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

NCT02750774 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-04-26

No results posted yet for this study

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

Interventions

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.

OTHER

Standard Care Group

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

Sponsors & Collaborators

  • Dr. Elisabetta Petrella

    collaborator UNKNOWN
  • University of Modena and Reggio Emilia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-07-31
Completion
2016-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02750774 on ClinicalTrials.gov