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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1374 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-13

Study Completion Date

2028-06-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Pregnancy Dietetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicenter, randomized, open-label clinical study.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

individual dietetic counseling

Intervention Type PROCEDURE

only the pregnant patient receives dietetic counseling

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.

Group Type ACTIVE_COMPARATOR

family-based dietetic conseling

Intervention Type PROCEDURE

the pregnant patient and her companion receive dietetic counseling

Interventions

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individual dietetic counseling

only the pregnant patient receives dietetic counseling

Intervention Type PROCEDURE

family-based dietetic conseling

the pregnant patient and her companion receive dietetic counseling

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No