk in order to determine the specific information that needs to be communicated through NHLBI’s awareness campaign. In addition, the NHLBI will need to determine parents’ efficacy related to the actions needed to promote their children’s heart health. Without this critical information, the NHLBI risks wasting government funds on what is hypothesized about parents’ knowledge and efficacy related to cardiovascular health versus what data shows are the core barriers that our messages need to overcome. A baseline measure using a quantitative national sample is necessary to help NHLBI efficiently and effectively implement outreach activities on a national level.

Additionally at a later point, the NHLBI will be submitting for OMB clearance to conduct a follow-up study using the same survey instrument with a similar national sample to evaluate campaign results.

There are no legal obstacles to reduce the burden.

A.7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

The NHLBI is not requesting the OMB to consider any special circumstances or offer special permission to conduct the information collection in a manner considered unfavorable by the OMB. The proposed project fully complies with all guidelines of 5 CFR 1320.5.

A.8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside Agency

The 60-day Notice to solicit public comments was published in the Federal Register (Volume 74, Number 144; Wednesday, July 29, 2009). There were no public comments received in response to the 60-day Federal Register Notice.

The NHLBI consulted with several individuals outside the agency regarding the proposed information collection. They include the following campaign staff, research partners, and parent/youth research experts:

Patricia Eitel Taylor, Ph.D., Ogilvy Public Relations Worldwide

202-729-4271; [email protected]

Jennifer Wayman, M.H.S., Ogilvy Public Relations Worldwide

202-729-4161; [email protected]

Karen Goldstein, M.P.H., Ogilvy Public Relations Worldwide

202-729-4174, [email protected]

Jennifer Scott, Ph.D., Ogilvy Public Relations Worldwide

212-880-5260; [email protected]

Heidi D’Agostino, Ogilvy Public Relations Worldwide

212-880-5248; Heidi.D’[email protected]

Rachel Geller, Geppetto Group

212-462-8142; [email protected]

Dana Ewing, Geppetto Group

212-462-8124; [email protected]

Michael J. Fassino, Ph.D., NODE Research

484-433-7675; [email protected]

These individuals will be consulted with, as needed, during the study period.

The NHLBI also consulted six parents about the types of information to be collected and the proposed data collection methods.

A.9. Explanation of Any Payment or Gift to Respondents

The NHLBI will not provide payment or gift incentives to respondents, as the time required to complete the information collection is relatively short.

A.10. Assurance of Confidentiality Provided to Respondents

The NHLBI will not be collecting personal, identifiable information and does not plan to match information collection responses to a particular person/respondent. The survey vendor, NODE Research, recognizes and protects the privacy of their panel members. Its registration databases that contain personally identifiable information (physical mailing addresses, phone numbers, etc.) are housed on computers not connected to the Internet and which can only be accessed by Node personnel with appropriate security credentials. Each respondent is assigned a unique panel identification number that is used to take the survey. NHLBI will not have access to this information.

Similar to language recommended by the OMB, the NHLBI intends to use the following language in the information collection survey instrument: “Your answers will not be disclosed to anyone but the researchers conducting this study.”

NHLBI will indicate that participation in the information collection is voluntary.

The NIH Privacy Act Officer reviewed the survey and determined that the Privacy Act does apply to this data collection. The data collection is covered by NIH Privacy Act Systems of Record 09-25-0156, “Records of Participants in Programs and Respondents in Surveys Used to Evaluate Programs of the Public Health Service, HHS/PHS/NIH/OD. See Attachment 2 for the memo outlining the applicability of the Privacy Act.

A.11. Justification for Sensitive Questions

The nature of this information collection is such that it does not require the respondent to disclose sensitive or personal information.

A.12. Estimates of Hour Burden Including Annualized Hourly Costs

Table 1 presents the estimated annual hour burden of this collection of information (196.23 hours). This burden was estimated by multiplying the number of expected respondents (1,175), by the frequency of response (1.0), by the annual hour burden (the number of minutes it takes a person to complete an information collection—.167 hours [10 minutes]). Time to complete the survey includes time needed to complete the screener, read the survey questions, and select an answer.

The estimated burden for the proposed information collection is based on Ogilvy and NHLBI staff experience and expertise, as well as on internal screener and survey instrument pretests conducted by Ogilvy with less than nine individuals.

TABLE 1 ESTIMATES OF HOUR BURDEN

Type of

Respondents

Number of

Respondents

Frequency of

Response

Average

Time per

Response

Annual Hour

Burden

Parents of children ages 0 to 7

1,175

.167

hours

(10 minutes)

196.23

Table 2 presents the annualized cost to respondents based on the most current available average U.S. hourly wage rate ($18.49), as published by the Bureau of Labor Statistics (DOL, 2009). The total estimated cost to each respondent is $3.09, with an overall annualized cost to respondents of $3,628.20 (see Table 2). This overall annualized cost was estimated by multiplying the number of respondents (1,175), by the frequency of response (1.0), by the average time per response (.167 hours), by the average hourly wage in the U.S. ($18.49).

TABLE 2 ANNUALIZED COST TO RESPONDENTS

Type of

Respondents

Number of

Respondents

Frequency of

Response

Hourly Wage Rate

Respondent

Cost

(for .167 hours)

Parents of children ages 0 to 7

1,175

$18.49

$3.09

Total . . . . . .

$3,628.20

A.13. Estimate of Other Total Annual Cost Burden to Respondents or Recordkeepers

Respondents will not incur capital, start-up, operational, or maintenance costs as a result of participation in this information collection. Respondents should be able to answer all questions without referring to their records and do not need any type of special equipment or processes to complete this information collection.

A.14. Annualized Cost to the Federal Government

The annualized cost to the Federal government is $29,988. The project will be completed in less than one year. Cost estimates cover the development, deployment, data collection, and analysis of the initial survey, including:

Development of the survey instrument for which clearance is requested
Development of screener requirements for survey
Deployment of the survey using NODE Research, and management of survey implementation
Data analysis and reporting
Creation of a final written summary report for NHLBI and for posting on the website

A.15. Explanation for Program Changes or Adjustments

The proposed study is a new project; program changes or adjustments are not needed for this information collection.

A.16. Plans for Tabulation and Publication and Project Time Schedule

The research will be primarily limited to data collection for program improvement purposes. It will also serve as a baseline level of knowledge and awareness that can be compared to a future follow-up survey to determine the effectiveness of campaign efforts.

The NHLBI intends to report the information collection results to stakeholders and the public via the campaign Website, and will look to prepare a paper for publication in a scholarly journal, either after this round of data collection and/or after the proposed follow-up study will be submitted for OMB clearance at a later date. The estimated project timeline is as follows (see Table 3):

TABLE 3 PROJECT TIME SCHEDULE
Activity	Time Schedule
Begin data collection.	1 week after OMB approval
Finish data collection.	3 weeks after OMB approval
Data analysis & reporting	4-5 weeks after OMB approval
Begin using results for program planning and implementation.	6 weeks after OMB approval

Analysis Plan

Under the guidance and direction of NHLBI, Ogilvy will conduct quantitative analyses of the data collected. Given that the purpose of the proposed research is to gather feedback to quickly assess the communications messages needed for the target audience, only top line reports outlining major themes will be prepared as the data are collected.

For this effort, responses to each survey question will be tallied. NHLBI, along with Ogilvy, Geppetto, and NODE Research, will then determine the final survey research findings through the following steps:

Step 1: Analysis of Quantitative Data

Examination of Data: Researchers will examine the data collected in response to the quantitative (close-ended) questions in the surveys. We will compute simple descriptive statistics for the data collected from each question on the survey (e.g., mean, median, mode, frequency of each response), reviewing the total number of responses received for each question. Researchers also will examine findings across segments of the target audience, including African Americans, Hispanics, and lower-income parents, and conduct basic statistical analysis to explore differences between these segments.

Step 2: Analysis of Qualitative Data

While the majority of data collected via the online surveys will be quantitative, some open-ended questions will be included as well to collect qualitative data. These questions, such as listing the name of campaigns related to children’s heart health, are fairly simple and do not require lengthy responses. The open-ended data will be coded and categorized and treated as categorized values.

Step 3: Integration of Quantitative and Qualitative Findings and Themes

Researchers will review both sets of data to identify areas of agreement and conflict between the two sets. Given the limited qualitative measures in the study, our focus will be on comparing aided and unaided knowledge.

A.17. Reason(s) Display of OMB Expiration Date is Inappropriate

The NHLBI intends to display the OMB approval expiration date in the upper right hand corner of the electronic survey tool. The information collection control number also will be displayed.

A.18. Exceptions to Certification for Paperwork Reduction Act Submissions

The NHLBI intends to meet all certification requirements and is, therefore, not seeking exception to any part of the Certification for Paperwork Reduction Act Submission.

File Type	application/vnd.openxmlformats-officedocument.wordprocessingml.document
File Title	Supporting Statement
Author	TollK
File Modified	0000-00-00
File Created	2021-02-03

NHLBI Supporting Statement A