Abstract
BackgroundIn China, about 53.4 million women (11%) have type 2 diabetes (T2DM). Women with prior 2 (GDM) are at a high risk for T2DM. Postpartum lifestyle interventions have been effective in reducing T2DM for this population, but the evidence is limited to interventions provided in urban areas, despite the fact that a higher prevalence of undiagnosed T2DM was found in rural areas in China. The primary purpose of this proposed study is to examine the effect of a postpartum intensive lifestyle modification (ILSM) program on physiological health outcomes (T2DM development, insulin resistance, and weight-related variables), weight-related health behaviors (dietary intake and physical activity), and psychosocial outcomes (self-efficacy, perceived stress, social support, and health-related quality of life) compared to usual care at 3, 6, and 18 months post baseline assessment. The secondary outcomes are to identify potential mediators and moderators on change of physiological health outcomes.Methods/designA multi-site randomized clinical trial (RCT) will be conducted to examine the efficacy of an evidence-based Intensive Lifestyle Modification (ILSM) program compared with usual care for women with prior GDM living in rural areas in China. A total sample of 256 participants will be recruited in the study. The intervention consists of six bi-weekly in-person group sessions, five bi-weekly telephone consultation sessions, and three monthly telephone consultations to encourage behavior change. The usual care provided to the control group will utilize current clinical guideline and recommendations for T2DM prevention. Outcome measures include physiological variables (OGTT-2 h, HbA1c, weight, and waist circumference); weight-related health behavioral (dietary intake and physical activities); and psychosocial variables (self-efficacy and social support) at 3-, 6- and 18- month after baseline. We will also assess the potential cost-effectiveness of ILSM (net cost per T2DM case and per DALY averted) compared with usual care.DiscussionIf successful, this ILSM program can be adapted and used in rural areas as a blueprint for clinical guidelines to decrease T2DM by improving postpartum GDM care in China. Findings of this study are expected to make a significant contribution to public health practice and health policy related to T2DM prevention in China.Trial registrationChinese Clinical Trial Registry, ChiCTR1800015023. Registered 1 March 2018 - Retrospectively registered, http://apps.who.int/trialsearch/default.aspx.
Highlights
In China, about 53.4 million women (11%) have type 2 diabetes (T2DM)
Residents in rural areas are largely unaware of their Type 2 Diabetes Mellitus (T2DM) risk [4] and health care program for women with prior Gestational diabetes mellitus (GDM) is absent despite the high rate of undiagnosed T2DM in rural areas [11], an intervention program tailored to this high risk group will be the first step for changing clinical practice and policy development aimed to decrease health inequity in China
A recent systematic review [11] examined the efficacy of lifestyle interventions in decreasing T2DM for women with GDM using randomized clinical trials found that the majority of the trials (92%) targeted women in an urban setting [13,14,15,16,17,18,19,20,21,22,23] and the results suggest that postpartum lifestyle interventions for women with GDM history can decrease T2DM risk significantly on the short-term follow up
Summary
Health disparities in T2DM are seen in rural areas in China as undiagnosed T2DM is higher in rural areas than urban [33]. Feasible and sustainable programs aimed to improve healthy lifestyle and decrease T2DM for this high risk group are extremely important for the health of women and their family, especially in rural areas To our knowledge, this proposed study will be the first to examine the efficacy of a culturally-tailored in-person postpartum lifestyle intervention for women with prior GDM in rural areas in China. Long-term effect of ILSM program to decrease the incidence of T2DM in women with prior GDM will be difficult to show in this proposed project because of the limited project time To reduce these limitations, we have included the sample size that is theoretically sufficient to detect meaningful clinical difference, used randomization techniques to maximize representation of the target population and increased follow up to 12 month post intervention given the grant funding duration and budget.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
