An interventional study of PROVEN-DIA Hybrid Lifestyle Intervention and Usual Care Lifestyle Guidance in Prediabetic State and Pre Diabetes, sponsored by Beneficência Portuguesa de São Paulo. Recruiting at 2 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Beneficência Portuguesa de São Paulo · Not applicable, Interventional, and Prevention
The aim of this multicenter, randomized controlled trial is to assess the effectiveness of the Brazilian Diabetes Prevention Program (delivered face-to-face or via e-health) in preventing type 2 diabetes (T2D) in at least 1,305 adults at high risk of T2D over a 3-year follow-up period. Our outcomes include the incidence of T2D, body weight (kg), BMI, glycemic biomarkers, use of antidiabetic drugs, the proportion of individuals achieving controlled glycemia or HbA1c levels without medication, diet quality, moderate-to-vigorous physical activity (min/week), prevalence of physical inactivity, sleep quality, perceived stress, alcohol consumption, smoking, and quality of life. In addition, social, cultural, educational, and geographical factors at the community level will be analyzed throughout the follow-up to determine their association with the incidence of T2D.
This is a multicenter controlled randomized trial coordinated by the Hospital Beneficência Portuguesa in São Paulo-Brazil and made possible by PROADI-SUS (SUS Institutional Development Support Program).
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
This study's planned enrollment of 1,305 is above the median of 62 across 762 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Beneficência Portuguesa de São Paulo is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Have, at least, one electronic device (includes any of the following devices):
Exclusion Criteria:
other than topical, ophthalmic, or inhaled preparations Antineoplastic agents Psychoactive agents Other medications.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The PROVEN-DIA program is a structured lifestyle change initiative organized into modules that include healthy eating, physical activity, sleep, stress management, and self-care. Based on materials developed by the Brazilian Ministry of Health, including the Dietary Guidelines for the Brazilian Population and the Physical Activity Guidelines for the Brazilian Population, the program considers participants' health status, lifestyle habits, and readiness to change in order to establish individualized lifestyle goals. Specifically, in this arm, PROVEN-DIA is delivered through a hybrid model combining in-person individual and group sessions with remote support contacts provided by trained Lifestyle Counselors and Lifestyle Coaches.
Behavioral: PROVEN-DIA Hybrid Lifestyle Intervention
The PROVEN-DIA program is a structured lifestyle change initiative organized into modules that include nutrition, physical activity, sleep, stress management, and self-care. Based on materials developed by the Brazilian Ministry of Health, including the Dietary Guidelines for the Brazilian Population and the Physical Activity Guidelines for the Brazilian Population, the program considers participants' health status, lifestyle habits, and readiness to change in order to establish individualized lifestyle goals. Specifically, in this arm, PROVEN-DIA is delivered exclusively through telehealth using videoconferencing and other remote communication technologies.
Behavioral: TelePROVEN-DIA Lifestyle Intervention
Participants allocated to the usual care control group receive the same lifestyle guidance content as the intervention groups, including recommendations regarding healthy eating, physical activity, sleep, stress management, alcohol consumption, and smoking behavior. However, this guidance is not delivered through a structured behavior change program. Individual visits are scheduled every six months according to a standardized study protocol.
Behavioral: Usual Care Lifestyle Guidance
A structured lifestyle intervention delivered through a hybrid model combining face-to-face and remote interactions over 36 months. The program includes 17 individual counseling sessions, 15 structured support contacts, and 6 group education sessions designed to improve diet quality, physical activity, sleep quality, stress management, alcohol consumption, smoking behavior, and self-care practices through behavior change strategies tailored to participants' readiness to change
Also known as: PROVEN-Dia
Lifestyle guidance based on the Dietary Guidelines for the Brazilian Population and the Physical Activity Guidelines for the Brazilian Population, including recommendations regarding healthy eating, physical activity, sleep, stress management, alcohol consumption, and smoking behavior. Guidance is delivered during scheduled follow-up visits without structured behavioral counseling, goal-setting procedures, self-monitoring support, ongoing support contacts, or group education sessions.
A structured lifestyle intervention delivered entirely through telehealth over 36 months. The program includes 17 individual counseling sessions, 15 structured support contacts, and 6 group education sessions designed to improve diet quality, physical activity, sleep quality, stress management, alcohol consumption, smoking behavior, and self-care practices through behavior change strategies tailored to participants' readiness to change.
