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

2026년 6월 8일 업데이트: 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.

연구 개요

상태

모집하지 않고 적극적으로

연구 유형

중재적

등록 (실제)

228

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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).
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.
간섭 없음: Control Group (CG)
The Control Group (CG) will only receive the usual antenatal care (UC)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Women With Adequate Gestational Weight Gain According to Institute of Medicine Guidelines
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Gestational age at delivery
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 4월 23일

기본 완료 (추정된)

2026년 11월 30일

연구 완료 (추정된)

2026년 11월 30일

연구 등록 날짜

최초 제출

2026년 6월 3일

QC 기준을 충족하는 최초 제출

2026년 6월 3일

처음 게시됨 (실제)

2026년 6월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 8일

마지막으로 확인됨

2026년 6월 1일

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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Motivational Interview (MI)에 대한 임상 시험

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