Cargando…
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
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 his...
Autores principales: | , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7881686/ https://www.ncbi.nlm.nih.gov/pubmed/33579240 http://dx.doi.org/10.1186/s12889-021-10392-w |
_version_ | 1783650929123262464 |
---|---|
author | Marrero, David G. Blew, Robert M. Palmer, Kelly N. B. James, Kyla Roe, Denise J. Hingle, Melanie D. |
author_facet | Marrero, David G. Blew, Robert M. Palmer, Kelly N. B. James, Kyla Roe, Denise J. Hingle, Melanie D. |
author_sort | Marrero, David G. |
collection | PubMed |
description | 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12889-021-10392-w. |
format | Online Article Text |
id | pubmed-7881686 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-78816862021-02-17 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 Marrero, David G. Blew, Robert M. Palmer, Kelly N. B. James, Kyla Roe, Denise J. Hingle, Melanie D. BMC Public Health Study Protocol 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12889-021-10392-w. BioMed Central 2021-02-12 /pmc/articles/PMC7881686/ /pubmed/33579240 http://dx.doi.org/10.1186/s12889-021-10392-w Text en © The Author(s) 2021 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Marrero, David G. Blew, Robert M. Palmer, Kelly N. B. James, Kyla Roe, Denise J. Hingle, Melanie D. 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7881686/ https://www.ncbi.nlm.nih.gov/pubmed/33579240 http://dx.doi.org/10.1186/s12889-021-10392-w |
work_keys_str_mv | AT marrerodavidg rationaleanddesignofatype2diabetespreventioninterventionforatriskmothersandchildrenatafederallyqualifiedhealthcarecenterepicelriofamiliesstudyprotocol AT blewrobertm rationaleanddesignofatype2diabetespreventioninterventionforatriskmothersandchildrenatafederallyqualifiedhealthcarecenterepicelriofamiliesstudyprotocol AT palmerkellynb rationaleanddesignofatype2diabetespreventioninterventionforatriskmothersandchildrenatafederallyqualifiedhealthcarecenterepicelriofamiliesstudyprotocol AT jameskyla rationaleanddesignofatype2diabetespreventioninterventionforatriskmothersandchildrenatafederallyqualifiedhealthcarecenterepicelriofamiliesstudyprotocol AT roedenisej rationaleanddesignofatype2diabetespreventioninterventionforatriskmothersandchildrenatafederallyqualifiedhealthcarecenterepicelriofamiliesstudyprotocol AT hinglemelanied rationaleanddesignofatype2diabetespreventioninterventionforatriskmothersandchildrenatafederallyqualifiedhealthcarecenterepicelriofamiliesstudyprotocol |