Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Early-customized Low Glycaemic-index (GI) Diet Prevents LGA Babies in Overweight/Obese Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02750774
Recruitment Status : Unknown
Verified April 2016 by Prof. Facchinetti Fabio, University of Modena and Reggio Emilia.
Recruitment status was:  Recruiting
First Posted : April 26, 2016
Last Update Posted : April 26, 2016
Sponsor:
Collaborator:
Dr. Elisabetta Petrella
Information provided by (Responsible Party):
Prof. Facchinetti Fabio, University of Modena and Reggio Emilia

Brief Summary:

High pre-pregnancy body mass index (BMI) and excessive gestational weight gain (GWG) are associated with many unfavourable maternal and neonatal outcomes.

Adherence to lifestyle recommendations could be a major determinant of the efficacy on preventing unfavorable outcomes, namely among overweight/obese women. Previous studies investigated adherence to specific dietary patterns and their effect on pregnancy outcomes; however, no study has investigated adherence among overweight/obese pregnant women and its effect on the onset of several maternal-neonatal outcomes.

This study aimed to determine whether the prescription of a lifestyle program, consisting of a customized low-glycemic index (GI) diet and a physical activity program, in overweight and obese women could affect the occurrence LGA babies. It also aimed to determine whether this kind of prescription influences the adherence to healthier eating habits, and how this, in turn, can influence the occurrence LGA.


Condition or disease Intervention/treatment Phase
Maternal Obesity Complicating Pregnancy, Birth,or Puerperium Gestational Diabetes Mellitus Birthweight Large for Gestational Age (LGA) Caloric Restriction Lifestyle Intervention Behavioral: Low-glycemic index group Other: Standard Care Group Not Applicable

Detailed Description:

High pre-pregnancy BMI and excessive GWG are associated with many unfavourable maternal and neonatal outcomes and are independent risk factors for gestational diabetes mellitus (GDM) and large for gestatiola age (LGA) babies. Overweight/obese women should be counselled regarding their body weight before conception; however, most women have access to obstetricians only when they are pregnant. The Institute of Medicine (IOM) revised the guidelines of recommended GWG according to the BMI; however, only a minority of women succeed in reaching the recommended GWG. Among the interventions aimed at preventing excessive GWG, few have demonstrated efficacy in high-risk populations; the principal issues are population heterogeneity, the interventional methods, and the timing of the interventional programs. Additionally, lifestyle interventions did not have a substantial effect on other clinical outcomes. Dietary advice to prevent gestational diabetes mellitus (GDM) appears to be beneficial in general, although the results are overly heterogeneous. A systematic review concerning exercise alone demonstrated no effect on preventing GDM, whereas another study showed only a slight protective effect. The reports evaluating the efficacy of diverse approaches (exercise, diet, lifestyle interventions, dietary supplements) to prevent GDM are of poor quality. Adherence to lifestyle recommendations could be a major determinant of their efficacy, specifically among overweight/obese women. Previous studies investigated adherence to specific dietary patterns and their effect on pregnancy outcomes; however, no study has investigated adherence among overweight/obese pregnant women and its effect on the onset of GDM. Nowadays, there are insufficient evidences for recommend a specific diet in preventing LGA babies.

This study aimed to determine whether the prescription of an early lifestyle program, consisting of a low-glycemic index (GI) caloric restriction and physical activity (PA), in overweight and obese women could affect the occurrence of LGA newborns. It also aimed to determine whether this kind of prescription influences the adherence to healthier eating habits, and how this, in turn, can influence the occurrence of LGA babies.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Customized Low Glycaemic-index (GI) Diet, Introduced at First Trimester of Pregnancy by Both Gynecologist and Dietitian, Prevents Large for Gestational Age (LGA) Newborns in Overweight/Obese Pregnant Women
Study Start Date : December 2015
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low-Glycemic Index Group
Women in the low- glycaemic index group received a dietary intervention based on 3 main meals and 3 snacks, with a precise macronutrient composition, and a physical activity counseling according to the ACOG and ACSM recommendations.
Behavioral: Low-glycemic index group
The dietary intervention consisted of the prescription of a Mediterranean style, low-glycaemic, low-fat, exchange diet (3 main meals and 3 snacks) with a total intake of 1500 kcal/day. In light of the PA, the dietitian adds 200 kcal/day for obese, 300 kcal/day for overweight women. The diet had a target macronutrient composition of 55% carbohydrates (80% complex carbohydrates with a low glycaemic index and 20% simple carbohydrates), 20% protein (50% animal and 50% vegetable) and 25% fat (12% mono-unsaturated, 7% polyunsaturated and 6% saturated) with moderately low saturated fat levels. The daily intake of carbohydrates was at least 225 g/day. The exercise intervention was focused on developing a more active lifestyle. The PA prescription is consistent with recommendations by the ACOG and ACSM for pregnant women. The "talk test" (being able to maintain a conversation during activity) was suggested to monitor the exercise intensity.

