[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Notices]
[Pages 3426-3427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01099]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-16-15BEB]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (a) 
Evaluate whether the proposed collection of information is necessary 
for the proper performance of the functions of the agency, including 
whether the information will have practical utility; (b) Evaluate the 
accuracy of the agencies estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (c) Enhance the quality, utility, and clarity of 
the information to be collected; (d) Minimize the burden of the 
collection of information on those who are to respond, including 
through the use of appropriate automated, electronic, mechanical, or 
other technological collection techniques or other forms of information 
technology, e.g., permitting electronic submission of responses; and 
(e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to [email protected]. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC Desk Officer, Office of Management and Budget, 
Washington, DC 20503 or by fax to (202) 395-5806. Written comments 
should be received within 30 days of this notice.

Proposed Project

    Balance After Baby Intervention--New--National Center for Chronic 
Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    The CDC Division of Reproductive Health (DRH) is focused on 
understanding and preventing complications due to pregnancy and the 
development of chronic diseases in reproductive age women. Similarly, 
the CDC established the National Diabetes Prevention Program (NDPP), 
administered through the Division of Diabetes Translation (DDT), to 
make strategies for preventing type 2 diabetes broadly available to 
individuals at high risk of developing diabetes. Gestational diabetes 
mellitus (GDM) is one of the most common pregnancy complications in the 
US, affecting approximately 3-13% of pregnancies, or approximately 
200,000 cases annually. As defined by the American Diabetes Association 
(2003), GDM is glucose intolerance that first presents during pregnancy 
after the first trimester. Women with a history of GDM have a 
substantially increased risk of developing type 2 diabetes mellitus 
(T2DM) within 5 to 16 years after their index pregnancy. It has also 
been shown that many women with a history of GDM gain weight after 
pregnancy, increasing their risk for obesity, which itself is a strong 
risk factor for repeat GDM and T2DM. Because of this, as US obesity 
prevalence continues to increase, there is a concurrent rise in the 
incidence and prevalence of GDM and T2DM, resulting in a large disease 
burden on individuals, families, and society. To assist in reducing 
this national disease burden, it is critical to develop and implement 
successful interventions that reduce the annual number of newly 
diagnosed T2DM cases, especially in increased risk populations, such as 
women with a history of GDM. As part of this Healthy People 2020 
objective, the Diabetes Prevention Program (DPP) demonstrated that an 
intensive lifestyle intervention (16 face-to-face sessions over a 24-
week period) promoting physical activity, healthy eating, and weight 
reduction significantly decreased T2DM incidence by 58% in high risk 
patients. However, the DPP included predominantly older individuals 
whose ability to attend group meetings and adopt healthy lifestyle 
changes is different than younger postpartum women. For this reason, 
successful adaptations of the DPP that address barriers in postpartum 
women with recent GDM, such as limited time and resources, fatigue, and 
childcare demands, must be identified and tested.
    This Balance After Baby Intervention (BABI) data collection request 
aims to collect information that can be used to evaluate an 
intervention that addresses

[[Page 3427]]

these barriers through the conduct of a randomized, controlled 
intervention trial of a Web site-based lifestyle program, Balance after 
Baby (BAB), that is adapted from the DPP and tailored specifically for 
postpartum women with recent GDM.
    The project aims to screen 293 (98 annualized over 3 years) women 
with a recent GDM pregnancy for enrollment into the study, followed by 
assessments at the following five post-partum time points: 6-Weeks, 6-
months, 12-months, 18-months, and 24-months. Of the estimated 190 (63 
annualized) women who are anticipated to meet eligibility requirements 
and attend the first study visit, approximately half will be assigned 
to the control group and the other half will be assigned to the 
intervention group. Women in the control group will have access to a 
``control version'' of the BABI Web site, containing post-partum 
information such as the ``It's Never too Early to Prevent Diabetes'' 
tip sheet and links to other related public Web sites. Those assigned 
to the intervention group will have access to the full, interactive 
version of the BABI Web site and will be instructed to log-on once a 
week to view educational modules regarding healthy lifestyle options 
and to enter and track their weight and physical activity against their 
self-appointed goals. They will also have access to a web-based 
Lifestyle Coach who will communicate with them throughout the first 
year of their participation.
    All participants will be required to complete clinical assessment 
visits involving the completion of visit-specific questionnaires with 
integrated food frequency questionnaires, laboratory testing, and the 
collection of physical measurements such as height and weight. The 
results of the two study arms, intervention and control, will be 
compared to assess whether the intervention significantly increased 
postpartum weight loss and decreased glucose tolerance for women at 
increased T2DM risk.
    For the calculation of the estimated burden hours per study visit 
detailed in the table below, a constant 5% rate of exclusion and 
attrition was applied between visits. The burden table provides a 
participant estimate, which will be evenly distributed across control 
and intervention groups for each information collection step (both 
groups complete the same questionnaires), annualized over a 3-year 
clearance period. Therefore, of the 190 women (63 annualized) who 
attend the 6-week visit, the estimated number of participants returning 
for the 6-month visit is reduced to 180 (60 annualized), followed by 
172 (57 annualized), 162 (54 annualized), and 154 (51 annualized) for 
the 12-, 18-, and 24-month visits respectively. The average burden per 
questionnaire ranges from 8 minutes for the BABI Screener Questionnaire 
up to 18 minutes for the BABI 6-Month Questionnaire. The average burden 
hours per response for the 6-Week, 6-, 12-, 18-, 24-Month 
Questionnaires, and Block(copyright) Food Frequency Questionnaire (FFQ) 
are shown in the table below. Participation is voluntary and there are 
no costs to respondents other than their time.
    The total estimated annualized burden hours are 183.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      No. of       Avg.  burden
          Type of respondents                   Form name             No. of       responses per   per  response
                                                                    respondents     respondent       (in hrs.)
----------------------------------------------------------------------------------------------------------------
Women with a recent history GDM.......  BABI Screener                         98               1            8/60
                                         Questionnaire.
                                        BABI 6-Week                           63               1           17/60
                                         Questionnaire.
                                        BABI 6-Month                          60               1           18/60
                                         Questionnaire.
                                        BABI 12-Month                         57               1           14/60
                                         Questionnaire.
                                        BABI 18-Month                         54               1           14/60
                                         Questionnaire.
                                        BABI 24-Month                         51               1           15/60
                                         Questionnaire.
                                        Block FFQ...............              63               5           18/60
----------------------------------------------------------------------------------------------------------------


Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2016-01099 Filed 1-20-16; 8:45 am]
 BILLING CODE 4163-18-P