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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Trieste、イタリア、34137
- Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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介入なし：Control Group (CG)
The Control Group (CG) will only receive the usual antenatal care (UC)
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Percentage of Women With Adequate Gestational Weight Gain According to Institute of Medicine Guidelines
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Gestational age at delivery
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Paola Pani, PhD、Institute for Maternal and Child Health IRCCS Burlo Garofolo
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- RC 07/24
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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