Supporting Statement A

Information Collection Request

Increase Enrollment in the CDC-Recognized Lifestyle Change Program

Generic Information Collection (0920-1154)

Supporting Statement Part A

March 3, 2018

Program Official/Project Officer

Robin Soler, Project Director

Division of Diabetes Translation

Buford Highway, NE, Mailstop F-75

770-488-5103

[email protected]

TABLE OF CONTENTS

A. JUSTIFICATION

1. Circumstances Making the Collection of Information Necessary

2. Purpose and Use of Information Collection

3. Use of Improved Information Technology and Burden Reduction

4. Efforts to Identify Duplication and Use of Similar Information

5. Impact on Small Businesses or Other Small Entities

6. Consequences of Collecting the Information Less Frequently

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

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

9. Explanation of Any Payment or Gift to Respondents 10. Protection of the Privacy and Confidentiality of Information Provided by Respondents

11. Institutional Review Board (IRB) and Justification for Sensitive Questions

12. Estimates of Annualized Burden Hours and Costs

13. Estimates of Other Total Annual Cost Burden to Respondents and Record Keepers

14. Annualized Cost to the Federal Government

15. Explanation for Program Changes or Adjustments

16. Plans for Tabulation and Publication and Project Time Schedule

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

18. Exceptions to Certification for Paperwork Reduction Act Submissions

REFERENCES

ATTACHMENTS

1. Pre-Session Survey

2. Post-Session Survey

3. Enrollment Materials & Referral Tracking Form

4. LCP Staff Interview Guide

5. Information Session Observation Tool

6. LCP Staff Interview Informed Consent

7. ABT IRB Approval Memo

• Goal of the study: To determine whether evaluation tools developed for a behaviorally-focused intervention, known as Be Your Best, are sensitive enough to detect mindset change among those receiving the intervention, when compared with those not receiving the intervention. The main objective of this information collection request is to pilot test a set of evaluation tools.

• Intended use of the resulting data: Improve evaluation tools to detect mindset change as a result of the pilot intervention and make necessary updates to the Be Your Best intervention implementation guide. CDC will share the final implementation guide (including updated evaluation tools) broadly with partners and stakeholders for future large scale implementation and evaluation of the intervention.

• The subpopulation to be studied: Twelve sites that are currently implementing the National Diabetes Prevention Program’s lifestyle change program (LCP), of which six sites will pilot test the behaviorally-focused enrollment intervention (Be Your Best) activities and six sites will continue their existing (non-intervention) LCP enrollment activities; respondents include LCP attendees and staff members.

• Methods to be used to collect: Two surveys will be conducted at the LCP sites to assess mindset change with up to 360 potential attendees: a Pre-Session Survey and a Post-Session Survey. Additional data on enrollment strategies will be collected from LCP personnel to determine the sensitivity of the surveys. We will use the following tools to gather this information: Enrollment Materials & Referral Tracking Form, Information Session Observation Tool, and LCP Staff Interview Guide.

• How data will be analyzed: Quantitative pilot data will be assessed using descriptive statistics and chi-square or t-tests to assess mindset change from the Pre-Session Survey to the Post-Session Survey and to examine differences by exposure to the pilot intervention. Qualitative and quantitative data from the additional data collection tools will be analyzed to develop an initial implementation profile for each site; this information will be compared with survey data to determine if survey observations are justified and whether the attendee surveys were sensitive enough to detect change among those receiving the pilot intervention.

1. Justification

This statement supports a request to conduct formative research to assess the sensitivity of evaluation tools designed to measure mindset change¹ among individuals exposed to a behaviorally-focused² pilot intervention aimed at increasing enrollment into Centers for Disease Control and Prevention (CDC)-recognized lifestyle change program (LCP) offered through the National Diabetes Prevention Program (National DPP). This pilot enrollment intervention, known as Be Your Best, relies on a behavioral economics approach and focuses on the social and psychological motivations that influence decision making, particularly those that may lead to lifestyle or behavior change. The three main components of the enrollment intervention include (1) a behaviorally-focused information session (non-intervention sites also conduct information sessions of their own)³, (2) optimized⁴ enrollment materials and (3) social referral activities.

