- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07635628
Motivational Interviewing on Diet, Lifestyle and Gestational Weight Gain of Pregnant Women (GLOW)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Trieste, Italien, 34137
- Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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).
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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.
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Ingen indgriben: Control Group (CG)
The Control Group (CG) will only receive the usual antenatal care (UC)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Percentage of Women With Adequate Gestational Weight Gain According to Institute of Medicine Guidelines
Tidsramme: At delivery
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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
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Gestational age at delivery
Tidsramme: At delivery
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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.
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At delivery
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Mode of delivery
Tidsramme: At delivery
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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.
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At delivery
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Newborn birth weight
Tidsramme: within 30 minute after birth
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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
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within 30 minute after birth
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Newborn birth length
Tidsramme: within 30 minute after birth
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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
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within 30 minute after birth
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Apgar Score at 1 Minute After Birth
Tidsramme: 1 minutes after birth
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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
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1 minutes after birth
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Apgar Score at 5 Minute After Birth
Tidsramme: 5 minutes after birth
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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
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5 minutes after birth
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Exclusive breastfeeding at Hospital Discharge
Tidsramme: At hospital discharge, expected within 2-5 days after delivery
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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.
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At hospital discharge, expected within 2-5 days after delivery
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Change in Dietary Behaviours from Baseline to 34 Weeks of Gestation
Tidsramme: Baseline and 34 weeks of gestation
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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.
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Baseline and 34 weeks of gestation
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Gestational Weight Gain at 18-22 Weeks of Gestation
Tidsramme: 18 weeks 0 days to 22 weeks 6 days of gestation
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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
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18 weeks 0 days to 22 weeks 6 days of gestation
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Gestational Weight Gain at 24-28 Weeks of Gestation
Tidsramme: 24 weeks 0 days to 28 weeks 6 days of gestation.
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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
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24 weeks 0 days to 28 weeks 6 days of gestation.
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Gestational Weight Gain at 30-34 Weeks of Gestation
Tidsramme: 30 weeks 0 days to 34 weeks 6 days of gestation.
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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
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30 weeks 0 days to 34 weeks 6 days of gestation.
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Paola Pani, PhD, Institute for Maternal and Child Health IRCCS Burlo Garofolo
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RC 07/24
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