Effects of a Dietary Intervention Based on the Dietary Guidelines for the Brazilian Population on the Reduction of Menopausal Symptoms in Overweight and Obese Women
10 сентября 2026 г. обновлено: Profª Drª Fernanda Michielin Busnello, Federal University of Health Science of Porto Alegre
The menopausal transition is associated with significant hormonal changes that negatively impact many women's quality of life. Vasomotor symptoms, sleep disturbances, mood changes, and genitourinary symptoms are frequently reported during this period. Concurrently, there is a tendency toward increased body weight and fat redistribution, specifically central fat accumulation, which raises the risk of metabolic diseases. Although hormonal therapy is effective, it is not suitable for all women, necessitating the consideration of non-pharmacological strategies as therapeutic alternatives. Scientific evidence indicates that healthy dietary patterns and weight loss are associated with reduced menopausal symptom severity.
The objective of the research is to evaluate the effects of a dietary intervention based on the guidelines of the Dietary Guidelines for the Brazilian Population (GAPB) on the reduction of menopausal symptoms.
A randomized clinical trial will be conducted to assess whether improving dietary quality and reducing body weight contribute to alleviating menopausal symptoms. Participants will be assigned to two groups: a control group (CG) and an intervention group (IG). Both groups will receive nutritional guidance based on the GAPB; however, the CG will receive the guidelines in printed format, whereas the IG will receive them through group sessions. The study will include perimenopausal or postmenopausal women who are overweight or obese and experiencing menopausal symptoms. Validated instruments will be administered at the beginning and end of the study to assess dietary patterns, menopausal symptoms, and nutritional status.
Обзор исследования
Статус
Рекрутинг
Условия
Вмешательство/лечение
- Другой: Nutritional guidelines on healthy eating based on the Dietary Guidelines for the Brazilian Population only in printed material
- Другой: Nutritional guidelines on healthy eating based on the Dietary Guidelines for the Brazilian Population in printed material and 5 in-person and virtual meetings
Тип исследования
Интервенционный
Регистрация (Оцененный)
74
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Бразилия, 90050170
- Рекрутинг
- Irmandade da Santa Casa de Misericórdia de Porto Alegre
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Контакт:
- Larissa V Nobre, RD
- Номер телефона: 55+5192114435
- Электронная почта: larissa.nobre@gmail.com
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Да
Описание
Inclusion Criteria:
- Aged 40 to 65 years; in the perimenopausal or postmenopausal stage (based on clinical criteria and/or self-report) and exhibiting clinical symptoms characteristic of menopause; diagnosed as overweight or obese (BMI ≥ 25 kg/m²); having internet access via mobile phone or computer; and agreeing to participate by signing the Informed Consent Form (ICF).
Exclusion Criteria:
- Pregnant women, women undergoing hormone replacement therapy or taking medications for obesity, diagnosed with active neoplasms undergoing chemotherapy or immunosuppressive treatment, and those with cognitive impairment.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Другой: Control group (CG)
The control group will receive nutritional guidance on healthy eating based on the Dietary Guidelines for the Brazilian Population, provided exclusively as printed material distributed at the start of the study.
The guidance will be standardized, with no individual follow-up or in-person meetings.
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The control group will receive nutritional guidance on healthy eating based on the Dietary Guidelines for the Brazilian Population, provided exclusively as printed material distributed at the start of the study.
The guidance will be standardized, with no individual follow-up or in-person meetings.
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Активный компаратор: Intervention group (IG)
The intervention group will receive nutritional guidance on healthy eating, based on the Dietary Guidelines for the Brazilian Population, provided via printed materials and five monthly in-person sessions.
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The intervention group will participate in five monthly Food and Nutrition Education sessions based on the Dietary Guidelines for the Brazilian Population.
The first session will be an individual session on nutritional guidance, while the second will be a virtual group session on the NOVA food classification system.
The third session will be a virtual group session on nutrition labeling.
The fourth session will be a virtual group session on reducing culinary ingredients (salt, sugar, and fat) in food preparation.
The fifth session will be an in-person group cooking workshop focused on preparing healthy and practical recipes.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Menopausal Symptoms
Временное ограничение: From the enrollment period to the end of the study: 5 months.
