Family-based dietary counseling to limit gestational weight gain
Efficacy of Family-based Dietary Counseling During Pregnancy on Gestational Weight Gain in Pregnant Women
NA · University Hospital, Toulouse · NCT06646965
This trial tests whether involving a household member in dietary counseling helps pregnant women limit weight gain during pregnancy compared with standard individual counseling.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1374 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Toulouse (other) |
| Locations | 3 sites (Auch and 2 other locations) |
| Trial ID | NCT06646965 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will assign pregnant women between 8 and 16 weeks' gestation to either family-based dietary monitoring, with a household member who shares at least one meal participating in counseling, or to standard individual dietetic counseling. The intervention focuses on meal planning, nutrition education, and ongoing monitoring of maternal diet to influence total gestational weight gain, with outcomes including maternal weight change and infant birth weight. Eligible participants are adults with singleton pregnancies, starting BMI 18.5–35, French-speaking, and affiliated with social security, while women with diabetes, prior bariatric surgery, eating disorders, certain metabolic or digestive conditions, or recent major weight loss are excluded. Study visits take place at participating centers in Toulouse and Auch, France.
Who should consider this trial
Good fit: Adult, French-speaking pregnant women (8–16 weeks gestation) with a singleton pregnancy and starting BMI 18.5–35 who can attend visits in Toulouse/Auch and be accompanied by a household member who shares at least one meal daily.
Not a fit: Women with pre-existing diabetes or gestational diabetes (by fasting glucose), prior bariatric surgery, eating disorders, metabolic or digestive conditions requiring special diets, recent >10% weight loss before pregnancy, those under legal guardianship, or those with BMI outside 18.5–35 are unlikely to benefit or are ineligible.
Why it matters
Potential benefit: If successful, this approach could help pregnant women stay within recommended weight-gain ranges and may improve newborn weight outcomes.
How similar studies have performed: Previous partner- or family-supported nutrition interventions in pregnancy have produced mixed results on gestational weight gain, so this particular family-based monitoring approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Auch and 2 other locations
- Hospital of Auch — Auch, France (RECRUITING)
- Clinique Rive Gauche — Toulouse, France (RECRUITING)
- University Hospital of Toulouse — Toulouse, France (RECRUITING)
Study contacts
- Study coordinator: Nadege ALGANS
- Email: algans.n@chu-toulouse.fr
- Phone: 0561777204
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pregnancy, Dietetics, Gestational weight gain, Birth weight, Recommendations, Intervention, Nutrition