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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Dietetics
• Intervention / Treatment: Procedure: individual dietetic counseling; Procedure: family-based dietetic conseling

• Study Type: Interventional
• Enrollment (Estimated): 1374
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nadège ALGANS; Phone Number: 0561777204; Email: algans.n@chu-toulouse.fr

Study Locations

• France
  • Auch, France
    • Recruiting
    • Hospital of Auch
    • Contact: Maud BASSO; Email: maud.basso@ch-auch.fr
    • Principal Investigator: Laure ANGLESIO
  • Toulouse, France
    • Recruiting
    • University Hospital of Toulouse
    • Contact: Delphine DUCHANOIS; Email: duchanois.d@chu-toulouse.fr
    • Principal Investigator: Clemence ROUBLIN
  • Toulouse, France, 31300
    • Recruiting
    • Clinique Rive Gauche
    • Contact: Johanna CHAUBE; Email: j.chaube@clinique-rivegauche.fr
    • Principal Investigator: Laura RANDE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: individual dietetic follw-up; the patient receives individual counseling (as usual clinical practice if the pregnant woman is followed by a dietetician during her pregancy).	Procedure: individual dietetic counseling; only the pregnant patient receives dietetic counseling
Active Comparator: family-based dietary counseling follw-up; the woman and the person who shares meals with her receive family-based counseling by a dietetician during her pregancy.	Procedure: family-based dietetic conseling; the pregnant patient and her companion receive dietetic counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal weight change	Maternal weight change will be calculated from the difference between the weight at delivery and the pre-pregnancy weight,	delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluation of BMI during pregnancy	from the weight of the patient, the BMI is calculated	from day 0 to delivery
Weight of the baby at birth	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.	delivery
The women's nutritional intake and its distribution	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	16 weeks of gestation, 24 weeks of gestation, 34 of gestation, 6 months of gestation
Screening for gestational diabetes	by fasting blood glucose or OGTT (orally induced glucose)	16 weeks of gestation, 24 weeks of gestation, 34 weeks of gestation
Maternal weight loss	Maternal weight loss will be calculated by the difference between the weight at delivery and the weight 6 months after delivery	6 months after delivery
Compliance	measured with the Goal Attainment Scaling (GAS)	24 weeks of gestation, 34 weeks of gestation, 6 months after delivery
Physical activity	will be measured with the Pregnancy Physical Activity Questionnaire (PPAQ)	16 weeks of gestation, 24 weeks of gestation, 34 of gestation, 6 months of gestation
The support of the entourage	will be measured by the Sarason Social Support Questionnaire (SSQ6 )	34 weeks of gestation, 6 months after delivery
Women's satisfaction with their follow-up during pregnancy	will be assessed by means of a satisfaction survey adapted to the needs of the study at 34 days' gestation	34 weeks of gestation, 6 months after delivery
Direct medical, non-medical and indirect costs, valued from the French Healthcare insurance	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)	from day 0 to 6 months after delivery

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Study Director: Clemence ROUBLIN, University Hospital of Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2025
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 15, 2028

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 16, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Birth weight; Nutrition; Intervention; Gestational weight gain; Recommendations
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Gestational Weight Gain; Weight Gain
• Other Study ID Numbers: RC31/23/0374

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No