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Pregnancy Complications in Women With BMI>25 kg/m2 Enrolled in a Healthy Lifestyle and Eating Habits Program (TLC)

This study is currently recruiting participants.
Verified February 2013 by University of Modena and Reggio Emilia
Sponsor:
Information provided by (Responsible Party):
Prof. Facchinetti Fabio, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier:
NCT01783210
First received: January 28, 2013
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

The investigators evaluate if changing eating habits and introducing a correct lifestyle in women with BMI >25 Kg/m2 would improve unfavorable maternal-fetal outcomes associated with excessive weight gain (EWG) during pregnancy. To pursue these goals, eligible women are randomly assigned to no intervention (Control group) that receive only a simple nutritional booklet about lifestyle and healthy diet during pregnancy without explicit caloric restriction or the Therapeutic Lifestyle Changes Program (TLC group) that receive a caloric restriction (1500 Kcal/day divided in3 main meals and 3 snacks + 300 kcal/die for overweight or 200 kcal/die for obese women submitted to energy expenditure program) associated to a mild physical activity (30 minutes at least 3 days/week) The investigators use a tool that could easily and practically evaluate not only total GWG at term, but also changes in maternal body composition: the bioimpedance analyzer. Needing, moreover, a simple and not harmful device that could assess effective energy expenditure and the adherence by pregnant women to prenatal exercise, the investigators use SenseWear system armband (SWA).


Condition Intervention
Maternal Obesity Complicating Pregnancy, Birth, or Puerperium
Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled
Exercise Addiction
High-Risk Pregnancy
Dietary Modification
 Behavioral: Specific Therapeutic Lifestyle Changes program during pregnancy
Behavioral: Generic dietary and behavioral counselling about lifestyle during pregnancy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pregnancy Complications in Women With BMI>25 kg/m2 Enrolled in a Healthy Lifestyle and Eating Habits Program: a Randomized Controlled Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Modena and Reggio Emilia:

Primary Outcome Measures:
  • bioimpedance analyzer [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    To assess not only total GWG at term, but also changes in maternal body composition during pregnancy, the investigators use a bioimpedance analyzer that could evaluate fat mass, fat-free mass and total body water . It determines the electrical impedance or opposition to the flow of an alternate electric current through body tissues, using a low intensity and high frequency system.

  • SenseWear system armband [ Time Frame: At 36 weeks ] [ Designated as safety issue: No ]
    This device can assess effective energy expenditure and the adherence by pregnant women to prenatal exercise. It uses sensors that continuously gather data estimating the wearer's caloric expenditure, duration of physical activity and number of steps taken. Resting energy expenditure, wich is the largest component of total daily energy expenditure, accounting for 60-70% of total expenditure, is measured.This method could be useful to evaluate the adherence to the physical activity program and to detect changes in lifestyle

  • Pedometer (Omron Walking Style III HJ-203-EK) [ Time Frame: At 36 weeks (TLC group) ] [ Designated as safety issue: No ]
    The exercise intervention is focused on increasing walking and developing a more active lifestyle. The recommended exercise prescription for pregnant women is generally consistent with recommendations for the general adult population. However, it is important to monitor and adjust exercise prescriptions according to the woman's symptoms, discomforts, and abilities during pregnancy and be aware of contraindications for exercising during pregnancy. All participants of TLC group are advised to participate in 30 min of moderate intensity activity at least 3 days a week. Subjects wear a pedometer (Omron Walking Style III HJ-203-EK) on a belt at the back of their waist during walking session for the assessment of the adherence to the physical activity program. Participants receive a physical activity diary where they would record the frequency and duration of the activity.


