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A Low Glycemic Load Diet During Pregnancy in Overweight Women

This study has been completed.
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Glycemic Load and Infant Birth Weight in Pregnant Overweight/Obese Women

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Birth weight as assessed by z-scores [ Time Frame: At birth ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   25 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Children's Hospital Boston
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 Children's Hospital Boston
Study Director: Erinn Rhodes, MD Children's Hospital Boston
  More Information

No publications provided by Children's Hospital Boston

Additional 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: R03 DK73335, R03DK073335
Study First Received: August 14, 2006
Last Updated: August 27, 2010
Health Authority: United States: Federal Government

Keywords provided by Children's Hospital Boston:
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

ClinicalTrials.gov processed this record on May 16, 2013