Pregnancy Complications in Women With BMI>25 kg/m2 Enrolled in a Healthy Lifestyle and Eating Habits Program (TLC)
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|ClinicalTrials.gov Identifier: NCT01783210|
Recruitment Status : Unknown
Verified May 2015 by Prof. Facchinetti Fabio, University of Modena and Reggio Emilia.
Recruitment status was: Recruiting
First Posted : February 4, 2013
Last Update Posted : May 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||October 2012|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
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.
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.
- Gestational diabetes mellitus. [ Time Frame: At 16-18 and/or 24-28 weeks ]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.
- Gestational wieght gain. [ Time Frame: At baseline, 16,20,28 and 36 weeks, at delivery and 3 months after delivery. ]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. ]The blood pressure is assessed at each visit.
- Preterm birth [ Time Frame: between 24 and 36+6 ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01783210
|Contact: Fabio F Facchinetti, MD||0039 059 firstname.lastname@example.org|
|Mother-Infant Department, University of Modena and Reggio Emilia, Italy||Recruiting|
|Modena, Italy, 41124|
|Contact: Fabio Fachhinetti, MD 0039 0594222512 email@example.com|
|Sub-Investigator: Elisabetta Petrella, MD|
|Sub-Investigator: Valentina Bertarini, PHD|
|Principal Investigator:||Fabio Facchinetti, MD||Mother-Infant Department, University of Modena and Reggio Emilia, Italy|