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

Tracking Information

First Received Date ^ICMJE

August 14, 2006

Last Updated Date

August 27, 2010

Start Date ^ICMJE

February 2007

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Birth weight as assessed by z-scores

Change History

Complete list of historical versions of study NCT00364403 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Low Glycemic Load Diet During Pregnancy in Overweight Women

Official Title ^ICMJE

Glycemic Load and Infant Birth Weight in Pregnant Overweight/Obese Women

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Overweight
Pregnancy

Intervention ^ICMJE

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

Study Arm (s)

Experimental: 1
Low glycemic load diet

Intervention: Behavioral: Low glycemic load
Active Comparator: 2
Low fat diet

Intervention: Behavioral: Low fat diet

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

February 2010

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

25 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00364403

Other Study ID Numbers ^ICMJE

R03 DK73335, R03DK073335

Has Data Monitoring Committee

Yes

Responsible Party

David Ludwig, MD, PhD, Children's Hospital Boston

Study Sponsor ^ICMJE

Children's Hospital Boston

Collaborators ^ICMJE

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Thrasher Research Fund
Beth Israel Deaconess Medical Center

Investigators ^ICMJE

Principal Investigator:	David S Ludwig, MD, PhD	Children's Hospital Boston
Study Director:	Erinn Rhodes, MD	Children's Hospital Boston

Information Provided By

Children's Hospital Boston

Verification Date

August 2010

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

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