Rationale and design of a type 2 diabetes prevention intervention for at-risk mothers and children at a Federally Qualified Healthcare Center: EPIC El Rio Families Study Protocol

Abstract

Background Exposure to gestational diabetes mellitus (GDM) is associated with increased risk for type 2 diabetes (T2DM) in mothers, and poor cardiovascular health among offspring. Identifying effective methods to mitigate T2DM risk has the potential to improve health outcomes for mothers with a history of GDM and their children. The goal of the EPIC El Rio Families Study is to implement and evaluate the effects of a 13-week behavioral lifestyle intervention on T2DM risk factors in at-risk mothers and their 8- to 12-year-old children. We describe herein the rationale for our specific approach, the adaption of the DPP-based curriculum for delivery to patients of a Federally Qualified Health Center (FQHC), and the study design and methodology. Methods The effects of the intervention on reduction in excess body weight (primary outcome), hemoglobin A1c, blood pressure, and changes in lifestyle behaviors associated with weight trajectory and T2DM risk in mother-child dyads will be evaluated during a 13-week, group randomized trial wherein 60 mothers and their children will be recruited to the intervention or wait-listed control conditions at one of two FQHC locations. Intervention participants (n = 30) will begin the group program immediately, whereas the wait-listed controls (n = 30) will receive a booklet describing self-guided strategies for behavior change. Associated program delivery costs, acceptability of the program to participants and FQHC staff, and potential for long-term sustainability will also be evaluated. Discussion Successful completion in our aims will produce a scalable program with high potential for replication and dissemination, and estimated intervention effects to inform T2DM prevention efforts on families who use the FQHC system. The results from this study will be critical in developing a T2DM prevention model that can be implemented and scaled across FQHCs serving populations disproportionately burdened by T2DM. Trial registration ClinicalTrials.gov NCT03781102; Date of registration: 19 December 2018.

Feasibility and Acceptability of a Type 2 Diabetes Prevention Intervention for Mothers and Children at a Federally Qualified Healthcare Center

“…42 We succeeded in demonstrating feasibility of implementing a diabetes prevention program that enrolled majority low income and Hispanic women, a population disproportionately burdened by diabetes. This program extended previous efforts by our team to introduce primordial prevention to the area of diabetes prevention, 19 and was highly accepted by participants and FQHC program staff. To our knowledge, ours was one of the first studies to integrate a family-based T2DM prevention program as part of a FQHC delivery system, and evaluate the feasibility and acceptability of such a program in this setting.…”

“…Our intervention was among the first to address T2DM risk of both mother and child simultaneously using the concept of “primordial prevention,” which explicitly leverages the motivation of mothers to address potential social and environmental conditions that promote or amplify chronic disease risk factors such as T2DM, thereby slowing or halting risk of transmission to their children. 18 , 19 , 38 Indeed, there is precedent for the application of primordial prevention to T2DM risk reduction. 39 Family-based pediatric obesity interventions in which parents or caregivers are actively involved and coached to use proactive food and physical activity parenting strategies have demonstrated higher rates of success compared with those that focus only on the child.…”

“…Intervention content and delivery was modeled after our previous T2DM prevention work with youth and families 16 - 19 ; selection of program outcomes was guided by the 2017 U.S. Preventive Task Force (USPSTF) to meet national recommendations for nutrition, physical activity, and behavior change for youth. A description of the study protocol and how we adapted the curriculum from the Diabetes Prevention Program 9 , 10 and our prior work are published elsewhere.…”