Behaviorally-focused Information Session: This component is a 90-minute introductory session that utilizes a series of behaviorally-focused strategies (such as self-affirmation activities) that empower and encourage attendees to enroll in the LCP. This session occurs prior to the first session of a LCP.

Optimized enrollment materials: These materials are different from standard LCP enrollment materials in that they have been optimized utilizing a variety of evidence-based, behavioral tactics such as including an element of personal relevance in the messaging. The content also includes information about the risk of developing type 2 diabetes and information about attending an Information Session.

Social referral activities: This component involves asking past or current LCP attendees to refer friends, colleagues, or family members who may be at risk for type 2 diabetes and would benefit from participating in a LCP. Social referrals require the use of optimized materials described above.

The CDC’s Division of Diabetes Translation (DDT), in collaboration with its contractors, developed the Be Your Best intervention which will be packaged as an implementation guide, to be shared with CDC partners and stakeholders. The evaluation tools that we are testing as part of this information collection request will also be offered as supplemental materials to interested partners and stakeholders. Because no tools measuring mindset change for the Be Your Best intervention exist, we are requesting approval to pilot test two brief surveys that we will use to determine mindset change in attendees at pilot intervention and non-intervention sites: 1) Pre-Session Survey (Attachment 1) and 2) Post-Session Survey (Attachment 2). A site may already utilize some elements of behaviorally-focused strategies in their enrollment activities. Therefore, we will also assess the sensitivity of these surveys to measure mindset change in both intervention and non-intervention sites by documenting enrollment activities at all sites. This documentation will occur though the collection of the: 3) Enrollment Materials & Referral Tracking Form (Attachment 3), 4) LCP Staff Interview Guide (Attachment 4), and 5) Information Session Observation Tool (Attachment 5). This formative research will allow CDC to develop materials that can be used for future large-scale implementation and evaluation of the Be Your Best enrollment intervention that can examine if such behaviorally-focused strategies (i.e., those that promote health decisions and behavior) are effective at increasing enrollment into LCPs.

A.1 Circumstances Making the Collection of Information Necessary

CDC is seeking approval for a new generic information collection request, Increase Enrollment in the CDC-Recognized Lifestyle Change Program (LCP. This information collection involves formative research to assess the sensitivity of evaluation tools designed to measure mindset change among individuals exposed to a behaviorally-focused enrollment intervention (Be Your Best) aimed at increasing enrollment into the LCP offered through the National DPP. The Be Your Best enrollment intervention has been developed by the CDC’s DDT and will be packaged as an implementation guide (including optional evaluation tools) to be shared with CDC partners and stakeholders. As CDC seeks to pilot the implementation guide over the coming year, it is critical that we also conduct formative research to test the evaluation tools that will accompany the implementation guide.

Our formative research uses a mixed methods approach including surveys, observations, implementation tracking, and interviews among a total of twelve sites with six sites piloting the Be Your Best intervention and six sites continuing to use their existing LCP enrollment activities. The main objective of this information collection request is to pilot test our evaluation tools.

This information collection request is authorized by the Public Health Service Act, Section 301 (42 U.S.C.241) (Attachment 1).

Diabetes

Type 2 diabetes is one of the largest health challenges affecting adults in the United States (U.S.). Data from CDC indicate that 30.3 million people have diabetes and another 84.1 million adults have prediabetes⁵ (CDC 2017). In addition, diabetes-related direct and indirect medical costs were estimated at $245 billion in 2012 (CDC 2017). Without proper intervention, one third of US adults will have diabetes by 2050 resulting in a large impact to population health and medical expenses.

Research has shown that type 2 diabetes can be delayed or prevented, particularly through structured LCPs focused on weight loss, healthy eating, at least 150 minutes of physical activity each week and use of problem-solving/coping strategies. Knowler et al. (2002) found that the National Diabetes Prevention Program’s LCP which emphasizes these health behaviors can reduce risk for type 2 diabetes by approximately 60% in people with prediabetes (Knowler et al. 2002). Further, economic studies indicate that research-based LCPs offered in the community with an average cost of $400 per person are cost effective and could result in reduced future medical costs (Ali et al. 2012; The Community Guide 2014).

CDC’s DDT understands the urgent need for addressing the increasing numbers of U.S. adults at risk for type 2 diabetes and the promise of LCPs in reducing the preventable burden of type 2 diabetes. The Division has addressed diabetes prevention through initiatives such as the National DPP. The foundation of the National DPP is a results-driven alliance that includes community-based organizations, health insurers, employers, health care systems, academia, and government agencies and includes four core elements: training, recognition program, intervention/LCP sites, and health marketing.

Despite the potential for an LCP such as the National DPP to positively impact health outcomes, program enrollment falls short of expectation. Significant work remains in increasing the uptake of LCP enrollment and participation. While some enrollment challenges are due to structural barriers, others can be addressed by better understanding and intervening on bottlenecks to enrollment and participation that are behaviorally-based, such as misperception of risk, commitment, and cost, and lack of urgency.

Be Your Best Enrollment Intervention

To address the barriers known to impact LCP enrollment, CDC has developed a behaviorally-focused intervention and supporting materials that have the potential to drive enrollment into LCPs and ultimately reduce the burden of type 2 diabetes nationally. The Be Your Best enrollment intervention was developed as a result of receiving feedback from several stakeholders including LCP staff and attendees, DDT subject matter experts, and national experts. The theoretical foundation of the design relies on tenets of a behavioral economic approach, which specifically focuses on human behavior and social and psychological motivations that influence decisions and lead to lifestyle or behavioral changes. As part of the intervention development, CDC has created an implementation guide that will be packaged for partners and stakeholders and will include step-by-step instructions for implementing each component of the enrollment intervention. The package will also include evaluation data collection tools. Because no tools to assess mindset change for a behaviorally-focused intervention to increase enrollment in the National DPP LCP currently exist, we seek to conduct formative research to develop these tools for the Be Your Best implementation guide.

The specific aims of the formative research are to:

• Develop behaviorally-informed tools (Be Your Best), which demonstrate a positive effect on the enrollment rates into the participating site’s National DPP LCP

• Pilot these behaviorally-informed tools with both sites piloting the Be Your Best intervention and sites continuing to use their existing enrollment activities

• Determine if the evaluation tools developed for the enrollment intervention are sensitive enough to detect mindset change

Beyond these specific aims, the formative research will also allow CDC to determine what changes to make to the Be Your Best intervention and implementation guide and/or evaluation tools before finalizing and preparing for broad distribution.

Tool Development Process

To develop the Pre-Session and Post-Session Survey tools, we have adopted the process outlined by Haynes & O’Brien (2000) that provides step-by-step guidance to ensure content validity during instrument development. Exhibit 1 below provides additional detail on this process and the status of tool development activities to date.

Exhibit 1: Content Validation Process

Steps	Status
Specify the construct(s) to be measured	Completed
Specify the domains of the construct Specify the facets, dimensions, response modes of the construct
Specify the contexts (settings, situations) for the measures	Completed
Specify the intended functions of the instrument	Completed
Select items (e.g., questionnaire items, individual behavior codes) congruent with decisions in 1-3 above	Completed
Match all other elements to facets, dimensions, response modes and goals	Completed
Examine each item for construction (grammar, reading level, form)	Completed
Establish quantitative parameters of the instrument (e.g., response formats, scales)	Completed
Develop specific and relevant instructions to attendees	Completed
Have multiple experts review all elements of assessment instrument (1-8 above)	Completed
Conduct population review	Completed
Refine elements on the basis of 9 and 10	Completed
Field test Be Your Best implementation guide	To be completed by Mid-March 2018
Pilot test the instrument and gather quantitative data on each element of the instrument	To be completed 2 months after OMB approval

As noted in Exhibit 1, Steps 1-11 have been completed. By mid-March 2018, we anticipate completing the field of the implementation guide (Step 12) with one to two LCP sites (< 9 LCP staff members total). As needed, based on population review and field testing feedback, we will refine the implementation guide and data collection tools (Step 11 and 12). The final step (Step 13) is to pilot test the Pre-Session and Post-Session data collection tools which is the objective of this information request.

