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NCT Number: NCT06646965

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

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.

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Key information

Conditions

Pregnancy Birth Weight Body Weight Body Weight Changes Dietetics Gestational Weight Gain Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of Auch, Auch, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

individual dietetic counseling

Procedure

only the pregnant patient receives dietetic counseling

family-based dietetic conseling

Procedure

the pregnant patient and her companion receive dietetic counseling

Primary outcomes

  1. 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,

Secondary outcomes

  1. evaluation of BMI during pregnancy

    Time frame: from day 0 to delivery

    from the weight of the patient, the BMI is calculated

  2. 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.

  3. 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

  4. 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)

  5. 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. Compliance

    Time frame: 24 weeks of gestation, 34 weeks of gestation, 6 months after delivery

    measured with the Goal Attainment Scaling (GAS)

  7. 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)

  8. 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 )

  9. 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

  10. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Nadege ALGANS

CONTACT

[email protected]

0561777204

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Efficacy of Family-based Dietary Counseling During Pregnancy on Gestational Weight Gain in Pregnant Women

Acronym: FAM-DIET

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 17, 2024
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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