A Low Glycemic Load Diet During Pregnancy in Overweight Women

This study has been completed.
Sponsor:
Collaborators:
Thrasher Research Fund
Beth Israel Deaconess Medical Center
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00364403
First received: August 14, 2006
Last updated: August 27, 2010
Last verified: August 2010

August 14, 2006
August 27, 2010
February 2007
December 2009   (final data collection date for primary outcome measure)
Birth weight as assessed by z-scores [ Time Frame: At birth ] [ Designated as safety issue: No ]
Birth weight as assessed by z-scores
Complete list of historical versions of study NCT00364403 on ClinicalTrials.gov Archive Site
  • Maternal energy intake [ Time Frame: During pregnancy ] [ Designated as safety issue: No ]
  • Maternal weight gain [ Time Frame: During pregnancy ] [ Designated as safety issue: No ]
  • Maternal insulin resistance assessed by HOMA [ Time Frame: During pregnancy ] [ Designated as safety issue: No ]
  • Maternal metabolic syndrome components [ Time Frame: During pregnancy ] [ Designated as safety issue: No ]
  • Infant body composition (ponderal index, skinfold thickness) [ Time Frame: At birth ] [ Designated as safety issue: No ]
  • Cord blood glucose [ Time Frame: At birth ] [ Designated as safety issue: No ]
  • cord blood insulin [ Time Frame: At birth ] [ Designated as safety issue: No ]
  • cord blood leptin [ Time Frame: At birth ] [ Designated as safety issue: No ]
  • Maternal energy intake
  • Maternal third trimester weight gain
  • Maternal insulin resistance assessed by HOMA
  • Maternal metabolic syndrome components
  • Infant body composition (ponderal index, skinfold thickness)
  • Cord blood glucose
  • cord blood insulin
  • cord blood leptin
Not Provided
Not Provided
 
A Low Glycemic Load Diet During Pregnancy in Overweight Women
Glycemic Load and Infant Birth Weight in Pregnant Overweight/Obese Women

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Overweight
  • Pregnancy
  • Behavioral: Low glycemic load
    Provision of foods and dietary counseling to promote a low glycemic load diet
  • Behavioral: Low fat diet
    Provision of foods and dietary counseling to promote a low fat diet
  • Experimental: 1
    Low glycemic load diet
    Intervention: Behavioral: Low glycemic load
  • Active Comparator: 2
    Low fat diet
    Intervention: Behavioral: Low fat diet
Rhodes ET, Pawlak DB, Takoudes TC, Ebbeling CB, Feldman HA, Lovesky MM, Cooke EA, Leidig MM, Ludwig DS. Effects of a low-glycemic load diet in overweight and obese pregnant women: a pilot randomized controlled trial. Am J Clin Nutr. 2010 Dec;92(6):1306-15. Epub 2010 Oct 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
February 2010
December 2009   (final data collection date for primary outcome measure)

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
Female
25 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00364403
R03 DK73335, R03DK073335
Yes
David Ludwig, MD, PhD, Children's Hospital Boston
Children's Hospital Boston
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Thrasher Research Fund
  • Beth Israel Deaconess Medical Center
Principal Investigator: David S Ludwig, MD, PhD Children's Hospital Boston
Study Director: Erinn Rhodes, MD Children's Hospital Boston
Children's Hospital Boston
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP