[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
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No. of Avg. burden
Type of respondents Form name No. of responses per per response
respondents respondent (in hrs.)
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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
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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