2. Purpose and Use of the Information

CDC will use the information collected as the basis for developing and finalizing evaluation tools for the Be Your Best Implementation Guide. Exhibit 2 provides an overview of the formative research data collection tools distributed to LCP attendees at both intervention and non-intervention sites. These tools are the focus of our formative research.

Exhibit 2. Data Collection Tools for Information Session Attendees^*

Information Session Attendees
Tool Name	Content	How it is being administered
Pre-Session Survey	Attendee contact information, how they heard about the Information Session Perceived type 2 diabetes risk Lifestyle/behavior change mindset (e.g., perceived sense of urgency to attend an LCP; Perceived importance of attending an LCP) Intention to participate in a LCP	Lead Session Coach will distribute to attendees at the beginning of each Information Session (intervention and non-intervention) Lead Session Coach will collect survey from attendees once completed (before the session begins)
Post-Session Survey	Perceived type 2 diabetes risk Lifestyle/behavior change mindset (e.g., perceived sense of urgency to attend an LCP; Perceived importance of attending an LCP) Intention to participate in a LCP Main reasons driving the intent among those who intend to sign up for an LCP	Lead Session Coach will distribute to attendees at the end of each Information Session (intervention and non-intervention) Lead Session Coach will collect survey from attendees once completed

* Surveys will be administered to those who attend a LCP delivering the behaviorally-focused Information Session (intervention site) and those who attend a LCP offering their existing Information Session (non-intervention site).

Because a site may already utilize some elements of behaviorally-focused strategies in their enrollment activities, we will also assess the sensitivity of these surveys to measure mindset change in both pilot intervention and non-intervention sites by documenting enrollment activities at all sites. This documentation will be conducted using the tools provided in the Exhibit 3.

Exhibit 3. Data Collection Tools for LCP Sites

Lifestyle Change Program Sites
Tool Name	Content	How it is being administered
Enrollment Materials & Referral Tracking Form	Number and type of enrollment materials distributed as well as the number of healthcare providers with whom materials were shared Number of social referrals received from past/current LCP attendees	Distributed to LCP staff by the CDC contractor at the beginning of the 4 to 6-month observation period (both intervention and non-intervention LCPs) Completed by LCP staff and submitted to CDC contractor at the end of the observation period
LCP Staff Interview Guide	Basic characteristics of the LCP, description of enrollment materials, pilot-testing of Information Sessions	Administered to LCP staff (up to 3 per site) by the CDC contractor during in-person site visits
Information Session Observation Tool*	Description of enrollment materials Description of Information Session activities (e.g., key components/activities, attendee engagement and Session Coach communication style and rapport with attendees).	Completed by CDC contractor during LCP Information Sessions (no burden to sites)

.

Sites will be selected from a pool of organizations that have noted interest and willingness to participate in the pilot study. Primary criteria for selection include full or pending CDC recognition, site LCP enrollment of ≥30 and one or more LCP classes scheduled to begin in late spring or early summer 2018. Because organization are still finalizing 2018 class schedules, we have not confirmed pilot sites; however, the pilot sites will be selected from those appearing in Exhibit 4 below.

Exhibit 4. Pool of Sites Being considered for Be Your Best Pilot

Organization Name	City	State
National Kidney Foundation	Ann Arbor	MI
EmblemHealth Diabetes Prevention Program	New York	NY
Fundamental Health Solutions	Jackson	TN
Soul so Good	District Heights	MD
Legacy Health	Portland	OR
Holland Hospital	Holland	MI
Rhode Island Parent Information Network	Cranston	RI
Skinny Gene Project	San Diego	CA
Potomac Valley Hospital	Keyser	WV
Community health and Nutrition NDSU	Various Cities	ND
Arlington-Mansfield YMCA	Arlington-Mansfield	TX
YMCA Hockomock	North Attleboro	MA
YMCA Nashville	Nashville	TN
Washington County Health Department	Hagerstown	MD
Victory Family YMCA	Yorktown	VA
Suffolk County Department of Health Services	Hauppauge	NY

3. Use of Improved Information Technology and Burden Reduction

As described in Exhibit 2, we will administer paper Pre- and Post-Session Surveys to attendees to ensure data collection is easy and efficient and accurately reflects attendees’ perceptions. For LCP staff interviews, our contractor will audio-record the interview (with permission of interviewees) to ensure responses are captured accurately. Last, we will provide LCP staff with an electronic versions of the Enrollment Materials & Referral Tracking Form.

