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
2026년 9월 10일 업데이트: 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.
연구 개요
상태
모병
개입 / 치료
연구 유형
중재적
등록 (추정된)
74
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, 브라질, 90050170
- 모병
- Irmandade da Santa Casa de Misericórdia de Porto Alegre
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연락하다:
- Larissa V Nobre, RD
- 전화번호: 55+5192114435
- 이메일: larissa.nobre@gmail.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Menopausal Symptoms
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Dietary pattern
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Fernanda M Busnello, PhD, Federal University of Health Science of Porto Alegre
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 5월 6일
기본 완료 (추정된)
2027년 7월 30일
연구 완료 (추정된)
2027년 7월 30일
연구 등록 날짜
최초 제출
2026년 9월 10일
QC 기준을 충족하는 최초 제출
2026년 9월 10일
처음 게시됨 (실제)
2026년 9월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 10일
마지막으로 확인됨
2026년 9월 1일
추가 정보
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