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

NCT06646965 | Recruiting

• 1 other identifier: RC31/23/0374
• Study Type: interventional
• Target: 1,374
• Locations: 1 country
• Sites: 3

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.

Conditions

Pregnancy; Dietetics

Keywords

Gestational weight gain; Birth weight; Recommendations; Intervention; Nutrition

Outcome Measures

Primary Outcomes (1)

• Maternal weight change

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

  delivery

Secondary Outcomes (10)

• evaluation of BMI during pregnancy

  from day 0 to delivery

• Weight of the baby at birth

  delivery

• The women's nutritional intake and its distribution

  16 weeks of gestation, 24 weeks of gestation, 34 of gestation, 6 months of gestation

• Screening for gestational diabetes

  16 weeks of gestation, 24 weeks of gestation, 34 weeks of gestation

• Maternal weight loss

  6 months after delivery

Study Arms (2)

individual dietetic follw-up

EXPERIMENTAL

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

family-based dietary counseling follw-up

ACTIVE COMPARATOR

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

Interventions

individual dietetic counseling PROCEDURE

only the pregnant patient receives dietetic counseling

individual dietetic follw-up

family-based dietetic conseling PROCEDURE

the pregnant patient and her companion receive dietetic counseling

family-based dietary counseling follw-up

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (3)

Hospital of Auch

Auch, France

RECRUITING

Clinique Rive Gauche

Toulouse, 31300, France

RECRUITING

University Hospital of Toulouse

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Gestational Weight Gain; Birth Weight

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clemence ROUBLIN

  University Hospital of Toulouse

  STUDY DIRECTOR

Central Study Contacts

Nadege ALGANS

CONTACT

0561777204; algans.n@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, randomized, open-label clinical study.

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 17, 2024
• Study Start: January 13, 2025
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 15, 2028
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

FR (3)