Across all evaluation tools, we have limited questions and items to those most relevant to the project purpose and objectives to reduce burden on respondents.

3. Efforts to Identify Duplication and Use of Similar Information

This project is the first to develop a novel enrollment intervention and associated evaluation tools to encourage participation in National DPP LCP. Although CDC has evaluated the effectiveness of National DPP LCP, there has been no previous work to date to examine sensitivity of an intervention (Be Your Best) designed to increase the perceived urgency and importance of enrolling in the LCP through mindset change; therefore no evaluation tools exist to detect mindset change in this context. As this is a unique intervention designed specifically for this project, the formative research to develop the evaluation tools related to this enrollment intervention does not duplicate existing or ongoing research.

3. Impact on Small Businesses or Other Small Entities

Testing the evaluation tools will involve up to 48 total staff across 12 National DPP LCP provider sites such as healthcare centers, local health departments, recreation centers, wellness centers or pharmacies, which may qualify as small entities. Participation in the pilot testing of the Be Your Best evaluation tools is voluntary. For National DPP LCP provider sties agreeing to participate, our data collection activities will not have a significant impact on the agencies or organizations because the data collection activities will not produce a high burden on staff and our team will be flexible when scheduling interviews and observations to minimize disruption. The Be Your Best pilot also has the potential added benefit to sites in that it may help them meet the standards needed to be considered a CDC-recognized lifestyle change program.

3. Consequences of Collecting the Information Less Frequently

This is a one-time information collection request.

3. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

There are no special circumstances with this information collection package. This request fully complies with the guidelines in 5 CFR 1320.5 and will be voluntary.

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

This information collection request does not require publication of a 60-day notice in the Federal Register.

CDC has been working with contractors at Abt Associates, FHI 360 and ideas42 on the intervention design and evaluation tools for this formative research study. Additionally, several CDC subject matter experts provided input on the implementation guide and instrument content.

Exhibit 5. External Consultants

Individuals Consulted Outside the Agency
Name	Organization	Contact Information
Cynthia Klein, PhD	Abt Associates	Email: [email protected] Phone: (404) 946-6310
Tara Earl, PhD	Abt Associates	Email: tara_earl@abtassoc.com Phone: (404) 946-6308
Stephanie Frost, PhD	Abt Associates	Email: [email protected] Phone: (404) 946-6379
Lauren Olsho, PhD	Abt Associates	Email: [email protected] Phone: (301) 572-0880
Dave Mills	Abt Associates	Email: [email protected] Phone: (404) 592-2190
Rebecca Ledsky	FHI 360	Email: [email protected] Phone: (919) 544-7040
Jennifer Kreslake, PhD, MPH	FHI 360	Email: [email protected] Phone: (919) 544-7040
Jess Leifer, MPP	ideas42	Email: [email protected] Phone: (646) 330-5700
Matt Darling, MS	ideas42	Email: [email protected] Phone: (646) 330-5700

3. Explanation of Any Payment or Gift to Respondents

Information Session attendees will not receive a monetary gift or other payment for their participation in the Information Session or completing the Pre-Session Survey or Post-Session Survey.

Program staff completing the Enrollment Materials & Referral Tracking Form (e.g., LCP coordinators and/or coaches) and those participating in the interview will not receive a monetary gift or other payment for participation in the data collection activity.

3. Protection of the Privacy and Confidentiality of Information Provided by Respondents

The CDC Human Subjects Advisor has determined that the Privacy Act does not apply to this information collection. Trained LCP staff will administer Pre-Session and Post-session Surveys and will assign attendees a unique user ID. Staff from Abt Associates, CDC’s contractor for this project, will collect the completed surveys directly while conducting site visits. CDC will not have direct contact with attendees or access to personally identifying information (PII). CDC staff may attend site visits along with members of the Abt team but will not participate in any data collection activities.

