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

8 giugno 2026 aggiornato da: IRCCS Burlo Garofolo

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

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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

228

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Italia
      • Trieste, Italia, 34137
        • Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Experimental Group (EG)
In addition to usual antenatal care (UC), the Experimental Group (EG) will receive four prenatal MI sessions between 11 and 15 weeks of gestation (T1), between 18 and 22 weeks (T2), between 24 and 28 weeks (T3), and between 30 and 34 weeks (T4).
Comportamentale: Motivational Interview (MI)
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.
Nessun intervento: Control Group (CG)
The Control Group (CG) will only receive the usual antenatal care (UC)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Women With Adequate Gestational Weight Gain According to Institute of Medicine Guidelines
Lasso di tempo: 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
At delivery

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Gestational age at delivery
Lasso di tempo: 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.
At delivery
Mode of delivery
Lasso di tempo: 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.
At delivery
Newborn birth weight
Lasso di tempo: 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
within 30 minute after birth
Newborn birth length
Lasso di tempo: 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
within 30 minute after birth
Apgar Score at 1 Minute After Birth
Lasso di tempo: 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
1 minutes after birth
Apgar Score at 5 Minute After Birth
Lasso di tempo: 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
5 minutes after birth
Exclusive breastfeeding at Hospital Discharge
Lasso di tempo: 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.
At hospital discharge, expected within 2-5 days after delivery
Change in Dietary Behaviours from Baseline to 34 Weeks of Gestation
Lasso di tempo: 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.
Baseline and 34 weeks of gestation
Gestational Weight Gain at 18-22 Weeks of Gestation
Lasso di tempo: 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
18 weeks 0 days to 22 weeks 6 days of gestation
Gestational Weight Gain at 24-28 Weeks of Gestation
Lasso di tempo: 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
24 weeks 0 days to 28 weeks 6 days of gestation.
Gestational Weight Gain at 30-34 Weeks of Gestation
Lasso di tempo: 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
30 weeks 0 days to 34 weeks 6 days of gestation.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

IRCCS Burlo Garofolo

Investigatori

  • Investigatore principale: Paola Pani, PhD, Institute for Maternal and Child Health IRCCS Burlo Garofolo

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

23 aprile 2025

Completamento primario (Stimato)

30 novembre 2026

Completamento dello studio (Stimato)

30 novembre 2026

Date di iscrizione allo studio

Primo inviato

3 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 giugno 2026

Primo Inserito (Effettivo)

9 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • RC 07/24

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Prove cliniche su Motivational Interview (MI)

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Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

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Sedi

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