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A Low Glycemic Load Diet During Pregnancy in Overweight Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00364403
First Posted: August 15, 2006
Last Update Posted: August 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Thrasher Research Fund
Beth Israel Deaconess Medical Center
Information provided by:
Boston Children’s Hospital
  Purpose
This study will compare the effects of a low glycemic load versus standard diet for pregnancy on outcomes related to risk for obesity, diabetes, and heart disease in both mother and infant.

Condition Intervention
Overweight Pregnancy Behavioral: Low glycemic load Behavioral: Low fat diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Glycemic Load and Infant Birth Weight in Pregnant Overweight/Obese Women

Resource links provided by NLM:


Further study details as provided by Boston Children’s Hospital:

Primary Outcome Measures:
  • Birth weight as assessed by z-scores [ Time Frame: At birth ]

Secondary Outcome Measures:
  • Maternal energy intake [ Time Frame: During pregnancy ]
  • Maternal weight gain [ Time Frame: During pregnancy ]
  • Maternal insulin resistance assessed by HOMA [ Time Frame: During pregnancy ]
  • Maternal metabolic syndrome components [ Time Frame: During pregnancy ]
  • Infant body composition (ponderal index, skinfold thickness) [ Time Frame: At birth ]
  • Cord blood glucose [ Time Frame: At birth ]
  • cord blood insulin [ Time Frame: At birth ]
  • cord blood leptin [ Time Frame: At birth ]

Estimated Enrollment: 60
Study Start Date: February 2007
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Low glycemic load diet
Behavioral: Low glycemic load
Provision of foods and dietary counseling to promote a low glycemic load diet
Active Comparator: 2
Low fat diet
Behavioral: Low fat diet
Provision of foods and dietary counseling to promote a low fat diet

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women with prepregnant or first trimester BMI equal to or greater than 25 kg/m2 and less than 45 kg/m2
  • Singleton pregnancy
  • Willing to consume the diets for duration of pregnancy
  • Participant to be at week 28 or less of pregnancy at baseline visit

Exclusion Criteria:

  • Smoking during pregnancy
  • Major medical illness (e.g., diabetes mellitus, hypertension, thyroid disease)
  • Patients taking prescription medication known to affect body weight
  • Alcohol consumption during pregnancy
  • Patients who declare their intention to deliver infants in the environment outside of Beth Israel Deaconess Medical Center, Boston
  • High level of physical activity
  Contacts and Locations
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): NCT00364403


Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Sponsors and Collaborators
Boston Children’s Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Thrasher Research Fund
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: David S Ludwig, MD, PhD Boston Children’s Hospital
Study Director: Erinn Rhodes, MD Boston Children’s Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Ludwig, MD, PhD, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00364403     History of Changes
Other Study ID Numbers: R03DK073335 ( U.S. NIH Grant/Contract )
First Submitted: August 14, 2006
First Posted: August 15, 2006
Last Update Posted: August 30, 2010
Last Verified: August 2010

Keywords provided by Boston Children’s Hospital:
Glycemic index
Glycemic load
Low fat
Impaired glucose tolerance
Large for gestational age infant
Excessive body weight

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms