Contemporary Clinical Trials Communications (Jun 2020)

Electronic Monitoring Of Mom's Schedule (eMOMS™): Protocol for a feasibility randomized controlled trial to improve postpartum weight, blood sugars, and breastfeeding among high BMI women

  • Lisette T. Jacobson,
  • Tracie C. Collins,
  • Meredith Lucas,
  • Rosey Zackula,
  • Hayrettin Okut,
  • Niaman Nazir,
  • David Robbins,
  • Judy E. Stern,
  • Michael Wolfe,
  • David A. Grainger

Journal volume & issue
Vol. 18
p. 100565

Abstract

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Background: Overweight and obesity are major risk factors for gestational diabetes among U.S. women. Evidence suggests that longer duration of breastfeeding among women with a history of gestational diabetes is associated with lower incidence of developing type 2 diabetes after pregnancy. Women may potentially benefit from a lifestyle change program that includes breastfeeding education and support. Purpose: To describe the design and justification of a combined breastfeeding, national Diabetes Prevention Program (DPP)-based feasibility randomized controlled trial, the electronic Monitoring Of Mom's Schedule (eMOMSTM) study. eMOMSTM compares the feasibility and efficacy of three interventions on six-month postpartum weight loss among women with a BMI ≥25. Methods: The intervention is delivered via Facebook and includes three groups: DPP and breastfeeding (eMOMS1); DPP only (eMOMS2); and Usual Care (eMOMS3). Recruitment is ongoing at two clinical sites (rural and urban). A total of 72 women, 24 per group, will be randomly assigned to one of the three groups. It is anticipated that women in eMOMS1 will have greater weight loss and increased length of breastfeeding at three and six months postpartum compared to women in eMOMS2 and eMOMS3. Additional data will be collected on metabolic markers, anthropometrics, physical activity, nutrition, breastfeeding, and depression. Program cost will be compared to that of traditionally scheduled group meetings. Expected study completion date: October 2021. Conclusions: This study has the potential to define a high impact, cost effective intervention that can improve public health by reducing negative health outcomes associated with gestational diabetes among an at-risk population.

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