Trained CDC contractors will conduct interviews with LCP staff. CDC will not participate in the interviews and will not receive data that identifies an individual by name. CDC contractors will assign an ID code for all notes and transcripts to identify the site location. Names will not be included in notes. Information from the interviews will be reported in aggregate and not in a way that makes it possible to identify the staff member participating in the interview.

We will keep all information collected through the formative research activities secure and confidential. CDC contractors will keep paper copies of surveys, interview notes and enrollment activity tracking forms locked cabinets at the contractor’s offices. CDC contractors will also store audio files of interviews and electronic copies of tools on a secure share drive and password-protected computers. Last, CDC contractors will enter data from the Pre- and Post-Session surveys and Enrollment Materials & Referral Tracking Form into an electronic database that will be stored on a password protected computer.

Any data delivered to CDC from the contractor or reports produced will not include PII or identifiable information.

3. Institutional Review Board (IRB) and Justification for Sensitive Questions

Institutional Review Board (IRB)

To ensure the privacy and protection of human subjects participating in this formative research, the data collection protocol and instruments were reviewed and approved through the contractor’s institutional review board (IRB) (Attachment 10). The contractor’s IRB holds a Federal wide Assurance (FWA00000664; Expiration, June 8, 2022) from the HHS Office for Human Research Protections (OHRP). This review ensures compliance of our formative research protocol with HHS regulations.

Justification for Sensitive Questions

All questions asked of LCP staff relate to pilot-testing the Be Your Best intervention or implementation of existing enrollment activities at non-intervention sites and are not sensitive in nature. For information session attendees, survey questions focus on perceptions, intentions, or mindset change with regard to type 2 diabetes and are also not sensitive in nature.

All attendees will be informed that they are not required to answer any question they do not wish to answer. In addition, attendees will be fully informed of safeguards put into place to ensure that their identity will not be shared and that information collected will be kept secure and survey responses confidential.

3. Estimates of Annualized Burden Hours and Costs

Exhibit 6 below describes the burden and costs associated with the information collection, estimates of average burden per response for surveys, the interview guide, and tracking form.

The burden estimates for the Enrollment Materials & Referral Tracking Form include the time to collect information and complete the tool. The burden estimate for the interview guide includes time to review the informed consent (Attachment 6). We estimate up to 768 total respondents (720 Information Session Attendees and up to 48 LCP staff across 12 sites). The Observation Tool has not been included in the burden table because it will be completed by CDC’s contractor and does not introduce a burden to the general public; burden to the contractor is 18 hours (1.5 hours per discovery Session x 12 Information Sessions).

Exhibit 6. Annualized Burden

Type of Respondent	Form Name	No. of Respondents	No. of Responses per Respondent	Average Burden Per Response (minutes)	Total Burden Hours
Information Session Attendee	Pre-Session Survey	360	1	10/60	60
	Post-Session Survey	360	1	10/60	60
LCP Staff	Enrollment Materials & Referral Tracking Form	12	1	15/60	3
	LCP Staff Interview Guide	36	1	75/60	45
Total		768			168

Exhibit 7 below describes the cost burden associated with this information collection. For Information Session attendees, costs were calculated based on the hourly wage rates for “all occupations” from the Bureau of Labor Statistics May 2015 National Occupational Employment and Wage Estimates (BLS, 2015) and from the U.S. Department of Labor Federal Minimum Wage Standards.

The hourly wage rates for LCP staff were calculated by averaging the hourly wages of the different categories of staff who will be participating in the formative research data collection activities.

Exhibit 7. Cost Burden

Type of Respondent	Form Name	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
Information Session Attendee	Attendee Sign-in Sheet & Pre-session Survey	60	$23.23	$1393.80
	Post-Session Survey	60	$23.23	$1393.80
LCP Staff	Enrollment Materials & Referral Tracking Form	3	$43.74	$131.22
	LCP Staff Interview Guide	45	$43.74	$1968.30
Total				$4887.12

13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers

There will be no direct costs to the respondents other than their time to participate in each information collection.

14. Annualized Cost to the Government

The total annualized cost to the government is $19,480. The breakdown of how that estimate was reached is below.

