Pre-pregnancy Lifestyle Intervention to Prevent the Recurrence of Gestational Diabetes in Overweight and Obese Women

California Polytechnic State University (Cal Poly)

Status: Completed

Conditions: Gestational Diabetes Mellitus

Treatments: Behavioral: Lifestyle intervention; Other: Health Promotion

Study type: Interventional

Funder types: Other

Identifiers

NCT02763150

CP-GDPP-trial

Details and patient eligibility

About

The overall purpose of this study is to determine the efficacy of a pre-pregnancy lifestyle intervention to reduce the recurrence of gestational diabetes mellitus in multiethnic women with overweight or obesity.

Enrollment: 199 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Prior diagnosis of gestational diabetes.
• BMI > 25 kg/m2
• Planning to have a baby in the next 1-3 years
• English or Spanish speaking

Exclusion criteria

• Age less than 18 years
• Women with Type 2 or Type 1 diabetes
• Current pregnancy
• Relocating in the next 2 years
• Medications that affect weight/diabetes
• Serious current physical disease
• History of eating disorders
• History of bariatric surgery
• Current problems with drug abuse
• Current treatment of a serious psychological disorder

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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199 participants in 2 patient groups

Lifestyle Intervention

Experimental group

Description:

Intervention group will receive a comprehensive, multicomponent weight loss intervention targeting diet, physical activity, and behavioral strategies.

Treatment:

Behavioral: Lifestyle intervention

Health Promotion

Active Comparator group

Description:

Health promotion group will receive education on healthy eating and activity before pregnancy.

Treatment:

Other: Health Promotion