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

Primary Purpose

Maternal Obesity Complicating Pregnancy, Birth,or Puerperium, Gestational Diabetes Mellitus, Birthweight

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Low-glycemic index group
Standard Care Group
Sponsored by
University of Modena and Reggio Emilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Maternal Obesity Complicating Pregnancy, Birth,or Puerperium

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Mother-Infant Department, University of Modena and Reggio Emilia, ItalyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Low-Glycemic Index Group

Standard Care Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Large-for-gestational-age (LGA) occurrence
LGA babies were defined if birthweight centile was ≥ 90°, and it was measured at delivery
Gestational Diabetes Mellitus (GDM) occurrence
The diagnosis of GDM was made for any glucose value exceeding the normal cut-off, according to the Guidelines

Secondary Outcome Measures

Gestational Weight Gain (GWG)
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.
Pre-term Birth (PTB)
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.
Neonatal hypoglycemia
Altered maternal glucose metabolism is associated with neonatal hypoglicemia
Neonatal Intensive Care Unit (NICU) admission
Maternal overweight and obesity are related to higher prevalence of neonatal complications

Full Information

First Posted
April 14, 2016
Last Updated
April 20, 2016
Sponsor
University of Modena and Reggio Emilia
Collaborators
Dr. Elisabetta Petrella
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1. Study Identification

Unique Protocol Identification Number
NCT02750774
Brief Title
An Early-customized Low Glycaemic-index (GI) Diet Prevents LGA Babies in Overweight/Obese Pregnant Women
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 Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Modena and Reggio Emilia
Collaborators
Dr. Elisabetta Petrella

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Obesity Complicating Pregnancy, Birth,or Puerperium, Gestational Diabetes Mellitus, Birthweight, Large for Gestational Age (LGA), Caloric Restriction, Lifestyle Intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-Glycemic Index Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care Group
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Low-glycemic index group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Care Group
Intervention Description
Women randomized to the Standard Care Group received general information about healthy lifestyle during pregnancy, according to the Guidelines
Primary Outcome Measure Information:
Title
Large-for-gestational-age (LGA) occurrence
Description
LGA babies were defined if birthweight centile was ≥ 90°, and it was measured at delivery
Time Frame
At delivery
Title
Gestational Diabetes Mellitus (GDM) occurrence
Description
The diagnosis of GDM was made for any glucose value exceeding the normal cut-off, according to the Guidelines
Time Frame
At 24-26 weeks
Secondary Outcome Measure Information:
Title
Gestational Weight Gain (GWG)
Description
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.
Time Frame
At baseline, at 16, 20, 28 and 36 weeks, at delivery and 3 months after delivery
Title
Pre-term Birth (PTB)
Description
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.
Time Frame
At delivery
Title
Neonatal hypoglycemia
Description
Altered maternal glucose metabolism is associated with neonatal hypoglicemia
Time Frame
Within 24 hours after delivery
Title
Neonatal Intensive Care Unit (NICU) admission
Description
Maternal overweight and obesity are related to higher prevalence of neonatal complications
Time Frame
Within 24 hours after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Mother-Infant Department, University of Modena and Reggio Emilia, Italy
City
Modena
ZIP/Postal Code
41124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabio Fachhinetti, MD
Phone
0039 0594222512
Email
facchi@unimore.it
First Name & Middle Initial & Last Name & Degree
Elisabetta Petrella, MD
First Name & Middle Initial & Last Name & Degree
Valentina Bertarini, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes

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

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