Governmental costs for this project include personnel costs for federal staff involved in the plan and data collection design, development of data collection instruments and OMB materials, data collection and analysis, and reporting. This level of effort includes approximately 25 percent of a GS-14 behavioral scientist’s time a $97,400 annual salary (total $19,480). There are no equipment or overhead costs; however, a contractor is being used to support the development of the instruments, data collection, and data analysis.

15. Explanation for Program Changes or Adjustments

This is a new information collection.

15. Plans for Tabulation and Publication and Project Time Schedule

Data will be analyzed and a report will be developed. Findings may also be included in a peer-reviewed journal article.

Exhibit 8. Project Time Schedule

Activity	Timeframe
Data Collection	2 months after OMB approval
Analysis	6 months after OMB approval
Submit Report	8-9 months after OMB approval

Tabulation

Pre- and Post-Session survey data will be analyzed to assess attendee’s perceived risk of type 2 diabetes and intention to enroll in an LCP as well as other attendee characteristics (being referred to a LCP by a friend, family member or health care provider) and lifestyle-change knowledge, attitudes and beliefs. Differences from Pre- to Post- Information Session will be assessed using t-tests and chi-squares. In addition, we will examine differences in Information Session survey data among pilot intervention (Be Your Best) and non-intervention sites.

Tracking, observation, and pilot intervention data will be combined to develop a profile of each intervention and non-intervention site. Audio-recorded interviews will be transcribed and reviewed to identify themes during the pilot-test. Observation and tracking forms will be coded to assess the extent to which activities align with the Be Your Best Intervention.

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

The expiration date of OMB approval will be displayed on all information collection instruments.

15. Exceptions to the Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification. These activities comply with the requirements in 5 CFR 1320

15. References

Ali MK, Echouffo-Tcheugui J, Williamson DF. How effective were lifestyle interventions in real-world settings that were modeled on the Diabetes Prevention Program? Health Aff (Millwood). 2012 Jan;31(1):67-75.

Boyle JP, Thompson TJ, Gregg EW, Barker LE, Williamson DF. Projection of the year 2050 burden of diabetes in the US adult population: dynamic modeling of incidence, mortality, and prediabetes prevalence. Popul Health Metr 2010 Oct 22;8:29.

Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2017. Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services; 2017.

Haynes S, O’Brien W. (2000). Principles and Practice of Behavioral Assessment. New York, NY: Kluwer Acedemic/Plenum Publishers.

Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403.

National Diabetes Prevention Program and Diabetes Prevention Recognition Program: http://www.cdc.gov/diabetes/prevention/index.htm

Richburg-Hayes L, Anzelone C, Dechausay N, S Datta S, Fiorillo A, Potok L, Darling M, Balz J (2014). Behavioral Economics and Social Policy: Designing Innovative Solutions for Programs Supported by the Administration for Children and Families, Technical Supplement: Commonly Applied Behavioral Interventions. OPRE Report No. 2014-16b. Washington, DC: Office of Planning, Research and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services. Available at: http://www.acf.hhs.gov/programs/opre/resource/behavioral-economics-and-social-policy-designing-innovative-solutions-for-programs-supported-by-the-administration-for

The Community Guide. Diabetes prevention and control: combined diet and physical activity promotion programs to prevent type 2 diabetes among people at increased risk. 2014. Available at http://www.thecommunityguide.org/diabetes/combineddietandpa.html. Accessed on April 19, 2015.

1 Defined as a change in an individual’s urgency and importance towards enrolling into a CDC-recognized lifestyle change program

2 Focused on the key factors that influence behavior change as noted in the research literature

3 Discovery Session is the term used to identify the Be Your Best version of the information session. We use the term information session when referencing a meeting scheduled with prospective LCP attendees prior to the first session of an upcoming LCP.

4 Enrollment materials revised/rewritten to address specific factors known to influence behavior change

5 Those with prediabetes are at high risk for developing type 2 diabetes. Prediabetes is a condition where blood sugar levels are above normal but not at the levels to be diagnosed with type 2 diabetes. https://www.cdc.gov/diabetes/basics/prediabetes.html