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

C

California Polytechnic State University (Cal Poly)

Status

Completed

Conditions

Gestational Diabetes Mellitus

Treatments

Other: Health Promotion
Behavioral: Lifestyle intervention

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

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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