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

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ClinicalTrials.gov Identifier: NCT02763150
Recruitment Status : Recruiting
First Posted : May 5, 2016
Last Update Posted : February 1, 2018
Sponsor:
Collaborator:
Brown University
Information provided by (Responsible Party):
Suzanne Phelan, California Polytechnic State University-San Luis Obispo

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus Behavioral: Lifestyle intervention Other: Health Promotion Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Gestational Diabetes Prevention Program
Study Start Date : August 2016
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lifestyle Intervention
Intervention group will receive a comprehensive, multicomponent weight loss intervention targeting diet, physical activity, and behavioral strategies.
Behavioral: Lifestyle intervention
Intervention group will receive comprehensive behavioral weight loss program.

Active Comparator: Health Promotion
Health promotion group will receive education on healthy eating and activity before pregnancy.
Other: Health Promotion
The health promotion group will receive education on healthy eating and activity




Primary Outcome Measures :
  1. Incidence of Gestational Diabetes Mellitus [ Time Frame: 26 weeks gestation ]

Secondary Outcome Measures :
  1. Changes in maternal levels of fasting glucose [ Time Frame: study entry, 16 weeks, 26 weeks gestation ]
  2. Changes in maternal levels of fasting insulin [ Time Frame: study entry, 16 weeks, 26 weeks gestation ]
  3. Changes in maternal levels of systolic and diastolic blood pressure [ Time Frame: study entry, 16 weeks, 26 weeks gestation ]
  4. Changes in maternal levels of C-reactive protein [ Time Frame: study entry, 16 weeks, 26 weeks gestation ]
  5. Incidence of preeclampsia [ Time Frame: Delivery ]
  6. Incidence of cesarean delivery [ Time Frame: Delivery ]
  7. Weight changes [ Time Frame: study entry, 16 weeks, 26 weeks gestation ]
  8. Daily caloric intake [ Time Frame: study entry, 16 weeks, 26 weeks gestation ]
  9. Minutes per week of moderate physical activity [ Time Frame: study entry, 16 weeks, 26 weeks gestation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02763150


Contacts
Contact: Casey Heaney, MS 805 756 5365 heaney@calpoly.edu
Contact: Angelica McHugh, MS 401 793 8978 amchugh1@lifespan.org

Locations
United States, California
California Polytechnic State University Recruiting
San Luis Obispo, California, United States, 93401
Contact: Casey Heaney, B.S.    805-756-5365    heaney@calpoly.edu   
Principal Investigator: Suzanne Phelan, PhD         
United States, Rhode Island
Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Angelica McHugh, MS    401-793-8978    amchugh1@lifespan.org   
Principal Investigator: Rena R Wing, PhD         
Sponsors and Collaborators
California Polytechnic State University-San Luis Obispo
Brown University
Investigators
Principal Investigator: Suzanne Phelan, PhD California Polytechnic State University-San Luis Obispo

Responsible Party: Suzanne Phelan, Professor, California Polytechnic State University-San Luis Obispo
ClinicalTrials.gov Identifier: NCT02763150     History of Changes
Other Study ID Numbers: CP-GDPP-trial
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A de-identified dataset will be made available to outside investigators after the primary and secondary analyses are completed and in accordance with local institutional review board and NIH policies.

Keywords provided by Suzanne Phelan, California Polytechnic State University-San Luis Obispo:
Gestational Diabetes Prevention

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications