SOURCES SOUGHT
A -- Lifestyle Interventions for Expectant Moms Phoenix
- Notice Date
- 8/17/2012
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Nat'l Institute of Diabetes, Digestive, & Kidney Diseases, 2 Democracy Plaza, Suite 700W, 6707 Democracy Blvd., MSC 5455, Bethesda, Maryland, 20892-5455
- ZIP Code
- 20892-5455
- Solicitation Number
- HHS-NIH-NIDDK-SBSS-13-001
- Archive Date
- 9/11/2012
- Point of Contact
- April N. Merriwether, Phone: 301-402-1517, Edward J Kostolansky,
- E-Mail Address
-
merriwetheran@mail.nih.gov, ekostola@mail.nih.gov
(merriwetheran@mail.nih.gov, ekostola@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. Background. The National Institute of Diabetes and Digestive and Kidney Diseases has a requirement for Support Services for the LIFE-Moms Phoenix project, which is a randomized clinical trial with the objective of testing an intensive lifestyle intervention tailored to overweight and obese pregnant women of ameliorating inappropriate gestational weight gain and testing its effects on gestational weight gain, control of maternal hyperglycemia, and post-partum return to pre-pregnancy weight. American Indians are at high risk for developing obesity and type 2 diabetes mellitus (T2DM) and its complications. A major factor responsible for this finding is intrauterine exposure to diabetes, which increases the risk of diabetes in the offspring particularly during childhood and adolescence. This study is designed to evaluate the effects of an intensive lifestyle intervention (ILI) in at least 200 adult (age ≥18 years) pregnant women who are eligible for prenatal care at Phoenix Indian Medical Center (PIMC). Almost all of these women or their fetuses will be of American Indian heritage. Interventions will be provided to overweight and obese pregnant women who do not have pre-gestational diabetes but are at high risk of developing gestational diabetes (GDM). The lifestyle intervention will be patterned after the Diabetes Prevention Program (DPP) that prevented or delayed the onset of diabetes in non-pregnant adults; the interventions will be modified to be appropriate in pregnancy. A major modification will be to encourage managed weight gain instead of weight loss. For women who develop diabetes, interventions will include coaching to optimize glycemic control. Outcomes include effects on gestational weight gain, control of maternal hyperglycemia, post-partum return to pre-pregnancy weight, and infant growth. Mothers and off-spring will be followed for a minimum of 1-year after birth. The LIFE-Moms Phoenix project is one of seven independent clinical trials involved in a larger LIFE-Moms consortium. The goal of the LIFE-Moms consortium is designed to test and identify effective behavioral and lifestyle interventions that will improve weight, glycemic control and other-pregnancy-related outcomes in obese and overweight pregnant women, and determine whether these interventions reduce obesity and metabolic abnormalities in their children. Although each clinical center is conducting a separate trial, the purpose of the collaboration is to: maximize the value of the individual trials by identifying core measures to be collected across all studies; ensure consistency of procedures, definitions and data collection; harmonize design elements of the trials and the proposed interventions; and jointly monitor progress and solving problems as the trials progress. The LIFE-Moms consortium and individual studies, including LIFE-Moms Phoenix have completed the design phase and finalized protocols and procedures. All decisions regarding protocol management, data management/analysis, and publication of results will be made by LIFE-Moms investigators, who will not be supported through this contract. The purpose of this contract is to provide resources for staff and approved study expenses in order to conduct the LIFE-Moms Phoenix study. Recruitment, intervention, and follow-up will occur over a four year period. Purpose and Objectives. The contractor will be required to perform support services to conduct the LIFE-Moms Phoenix project. This will include four primary areas. (1) Providing Resource Management and Coordination that includes implementing the LIFE-Moms Phoenix protocol, as well as providing project coordination, management, administration support, and quality control. This includes appropriate staff training and experience overseeing, implementing and monitoring the protocol activities in an efficient, effective, and culturally-appropriate way. It also includes participating with required activities of the LIFE-Moms consortium. (2) Ensuring Participant Recruitment and Retention, including identification and screening of potential participants, addressing barriers to participation, managing participant activities, maintaining contact with participants, providing social and cultural support and participating in cultural events, and monitoring attendance at study visits. (3) Implementing the study interventions (control and lifestyle intervention), and assuring that intervention sessions are managed in accordance with the protocol. (4) Completing all data collection requirements per the protocol, complying with all applicable Federal policies and requirements, and submitting and managing core LIFE-Moms data to the consortium as required, verifying and editing data as necessary. Anticipated Period of Performance. The anticipated period of performance of this project is four years. Capability statement/information sought. Information submitted should be relevant and specific in the technical area under consideration. Information provided must address experience outlining previous similar projects, specifically the services provided in the areas described above. Respondents should identify specific personnel, including names, professional qualifications, specific experience in the work requested, and their availability. Corporate and management capability must also be addressed. Personnel and organizational experience must include and describe successful experience working in a culturally-appropriate manner with these specific populations. All capability statements must provide the respondents' DUNS number, organization name, address, point of contact, and size and type of business pursuant to the applicable NAICS code. Capability statements must be received no later than 12:00pm local time on August 27, 2012. Questions may be directed to Ms. April Merriwether at merriwetheran@mail.nih.gov. Electronic or capability statements will not be accepted. Respondents must submit their capability statements in three copies to the following address: Ms. April Merriwether NIDDK Acquisitions Branch Office of Acquisitions, NLM 2 Democracy Plaza, Suite 700W 6707 Democracy Boulevard, MSC 5455 Bethesda, Maryland 20892-5455 If hand-delivered or using delivery service, use Bethesda, Maryland 20817 Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provided feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDDKD/HHS-NIH-NIDDK-SBSS-13-001/listing.html)
- Place of Performance
- Address: Phoenix, Arizona, United States
- Record
- SN02844441-W 20120819/120817235509-8b0567ca707a35cdddb86e58d77554ae (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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