Standard Care Group
Women in the Standard Care Group received a simple nutritional booklet regarding lifestyle, which was in agreement with the Italian Guidelines for a healthy diet during pregnancy that included general advice regarding food consumption and physical activity.
Other: Standard Care Group
Women randomized to the Standard Care Group received general information about healthy lifestyle during pregnancy, according to the Guidelines




Primary Outcome Measures :
  1. Large-for-gestational-age (LGA) occurrence [ Time Frame: At delivery ]
    LGA babies were defined if birthweight centile was ≥ 90°, and it was measured at delivery

  2. Gestational Diabetes Mellitus (GDM) occurrence [ Time Frame: At 24-26 weeks ]
    The diagnosis of GDM was made for any glucose value exceeding the normal cut-off, according to the Guidelines


Secondary Outcome Measures :
  1. Gestational Weight Gain (GWG) [ Time Frame: At baseline, at 16, 20, 28 and 36 weeks, at delivery and 3 months after delivery ]
    Excessive GWG is related to unfavorable pregnancy outcomes. Weight gain is measured at each follow-up visit, at delivery and 3 months after delivery in both groups, to evaluate possible effects of the intervention.

  2. Pre-term Birth (PTB) [ Time Frame: At delivery ]
    Both spontaneous and medically indicated preterm births are associated with obesity. We recorded cases of preterm birth, if it was spontaneous or not and the eventual indication.

  3. Neonatal hypoglycemia [ Time Frame: Within 24 hours after delivery ]
    Altered maternal glucose metabolism is associated with neonatal hypoglicemia

  4. Neonatal Intensive Care Unit (NICU) admission [ Time Frame: Within 24 hours after delivery ]
    Maternal overweight and obesity are related to higher prevalence of neonatal complications



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age >18 years
  • singleton pregnancy
  • BMI >= 25 kg/m2

Exclusion Criteria:

  • Chronic diseases including diabetes mellitus (first trimester glycosuria> 100 mg/dl or fasting plasma glucose ≥126 mg/dL or random glycemia ≥ 200 mg/dL) and hypertension
  • Previous GDM
  • Medical conditions or dietary supplements that might affect the body weight (i.e., thyroid diseases)
  • Previous bariatric surgery
  • Smoking habits
  • Contraindications to exercise
  • Intent to deliver outside our hospital

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750774


Locations
Layout table for location information
Italy
Mother-Infant Department, University of Modena and Reggio Emilia, Italy Recruiting
Modena, Italy, 41124
Contact: Fabio Fachhinetti, MD    0039 0594222512    facchi@unimore.it   
Sub-Investigator: Elisabetta Petrella, MD         
Sub-Investigator: Valentina Bertarini, PhD         
Sponsors and Collaborators
University of Modena and Reggio Emilia
Dr. Elisabetta Petrella

Layout table for additonal information
Responsible Party: Prof. Facchinetti Fabio, Professor Fabio Facchinetti, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT02750774     History of Changes
Other Study ID Numbers: Pratica CE 136/15
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: April 26, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes, Gestational
Pregnancy Complications
Fetal Macrosomia
Diabetes Mellitus
Overweight
Birth Weight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms
Fetal Diseases
Pregnancy in Diabetics
Diabetes Complications