A Low Glycemic Load Diet During Pregnancy in Overweight Women

NCT ID: NCT00364403

Last Updated: 2010-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2010-02-28

Brief Summary

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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

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Conditions

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Overweight Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Low glycemic load diet

Group Type EXPERIMENTAL

Low glycemic load

Intervention Type BEHAVIORAL

Provision of foods and dietary counseling to promote a low glycemic load diet

2

Low fat diet

Group Type ACTIVE_COMPARATOR

Low fat diet

Intervention Type BEHAVIORAL

Provision of foods and dietary counseling to promote a low fat diet

Interventions

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Low glycemic load

Provision of foods and dietary counseling to promote a low glycemic load diet

Intervention Type BEHAVIORAL

Low fat diet

Provision of foods and dietary counseling to promote a low fat diet

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Thrasher Research Fund

OTHER

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role collaborator

Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Children's Hospital Boston

Principal Investigators

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David S Ludwig, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Erinn Rhodes, MD

Role: STUDY_DIRECTOR

Boston Children's Hospital

Locations

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Children's Hospital Boston

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 20962162 (View on PubMed)

Other Identifiers

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R03DK073335

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R03DK073335

Identifier Type: NIH

Identifier Source: org_study_id

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