A Low Glycemic Load Diet During Pregnancy in Overweight Women

This study has been completed.

First Received on August 14, 2006. Last Updated on August 27, 2010 History of Changes

Sponsor:	Children's Hospital Boston
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

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:

MedlinePlus related topics: Diabetes Medicines Obesity

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):

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.

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 February 09, 2012