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
torstai 10. syyskuuta 2026 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Rekrytointi
Ehdot
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
74
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brasilia, 90050170
- Rekrytointi
- Irmandade da Santa Casa de Misericórdia de Porto Alegre
-
Ottaa yhteyttä:
- Larissa V Nobre, RD
- Puhelinnumero: 55+5192114435
- Sähköposti: larissa.nobre@gmail.com
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Joo
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Muut: 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.
|
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.
|
|
Active Comparator: 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.
|
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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Menopausal Symptoms
Aikaikkuna: From the enrollment period to the end of the study: 5 months.
|
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.
|
From the enrollment period to the end of the study: 5 months.
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Dietary pattern
Aikaikkuna: From the date of enrollment to the end of the intervention: 5 months
|
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).
|
From the date of enrollment to the end of the intervention: 5 months
|
|
Body mass index
Aikaikkuna: From the date of enrollment to the end of the intervention: 5 months
|
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.
|
From the date of enrollment to the end of the intervention: 5 months
|
|
Waist circumference
Aikaikkuna: From the date of enrollment to the end of the intervention: 5 months
|
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.
|
From the date of enrollment to the end of the intervention: 5 months
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Yhteistyökumppanit
Tutkijat
- Päätutkija: Fernanda M Busnello, PhD, Federal University of Health Science of Porto Alegre
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
- Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults: executive summary. Expert Panel on the Identification, Evaluation, and Treatment of Overweight in Adults. Am J Clin Nutr. 1998 Oct;68(4):899-917. doi: 10.1093/ajcn/68.4.899. No abstract available.
- Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- 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.
- Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
- Heinemann K, Ruebig A, Potthoff P, Schneider HP, Strelow F, Heinemann LA, Do MT. The Menopause Rating Scale (MRS) scale: a methodological review. Health Qual Life Outcomes. 2004 Sep 2;2:45. doi: 10.1186/1477-7525-2-45.
- Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother. 2010 Jul;1(2):100-7. doi: 10.4103/0976-500X.72352. No abstract available.
- 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
- Sociedade Portuguesa de Ginecologia, Secção Portuguesa de Menopausa.. Coimbra: SPG; 2021
- Instituto Brasileiro De Geografia E Estatística (IBGE). Censo demográfico 2022: panorama do Brasil. 2023. https://censo2022.ibge.gov.br/panorama/index.html?localidade=BR
- World Health Organization. Menopause. Geneva: WHO; 2024. https://www.who.int/news-room/fact-sheets/detail/menopause
- Research on the menopause. World Health Organ Tech Rep Ser. 1981;670:1-120. No abstract available.
- 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.
- Thurston RC, Ewing LJ, Low CA, Christie AJ, Levine MD. Behavioral weight loss for the management of menopausal hot flashes: a pilot study. Menopause. 2015 Jan;22(1):59-65. doi: 10.1097/GME.0000000000000274.
- Noll PRES, Campos CAS, Leone C, Zangirolami-Raimundo J, Noll M, Baracat EC, Junior JMS, Sorpreso ICE. Dietary intake and menopausal symptoms in postmenopausal women: a systematic review. Climacteric. 2021 Apr;24(2):128-138. doi: 10.1080/13697137.2020.1828854. Epub 2020 Oct 28.
- Moradi M, Ghavami V, Niazi A, Seraj Shirvan F, Rasa S. The Effect of Salvia Officinalis on Hot Flashes in Postmenopausal Women: A Systematic Review and Meta-Analysis. Int J Community Based Nurs Midwifery. 2023 Jul;11(3):169-178. doi: 10.30476/IJCBNM.2023.97639.2198.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Keskiviikko 6. toukokuuta 2026
Ensisijainen valmistuminen (Arvioitu)
Perjantai 30. heinäkuuta 2027
Opintojen valmistuminen (Arvioitu)
Perjantai 30. heinäkuuta 2027
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Torstai 10. syyskuuta 2026
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 10. syyskuuta 2026
Ensimmäinen Lähetetty (Todellinen)
Keskiviikko 16. syyskuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Keskiviikko 16. syyskuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Torstai 10. syyskuuta 2026
Viimeksi vahvistettu
Tiistai 1. syyskuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- CAAE93638725.5.3001.5345
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Ei
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .