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Completed

NCT Number: NCT00364403

A Low Glycemic Load Diet During Pregnancy in Overweight 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.

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Key information

Conditions

Overweight Body Weight Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Pregnancy Signs and Symptoms

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low glycemic load

Behavioral

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

Low Fat Diet

Behavioral

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

Primary outcomes

  1. Birth weight as assessed by z-scores

    Time frame: At birth

Secondary outcomes

  1. Maternal energy intake

    Time frame: During pregnancy

  2. Maternal weight gain

    Time frame: During pregnancy

  3. Maternal insulin resistance assessed by HOMA

    Time frame: During pregnancy

  4. Maternal metabolic syndrome components

    Time frame: During pregnancy

  5. Infant body composition (ponderal index, skinfold thickness)

    Time frame: At birth

  6. Cord blood glucose

    Time frame: At birth

  7. cord blood insulin

    Time frame: At birth

  8. cord blood leptin

    Time frame: At birth

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

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

Registry information

Official study title

Glycemic Load and Infant Birth Weight in Pregnant Overweight/Obese Women

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Aug 15, 2006
Registry last updated
Aug 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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