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. září 2026 aktualizováno: 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.
Přehled studie
Postavení
Nábor
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Odhadovaný)
74
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazílie, 90050170
- Nábor
- Irmandade da Santa Casa de Misericórdia de Porto Alegre
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Kontakt:
- Larissa V Nobre, RD
- Telefonní číslo: 55+5192114435
- E-mail: larissa.nobre@gmail.com
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Jiný: 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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Aktivní komparátor: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Menopausal Symptoms
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Dietary pattern
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Fernanda M Busnello, PhD, Federal University of Health Science of Porto Alegre
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
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- Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149.
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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.
- 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
- Matsudo S, Araújo T, Matsudo V, Andrade D, Andrade E, Oliveira LC, et al. Questionário Internacional de Atividade Física (IPAQ): estudo de validade e reprodutibilidade no Brasil. Rev Bras Ativ Fís Saúde. 2001;6(2):5-18
- 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
- Brasil. Ministério da Saúde; Universidade Federal de Minas Gerais. Instrutivo: Metodologia de trabalho em grupos para ações de alimentação e nutrição na atenção básica. Brasília: Ministério da Saúde; 2016
- Brasil. Ministério da Saúde; Universidade de São Paulo, Núcleo de Pesquisas Epidemiológicas em Nutrição e Saúde (Nupens). Fascículo 1: Protocolos de uso do Guia Alimentar para a População Brasileira na orientação alimentar: bases teóricas e metodológicas e protocolo para a população adulta. Brasília: Ministério da Saúde; 2021. https://www.fsp.usp.br/nupens/
- Brasil. Ministério da Saúde. Guia alimentar para a população brasileira. Brasília: Ministério da Saúde; 2014. https://bvsms.saude.gov.br/bvs/publicacoes/guia_alimentar_populacao_brasileira_2ed.pdf
- Wender M, Fernandes C, Sá M. Climatério e Menopausa. 1ª ed. Rio de Janeiro: Elsevier; 2019. pág. 39-49
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- Brasil. Ministério da Saúde. Secretaria de Atenção à Saúde. Departamento de Ações Programáticas Estratégicas. Manual de atenção à mulher no climatério/menopausa. Brasília: Editora do Ministério da Saúde; 2008. pág. 9-146
- New Collective Author. The 2023 nonhormone therapy position statement of The North American Menopause Society. Menopause. 2023 Jun 1;30(6):573-590. doi: 10.1097/GME.0000000000002200.
- Kroenke CH, Caan BJ, Stefanick ML, Anderson G, Brzyski R, Johnson KC, LeBlanc E, Lee C, La Croix AZ, Park HL, Sims ST, Vitolins M, Wallace R. Effects of a dietary intervention and weight change on vasomotor symptoms in the Women's Health Initiative. Menopause. 2012 Sep;19(9):980-8. doi: 10.1097/gme.0b013e31824f606e.
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Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
6. května 2026
Primární dokončení (Odhadovaný)
30. července 2027
Dokončení studie (Odhadovaný)
30. července 2027
Termíny zápisu do studia
První předloženo
10. září 2026
První předloženo, které splnilo kritéria kontroly kvality
10. září 2026
První zveřejněno (Aktuální)
16. září 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
16. září 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
10. září 2026
Naposledy ověřeno
1. září 2026
Více informací
Termíny související s touto studií
Klíčová slova
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