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Prevention of gestational diabetes through lifestyle modification before pregnancy

Award Number: R01HD084282
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/18/2016
PERIOD OF PERFORMANCE END DATE: 03/31/2022

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Prevention of gestational diabetes through lifestyle modification before pregnancy - DESCRIPTION (provided by applicant): Gestational diabetes mellitus (GDM) is linked with several acute maternal risks, including preeclampsia, caesarean sections, induced deliveries, and pre-term labor, and long-term risks of type 2 diabetes, metabolic syndrome, and cardiovascular disease. Women with GDM are more likely to display features of insulin resistance - a strong precursor to type 2 diabetes and cardiovascular disease (CVD). Intrauterine exposure to GDM raises neonatal health risks, including fetal demise, macrosomia, and birth trauma and long-term risk of metabolic disease. GDM recurrence is also common, affecting 40- 73% of women overall, and augments associated maternal/fetal health risks. Preliminary data from epidemiologic and bariatric surgery studies suggest that reducing body weight before pregnancy can prevent development of GDM and associated maternal/fetal complications. Our preliminary research suggested that it was feasible to recruit women before pregnancy and promote significant weight loss prior to conception. However, a full scale trial to test the effects of maternal lifestyle intervention before pregnancy to reduce body weight and prevent GDM recurrence has never been conducted. The principal aim of this study is to determine whether a lifestyle intervention to reduce body weight before pregnancy can reduce GDM recurrence and improve biomarkers of insulin resistance and cardiovascular disease. This two-site trial proposes to recruit 350 overweight/obese women with previous histories of GDM who plan to have another pregnancy in the next 1-2 years. Women will be randomized within site to a 16-week comprehensive pre-pregnancy lifestyle weight loss intervention (with ongoing treatment until conception) or an educational control group. Assessments will occur before pregnancy (at study entry, after 4 months, and at brief quarterly visits until conception), during pregnancy (at 26 weeks gestation) and at delivery at 6 weeks postpartum. Secondary aims will examine treatment-related reductions in prenatal and perinatal complications and changes in pre- pregnancy weight, eating, and activity. If found effective, the proposed lifestyle interventio could shift current treatment practices towards the interconception period and provide an "evidence based" immediately useable therapy targeted to optimize reproductive outcomes and prevent GDM and associated chronic conditions in the more than 200,000 US women diagnosed with GDM each year. The study is also innovative, as there have been no randomized controlled trials evaluating the effects of a lifestyle intervention delivered before pregnancy to prevent GDM. With a focus on prevention, the proposed study will directly challenge the current conventional approach to GDM - which focuses on early identification and treatment during pregnancy - and shift efforts towards the preconception period.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2020	CAL POLY CORPORATION	1 GRAND AVE BLDG 15	SAN LUIS OBISPO	CA	93407	SAN LUIS OBISPO	USA	Child Health and Human Development Extramural Research	000	5	5/15/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $546,655 )
2020	2020	CAL POLY CORPORATION	1 GRAND AVE	SAN LUIS OBISPO	CA	93407	SAN LUIS OBISPO	USA	Child Health and Human Development Extramural Research	000	5	3/18/2020	NON-COMPETING CONTINUATION	$546,655
														Subtotal = $546,655

Issue Date FY: 2019 ( Subtotal = $545,657 )
2019	2019	CAL POLY CORPORATION	1 GRAND AVE	SAN LUIS OBISPO	CA	93407	SAN LUIS OBISPO	USA	Child Health and Human Development Extramural Research	000	4	2/22/2019	NON-COMPETING CONTINUATION	$545,657
														Subtotal = $545,657

Issue Date FY: 2018 ( Subtotal = $561,621 )
2018	2018	CAL POLY CORPORATION	1 GRAND AVE	SAN LUIS OBISPO	CA	93407	SAN LUIS OBISPO	USA	Child Health and Human Development Extramural Research	001	3	5/1/2018	NON-COMPETING CONTINUATION	$56,164
2018	2018	CAL POLY CORPORATION	1 GRAND AVE	SAN LUIS OBISPO	CA	93407	SAN LUIS OBISPO	USA	Child Health and Human Development Extramural Research	000	3	3/10/2018	NON-COMPETING CONTINUATION	$505,457
														Subtotal = $561,621

Issue Date FY: 2017 ( Subtotal = $575,995 )
2017	2017	CAL POLY CORPORATION	1 GRAND AVE	SAN LUIS OBISPO	CA	93407	SAN LUIS OBISPO	USA	Child Health and Human Development Extramural Research	000	2	3/24/2017	NON-COMPETING CONTINUATION	$518,395
2017	2017	CAL POLY CORPORATION	1 GRAND AVE	SAN LUIS OBISPO	CA	93407	SAN LUIS OBISPO	USA	Child Health and Human Development Extramural Research	001	2	6/28/2017	NON-COMPETING CONTINUATION	$57,600
														Subtotal = $575,995

Issue Date FY: 2016 ( Subtotal = $604,504 )
2016	2016	CAL POLY CORPORATION	**	SAN LUIS OBISPO	CA	93407	SAN LUIS OBISPO	USA	Child Health and Human Development Extramural Research	000	1	4/15/2016	NEW	$604,504
														Subtotal = $604,504

Grand Total All Awards = $2,834,432

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Prevention of gestational diabetes through lifestyle modification before pregnancy

Award Number: R01HD084282

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 04/18/2016

PERIOD OF PERFORMANCE END DATE: 03/31/2022

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