Secondary Outcome Measures:
  • 75-g 2-h Oral Glucose Tolerance Test (OGTT) [ Time Frame: At 16-18 and/or 24-28 weeks ] [ Designated as safety issue: No ]
    An excessive pre-pregnancy BMI is as a risk factor for gestational diabetes mellitus (GDM). Subjects of both groups receive a 75-g 2-h Oral Glucose Tolerance Test (OGTT) at 16-18 and/or 24-28 weeks. The diagnosis of GDM is made for any glucose value exceeding the normal cut-off, as reported by the HAPO study. If OGTT is pathological, women are referred to other health care specialists.

  • Blood Pressure assessment [ Time Frame: At baseline, 16,20,28 and 36 weeks and 3 months after delivery ] [ Designated as safety issue: No ]
    An excessive pre-pregnancy BMI is as a risk factor for hypertensive disorders of pregnancy. Therefore, the blood pressure is assessed at each visit


Estimated Enrollment: 400
Study Start Date: October 2012
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TLC (Therapeutic Lifestyle Changes) group
TLC Program includes a diet and mild physical activity. The TLC comprises 1500 kcal/day and consists of 3 main meals and 3 snacks. The dietitian adds an amount of 200 kcal/day for obese or 300 kcal/day for overweight women. The diet has a target macronutrient composition of 55% carbohydrate, 20% protein, and 25% fat. The exercise intervention is focused on increasing walking. All participants are advised to participate in 30 min of moderate intensity activity at least 3 days a week. Subjects wear a pedometer waist during walking session for the assessment of the adherence to the physical activity program. Because of heart rate variability during pregnancy, women are told to consider using the "talk test" (being able to maintain a conversation during activity) to monitor exercise intensity. Participants receive a physical activity diary where they would record the frequency and duration of the activity. Women are scheduled to have a follow-up at 16, 20, 28, 36 weeks.
 Behavioral: Specific Therapeutic Lifestyle Changes program during pregnancy
A specific caloric restriction of 1500 Kcal/day (+ 300 Kcal/day for overweight and + 200 kcal/day for obese pregnant women submitted to physical activity program) associated to a consistent mild physical activity program(30 minutes/day, 3 times/week).
Control group

The Control group receives only a simple nutritional booklet about a lifestyle and healthy diet during pregnancy without explicit caloric restriction, in accordance with Italian Guidelines for a healthy diet during pregnancy, compatible with a recommended nutritional intake.

30 minutes counseling session about the appropriate gestational weight gain (GWG) at term for each different BMI category is performed. Moreover, the importance of the limited GWG for preventing unfavorable maternal-neonatal outcomes related to excessive weight gain is explained. Women are scheduled to have a follow-up at 16, 20, 28, 36 weeks.

 Behavioral: Generic dietary and behavioral counselling about lifestyle during pregnancy

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  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI ≥ 25 kg/m2
  • age >18 years
  • single pregnancy
  • 1st trimester

Exclusion Criteria:

  • twin pregnancies
  • chronic diseases (i.e., diabetes mellitus, chronic hypertension, untreated thyroid diseases)
  • Gestational diabetes mellitus in previous pregnancies
  • smoking during pregnancy
  • dietary supplements or herbal products known to affect body weight
  • other medical conditions that might affect body weight
  • to plan to deliver outside of the Birth Center.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01783210

Contacts
Contact: Fabio F Facchinetti, MD 0039 059 4222512 facchi@unimore.it

Locations
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
Investigators
Principal Investigator: Fabio Facchinetti, MD Mother-Infant Department, University of Modena and Reggio Emilia, Italy
  More Information

No publications provided

Responsible Party: Prof. Facchinetti Fabio, Associated Professor, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT01783210     History of Changes
Other Study ID Numbers: 4043/CE
Study First Received: January 28, 2013
Last Updated: February 4, 2013
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Pregnancy Complications
Pregnancy in Diabetics
Diabetes Mellitus
Obesity
Diabetes, Gestational
Behavior, Addictive
Food Habits
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Compulsive Behavior
Impulsive Behavior
Habits

ClinicalTrials.gov processed this record on May 19, 2013