Effects of a Lifestyle Intervention on Gestational Diabetes Management

Nevada System of Higher Education (NSHE)

Status: Completed

Conditions: Gestational Diabetes; Nutritional and Metabolic Disease; Type 2 Diabetes

Treatments: Behavioral: Dietary Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04861324

1610677

Details and patient eligibility

About

The purpose of this study is to investigate the effects of nutrition education focusing on colorful fruit and vegetable intake with after-meal physical activity guidance on glycemic control and complications in women with gestational diabetes and pre-gestational diabetes.

Full description

Diabetes (high blood sugar) developed during pregnancy can be harmful to the mother as it can lead to delivery complications because of a large baby and increases risks of type 2 diabetes and heart disease in the mother and baby in later life. Thus, pregnancy is a critical time during the human lifespan to make effective dietary changes that are safe for both mother and the fetus and reduce risks of developing diabetes and pregnancy complications. Women at risk for gestational diabetes will be randomly assigned to the standard care or the nutrition education group. Blood draws and other biomedical measures will be collected at baseline and at end of the study before delivery.

Enrollment: 45 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• high risk for gestational diabetes
• willing to make lifestyle changes
• history of diabetes

Exclusion criteria

• carrying more than one fetus
• history of chronic conditions except diabetes and hypertension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 2 patient groups

Prenatal Care/Nutrition Education

No Intervention group

Description:

Standard prenatal care with primary care physician with USDA-based federal guidelines

Fruit/veggie + postprandial physical activity

Experimental group

Description:

Nutrition education on increasing fruit and vegetable consumption and physical education on increasing postprandial physical activity for the duration from GDM diagnosis till delivery

Treatment:

Behavioral: Dietary Intervention