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

NCT02750774 | Unknown

• 1 other identifier: Pratica CE 136/15
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal Obesity Complicating Pregnancy, Birth,or Puerperium; Gestational Diabetes Mellitus; Birthweight; Large for Gestational Age (LGA); Caloric Restriction; Lifestyle Intervention

Outcome Measures

Primary Outcomes (2)

• Large-for-gestational-age (LGA) occurrence

  LGA babies were defined if birthweight centile was ≥ 90°, and it was measured at delivery

  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

  At 24-26 weeks

Secondary Outcomes (4)

• Gestational Weight Gain (GWG)

  At baseline, at 16, 20, 28 and 36 weeks, at delivery and 3 months after delivery

• Pre-term Birth (PTB)

  At delivery

• Neonatal hypoglycemia

  Within 24 hours after delivery

• Neonatal Intensive Care Unit (NICU) admission

  Within 24 hours after delivery

Study Arms (2)

Low-Glycemic Index Group

EXPERIMENTAL

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

Standard Care Group

OTHER

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

Interventions

Low-glycemic index group BEHAVIORAL

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.

Low-Glycemic Index Group

Standard Care Group OTHER

Women randomized to the Standard Care Group received general information about healthy lifestyle during pregnancy, according to the Guidelines

Standard Care Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Modena and Reggio Emilia: lead
• Dr. Elisabetta Petrella: collaborator

Study Sites (1)

Mother-Infant Department, University of Modena and Reggio Emilia, Italy

Modena, 41124, Italy

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational; Birth Weight

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Fabio Facchinetti

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: April 26, 2016
• Study Start: December 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 26, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)