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

8. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

228

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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).
Atferdsmessig: 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.
Ingen inngripen: Control Group (CG)
The Control Group (CG) will only receive the usual antenatal care (UC)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Women With Adequate Gestational Weight Gain According to Institute of Medicine Guidelines
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Gestational age at delivery
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

IRCCS Burlo Garofolo

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

23. april 2025

Primær fullføring (Antatt)

30. november 2026

Studiet fullført (Antatt)

30. november 2026

Datoer for studieregistrering

Først innsendt

3. juni 2026

Først innsendt som oppfylte QC-kriteriene

3. juni 2026

Først lagt ut (Faktiske)

9. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RC 07/24

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