Physical Activity Intervention for Gestational Diabetes
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/18/2018 |
| Start Date: | September 10, 2018 |
| End Date: | December 31, 2021 |
Gestational diabetes mellitus (GDM) portends immediate, increased risk for both type 2
diabetes mellitus (T2DM). These increased risks are 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 and/or delay T2DM.Our long-term goal
is to prevent T2DM among women with GDM. The objective here is to evaluate the efficacy of a
simple, novel, activity-boosting intervention on weight loss among women with GDM.
diabetes mellitus (T2DM). These increased risks are 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 and/or delay T2DM.Our long-term goal
is to prevent T2DM among women with GDM. The objective here is to evaluate the efficacy of a
simple, novel, activity-boosting intervention on weight loss among women with GDM.
Gestational diabetes mellitus (GDM) portends immediate, increased risk for both type 2
diabetes mellitus (T2DM). These increased risks are 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 and/or delay T2DM. The long-term
goal is to prevent T2DM among women with GDM. The objective here is to evaluate the efficacy
of a simple, novel, 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, etc.)) 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, resulting in more and clinically significant weight loss compared with controls
who only receive standard information on recommended physical activity. The rationale for the
proposed research is that once an intervention that women with GDM will adopt and improves
T2DM risk factors is known, early intervention specific to this restricted time can be
implemented.
diabetes mellitus (T2DM). These increased risks are 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 and/or delay T2DM. The long-term
goal is to prevent T2DM among women with GDM. The objective here is to evaluate the efficacy
of a simple, novel, 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, etc.)) 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, resulting in more and clinically significant weight loss compared with controls
who only receive standard information on recommended physical activity. The rationale for the
proposed research is that once an intervention that women with GDM will adopt and improves
T2DM risk factors is known, early intervention specific to this restricted time can be
implemented.
Inclusion Criteria:
- Age 18+ years
- 30-40 weeks' gestation
- Diagnosed with GDM in current pregnancy
- English language ability adequate for participating
- 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 multiple (i.e. twin, triple, 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), or taking medications affecting body weight
- Live outside 35 mile radius
- Woman is an appointed surrogate
- Infant will be adopted after delivery
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