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NCT Number: NCT07635628

Motivational Interviewing on Diet, Lifestyle and Gestational Weight Gain of Pregnant Women

It is widely recognized that nutrition, metabolism and physical activity during pregnancy play a central role in several aspects of the health and well-being of pregnant women and their offspring. Pre-pregnancy Body Mass Index (BMI) and Gestational Weight Gain (GWG) are important predictors of maternal and neonatal health outcomes. In particular, excessive maternal pre-pregnancy BMI (BMI ≥ 25) and GWG outside the range recommended by the Institute of Medicine (IOM), may put mothers at risk of complications during pregnancy and delivery and can affect the short and long-term health of the offspring. They are also predicting factors of postpartum weight retention and long-term risk of offspring overweight or higher BMI. Similarly to obesity, also maternal pre-pregnancy underweight can cause negative health effects with short and long-term consequences for the mother and the foetus.

The most recent scientific evidence acknowledges the complex interplay between factors that influence the nutritional status and GWG of pregnant women, suggesting the need for multifaceted interventions that include counselling approaches, implemented during routine antenatal care for broad public health benefits. In particular, interventions based on health-related behavioural changes such as motivational interviewing (MI), used to address motivation, self-efficacy and self-regulation, have shown to have high chances of success. MI is a person-centred technique for communication that is effective for overcoming ambivalence and eliciting motivation for change.

The starting hypothesis is that inadequate GWG at the end of pregnancy may bear some relation with dietary habits and lifestyle before and during pregnancy and that MI might be effective in initiating and sustaining behavioural changes, including weight control. The study will compare a group of pregnant women, randomly assigned to receive, as part of the hospital-based prenatal care program, a behavioral intervention based on the MI methodology focused on dietary habits and lifestyle, with a group of women randomly assigned to the standard prenatal care program. It is expected that the dietary habits of women in the MI group will change as a result of the intervention, and that the resulting effective management of weight gain during pregnancy will contribute to improved maternal and neonatal outcomes.

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Key information

Conditions

Gestational Weight Gain Body Weight Body Weight Changes 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

Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"

Trieste, 34137, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pregnant women >=18 years, accessing hospital for the first scheduled ultrasound scan at 11-13 weeks of gestation and who express the intention of giving birth in the recruiting hospital

Exclusion criteria

  • gestational age at enrollment > 15 weeks
  • preexisting type 1 diabetes
  • multiple pregnancy
  • insufficient knowledge of the Italian language.

Treatment and study plan

Motivational interview (MI)

Behavioral

The four MI sessions, centered on eating habits, physical activity and lifestyle behaviours, will be led by a multidisciplinary group of health professionals - dieticians/nutritionists/ expert in motor sciences/psychologist - trained by a psychologist with expertise in MI. During the motivational sessions, personal barriers to behavioural change will be explored and positive verbal reinforcement will be given to increase self-confidence and self-efficacy. Women will be asked to identify the lifestyle behaviours they need to change and to set small stepwise goals based on their own intention to achieve a healthier lifestyle. Weight will be measured and GWG monitored at each of the four sessions.

Primary outcomes

  1. Percentage of Women With Adequate Gestational Weight Gain According to Institute of Medicine Guidelines

    Time frame: At delivery

    Gestational weight gain will be calculated as maternal weight at delivery minus self-reported pre-pregnancy weight. Adequate gestational weight gain will be defined according to the Institute of Medicine guidelines, based on pre-pregnancy body mass index category. The outcome will be reported as the percentage of women with gestational weight gain within the recommended range:

    number of women with adequate gestational weight gain / total number of women assessed x100

Secondary outcomes

  1. Gestational age at delivery

    Time frame: At delivery

    Gestational age at delivery will be calculated in completed weeks of gestation, based on the first day of the last menstrual period and/or obstetric dating. The outcome will be reported as a continuous variable.

  2. Mode of delivery

    Time frame: At delivery

    Mode of delivery will be categorized as spontaneous vaginal delivery, assisted vaginal delivery by vacuum or forceps, or cesarean delivery. The outcome will be reported as the number and percentage of women in each category.

  3. Newborn birth weight

    Time frame: within 30 minute after birth

    Newborn birth weight will be measured in grams and abstracted from the delivery or neonatal medical record. The outcome will be reported as a continuous variable

  4. Newborn birth length

    Time frame: within 30 minute after birth

    Newborn birth length will be measured in centimeters and abstracted from the delivery or neonatal medical record. The outcome will be reported as a continuous variable

  5. Apgar Score at 1 Minute After Birth

    Time frame: 1 minutes after birth

    Neonatal well-being will be assessed using the Apgar score at 1 minute after birth. The Apgar score ranges from 0 to 10, with higher scores indicating better neonatal condition. The outcome will be reported as a score or, if pre-specified, as the number and percentage of newborns with Apgar score less than 7

  6. Apgar Score at 5 Minute After Birth

    Time frame: 5 minutes after birth

    Neonatal well-being will be assessed using the Apgar score at 5 minute after birth. The Apgar score ranges from 0 to 10, with higher scores indicating better neonatal condition. The outcome will be reported as a score or, if pre-specified, as the number and percentage of newborns with Apgar score less than 7

  7. Exclusive breastfeeding at Hospital Discharge

    Time frame: At hospital discharge, expected within 2-5 days after delivery

    Exclusive breastfeeding at hospital discharge will be defined as the newborn receiving only breast milk, with no formula or other liquids/foods, except medications or vitamin/mineral supplements if applicable. The outcome will be reported as the percentage of mother-newborn dyads with exclusive breastfeeding at discharge.

  8. Change in Dietary Behaviours from Baseline to 34 Weeks of Gestation

    Time frame: Baseline and 34 weeks of gestation

    Differences in consumption frequency by food group. To evaluate consumption frequency a validated self-reported food frequency questionnaire will be used Dietary behaviours will be assessed using a validated self-reported food frequency questionnaire. Dietary behaviours changes will be evaluated within and between groups and compared with the national dietary recommendations. The outcome will be reported as the change from baseline to 34 weeks of gestation.

  9. Gestational Weight Gain at 18-22 Weeks of Gestation

    Time frame: 18 weeks 0 days to 22 weeks 6 days of gestation

    Gestational weight gain at 18-22 weeks of gestation will be calculated as maternal weight measured between 18 weeks 0 days and 22 weeks 6 days of gestation minus self-reported pre-pregnancy weight. The outcome will be reported in kilograms

  10. Gestational Weight Gain at 24-28 Weeks of Gestation

    Time frame: 24 weeks 0 days to 28 weeks 6 days of gestation.

    Gestational weight gain at 24-28 weeks of gestation will be calculated as maternal weight measured between 24 weeks 0 days and 28 weeks 6 days of gestation minus self-reported pre-pregnancy weight. The outcome will be reported in kilograms

  11. Gestational Weight Gain at 30-34 Weeks of Gestation

    Time frame: 30 weeks 0 days to 34 weeks 6 days of gestation.

    Gestational weight gain at 30-34 weeks of gestation will be calculated as maternal weight measured between 30 weeks 0 days and 34 weeks 6 days of gestation minus self-reported pre-pregnancy weight. The outcome will be reported in kilograms

Sponsors and collaborators

Lead sponsor

IRCCS Burlo Garofolo

Other

Registry information

Official study title

Effectiveness on Gestational Weight Gain of Pregnant Women of Motivational Interviewing on Diet and Lifestyle: a Randomized Controlled Trial

Acronym: GLOW

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 9, 2026
Registry last updated
Jun 10, 2026

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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