Back to resultsA Low Glycemic Load Diet During Pregnancy in Overweight Women
Primary Purpose
Overweight, Pregnancy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low glycemic load
Low fat diet
Sponsored by
About this trial
This is an interventional prevention trial for Overweight focused on measuring Glycemic index, Glycemic load, Low fat, Impaired glucose tolerance, Large for gestational age infant, Excessive body weight
Eligibility 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
Sites / Locations
- Children's Hospital Boston
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Low glycemic load diet
Low fat diet
Outcomes
Primary Outcome Measures
Birth weight as assessed by z-scores
Secondary Outcome Measures
Maternal energy intake
Maternal 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
Full Information
NCT ID
NCT00364403
First Posted
August 14, 2006
Last Updated
August 27, 2010
Sponsor
Boston Children's Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Thrasher Research Fund, Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00364403
Brief Title
A Low Glycemic Load Diet During Pregnancy in Overweight Women
Official Title
Glycemic Load and Infant Birth Weight in Pregnant Overweight/Obese Women
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Boston Children's Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Thrasher Research Fund, Beth Israel Deaconess Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Pregnancy
Keywords
Glycemic index, Glycemic load, Low fat, Impaired glucose tolerance, Large for gestational age infant, Excessive body weight
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Low glycemic load diet
Arm Title
2
Arm Type
Active Comparator
Arm Description
Low fat diet
Intervention Type
Behavioral
Intervention Name(s)
Low glycemic load
Intervention Description
Provision of foods and dietary counseling to promote a low glycemic load diet
Intervention Type
Behavioral
Intervention Name(s)
Low fat diet
Intervention Description
Provision of foods and dietary counseling to promote a low fat diet
Primary Outcome Measure Information:
Title
Birth weight as assessed by z-scores
Time Frame
At birth
Secondary Outcome Measure Information:
Title
Maternal energy intake
Time Frame
During pregnancy
Title
Maternal weight gain
Time Frame
During pregnancy
Title
Maternal insulin resistance assessed by HOMA
Time Frame
During pregnancy
Title
Maternal metabolic syndrome components
Time Frame
During pregnancy
Title
Infant body composition (ponderal index, skinfold thickness)
Time Frame
At birth
Title
Cord blood glucose
Time Frame
At birth
Title
cord blood insulin
Time Frame
At birth
Title
cord blood leptin
Time Frame
At birth
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S Ludwig, MD, PhD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erinn Rhodes, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20962162
Citation
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. doi: 10.3945/ajcn.2010.30130. Epub 2010 Oct 20.
Results Reference
derived
Learn more about this trial
A Low Glycemic Load Diet During Pregnancy in Overweight Women
We'll reach out to this number within 24 hrs