Pregnancy Complications in Women With BMI>25 kg/m2 Enrolled in a Healthy Lifestyle and Eating Habits Program (TLC)
Primary Purpose
Maternal Obesity Complicating Pregnancy, Birth,or Puerperium, Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled, Exercise Addiction
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Specific Therapeutic Lifestyle Changes program in pregnancy
Dietary and behavioral counselling in pregnancy
Sponsored by
About this trial
This is an interventional prevention trial for Maternal Obesity Complicating Pregnancy, Birth,or Puerperium
Eligibility 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.
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
TLC(Therapeutic Lifestyle Changes) group
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Gestational diabetes mellitus.
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.
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
The blood pressure is assessed at each visit.
Preterm birth
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
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
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.
Full Information
NCT ID
NCT01783210
First Posted
January 28, 2013
Last Updated
October 5, 2021
Sponsor
University of Modena and Reggio Emilia
1. Study Identification
Unique Protocol Identification Number
NCT01783210
Brief Title
Pregnancy Complications in Women With BMI>25 kg/m2 Enrolled in a Healthy Lifestyle and Eating Habits Program
Acronym
TLC
Official Title
Pregnancy Complications in Women With BMI>25 kg/m2 Enrolled in a Healthy Lifestyle and Eating Habits Program: a Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
June 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Modena and Reggio Emilia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
Pregnant women, recruited from antenatal clinics, with pre-pregnancy BMI ≥ 25 kg/m2, age >18 years and single pregnancy are enrolled within 12th week at the Obstetric Unit of Policlinico Hospital of Modena.
Exclusion criteria are as follows: twin pregnancies, chronic diseases (i.e., diabetes mellitus, chronic hypertension, untreated thyroid diseases), gestational diabetes mellitus (GDM) in previous pregnancies, smoking during pregnancy, dietary supplements or herbal products known to affect body weight, other medical conditions that might affect body weight, and plans to deliver outside of the Birth Center.
At the first visit, an accurate obstetric history, family history, and personal history is collected for the assessment of exclusion criteria. The blood pressure, height and weight are measured, and the BMI is calculated.
Eligible women are randomly assigned to no intervention (Control group) or the Therapeutic Lifestyle Changes Program (TLC group). Randomization is performed using sealed envelopes(using a computer-generated random allocation). Study randomization is numbered and sealed in white envelops. Randomization occurs in consecutive order at time of the first visit. Due to study design, both gynecologist and dietitian know the allocation of the patient.
Every subject receives care in another institution (Antenatal Clinics of Modena Health program). Hence, women in both groups receive the same antenatal evaluation including two ultrasound examinations and at least 4 obstetric evaluations until term. However, referral gynecologists possibly know the allocated arm of their women.
Randomized subjects 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.
Women randomized to both group are scheduled to have a specific follow-up for adherence to the program at 16, 20, 28, 36 weeks and 3 months after delivery also evaluating the fat mass, fat-free mass and total body water through the use of the bioimpedance analyzer. At baseline and 36 weeks each subject have to complete a Food Frequency Questionnaire (FFQ) to identify any change in eating habits. The FFQ includes questions about specific food items, such as the frequency of sauce consumption, the fat content of several food items, and seasonal consumption of fruit and vegetables. While the Control group receives only a simple nutritional booklet about a lifestyle (in accordance with Italian Guidelines for a healthy diet during pregnancy), the TLC Program includes a specific caloric restriction associated to a mild physical activity program.
The TLC diet comprises 1500 kcal/day and consists of 3 main meals and 3 snacks (breakfast, snack, lunch, snack, dinner, and evening snack) that corresponds to the baseline metabolism of a pregnant woman. The dietitian adds an amount of 200 kcal/day for obese or 300 kcal/day for overweight pregnant women submitted to physical activity program.The TLC diet has a target macronutrient composition of 55% carbohydrate, 20% protein, and 25% fat with moderately low saturated fat levels. The exercise intervention is focused on increasing walking and developing a more active lifestyle (i.e., walking rather than driving for short distances). 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 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.
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 in Pregnancy, Diet- Controlled, Exercise Addiction, High-Risk Pregnancy, Dietary Modification
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TLC(Therapeutic Lifestyle Changes) group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Specific Therapeutic Lifestyle Changes program in pregnancy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dietary and behavioral counselling in pregnancy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gestational diabetes mellitus.
Description
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.
Time Frame
At 16-18 and/or 24-28 weeks
Secondary Outcome Measure Information:
Title
Gestational wieght gain.
Description
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.
Time Frame
At baseline, 16,20,28 and 36 weeks, at delivery and 3 months after delivery.
Title
Pregnancy induced hypertension
Description
The blood pressure is assessed at each visit.
Time Frame
At baseline, 16,20,28, 36 week and, at delivery.
Title
Preterm birth
Description
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.
Time Frame
between 24 and 36+6
Title
Birthweight of the newborn
Description
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.
Time Frame
At delivery
Title
Mode and timing of delivery
Description
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.
Time Frame
At delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabio F Facchinetti, MD
Phone
0039 059 4222512
Email
facchi@unimore.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio Facchinetti, MD
Organizational Affiliation
Mother-Infant Department, University of Modena and Reggio Emilia, Italy
Official's Role
Principal Investigator
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
Learn more about this trial
Pregnancy Complications in Women With BMI>25 kg/m2 Enrolled in a Healthy Lifestyle and Eating Habits Program
We'll reach out to this number within 24 hrs