NCT03664089

Physical Activity Intervention for Gestational Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Sarah Keim · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Gestational diabetes mellitus (GDM) portends an immediate, increased risk for Type 2 diabetes mellitus (T2DM). The increased risk associated with having GDM is compounded by excess weight retention. Therefore, the weeks and months immediately after a GDM-complicated pregnancy present an optimal window to initiate lifestyle changes to prevent or delay T2DM. The long-term goal is to prevent T2DM among women with GDM. This study's objective is to evaluate the efficacy of a novel, yet simple, activity-boosting intervention on weight loss among women with GDM.

Detailed description

Gestational diabetes mellitus (GDM) portends an immediate, increased risk for Type 2 diabetes mellitus (T2DM). The increased risk associated with having GDM is compounded by excess weight retention, a common issue after any pregnancy. Considering excess weight is the best predictor of developing T2DM, the weeks and months immediately after a GDM-complicated pregnancy present an optimal window to initiate lifestyle changes to prevent or delay T2DM. The long-term goal is to prevent T2DM among women with GDM. This study's objective is to evaluate the efficacy of a novel, yet simple, activity-boosting intervention on weight loss among women with GDM in a parallel two-arm randomized controlled trial (n=80 women/arm, N=160). The intervention uses ankle weights (2.5 pounds \[1.1 kg\]) worn on each ankle during routine daily activities (e.g., cleaning, cooking, child care) to increase energy expenditure. The central hypothesis, based on existing literature and preliminary data, is that postpartum women with GDM will adopt an intervention that requires minimal additional time outside of their daily activities. We anticipate that this will result in additional weight loss that is clinically significant when compared with controls who only receive standard information on recommended physical activity. The rationale for the proposed research is that once an intervention that both improves T2DM factors and is easily adopted by women with GDM is known, early intervention specific to this restricted timeframe can be implemented.

Conditions

• Gestational Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	Ankle weights (2.5 pounds [1.1 kg]/ankle)	Women will receive the standard recommendation for engaging in 150 minutes of physical activity per week, ankle weights (2.5 pounds \[1.1 kg\]/ankle), documentation for ankle weight usage, an accelerometer, and instructions for accelerometer usage.
BEHAVIORAL	Control	Women will receive the standard recommendation for engaging in 150 minutes of physical activity per week.

Timeline

• Start date: 2018-09-10
• Primary completion: 2022-02-22
• Completion: 2022-07-01
• First posted: 2018-09-10
• Last updated: 2022-07-20

Locations

1 site across 1 country: United States