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

June 27, 2025 updated by: University Hospital, Toulouse

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1374

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Auch, France
        • Recruiting
        • Hospital of Auch
        • Contact:
        • Principal Investigator:
          • Laure ANGLESIO
      • Toulouse, France
        • Recruiting
        • University Hospital of Toulouse
        • Contact:
        • Principal Investigator:
          • Clemence ROUBLIN
      • Toulouse, France, 31300

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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).
Procedure: individual dietetic counseling
only the pregnant patient receives dietetic counseling
Active Comparator: 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.
Procedure: family-based dietetic conseling
the pregnant patient and her companion receive dietetic counseling

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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,
delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
evaluation of BMI during pregnancy
Time Frame: from day 0 to delivery
from the weight of the patient, the BMI is calculated
from day 0 to delivery
Weight of the baby at birth
Time Frame: delivery
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.
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
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
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
by fasting blood glucose or OGTT (orally induced glucose)
16 weeks of gestation, 24 weeks of gestation, 34 weeks of gestation
Maternal weight loss
Time Frame: 6 months after delivery
Maternal weight loss will be calculated by the difference between the weight at delivery and the weight 6 months after delivery
6 months after delivery
Compliance
Time Frame: 24 weeks of gestation, 34 weeks of gestation, 6 months after delivery
measured with the Goal Attainment Scaling (GAS)
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
will be measured with the Pregnancy Physical Activity Questionnaire (PPAQ)
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
will be measured by the Sarason Social Support Questionnaire (SSQ6 )
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
will be assessed by means of a satisfaction survey adapted to the needs of the study at 34 days' gestation
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
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)
from day 0 to 6 months after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Toulouse

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clemence ROUBLIN, University Hospital of Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 13, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC31/23/0374

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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