A Low Glycemic Load Diet During Pregnancy in Overweight W... | NCT00364403

Studies
A Low Glycemic Load Diet During Pregnancy in Overweight Women

NCT00364403

Sponsor

Boston Children's Hospital

Status

Completed

Last Update Posted

Aug 30, 2010Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Overweight
Pregnancy

Interventions

Low glycemic load
Low fat diet

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R03DK073335	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Aug 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

Dec 2009Actual

Completion Date

Feb 2010Actual

First Submitted Date

Aug 14, 2006

First Submission Date that Met QC Criteria

Aug 14, 2006

First Posted Date

Aug 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2010

Last Update Posted Date

Aug 30, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Boston Children's HospitalOTHER

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Low glycemic load diet	Behavioral: Low glycemic load
2	Active Comparator	Low fat diet	Behavioral: Low fat diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low glycemic load	Behavioral	Provision of foods and dietary counseling to promote a low glycemic load diet	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Maternal energy intake		During pregnancy
Maternal weight gain		During pregnancy
Maternal insulin resistance assessed by HOMA

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital Boston		Boston	Massachusetts	02115	United States
Beth Israel Deaconess Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20962162	Derived	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.

ID	Term
D050177	Overweight
D018149	Glucose Intolerance

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

ID	Term
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics
D004032	Diet
D009747