Briana J Stith1, Samantha M Buls1, Sarah A Keim1,2,3, Stephen F Thung4, Mark A Klebanoff2,3,4,5, Mark B Landon4, Steven G Gabbe4, Kajal K Gandhi6, Reena Oza-Frank7,8. 1. Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, 700 Children's Drive, Columbus, OH, 43205, USA. 2. Department of Pediatrics, College of Medicine, The Ohio State University, 370 W. 9th Avenue, Columbus, OH, 43210, USA. 3. Division of Epidemiology, College of Public Health, The Ohio State University, 250 Cunz Hall, 1841 Neil Avenue, Columbus, OH, 43210, USA. 4. Department of Obstetrics and Gynecology, College of Medicine, The Ohio State University, 370 W. 9th Avenue, Columbus, OH, 43210, USA. 5. Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, 700 Children's Drive, Columbus, OH, 43205, USA. 6. Department of Pediatric Endocrinology, Nationwide Children's Hospital, 700 Children's Drive, Columbus, OH, 43205, USA. 7. Department of Obstetrics and Gynecology, College of Medicine, The Ohio State University, 370 W. 9th Avenue, Columbus, OH, 43210, USA. reena.oza-frank@odh.ohio.gov. 8. Ohio Department of Health, 246 N High Street, Columbus, OH, 43215, USA. reena.oza-frank@odh.ohio.gov.
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.
RCT Entities:
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.
Entities:
Keywords:
Clinical trial; Exercise; Gestational diabetes mellitus; Lifestyle intervention; Physical activity; Prevention of type 2 diabetes mellitus; Weight loss
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