Obesity & Pregnancy: Factors Influencing Participation in a Physical Activity and Nutritional Counseling Program (OGAN)
Primary Purpose
Obesity, Overweight, Pregnancy
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
physical activity and nutritional counseling
Sponsored by

About this trial
This is an interventional supportive care trial for Obesity focused on measuring Macrosomia, Weight gain, Participation, Adhesion, Physical activity, Nutrition
Eligibility Criteria
Inclusion criteria :
- Overweight and obese pregnant women
- Age from 18 to 45 years old
- Singleton pregnancy between 12+0 to 22+6 weeks of pregnancy
Exclusion criteria:
- History of more than 2 miscarriages
- Severe heart disease (arrhythmias, history of myocardial infarction)
- Multiple pregnancy
- Unstable thyroid disease
- Uncontrolled hypertension
- Pre-gestational diabetes
- Bariatric surgery
- Any medical condition that may interfere with physical activity during pregnancy
- Minor or absence of health insurance
- Trusteeship or tutorship
- Refusal to participate in research
Sites / Locations
- CHRU,Hôpital Jeanne de Flandres
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
participant
no participant
Arm Description
agree to participate to the program combining physical activity and nutritional counseling
disagree to participate to the program
Outcomes
Primary Outcome Measures
Number of participant that will participate to the program
Secondary Outcome Measures
Macrosomia / Birth weight
Gestational weight gain
Pregnancy complications
Gestational diabetes, gravidic hypertension and preeclampsia
Number of patients with C-section or an instrumental extraction
C-section vaginal delivery, instrumental extraction
eating behavior before, during and after the program
Three eating factors questionnaire / semi-qualitative questionnaire
Questionnaire of physical activity
french questionnaire of physical activity
Questionnaire for self-esteem
Positive and Negative Affect Schedule (PANAS) questionnaire
number of neonates with neonatal trauma
fractures, shoulder dystocia, brachial plexus injury
Apgar score
Arterial umbilical pH
number of neonates with hyperbilirubinemia
total serum bilirubin level > 86 micro mol/L
Number of neonates needing intensive care transfer
Neonatal adiposity
measurement of shoulder fat thickness in mm
Maternal weight
Infant weight
duration of Breastfeeding
in weeks
Maternal Plasmatic cholesterol levels before, during and after the program
Maternal Plasmatic leptin levels
maternal plasmatic glycemic levels
microRNA levels in maternal milk
Physical activity measured with accelerometers
measurements for 1 week
Maternal Plasmatic triglyceride levels before, during and after the program
Maternal Plasmatic Apolipoprotein levels before, during and after the program
Maternal plasmatic apelin levels
maternal plasmatic insulin levels
Pittsburgh Sleep Quality Index
is a self-report questionnaire that assesses sleep quality over a 1-month time interval.
Full Information
NCT ID
NCT02701426
First Posted
February 25, 2016
Last Updated
February 19, 2019
Sponsor
University Hospital, Lille
Collaborators
University of Lille Nord de France, Région Nord-Pas de Calais, France
1. Study Identification
Unique Protocol Identification Number
NCT02701426
Brief Title
Obesity & Pregnancy: Factors Influencing Participation in a Physical Activity and Nutritional Counseling Program
Acronym
OGAN
Official Title
Obesity and Pregnancy : Study of Factors Influencing Participation in a Program Combining Physical Activity and Nutritional Counseling
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
end of funding granted
Study Start Date
February 2016 (Actual)
Primary Completion Date
October 29, 2018 (Actual)
Study Completion Date
October 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
University of Lille Nord de France, Région Nord-Pas de Calais, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background:
Obesity increasingly affects young women and contributes to increased maternal, fetal and neonatal complications. Maternal obesity contributes to the subsequent development of childhood obesity not only through social and environmental mechanisms but also through biological processes referring to the original concept of the developmental health and disease. Data suggest that management during pregnancy through nutrition counseling and adequate physical activity will help to break the familial vicious circle of obesity. To help program to be effective it is important to understand the factors that modulate participation. However, few studies have been conducted to assess the determinants that influence participation.
Goal:
The main objective is to analyze 15 factors that influence participation in a program combining physical activity and nutritional counseling among pregnant women with BMI ≥ 25 kg/m2. Secondary objectives are :
to identify the data that influence adherence and to show that assiduous women will have a better control of weight gain and a reduction of maternal and fetal complications.
to understand the biological mechanisms involved
Strategy and method:
A prospective research evaluating the participation in an educational program, including nutritional support and adequate physical activity, will be offered to overweight and obese pregnant women. The program will last 12 weeks, and will include three workshops on diet of the pregnant and lactating women, and the young child. Physical activity sessions will be offered once a week. Fifteen independent variables likely to influence participation will be analyzed. The association between participation and the risk of maternal and fetal pregnancy complications related to obesity will be analysed. Meanwhile, more fundamental research will be considered to determine of the biological factors involved.
