Climactericum, Menopause, Menopause Hot Flashes, Menopause Related Conditions, Menopause-related Hot Flashes, Menopause Symptoms, Overweight , Obesity, Perimenopause, Climacteric Syndrome, Postmenopause
Conditions
Keywords
menopause, postmenopause, perimenopause, overweight, obesity, climacteric
Brief summary
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.
Interventions
OTHERNutritional guidelines on healthy eating based on the Dietary Guidelines for the Brazilian Population in printed material and 5 in-person and virtual meetings
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.
OTHERNutritional guidelines on healthy eating based on the Dietary Guidelines for the Brazilian Population only in printed material
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.
Sponsors
Federal University of Health Science of Porto Alegre
Irmandade Santa Casa de Misericórdia de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a randomized, parallel-group clinical trial with a 1:1 allocation ratio comparing a dietary intervention based on the Dietary Guidelines for the Brazilian Population with the control intervention.
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Menopausal Symptoms | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dietary pattern | 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). |
| Body mass index | 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. |
| Waist circumference | 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. |
Countries
Brazil
Contacts
PRINCIPAL_INVESTIGATORFernanda M Busnello, PhD
Federal University of Health Science of Porto Alegre
Outcome results
None listed