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

NCT01783210 | Unknown DMC

• 1 other identifier: 4043/CE
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Gestational wieght gain.

  At baseline, 16,20,28 and 36 weeks, at delivery and 3 months after delivery.

• Pregnancy induced hypertension

  At baseline, 16,20,28, 36 week and, at delivery.

• Preterm birth

  between 24 and 36+6

• Birthweight of the newborn

  At delivery

• Mode and timing of delivery

  At delivery

Study Arms (2)

TLC(Therapeutic Lifestyle Changes) group

EXPERIMENTAL

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

Control group

OTHER

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

Interventions

Specific Therapeutic Lifestyle Changes program in pregnancy BEHAVIORAL

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.

TLC(Therapeutic Lifestyle Changes) group

Dietary and behavioral counselling in pregnancy BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Modena and Reggio Emilia: lead

Study Sites (1)

Mother-Infant Department, University of Modena and Reggio Emilia, Italy

Modena, 41124, Italy

RECRUITING

MeSH Terms

Interventions

Pregnancy; Diet

Intervention Hierarchy (Ancestors)

Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Fabio Facchinetti, MD

  Mother-Infant Department, University of Modena and Reggio Emilia, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio F Facchinetti, MD

CONTACT

0039 059 4222512; facchi@unimore.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Obstetrics and Gynecology Unit

Study Record Dates

• First Submitted: January 28, 2013
• First Posted: February 4, 2013
• Study Start: July 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2022
• Last Updated: October 6, 2021

Record last verified: 2021-10

Locations

IT (1)