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. (see Contacts and Locations)
Verified May 2015 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: May 12, 2015
Last verified: May 2015
  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.


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 in pregnancy
Behavioral: Dietary and behavioral counselling in 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.

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

Primary Outcome Measures:
  • Gestational diabetes mellitus. [ Time Frame: At 16-18 and/or 24-28 weeks ] [ Designated as safety issue: No ]
    Subjects of both groups receive a 75-g 2-h Oral Glucose Tolerance Test (OGTT) at 16-18 weeks and, if negative, repeated at 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 for glycemia monitoring and evalution of further therapies, in addition to the diet.


Secondary Outcome Measures:
  • Gestational wieght gain. [ Time Frame: At baseline, 16,20,28 and 36 weeks, at delivery and 3 months after delivery. ] [ Designated as safety issue: No ]
    Excessive gestational wieght gain is a cause of unfavorable outcome of pregnancy. Weight gain is measured at each follow-up visit, at delivery and 3 months after delivery in both group, to evaluate possible effects of the intervention.

  • Pregnancy induced hypertension [ Time Frame: At baseline, 16,20,28, 36 week and, at delivery. ] [ Designated as safety issue: No ]
    The blood pressure is assessed at each visit.

  • Preterm birth [ Time Frame: between 24 and 36+6 ] [ Designated as safety issue: No ]
    Both spontaneous and medically indicated preterm births are associated with obesity. We record cases of preterm birth, if it's spontaneous or not and the eventual indication.

  • Birthweight of the newborn [ Time Frame: At delivery ] [ Designated as safety issue: No ]
    Obesity is associated with an increase of babies large for gestational age and macrosomia, while caloric restriction is not. We evaluted the centiles of growth and the rates of large for gestational age and small for gestational age.

  • Mode and timing of delivery [ Time Frame: At delivery ] [ Designated as safety issue: No ]
    Obesity is associated with an higher incidence of caesarean delivery and operative vaginal delivery. Moreover, being associated with hypertensive disorders and gestational diabetes mellitus, it leads to an higher incidence of induction of labour, both in case of pregnancy preterm or at term.


Estimated Enrollment: 400
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TLC(Therapeutic Lifestyle Changes) group
Intervention: "Specific Therapeutic Lifestyle Changes program in pregnancy". TLC Program includes a diet (with a specific amount of calories and macronutrients) and a mild physical activity.
Behavioral: Specific Therapeutic Lifestyle Changes program in pregnancy
TLC Program includes diet and mild physical activity. The TLC comprises 1500 kcal/day (3 main meals and 3 snacks) composed of 55% carbohydrate, 20% protein, and 25% fat. The dietitian adds an 200 kcal/day for obese or 300 kcal/day for overweight. 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. Women are told to consider using the "talk test" (being able to maintain a conversation during activity) to monitor exercise intensity, and to record the frequency and duration of the activity on a diary . Follow-up is performed at 16, 20, 28, 36 weeks.
Control group
Intervention: "Dietary and behavioral counselling in pregnancy". 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.
Behavioral: Dietary and behavioral counselling in pregnancy

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.


  Show Detailed Description

  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
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, see Learn About Clinical Studies.

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, Chairman of Obstetrics and Gynecology Unit, 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: May 12, 2015
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Diabetes, Gestational
Pregnancy Complications
Pregnancy in Diabetics
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 01, 2015