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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Menopausal Symptoms
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Nutritional guidelines on healthy eating based on the Dietary Guidelines for the Brazilian Population only in printed material (Other)
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.
干预措施: Nutritional guidelines on healthy eating based on the Dietary Guidelines for the Brazilian Population in printed material and 5 in-person and virtual meetings (Other)
结局指标
主要结局
Menopausal Symptoms
时间窗: 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.
次要结局
- Dietary pattern(From the date of enrollment to the end of the intervention: 5 months)
- Body mass index(From the date of enrollment to the end of the intervention: 5 months)
- Waist circumference(From the date of enrollment to the end of the intervention: 5 months)
研究者
Profª Drª Fernanda Michielin Busnello
Professor , PhD
Federal University of Health Science of Porto Alegre