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Moms in motion: weight loss intervention for postpartum mothers after gestational diabetes: a randomized controlled trial
BACKGROUND: Up to 50 % of women with gestational diabetes mellitus (GDM) will receive a diagnosis of type 2 diabetes mellitus (T2DM) within a decade after pregnancy. While excess postpartum weight retention exacerbates T2DM risk, lifestyle changes and behavior modifications can promote healthy postp...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8240610/ https://www.ncbi.nlm.nih.gov/pubmed/34187391 http://dx.doi.org/10.1186/s12884-021-03886-3 |
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author | Stith, Briana J. Buls, Samantha M. Keim, Sarah A. Thung, Stephen F. Klebanoff, Mark A. Landon, Mark B. Gabbe, Steven G. Gandhi, Kajal K. Oza-Frank, Reena |
author_facet | Stith, Briana J. Buls, Samantha M. Keim, Sarah A. Thung, Stephen F. Klebanoff, Mark A. Landon, Mark B. Gabbe, Steven G. Gandhi, Kajal K. Oza-Frank, Reena |
author_sort | Stith, Briana J. |
collection | PubMed |
description | BACKGROUND: Up to 50 % of women with gestational diabetes mellitus (GDM) will receive a diagnosis of type 2 diabetes mellitus (T2DM) within a decade after pregnancy. While excess postpartum weight retention exacerbates T2DM risk, lifestyle changes and behavior modifications can promote healthy postpartum weight loss and contribute to T2DM prevention efforts. However, some women have difficulty prioritizing self-care during this life stage. Efficacious interventions that women can balance with motherhood to reduce T2DM risk remain a goal. The objective of the Moms in Motion study is to evaluate the efficacy of a simple, novel, activity-boosting intervention using ankle weights worn with daily activities during a 6-month postpartum intervention among women with GDM. We hypothesize that women randomized to the 6-month intensity-modifying intervention will (1) demonstrate greater weight loss and (2) greater improvement in body composition and biomarker profile versus controls. METHODS: This study will be a parallel two-arm randomized controlled trial (n = 160). Women will be allocated 1:1 to an ankle weight intervention group or a standard-of-care control group. The intervention uses ankle weights (1.1 kg) worn on each ankle during routine daily activities (e.g., cleaning, childcare). Primary outcomes include pre- and post-assessments of weight from Visit 2 to Visit 3. Secondary outcomes include body composition, glycemia (2-h, 75 g oral glucose tolerance test), and fasting insulin. Exploratory outcomes include energy expenditure, diet, and psychosocial well-being. DISCUSSION: Beyond the expected significance of this study in its direct health impacts from weight loss, it will contribute to exploring (1) the mechanism(s) by which the intervention is successful (mediating effects of energy expenditure and diet on weight loss) and (2) the effects of the intervention on body composition and biomarkers associated with insulin resistance and metabolic health. Additionally, we expect the findings to be meaningful regarding the intervention’s effectiveness on engaging women with GDM in the postpartum period to reduce T2DM risk. TRIAL REGISTRATION: The ClinicalTrials.gov Identifier, is NCT03664089. The trial registration date is September 10, 2018. The trial sponsor is Dr. Sarah A. Keim. |
format | Online Article Text |
id | pubmed-8240610 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-82406102021-06-29 Moms in motion: weight loss intervention for postpartum mothers after gestational diabetes: a randomized controlled trial Stith, Briana J. Buls, Samantha M. Keim, Sarah A. Thung, Stephen F. Klebanoff, Mark A. Landon, Mark B. Gabbe, Steven G. Gandhi, Kajal K. Oza-Frank, Reena BMC Pregnancy Childbirth Study Protocol BACKGROUND: Up to 50 % of women with gestational diabetes mellitus (GDM) will receive a diagnosis of type 2 diabetes mellitus (T2DM) within a decade after pregnancy. While excess postpartum weight retention exacerbates T2DM risk, lifestyle changes and behavior modifications can promote healthy postpartum weight loss and contribute to T2DM prevention efforts. However, some women have difficulty prioritizing self-care during this life stage. Efficacious interventions that women can balance with motherhood to reduce T2DM risk remain a goal. The objective of the Moms in Motion study is to evaluate the efficacy of a simple, novel, activity-boosting intervention using ankle weights worn with daily activities during a 6-month postpartum intervention among women with GDM. We hypothesize that women randomized to the 6-month intensity-modifying intervention will (1) demonstrate greater weight loss and (2) greater improvement in body composition and biomarker profile versus controls. METHODS: This study will be a parallel two-arm randomized controlled trial (n = 160). Women will be allocated 1:1 to an ankle weight intervention group or a standard-of-care control group. The intervention uses ankle weights (1.1 kg) worn on each ankle during routine daily activities (e.g., cleaning, childcare). Primary outcomes include pre- and post-assessments of weight from Visit 2 to Visit 3. Secondary outcomes include body composition, glycemia (2-h, 75 g oral glucose tolerance test), and fasting insulin. Exploratory outcomes include energy expenditure, diet, and psychosocial well-being. DISCUSSION: Beyond the expected significance of this study in its direct health impacts from weight loss, it will contribute to exploring (1) the mechanism(s) by which the intervention is successful (mediating effects of energy expenditure and diet on weight loss) and (2) the effects of the intervention on body composition and biomarkers associated with insulin resistance and metabolic health. Additionally, we expect the findings to be meaningful regarding the intervention’s effectiveness on engaging women with GDM in the postpartum period to reduce T2DM risk. TRIAL REGISTRATION: The ClinicalTrials.gov Identifier, is NCT03664089. The trial registration date is September 10, 2018. The trial sponsor is Dr. Sarah A. Keim. BioMed Central 2021-06-29 /pmc/articles/PMC8240610/ /pubmed/34187391 http://dx.doi.org/10.1186/s12884-021-03886-3 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/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/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://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 Stith, Briana J. Buls, Samantha M. Keim, Sarah A. Thung, Stephen F. Klebanoff, Mark A. Landon, Mark B. Gabbe, Steven G. Gandhi, Kajal K. Oza-Frank, Reena Moms in motion: weight loss intervention for postpartum mothers after gestational diabetes: a randomized controlled trial |
title | Moms in motion: weight loss intervention for postpartum mothers after gestational diabetes: a randomized controlled trial |
title_full | Moms in motion: weight loss intervention for postpartum mothers after gestational diabetes: a randomized controlled trial |
title_fullStr | Moms in motion: weight loss intervention for postpartum mothers after gestational diabetes: a randomized controlled trial |
title_full_unstemmed | Moms in motion: weight loss intervention for postpartum mothers after gestational diabetes: a randomized controlled trial |
title_short | Moms in motion: weight loss intervention for postpartum mothers after gestational diabetes: a randomized controlled trial |
title_sort | moms in motion: weight loss intervention for postpartum mothers after gestational diabetes: a randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8240610/ https://www.ncbi.nlm.nih.gov/pubmed/34187391 http://dx.doi.org/10.1186/s12884-021-03886-3 |
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