Type 2 diabetes (T2DM) develops in 50% of women with gestational diabetes (GDM) within 5 years after delivery. So far, no lifestyle interventions have been translated for use in women with GDM during the early postpartum period. The screening for GDM practiced in the health system presents a highly efficient identification of a population at high risk of T2DM. The primary aim of the study is to implement and evaluate a diet and physical activity (PA) intervention tailored to postpartum mothers and feasible for a health plan setting, with the primary goals of: a) reaching pre-pregnancy weight if women had a normal pre-pregnancy weight;or b) achieving a 5% reduction from pre-pregnancy weight if overweight or obese before pregnancy. The primary outcomes are the proportion of women who reach their postpartum body weight goal and the total amount of weight change. Secondary outcomes are plasma glucose levels, percent calories from fat, total calories and time spent in PA. Participants will be from a large population (66% from ethinic minority groups) receiving medical care at Kaiser. Women will be randomly assigned to lifestyle intervention or usual medical care (175 in each arm). The interventionists will be dieticians trained in social cognitive strategies and motivational interviewing techniques and located at the Kaiser Perinatal Service Center. The intervention will be delivered via individual telephone contacts and brief in-person counseling sessions augmented with e-mails and a website. Goals for the intervention during pregnancy (Phase I) are to help women comply with the IOM guidelines for weight gain. Phase I will be delivered through 1 individual in-person session and 2 telephone counseling contacts. Phase II begins at 6-weeks postpartum and will be delivered through 2 individual in- person sessions and 10 telephone counseling contacts over a period of 4 months, after which Phase III (maintenance) will begin and participants will receive 9 tailored diet and PA reminders until 24-months postpartum. Intervention women will also be taught about their diabetes risk and how to prevent it. Measurements will be collected at study entry and at 6-wks, 6-m, 12-m, 18-m and 24-m postpartum. Data analyses will be by intent-to-treat. Tertiary aims address psychosocial modeling, within trial cost-effectiveness analysis and evaluation of the intervention for possible adoption. A finding that this intervention is cost-effective in this setting should motivate changes in the health system that would facilitate its adoption.

Public Health Relevance

Gestational diabetes is defined as abnormal glucose metabolism during pregnancy. Type 2 diabetes develops in 50% of women with gestational diabetes (GDM) within 5 years after delivery. Although randomized trials have shown that weight reduction by diet and physical activity reduces the risk of type 2 diabetes in older adults, no lifestyle interventions have been translated for use in pregnant and early postpartum women with GDM. The primary aim of the study is to implement and evaluate among women with GDM an intervention of diet and physical activity that starts during pregnancy and continues after pregnancy with the primary goals of a) reaching prepregnancy weight if women had normal weight prior to pregnancy;or b) reaching a 5% reduction of the prepregnancy body weight if women were overweight or obese prior to pregnancy. Targets for the intervention during pregnancy (Phase I) are to help women comply with the Institute of Medicine guidelines for pregnancy weight gain. Phase I will be delivered through 1 individual in-person session and 2 telephone counseling contacts. After pregnancy (Phase II), starting from 6 weeks postpartum, targets for the intervention are to help women reach their postpartum weight goals. Phase II will be delivered through 2 in-person sessions and 10 telephone counseling contacts and will end at 5-6 months postpartum. The maintenance period (Phase III) begins soon after Phase II ends and it will end at 24 months postpartum and will include 9 mailed tailored reminders. If this translational intervention is found to be cost-effective in this setting it should motivate changes to the health care system that would facilitate adoption of the program for all women with GDM.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Demonstration and Dissemination Projects (R18)
Project #
5R18DK067334-06
Application #
8501430
Study Section
Special Emphasis Panel (ZDK1-GRB-1 (M1))
Program Officer
Bremer, Andrew
Project Start
2004-04-01
Project End
2015-06-30
Budget Start
2013-07-01
Budget End
2014-06-30
Support Year
6
Fiscal Year
2013
Total Cost
$622,084
Indirect Cost
$212,245
Name
Kaiser Foundation Research Institute
Department
Type
DUNS #
150829349
City
Oakland
State
CA
Country
United States
Zip Code
94612
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Ehrlich, Samantha F; Crites, Yvonne M; Hedderson, Monique M et al. (2011) The risk of large for gestational age across increasing categories of pregnancy glycemia. Am J Obstet Gynecol 204:240.e1-6
Ehrlich, Samantha F; Hedderson, Monique M; Feng, Juanran et al. (2011) Change in body mass index between pregnancies and the risk of gestational diabetes in a second pregnancy. Obstet Gynecol 117:1323-30
Ferrara, Assiamira; Hedderson, Monique M; Albright, Cheryl L et al. (2011) A pregnancy and postpartum lifestyle intervention in women with gestational diabetes mellitus reduces diabetes risk factors: a feasibility randomized control trial. Diabetes Care 34:1519-25
Ferrara, Assiamira; Peng, Tiffany; Kim, Catherine (2009) Trends in postpartum diabetes screening and subsequent diabetes and impaired fasting glucose among women with histories of gestational diabetes mellitus: A report from the Translating Research Into Action for Diabetes (TRIAD) Study. Diabetes Care 32:269-74