Detailed Description
This is a prospective study that will be conducted in pregnant women with a BMI ≥ 25 kg/m2, aged from 18 to 42 years. Participation in the program will be offered between 12 and 22 + 6 weeks of pregnancy. Women with a history of more than 2 miscarriages, severe heart disease (arrhythmia, previous myocardial infarction), bleeding in the first trimester, multiple pregnancy, unstable thyroid disease, hypertension, diabetes, or any other medical conditions that can interfere with the practice of physical activity during pregnancy will not be allowed to participate in the program for medical reasons. The participants will sign an informed consent. The intervention will be an educational program called "Eat well, move well for to the baby's health," including nutritional counselling and physical activity exercises. The control group will receive usual care as a simple information. The intervention will take place between 24 and 36 weeks of pregnancy. Women will be evaluated before (20-24 weeks gestation (SA)), during the intervention (32-34 SA), and finally 8 weeks after childbirth during the postnatal visit. All patients with benefit from obstetric monitoring according with the French recommendations with a monthly consultation and ultrasonography exams at 22 and 32 wks.
Nutritional support will include 3 workshops of 2 hours within the 12 weeks (one workshop per month). Each workshop session will be conducted in groups of 10 to 15 participants. These workshops will aim firstly to inform patients of weight gain recommendations during pregnancy and food recommendations.
Workshop No. 1 will provide information on the goals of weight gain during pregnancy, and will target the implementation of recommendations in terms of diet during pregnancy. The messages will be specifically adapted to the population of obese women including dietary advices, work on erroneous beliefs and representations, work on the motivation to change eating habits and reduction of the harmful link between emotions and eating. Thus, beyond the information, this workshop will have the primary role to develop a diet suitable for pregnancy in obese women. This workshop will be led by a dietician and psychologist. It will take place between the 1st and 4th week of the program.
Workshop No. 2 will inform the benefits of breastfeeding for the child and the mother (including its impact on weight loss during the postpartum period, especially important in obese women). As in the previous workshop, the objective will be to obtain the application of the recommendations on diet during breastfeeding. The general message will be adapted to the problems specific to obese women: work on the social, educational, family, removal of beliefs and motivational brakes. This workshop will be led by a dietician and a midwife and will take place between the 5th and 8th week of the program.
Workshop No. 3 will target the diet in the postpartum period and nutritional needs of the newborn and young child. Beyond dietary information, specific work will be done on motivation to take care of the body after pregnancy and breastfeeding, and especially the fight against the beliefs of the food needs of the newborn, typically found in obese mothers (fear of missing, hunger equated with suffering, the emotional power as substitute) This workshop will take place between the 9th and 12th week of the program and will be led by a dietician and a pediatric nurse.
The exercise program will feature sessions developed by the North Committee of the French Federation of Physical Education and Voluntary Gymnastics. On the program, which lasts 12 weeks per patient, there will be inputs and outputs permanent in the group based on inclusions. The program will be continued for the duration of the research. This program will propose 3 weekly slots of physical activities so that participants can take at least a weekly session. Ideally they will be encouraged to practice a second session and to perform exercises by their own. The personal session can be a walk on the weekend, or an indoor gym classes in one a club, an aqua fit session ... or exercises proposed by the coach to replicate at home. The participants will be able to record and monitor their practice using the logbook.
Evaluation of the program "Eat well, move well for the baby's health" The investigators will do the assessment before during and after the program. Patients will have a logbook in which they will notice physical activity performed. This book will include questionnaires to complete.
Food Evaluation The investigators will use a food behavior questionnaire (18 items) and 5 direct questions for a semi-quantitative assessment (sweet beverages consumption, fat, portion sizes). All these elements for assessing eating behavior (uncontrolled eating, hunger, cognitive restriction), the type of food consumed (carbohydrates, fats and proteins). The evaluation will be conducted by dieticians.
Evaluation of physical activity Physical activity of patients will be estimated using the French Physical Activity Questionnaire in Pregnancy (QFAPG). This self administered questionnaire will have a qualitative vision (business type) and quantitative activity through 33 questions on "sports" on "household activities " on "activities at work " and also on "activities related to transportation".
Physical activity will be quantitatively measured for each patient who will receive an accelerometer (The Actigraph, Manufacturing Technology Inc., model wActisleep +, Pensacola, Florida USA) that will record the intensity of the efforts made during a period of 7 days.
Well-being Evaluation Well-being will be evaluated using the positive and negative affect schedule Questionnaire. which is sensitive to changes over time and assesses the positive and negative affects. It will assess the program's impact on the positive / negative affect.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Pregnancy
Keywords
Macrosomia, Weight gain, Participation, Adhesion, Physical activity, Nutrition
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
195 (Actual)
8. Arms, Groups, and Interventions
Arm Title
participant
Arm Type
Experimental
Arm Description
agree to participate to the program combining physical activity and nutritional counseling
Arm Title
no participant
Arm Type
No Intervention
Arm Description
disagree to participate to the program
Intervention Type
Behavioral
Intervention Name(s)
physical activity and nutritional counseling
Intervention Description
The program will last 12 weeks, and will include three workshops on diet of the pregnant and lactating women, and the young child. Physical activity sessions will be offered once a week.
Primary Outcome Measure Information:
Title
Number of participant that will participate to the program
Time Frame
at 36 weeks of gestation (WG)
Secondary Outcome Measure Information:
Title
Macrosomia / Birth weight
Time Frame
at birth
Title
Gestational weight gain
Time Frame
at birth
Title
Pregnancy complications
Description
Gestational diabetes, gravidic hypertension and preeclampsia
Time Frame
between 28 weeks of gestation and term
Title
Number of patients with C-section or an instrumental extraction
Description
C-section vaginal delivery, instrumental extraction
Time Frame
at birth
Title
eating behavior before, during and after the program
Description
Three eating factors questionnaire / semi-qualitative questionnaire
Time Frame
between 20-24 weeks of gestation, between 32 and 34 weeks of gestation, within 6-8 weeks post-partum
Title
Questionnaire of physical activity
Description
french questionnaire of physical activity
Time Frame
between 20-24 weeks of gestation, between 32 and 34 weeks of gestation, within 6-8 weeks post-partum
Title
Questionnaire for self-esteem
Description
Positive and Negative Affect Schedule (PANAS) questionnaire
Time Frame
between 20-24 weeks of gestation, between 32 and 34 weeks of gestation, within 6-8 weeks post-partum
Title
number of neonates with neonatal trauma
Description
fractures, shoulder dystocia, brachial plexus injury
Time Frame
at birth
Title
Apgar score
Time Frame
at birth
Title
Arterial umbilical pH
Time Frame
at birth
Title
number of neonates with hyperbilirubinemia
Description
total serum bilirubin level > 86 micro mol/L
Time Frame
Within 7 days after birth
Title
Number of neonates needing intensive care transfer
Time Frame
Within 7 days after birth
Title
Neonatal adiposity
Description
measurement of shoulder fat thickness in mm
Time Frame
at birth
Title
Maternal weight
Time Frame
within 6-8 weeks post-partum
Title
Infant weight
Time Frame
within 6-8 weeks post-partum
Title
duration of Breastfeeding
Description
in weeks
Time Frame
within 6-8 weeks post-partum
Title
Maternal Plasmatic cholesterol levels before, during and after the program
Time Frame
between 20-24 weeks of gestation, between 32 and 34 weeks of gestation and at birth
Title
Maternal Plasmatic leptin levels
Time Frame
between 20-24 weeks of gestation, between 32 and 34 weeks of gestation and at birth
Title
maternal plasmatic glycemic levels
Time Frame
between 20-24 weeks of gestation, between 32 and 34 weeks of gestation and at birth
Title
microRNA levels in maternal milk
Time Frame
2 or 3 days after birth
Title
Physical activity measured with accelerometers
Description
measurements for 1 week
Time Frame
between 32 and 34 Weeks of gestation and within 6-8 weeks post-partum
Title
Maternal Plasmatic triglyceride levels before, during and after the program
Time Frame
between 20-24 weeks of gestation, between 32 and 34 weeks of gestation and at birth
Title
Maternal Plasmatic Apolipoprotein levels before, during and after the program
Time Frame
between 20-24 weeks of gestation, between 32 and 34 weeks of gestation and at birth
Title
Maternal plasmatic apelin levels
Time Frame
between 20-24 weeks of gestation, between 32 and 34 weeks of gestation and at birth
Title
maternal plasmatic insulin levels
Time Frame
between 20-24 weeks of gestation, between 32 and 34 weeks of gestation and at birth
Title
Pittsburgh Sleep Quality Index
Description
is a self-report questionnaire that assesses sleep quality over a 1-month time interval.
Time Frame
during 7 days between 20-24 weeks of gestation, between 32 and 34 weeks of gestation, within 6-8 weeks post-partum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria :
Overweight and obese pregnant women
Age from 18 to 45 years old
Singleton pregnancy between 12+0 to 22+6 weeks of pregnancy
Exclusion criteria:
History of more than 2 miscarriages
Severe heart disease (arrhythmias, history of myocardial infarction)
Multiple pregnancy
Unstable thyroid disease
Uncontrolled hypertension
Pre-gestational diabetes
Bariatric surgery
Any medical condition that may interfere with physical activity during pregnancy
Minor or absence of health insurance
Trusteeship or tutorship
Refusal to participate in research
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Deruelle, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU,Hôpital Jeanne de Flandres
City
Lille
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21317009
Citation
Deruelle P. [Obesity and pregnancy]. Gynecol Obstet Fertil. 2011 Feb;39(2):100-5. doi: 10.1016/j.gyobfe.2010.12.001. Epub 2011 Feb 12. French.
Results Reference
background
PubMed Identifier
22596383
Citation
Thangaratinam S, Rogozinska E, Jolly K, Glinkowski S, Roseboom T, Tomlinson JW, Kunz R, Mol BW, Coomarasamy A, Khan KS. Effects of interventions in pregnancy on maternal weight and obstetric outcomes: meta-analysis of randomised evidence. BMJ. 2012 May 16;344:e2088. doi: 10.1136/bmj.e2088.
Results Reference
background
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Obesity & Pregnancy: Factors Influencing Participation in a Physical Activity and Nutritional Counseling Program
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