Efficacy of Family-based Dietary Counseling During Pregnancy on Gestational Weight Gain in Pregnant Women in a Randomized Controlled Trial

Not Applicable

Not yet recruiting

• Conditions: Pregnancy; Dietetics

• Registration Number: NCT06646965
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

The study aims to evaluate the efficacy of a family-based dietary monitoring during pregnancy on gestational weight gain in pregnant women. The study will be conducted as a randomized controlled trial, women will be randomly allocated into two groups: a group receiving family-based dietary monitoring, and a control group receiving individual dietary monitoring per standard recommendation.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-15
• Study First Submitted QC: 2024-10-16
• Study First Posted: 2024-10-17
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-24
• Study Start: 2024-11-15
• Primary Completion: 2025-06-15
• Study Completion: 2028-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1374

Inclusion Criteria

Adult (+18 years old) Pregnant woman who can be accompanied by a member of the household, adult sharing at least 1 meal per day with her. Affiliated to the social security. French speaking person (read/written and spoken). Single pregnancy between 8 SA and 16 SA. Starting BMI between 18.5 and 35

Exclusion Criteria

• Person under legal protection or guardianship
• Women suffering from a disease requiring a dietary follow-up:
• Type 1 or type 2 diabetes.
• Gestational diabetes diagnosed on the basis of fasting blood sugar.
• History of bariatric surgery.
• Eating disorders.
• Metabolic pathologies leading to special diets (phenylketonuria).
• Digestive pathologies (with an indication) with special diets
• Women who have lost more than 10% of their weight at the beginning of pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maternal weight change	delivery	Maternal weight change will be calculated from the difference between the weight at delivery and the pre-pregnancy weight,

Secondary Outcome Measures

Name	Time	Method
evaluation of BMI during pregnancy	from day 0 to delivery	from the weight of the patient, the BMI is calculated
Weight of the baby at birth	delivery	The weight of the child will be measured at delivery by a baby-scale measured in kilograms on the day of birth. This weight will be adjusted to the gestational age, in accordance with ARS recommendations defining weight standards according to gestational age.
The women's nutritional intake and its distribution	16 weeks of gestation, 24 weeks of gestation, 34 of gestation, 6 months of gestation	The women's nutritional intake and its distribution will be assessed through a food frequency questionnaire and recall from 24 hours to 16 SA (over a period of 8-16 SA). At the next two appointments during pregnancy and postpartum, a 3-day dietary survey will be conducted at 24 SA (over a period of 21- 24 SA) and 34 SA (over a period of 31-34 SA), as well as at 6 months postpartum
Screening for gestational diabetes	16 weeks of gestation, 24 weeks of gestation, 34 weeks of gestation	by fasting blood glucose or OGTT (orally induced glucose)
Maternal weight loss	6 months after delivery	Maternal weight loss will be calculated by the difference between the weight at delivery and the weight 6 months after delivery
Compliance	24 weeks of gestation, 34 weeks of gestation, 6 months after delivery	measured with the Goal Attainment Scaling (GAS)
Physical activity	16 weeks of gestation, 24 weeks of gestation, 34 of gestation, 6 months of gestation	will be measured with the Pregnancy Physical Activity Questionnaire (PPAQ)
The support of the entourage	34 weeks of gestation, 6 months after delivery	will be measured by the Sarason Social Support Questionnaire (SSQ6 )
Women's satisfaction with their follow-up during pregnancy	34 weeks of gestation, 6 months after delivery	will be assessed by means of a satisfaction survey adapted to the needs of the study at 34 days' gestation
Direct medical, non-medical and indirect costs, valued from the French Healthcare insurance	from day 0 to 6 months after delivery	measured with the EQ-5D-5L questionnaire evaluated at 6 months after delivery (for the cost-utility analysis), the number of caesarean sections avoided (for the cost-effectiveness analysis)

Trial Locations

Locations (3)

Hospital of Auch; 🇫🇷 Auch, France

Clinique Rive Gauche; 🇫🇷 Toulouse, France

University Hospital of Toulouse; 🇫🇷 Toulouse, France