A Low Glycemic Load Diet During Pregnancy in Overweight Women

August 27, 2010 updated by: Boston Children's Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston
      • Boston, Massachusetts, United States
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Birth weight as assessed by z-scores
Time Frame: At birth
At birth

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Collaborators

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

Investigators

  • Study Director: Erinn Rhodes, MD, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

August 14, 2006

First Submitted That Met QC Criteria

August 14, 2006

First Posted (Estimate)

August 15, 2006

Study Record Updates

Last Update Posted (Estimate)

August 30, 2010

Last Update Submitted That Met QC Criteria

August 27, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R03DK073335 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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