David G Marrero1, Robert M Blew2,3, Kelly N B Palmer1, Kyla James4, Denise J Roe5, Melanie D Hingle6,7. 1. University of Arizona Health Sciences Center for Border Health Disparities, 1295 North Martin Ave., P.O. Box 210202, Tucson, AZ, 85721, USA. 2. Department of Nutritional Sciences, College of Agriculture & Life Sciences, The University of Arizona, 1177 E. 4th Street, Shantz Building, Room 328, Tucson, AZ, 85721, USA. 3. University of Arizona Collaboratory for Metabolic Disease and Prevention, Abrams Public Health Center, 3950 S. Country Club Rd, Tucson, AZ, 85714, USA. 4. Family and Child Wellness at El Rio Community Health Center, 450 W Paseo Redondo, Tucson, AZ, 85701, USA. 5. Department of Epidemiology and Biostatistics, Mel and Enid Zuckerman College of Public Health, The University of Arizona, 1295 N. Martin Ave., P.O. Box 245210, Tucson, AZ, 85724, USA. 6. Department of Nutritional Sciences, College of Agriculture & Life Sciences, The University of Arizona, 1177 E. 4th Street, Shantz Building, Room 328, Tucson, AZ, 85721, USA. hinglem@email.arizona.edu. 7. University of Arizona Collaboratory for Metabolic Disease and Prevention, Abrams Public Health Center, 3950 S. Country Club Rd, Tucson, AZ, 85714, USA. hinglem@email.arizona.edu.
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.
RCT Entities:
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.
Entities:
Keywords:
Body weight; Child; Diabetes mellitus, type 2; Diabetes, gestational; Life style; Mothers; Preventive health; Primordial prevention
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