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Open Access 01-12-2021 | Gestational Diabetes | Study protocol

Moms in motion: weight loss intervention for postpartum mothers after gestational diabetes: a randomized controlled trial

Authors: Briana J. Stith, Samantha M. Buls, Sarah A. Keim, Stephen F. Thung, Mark A. Klebanoff, Mark B. Landon, Steven G. Gabbe, Kajal K. Gandhi, Reena Oza-Frank

Published in: BMC Pregnancy and Childbirth | Issue 1/2021

Abstract

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.

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Title: Moms in motion: weight loss intervention for postpartum mothers after gestational diabetes: a randomized controlled trial
Authors: Briana J. Stith
Samantha M. Buls
Sarah A. Keim
Stephen F. Thung
Mark A. Klebanoff
Mark B. Landon
Steven G. Gabbe
Kajal K. Gandhi
Reena Oza-Frank
Publication date: 01-12-2021
Publisher: BioMed Central
Keywords: Gestational Diabetes
Gestational Diabetes
Diabetes
Type 2 Diabetes
Published in: BMC Pregnancy and Childbirth / Issue 1/2021
Electronic ISSN: 1471-2393
DOI: https://doi.org/10.1186/s12884-021-03886-3

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Moms in motion: weight loss intervention for postpartum mothers after gestational diabetes: a randomized controlled trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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