Physical Activity Intervention for Gestational Diabetes (GDM)

Sarah Keim

Status: Completed

Conditions: Gestational Diabetes

Treatments: Behavioral: Ankle weights (2.5 pounds [1.1 kg]/ankle); Behavioral: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03664089

18-00178

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18+ years
• Diagnosed with GDM in current pregnancy
• English language ability adequate for participation
• Plan to remain in the area for study duration
• Ability to provide informed consent

Exclusion criteria

• Prior Type 1 or Type 2 diabetes
• Pregnant with multiples (e.g., twin, triplets, etc.)
• Premature infant [<35 completed weeks gestation (assessed after delivery, before randomization)]
• Heart disease, serious illness, or conditions that may impede or prohibit participation in either study arm
• Pre-pregnancy BMI <18.5 (underweight)
• Live outside 35 mile radius of Ohio State University
• Woman is an appointed surrogate
• Infant will be adopted after delivery

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

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), instructions on ankle weight usage (wear during normal activity for 2 hours/day, 7 days/week). The weight type and weight amount were chosen based on previously published literature and used in our preliminary work.

Treatment:

Behavioral: Ankle weights (2.5 pounds [1.1 kg]/ankle)

Control

Placebo Comparator group

Description:

All women in the control group will receive the standard recommendation for engaging in 150 minutes of physical activity per week.

Treatment:

Behavioral: Control