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

Toulouse University Hospital

Status: Not yet enrolling

Conditions: Dietetics; Pregnancy

Treatments: Procedure: individual dietetic counseling; Procedure: family-based dietetic conseling

Study type: Interventional

Funder types: Other

Identifiers

NCT06646965

RC31/23/0374

Details and patient eligibility

About

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.

Enrollment: 1,374 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,374 participants in 2 patient groups

individual dietetic follw-up

Experimental group

Description:

the patient receives individual counseling (as usual clinical practice if the pregnant woman is followed by a dietetician during her pregancy).

Treatment:

Procedure: individual dietetic counseling

family-based dietary counseling follw-up

Active Comparator group

Description:

the woman and the person who shares meals with her receive family-based counseling by a dietetician during her pregancy.

Treatment:

Procedure: family-based dietetic conseling