Efficacy of Family-based Dietary Counseling During Pregnancy on Gestational Weight Gain in Pregnant Women in a Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: individual dietetic counseling, family-based dietetic conseling.
- Who it may be relevant to
- Registry conditions: Pregnancy, Dietetics. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy of Family-based Dietary Counseling During Pregnancy on Gestational Weight Gain in Pregnant Women
Overview
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.
Interventions
- Procedure individual dietetic counseling
only the pregnant patient receives dietetic counseling - Procedure family-based dietetic conseling
the pregnant patient and her companion receive dietetic counseling
Primary outcome measures
- Maternal weight change [Time frame: delivery]
Secondary outcome measures (10)
- evaluation of BMI during pregnancy [Time frame: from day 0 to delivery]
- Weight of the baby at birth [Time frame: delivery]
- The women's nutritional intake and its distribution [Time frame: 16 weeks of gestation, 24 weeks of gestation, 34 of gestation, 6 months of gestation]
- Screening for gestational diabetes [Time frame: 16 weeks of gestation, 24 weeks of gestation, 34 weeks of gestation]
- Maternal weight loss [Time frame: 6 months after delivery]
- Compliance [Time frame: 24 weeks of gestation, 34 weeks of gestation, 6 months after delivery]
- Physical activity [Time frame: 16 weeks of gestation, 24 weeks of gestation, 34 of gestation, 6 months of gestation]
- The support of the entourage [Time frame: 34 weeks of gestation, 6 months after delivery]
- Women's satisfaction with their follow-up during pregnancy [Time frame: 34 weeks of gestation, 6 months after delivery]
- Direct medical, non-medical and indirect costs, valued from the French Healthcare insurance [Time frame: from day 0 to 6 months after delivery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
France · 3 centers
- Hospital of Auch — Auch
- Clinique Rive Gauche — Toulouse
- University Hospital of Toulouse — Toulouse
Identifiers
NCT: NCT06646965 · RC31/23/0374