The National Institute of Diabetes and Digestive and Kidney Diseases plans to award a sole source contract to ACKCO, Inc., American Indian Professional Services, 1326 N. Central Avenue, Suite 208, Phoenix, Arizona 85004. The requirement is for LIFE-Moms Phoenix, 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.

LIFE-Moms Phoenix is one of seven independent clinical trials involved in a larger LIFE-Moms consortium. The goal of the LIFE-Moms consortium is 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; ensuring consistency of procedures, definitions and data collection; harmonizing design elements of the trials and the proposed interventions; and jointly monitoring progress and solving problems as the trials progress.

The LIFE-Moms consortium has completed the design phase and finalized protocols and procedures. The purpose of this contract is for a contractor to provide support services in order to conduct the LIFE-Moms Phoenix study. Recruitment, intervention, and follow-up will occur over a four year period.

This action is being conducted under the authority of 41 U.S.C. 253( c )(1), as set forth in FAR 6.302-1 and HHSAR 306.302-1, only one responsible source and no other supplies or services will satisfy agency requirements. ACKCO possesses unique experience and qualifications that are necessary for conducting these clinical trial support services in the Phoenix, Arizona area with this American Indian population. ACKCO's experience includes the successful implementation and completion of multiple studies and clinical trial protocols with this American Indian population, including the Diabetes Prevention Program (DPP/DPPOS) and the Look AHEAD (Action for Health in Diabetes) project. This acquisition requires specific and extensive experience for conducting weight-control and weight-loss studies along with strong, proven working relationships with this American Indian community. ACKCO is the only source that has the necessary experience and the working relationships with this American Indian community necessary for successful study completion.

This notice is not a request for competitive proposals. However, all proposals received within 45 days after publication of this synopsis will be considered by the Government. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.

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