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ObesityOGANNCT02701426

Obesity & Pregnancy: Factors Influencing Participation in a Physical Activity and Nutritional Counseling Program

A study testing physical activity and nutritional counseling in people with Obesity and Overweight, run by University Hospital, Lille at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Obesity, Overweight, Pregnancy
What is being tested?
physical activity and nutritional counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
195 participants
Where
1 siteFrance
Study dates
Feb 2016to 29 Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Overweight and obese pregnant women
  • Age from 18 to 45 years old
  • Singleton pregnancy between 12+0 to 22+6 weeks of pregnancy

Who cannot join

  • History of more than 2 miscarriages
  • Severe heart disease (arrhythmias, history of myocardial infarction)
  • Multiple pregnancy
  • Unstable thyroid disease
  • Uncontrolled hypertension
  • Pre-gestational diabetes
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site
  • CHRU,Hôpital Jeanne de Flandres

    Lille

Other trials in France

About this study

Official title: Obesity and Pregnancy : Study of Factors Influencing Participation in a Program Combining Physical Activity and Nutritional Counseling

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.

Read more

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.

Read the 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.

  1. 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.
  2. 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.
  3. 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.
Being tested
physical activity and nutritional counseling
Keywords
Macrosomia, Weight gain, Participation, Adhesion, Physical activity, Nutrition
Medical subject headings
Obesity, Overweight, Weight Gain, Tissue Adhesions, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • physical activity and nutritional counselingBehavioural

    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.

Study groups in NCT02701426
Study groupRoleWhat they receive
participantExperimentalagree to participate to the program combining physical activity and nutritional counseling
Receives: Behavioral: physical activity and nutritional counseling
no participantNo interventiondisagree to participate to the program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participant that will participate to the program

    Measured: at 36 weeks of gestation (WG)

Secondary outcomes (26)
  1. Macrosomia / Birth weight

    Measured: at birth

  2. Gestational weight gain

    Measured: at birth

  3. Pregnancy complications

    Gestational diabetes, gravidic hypertension and preeclampsia

    Measured: between 28 weeks of gestation and term

  4. Number of patients with C-section or an instrumental extraction

    C-section vaginal delivery, instrumental extraction

    Measured: at birth

  5. eating behavior before, during and after the program

    Three eating factors questionnaire / semi-qualitative questionnaire

    Measured: between 20-24 weeks of gestation, between 32 and 34 weeks of gestation, within 6-8 weeks post-partum

  6. Questionnaire of physical activity

    french questionnaire of physical activity

    Measured: between 20-24 weeks of gestation, between 32 and 34 weeks of gestation, within 6-8 weeks post-partum

  7. Questionnaire for self-esteem

    Positive and Negative Affect Schedule (PANAS) questionnaire

    Measured: between 20-24 weeks of gestation, between 32 and 34 weeks of gestation, within 6-8 weeks post-partum

  8. number of neonates with neonatal trauma

    fractures, shoulder dystocia, brachial plexus injury

    Measured: at birth

  9. Apgar score

    Measured: at birth

  10. Arterial umbilical pH

    Measured: at birth

  11. number of neonates with hyperbilirubinemia

    total serum bilirubin level > 86 micro mol/L

    Measured: Within 7 days after birth

  12. Number of neonates needing intensive care transfer

    Measured: Within 7 days after birth

  13. Neonatal adiposity

    measurement of shoulder fat thickness in mm

    Measured: at birth

  14. Maternal weight

    Measured: within 6-8 weeks post-partum

  15. Infant weight

    Measured: within 6-8 weeks post-partum

  16. duration of Breastfeeding

    in weeks

    Measured: within 6-8 weeks post-partum

  17. Maternal Plasmatic cholesterol levels before, during and after the program

    Measured: between 20-24 weeks of gestation, between 32 and 34 weeks of gestation and at birth

  18. Maternal Plasmatic leptin levels

    Measured: between 20-24 weeks of gestation, between 32 and 34 weeks of gestation and at birth

  19. maternal plasmatic glycemic levels

    Measured: between 20-24 weeks of gestation, between 32 and 34 weeks of gestation and at birth

  20. microRNA levels in maternal milk

    Measured: 2 or 3 days after birth

  21. Physical activity measured with accelerometers

    measurements for 1 week

    Measured: between 32 and 34 Weeks of gestation and within 6-8 weeks post-partum

  22. Maternal Plasmatic triglyceride levels before, during and after the program

    Measured: between 20-24 weeks of gestation, between 32 and 34 weeks of gestation and at birth

  23. Maternal Plasmatic Apolipoprotein levels before, during and after the program

    Measured: between 20-24 weeks of gestation, between 32 and 34 weeks of gestation and at birth

  24. Maternal plasmatic apelin levels

    Measured: between 20-24 weeks of gestation, between 32 and 34 weeks of gestation and at birth

  25. maternal plasmatic insulin levels

    Measured: between 20-24 weeks of gestation, between 32 and 34 weeks of gestation and at birth

  26. Pittsburgh Sleep Quality Index

    is a self-report questionnaire that assesses sleep quality over a 1-month time interval.

    Measured: during 7 days between 20-24 weeks of gestation, between 32 and 34 weeks of gestation, within 6-8 weeks post-partum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completion29 Oct 2018
  4. Study completion29 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02701426
Sponsor's protocol ID
2014_72
Other IDs
2015-A01085-44
Acronym
OGAN
Status last verified
Feb 2019
First submitted
25 Feb 2016
Last updated
21 Apr 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 21317009
  • 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.

    PubMed 22596383
  • Lelorain S, Deruelle P, Behal H, Machet E, Thiblet M, Lengagne-Piedbois C, Deken-Delannoy V, Pigeyre M. Factors influencing participation and regular attendance in a program combining physical activity and nutritional advice for overweight and obese pregnant women. BMC Pregnancy Childbirth. 2024 Jun 28;24(1):449. doi: 10.1186/s12884-024-06648-z.

    PubMed 38943053

Questions about this trial

What is this clinical trial studying?

A study testing physical activity and nutritional counseling in people with Obesity and Overweight, run by University Hospital, Lille at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participant that will participate to the program (time frame: at 36 weeks of gestation (WG)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02701426, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.

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OGAN Clinical Trial NCT02701426 | AzTrials