PregnancyFAM-DIETNCT06646965
Efficacy of Family-based Dietary Counseling During Pregnancy on Gestational Weight Gain in Pregnant Women in a Randomized Controlled Trial
A study testing individual dietetic counseling and family-based dietetic conseling in people with Pregnancy and Dietetics, run by University Hospital, Toulouse at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- individual dietetic counseling and family-based dietetic conseling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,374 participants
- Where
- 3 sitesFrance
- Study dates
- 13 Jan 2025to 15 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Hospital of Auch
Auch
Maud BASSO, maud.basso@ch-auch.fr
Laure ANGLESIO
- Recruiting
Clinique Rive Gauche
Toulouse, 31300
Johanna CHAUBE, j.chaube@clinique-rivegauche.fr
Laura RANDE
- Recruiting
University Hospital of Toulouse
Toulouse
Delphine DUCHANOIS, duchanois.d@chu-toulouse.fr
Clemence ROUBLIN
About this study
Official title: Efficacy of Family-based Dietary Counseling During Pregnancy on Gestational Weight Gain in Pregnant Women
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.
- Being tested
- individual dietetic counseling, family-based dietetic conseling
- Keywords
- Gestational weight gain, Birth weight, Recommendations, Intervention, Nutrition
- Medical subject headings
- Gestational Weight Gain, Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individual dietetic counselingProcedure or surgery
only the pregnant patient receives dietetic counseling
family-based dietetic conselingProcedure or surgery
the pregnant patient and her companion receive dietetic counseling
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Procedure: family-based dietetic conseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal weight change
Maternal weight change will be calculated from the difference between the weight at delivery and the pre-pregnancy weight,
Measured: delivery
Secondary outcomes (10)
evaluation of BMI during pregnancy
from the weight of the patient, the BMI is calculated
Measured: from day 0 to delivery
Weight of the baby at birth
The weight of the child will be measured at delivery by a baby-scale measured in kilograms on the day of birth. This weight will be adjusted to the gestational age, in accordance with ARS recommendations defining weight standards according to gestational age.
Measured: delivery
The women's nutritional intake and its distribution
The women's nutritional intake and its distribution will be assessed through a food frequency questionnaire and recall from 24 hours to 16 SA (over a period of 8-16 SA). At the next two appointments during pregnancy and postpartum, a 3-day dietary survey will be conducted at 24 SA (over a period of 21- 24 SA) and 34 SA (over a period of 31-34 SA), as well as at 6 months postpartum
Measured: 16 weeks of gestation, 24 weeks of gestation, 34 of gestation, 6 months of gestation
Screening for gestational diabetes
by fasting blood glucose or OGTT (orally induced glucose)
Measured: 16 weeks of gestation, 24 weeks of gestation, 34 weeks of gestation
Maternal weight loss
Maternal weight loss will be calculated by the difference between the weight at delivery and the weight 6 months after delivery
Measured: 6 months after delivery
Compliance
measured with the Goal Attainment Scaling (GAS)
Measured: 24 weeks of gestation, 34 weeks of gestation, 6 months after delivery
Physical activity
will be measured with the Pregnancy Physical Activity Questionnaire (PPAQ)
Measured: 16 weeks of gestation, 24 weeks of gestation, 34 of gestation, 6 months of gestation
The support of the entourage
will be measured by the Sarason Social Support Questionnaire (SSQ6 )
Measured: 34 weeks of gestation, 6 months after delivery
Women's satisfaction with their follow-up during pregnancy
will be assessed by means of a satisfaction survey adapted to the needs of the study at 34 days' gestation
Measured: 34 weeks of gestation, 6 months after delivery
Direct medical, non-medical and indirect costs, valued from the French Healthcare insurance
measured with the EQ-5D-5L questionnaire evaluated at 6 months after delivery (for the cost-utility analysis), the number of caesarean sections avoided (for the cost-effectiveness analysis)
Measured: from day 0 to 6 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start13 Jan 2025
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, randomized, open-label clinical study.
- Masking
- None (open label)
- Enrolment
- 1,374 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clemence ROUBLIN, Study director, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646965
- Sponsor's protocol ID
- RC31/23/0374
- Acronym
- FAM-DIET
- Status last verified
- Jun 2025
- First submitted
- 15 Oct 2024
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Family-based Dietary Counseling During Pregnancy on Gestational Weight Gain in Pregnant Women
- ClinicalTrials.gov ID
- NCT06646965
- Acronym / sponsor ID
- FAM-DIET / RC31/23/0374
- Keywords
- Gestational weight gain, Birth weight, Recommendations, Intervention, Nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,374 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 2028 (estimated)
- First posted
- 17 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, randomized, open-label clinical study.
| Arm | Type | Receives |
|---|---|---|
| individual dietetic follw-up | Experimental | Procedure: individual dietetic counselingthe patient receives individual counseling (as usual clinical practice if the pregnant woman is followed by a dietetician during her pregancy). |
| family-based dietary counseling follw-up | Active comparator | Procedure: family-based dietetic conselingthe woman and the person who shares meals with her receive family-based counseling by a dietetician during her pregancy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| individual dietetic counselingonly the pregnant patient receives dietetic counseling | Procedure or surgery | individual dietetic follw-up |
| family-based dietetic conselingthe pregnant patient and her companion receive dietetic counseling | Procedure or surgery | family-based dietary counseling follw-up |
Primary outcome
Maternal weight change
Time frame: delivery
Maternal weight change will be calculated from the difference between the weight at delivery and the pre-pregnancy weight,
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clemence ROUBLIN study director
University Hospital of Toulouse
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing individual dietetic counseling and family-based dietetic conseling in people with Pregnancy and Dietetics, run by University Hospital, Toulouse at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadege ALGANS (0561777204, algans.n@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal weight change (time frame: delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.