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

Autor: David C. Robbins, Rosey Zackula, Lisette T. Jacobson, Hayrettin Okut, Michael Wolfe, Judy E. Stern, David A. Grainger, Tracie C. Collins, Niaman Nazir, Meredith Lucas
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: Contemporary Clinical Trials Communications, Vol 18, Iss, Pp 100565-(2020)
Contemporary Clinical Trials Communications
Contemp Clin Trials Commun
ISSN: 2451-8654
Popis: 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.
Highlights • Delivery of a combined breastfeeding and lifestyle change program via social media. • Comparison of 3 programs on 6-month postpartum weight loss among high-BMI women. • Comparison of 3 programs on length of breastfeeding among high-BMI women. • Programs: lifestyle change and breastfeeding, lifestyle change only, and usual care. • Cost analysis of online program delivery versus in-person meetings.
Databáze: OpenAIRE