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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pregnancy Complications in Women With BMI>25 kg/m2 Enrolled in a Healthy Lifestyle and Eating Habits Program: a Randomized Controlled Trial.

Conditions
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Maternal Obesity Complicating Pregnancy, Birth,or Puerperium, Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled, Exercise Addiction, High-Risk Pregnancy, Dietary Modification

Intervention / Treatment
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* Behavioral: Specific Therapeutic Lifestyle Changes program in pregnancy
* Behavioral: Dietary and behavioral counselling in pregnancy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TLC(Therapeutic Lifestyle Changes) group<br>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<br>* 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.<br>|
| Other: Control group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 16-18 and/or 24-28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At baseline, 16,20,28 and 36 weeks, at delivery and 3 months after delivery. | 
| Pregnancy induced hypertension | The blood pressure is assessed at each visit. | At baseline, 16,20,28, 36 week and, at delivery. | 
| 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. | between 24 and 36+6 | 
| 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. | At delivery | 
| 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. | At delivery |