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Baseline and outcome variables will be collected for both groups (control and intervention) prior to the start and at the end of the five-month follow-up period.
Menopausal symptom intensity, measured using the Menopause Rating Scale (MRS) questionnaire, will be the primary outcome indicator.
This instrument assesses 11 symptoms on a scale of 0 to 4, where 0 indicates no complaints, 1 mild, 2 moderate, 3 severe, and 4 very severe, with a maximum possible score of 44 points.
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From the enrollment period to the end of the study: 5 months.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Dietary pattern
Временное ограничение: From the date of enrollment to the end of the intervention: 5 months
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Baseline and outcome variables will be collected for both groups (control and intervention) prior to the start and at the end of the five-month follow-up period.
Dietary patterns will be assessed using the NOVA 24-Hour Dietary Recall, based on data regarding food intake from the previous day.
This tool was developed by the Center for Epidemiological Research in Nutrition and Health (NUPENS) at the University of São Paulo (USP) on the QUEST NOVA platform-available at https://www.fsp.usp.br/nupens/quest-nova/-and
classifies foods according to their degree of processing based on the NOVA classification system.
The results show total caloric intake categorized into four groups: Group 1 (unprocessed or minimally processed foods), Group 2 (culinary ingredients), Group 3 (processed foods), and Group 4 (ultra-processed foods).
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From the date of enrollment to the end of the intervention: 5 months
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Body mass index
Временное ограничение: From the date of enrollment to the end of the intervention: 5 months
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Baseline and outcome variables will be collected for both groups (control and intervention) prior to the start and at the end of the five-month follow-up period.
The BMI (Body Mass Index) classification is calculated by dividing body weight (kg) by height (m) squared and is used to classify nutritional status according to WHO standards.
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From the date of enrollment to the end of the intervention: 5 months
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Waist circumference
Временное ограничение: From the date of enrollment to the end of the intervention: 5 months
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Baseline and outcome variables will be collected for both groups (control and intervention) prior to the start and at the end of the five-month follow-up period.
Waist circumference will be measured, with the participant standing, at the end of a normal exhalation, with an inelastic and non-extensive anthropometric tape surrounding the abdominal region at the midpoint between the lower edge of the last rib and the iliac crest.
Measurements will be taken in duplicate and recorded in centimeters on the data collection form.
The average will be used to classify metabolic risk, with a cutoff point of 88 cm for women.
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From the date of enrollment to the end of the intervention: 5 months
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Fernanda M Busnello, PhD, Federal University of Health Science of Porto Alegre
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
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- Oliveira GMM, Almeida MCC, Arcelus CMA, Neto Espindola L, Rivera MAM, Silva-Filho ALD, Marques-Santos C, Fernandes CE, Albuquerque CJDM, Freire CMV, Izar MCO, Costa MENC, Castro ML, Lemke VMG, Lucena AJG, Brandao AA, Macedo AVS, Polanczyk CA, Lantieri CJB, Nahas EP, Alexandre ERG, Campana EMG, Braganca EOV, Colombo FMC, Barbosa ICQ, Rivera IR, Kulak J, Moura LAZ, Pompei LM, Baccaro LFC, Barbosa MM, Rodrigues MAH, Albernaz MA, Decoud MSP, Paiva MSMO, Sanchez-Zambrano MB, Campos MDSB, Acevedo M, Ramirez MS, Souza OF, Medeiros OO, Carvalho RCM, Machado RB, Silva SCTFD, Rodrigues TCV, Avila WS, Costa-Paiva LHSD, Wender MCO. Brazilian Guideline on Menopausal Cardiovascular Health - 2024. Arq Bras Cardiol. 2024 Aug 16;121(7):e20240478. doi: 10.36660/abc.20240478. No abstract available. English, Portuguese.
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Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
6 мая 2026 г.
Первичное завершение (Оцененный)
30 июля 2027 г.
Завершение исследования (Оцененный)
30 июля 2027 г.
Даты регистрации исследования
Первый отправленный
10 сентября 2026 г.
Впервые представлено, что соответствует критериям контроля качества
10 сентября 2026 г.
Первый опубликованный (Действительный)
16 сентября 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
16 сентября 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
10 сентября 2026 г.
Последняя проверка
1 сентября 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CAAE93638725.5.3001.5345
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .