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
2026年9月10日 更新者：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.
研究概览
地位
招聘中
研究类型
介入性
注册 (估计的)
74
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Rio Grande do Sul
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Porto Alegre、Rio Grande do Sul、巴西、90050170
- 招聘中
- Irmandade da Santa Casa de Misericórdia de Porto Alegre
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接触：
- Larissa V Nobre, RD
- 电话号码：55+5192114435
- 邮箱：larissa.nobre@gmail.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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其他：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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有源比较器：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Menopausal Symptoms
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Dietary pattern
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Fernanda M Busnello, PhD、Federal University of Health Science of Porto Alegre
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Conselho Nacional de Saúde (Brasil). Resolução nº 466, de 12 de dezembro de 2012: diretrizes e normas regulamentadoras de pesquisas envolvendo seres humanos. Brasília (DF): Ministério da Saúde; 2012
- World Medical Association. WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Participants. [S.l.]: World Medical Association; 2024. https://www.wma.net/policies-post/wma-declaration-of-helsinki
- Organização Mundial da Saúde. Boas práticas clínicas: documento das Américas, República Dominicana, 2-4 de março de 2005
- World Health Organization (WHO). Body mass index - BMI [Internet]. Geneva: WHO. https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight. Acesso em: 05 Aug 2025
- Brasil. Ministério da Saúde. Secretaria de Atenção à Saúde. Departamento de Atenção Básica. Orientações para a coleta e análise de dados antropométricos em serviços de saúde: norma técnica do Sistema de Vigilância Alimentar e Nutricional - SISVAN. Brasília: Ministério da Saúde; 2011. 76 p. (Série G. Estatística e Informação em Saúde). https://bvsms.saude.gov.br/bvs/publicacoes/orientacoes_coleta_analise_dados_antropometricos.pdf. Acesso em: 05 Aug 2025
- National Institute on Drug Abuse. Alcohol Use Disorders Identification Test-Concise (AUDIT-C) Questionnaire. NIH Common Data Element Repository; 2015. Disponível em: https://cde.nlm.nih.gov/formView?tinyId=myWNfJaZwe. Acesso: 15 Aug. 2025
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- BRASIL. Ministério da Saúde. Universidade de São Paulo. Manual instrutivo: implementando o Guia Alimentar para a População Brasileira. Brasília: Ministério da Saúde; 2019. http://189.28.128.100/dab/docs/portaldab/publicacoes/manual_instrutivo_guia_alimentar_pop_brasileira.pdf
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月6日
初级完成 (估计的)
2027年7月30日
研究完成 (估计的)
2027年7月30日
研究注册日期
首次提交
2026年9月10日
首先提交符合 QC 标准的
2026年9月10日
首次发布 (实际的)
2026年9月16日
研究记录更新
最后更新发布 (实际的)
2026年9月16日
上次提交的符合 QC 标准的更新
2026年9月10日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.