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

NCT02701426 | Completed

• 2 other identifiers: 2014_722015-A01085-44
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Overweight; Pregnancy

Keywords

Macrosomia; Weight gain; Participation; Adhesion; Physical activity; Nutrition

Outcome Measures

Primary Outcomes (1)

• Number of participant that will participate to the program

  at 36 weeks of gestation (WG)

Secondary Outcomes (26)

• Macrosomia / Birth weight

  at birth

• Gestational weight gain

  at birth

• Pregnancy complications

  between 28 weeks of gestation and term

• Number of patients with C-section or an instrumental extraction

  at birth

• eating behavior before, during and after the program

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

Study Arms (2)

participant

EXPERIMENTAL

agree to participate to the program combining physical activity and nutritional counseling

Behavioral: physical activity and nutritional counseling

no participant

NO INTERVENTION

disagree to participate to the program

Interventions

physical activity and nutritional counseling BEHAVIORAL

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.

participant

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• University of Lille Nord de France: collaborator
• Région Nord-Pas de Calais, France: collaborator

Study Sites (1)

CHRU,Hôpital Jeanne de Flandres

Lille, France

Location

Related Publications (3)

• 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.

  PMID: 21317009 BACKGROUND

• 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.

  PMID: 22596383 BACKGROUND

• 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.

  PMID: 38943053 RESULT

MeSH Terms

Conditions

Obesity; Overweight; Weight Gain; Tissue Adhesions; Motor Activity

Interventions

Exercise; Nutrition Assessment

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Cicatrix; Fibrosis; Pathologic Processes; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Philippe Deruelle, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 8, 2016
• Study Start: February 1, 2016
• Primary Completion: October 29, 2018
• Study Completion: October 29, 2018
• Last Updated: April 21, 2026

Record last verified: 2019-02

Locations

FR (1)