Also known as: TelePROVEN-Dia
Incidence of type 2 diabetes mellitus (T2DM)
to analyze the incidence of type 2 diabetes mellitus
Time frame: 36 months
Mean value of Glycated Hemoglobin level (HbA1c in %)
to compare mean HbA1c(%) obtained through laboratory exams/tests between groups
Time frame: 6, 12, 24 and 36 months
Mean value of Fasting Blood Glucose (mg/dL)
to compare mean fasting blood glucose (mg/dL) obtained through laboratory exams/tests between groups
Time frame: 6, 12, 24 and 36 months
Number of Participants with controlled Fasting blood glucose (<126mg/dL)
to compare the proportion of individuals with controlled blood glucose (\<126mg/dl) obtained through laboratory exams/tests without the use of hypoglycemic medication
Time frame: 6, 12, 24 and 36 months
Number of Participants with controlled Glycated Hemoglobin level (<6.4%)
to compare the proportion of individuals with HbA1c (\<6.4%) obtained through laboratory exams/tests without the use of hypoglycemic medication
Time frame: 6, 12, 24 and 36 months
body weight
to compare mean weight (kg) between groups
Time frame: 6, 12, 24 and 36 months
Number of Participants who performed, at least, 150 minutes of moderate-to-vigorous physical activity obtained by International Physical Activity Questionnaire
to compare the proportion of individuals who are physically active (\>150 minutes of moderate to vigorous physical activity) and inactive (\<150 minutes of moderate to vigorous physical activity) between groups
Time frame: 6, 12, 24 and 36 months
Minutes spent on moderate-to-vigorous physical activity
to compare mean time in minutes of practice of moderate/vigorous physical activity over a week between groups
Time frame: 6, 12, 24 and 36 months
Moderate-to-vigorous physical activity and sedentary behavior
to compare the proportion of individuals engaging in moderate or vigorous physical activity and sedentary behavior
Time frame: 6, 12, 24 and 36 months
Physical activity
to compare the proportion of individuals who engage in 150 minutes or more of physical activity per week
Time frame: 6, 12, 24 and 36 months
Sedentary behavior
to compare the proportion of sedentary individuals
Time frame: 6, 12, 24 and 36 months
Quality of diet (Mean score of The Diet Quality Index Revised (DQI-R))
to compare mean score of the Diet Quality Index Revised (DQI-R) between groups Minimum: 0 Maximum: 100 When higher the score, better the quality of diet
Time frame: 6, 12, 24 and 36 months
Mean of kcal from ultra processed food intake
to compare the mean caloric intake (kcal) from ultra-processed foods obtained through two 24-hour Dietary Recall applied within a period of fifteen days
Time frame: 6, 12, 24 and 36 months
Delta value (Change score from baseline to 6, 12, 24 and 36 months) for each domain of Quality of life obtained through Short Form Health Survey (SF-36)
to analyze the quality of life based on delta value of the eight domains (Functional capacity, Physical aspects, Pain, General health status, Vitality, Social aspects, Emotional aspects and Mental health) When higher the score, better the quality of life related to the assessed domain
Time frame: 6, 12, 24 and 36 months
Cost
To compare the cost of interventions. To estimate healthcare system costs, we will consider only direct medical costs, which include screening costs, intervention costs, and costs of healthcare service utilization. To estimate social costs, we will consider not only direct medical costs but also non-medical direct costs, such as transportation, food, and accommodation expenses reported by participants when seeking medical assistance, as well as time spent traveling to and participating in group sessions. Additionally, we will include indirect costs, calculated based on the assumption that each necessary hospitalization results in a loss of 9 hours of paid work and each outpatient visit results in a loss of half a day (4.5 hours) of paid work
Time frame: 36 months
Scholarity
To analyze the correlation between years of study and the incidence of type 2 diabetes
Time frame: 36 months
Geo-Stratified Analysis
T2DM incidence across Brazillian five geographic regions (North, Northeast, Central-West (Midwest), Southeast, South)
Time frame: 36 months
Household income
Association between T2DM incidence and individual Low or high income (accessed by ABEP - Critério Brasil 2022 questionnaire. A Brazilian validated questionnaire to evaluate Household income)
Time frame: 36 months
Neighbourhood value
correlation between neighborhood value (as assessed using the Gini index) and incidence of type 2 diabetes (DM2)
Time frame: 36 months
Mean value of BMI (kg/m2)
to compare mean BMI (kg/m2) between groups
Time frame: 6, 12, 24 and 36 months
Number of Participants in use of hypoglycemic medication
to compare the proportion of individuals in use of hypoglycemic medication
Time frame: 6, 12, 24 and 36 months
delta body weight
to compare mean delta weight (kg) between groups (delta = final mean weight - baseline mean weight)
Time frame: 6, 12, 24 and 36 months
delta glycemia
To compare the mean delta glycemia (mg/dL) between groups: Delta = Mean glycemia at the final measurement - Mean glycemia at baseline This approach evaluates the difference in blood glucose changes across the groups over the study period, reflecting the intervention's impact on glycemic control.
Time frame: 6, 12, 24 and 36 months
delta HbA1c (%)
To compare the mean delta HbA1c (%) between groups: Delta = Mean HbA1c at the final measurement - Mean HbA1c at baseline This approach evaluates the difference in blood glucose changes across the groups over the study period, reflecting the intervention's impact on glycemic control.
Time frame: 6, 12, 24 and 36 months
delta Insulin (μU/mL)
To compare the mean delta Insulin (μU/mL) between groups: Delta = Mean Insulin at the final measurement - Mean Insulin at baseline This approach evaluates the difference in Insulin changes across the groups over the study period, reflecting the intervention's impact on glycemic control.
Time frame: 6, 12, 24 and 36 months
delta HOMA-IR (homeostasis model assessment-estimated insulin resistance)
To compare the mean delta HOMA-IR between groups: Delta = Mean HOMA-IR at the final measurement - Mean HOMA-IR at baseline HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) is calculated using the following formula: HOMA-IR = \[Fasting insulin (μU/mL) × Fasting glucose (mg/dL)\] / 405 This approach evaluates the difference in insulin resistance changes across the groups over the study period, reflecting the intervention's impact on metabolic control.
Time frame: 6, 12, 24 and 36 months
delta HOMA-Beta *homeostasis model assessment of β-cell function)
To compare the mean delta HOMA-Beta between groups: Delta = Mean HOMA-Beta at the final measurement - Mean HOMA-Beta at baseline HOMA-Beta (Homeostatic Model Assessment of Beta-Cell Function) is calculated using the following formula: HOMA-Beta = \[360 × Fasting insulin (μU/mL)\] / \[Fasting glucose (mg/dL) - 63\] This approach evaluates the difference in beta-cell function changes across the groups over the study period, reflecting the intervention's impact on pancreatic function.
Time frame: 6, 12, 24 and 36 months
delta PSQI-BR scores (Pittsburgh Sleep Quality Index - Brazilian version)
To compare the mean delta PSQI-BR scores between groups: Delta = Mean PSQI-BR score at the final measurement - Mean PSQI-BR score at baseline The PSQI-BR (Pittsburgh Sleep Quality Index - Brazilian version) is a validated instrument used to assess sleep quality. It generates a total score based on seven components: Subjective sleep quality Sleep latency Sleep duration Habitual sleep efficiency Sleep disturbances Use of sleeping medications Daytime dysfunction Each component is scored from 0 to 3, and the total PSQI score ranges from 0 to 21, with higher scores indicating worse sleep quality. This approach evaluates the difference in sleep quality changes across the groups over the study period, reflecting the intervention's impact on sleep outcomes.
Time frame: 6, 12, 24 and 36 months
delta PSS-10 (Perceived Stress Scale - 10-item Brazilian version)
To compare the mean delta PPS-10 scores between groups: Delta = Mean PPS-10 score at the final measurement - Mean PPS-10 score at baseline The PPS-10 (Perceived Stress Scale - 10-item Brazilian version) is a validated instrument used to assess perceived stress over the last month. It consists of 10 questions scored on a 5-point Likert scale (0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often). The total score ranges from 0 to 40, with higher scores indicating greater perceived stress. This approach evaluates the difference in perceived stress levels across the groups over the study period, reflecting the intervention's impact on stress outcomes.
Time frame: 6, 12, 24 and 36 months
mean alcohol consumption (g/day)
To compare the mean alcohol consumption (g/day) between groups. Alcohol consumption will be assessed using a specific Alcohol Frequency Questionnaire, which records the type, frequency, and quantity of alcoholic beverages consumed. The total alcohol intake will be calculated in grams per day using the formula: Grams of alcohol/day = (Volume consumed \[mL\] × Alcohol content \[%\] × 0.8) / Days Where: Volume consumed is the reported quantity of alcoholic beverage. Alcohol content \[%\] is the average alcohol percentage for each beverage type. 0.8 is the density of pure ethanol. This approach evaluates the difference in perceived stress levels across the groups over the study period, reflecting the intervention's impact on stress outcomes.
Time frame: 6, 12, 24 and 36 months
proportion of smokers
To compare the proportion of smokers between groups at the end of the study: Smoking status will be assessed by self-report as either: Current smokers Former smokers Never smoked The proportion of smokers will be calculated as: Proportion of smokers (%) = (Number of smokers / Total participants in the group) × 100 The comparison will focus on the proportion of current smokers in each group at the study's conclusion to evaluate the intervention's impact on smoking prevalence.
Time frame: 6, 12, 24 and 36 months
mean number of cigarettes smoked per day
To compare the mean number of cigarettes smoked per day between groups at the end of the study: Smoking behavior will be assessed by participants self-report the average number of cigarettes smoked per day. The mean number of cigarettes smoked per day for each group will be calculated as: Mean number of cigarettes/day = (Total number of cigarettes smoked by participants in the group) / (Number of participants who are current smokers) This comparison will evaluate the intervention's impact on the average smoking intensity among individuals who continue to smoke.
Time frame: 6, 12, 24 and 36 months
mean scores of the eight SF-36 quality of life domains
To compare the mean scores of the eight SF-36 quality of life domains between groups at the end of the study: Quality of life will be assessed using the SF-36 Health Survey, which evaluates eight domains: Physical functioning Role limitations due to physical health Role limitations due to emotional problems Energy/fatigue Emotional well-being Social functioning Pain General health Each domain generates a score ranging from 0 to 100, where higher scores indicate better quality of life. The mean scores for each domain will be calculated as: Mean domain score = (Sum of scores for all participants in the group) / (Number of participants in the group) This comparison will assess differences in quality of life between groups at the study's conclusion, reflecting the intervention's impact across various health dimensions.
Time frame: 6, 12, 24 and 36 months
Plan to share: No
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Started Dec 2024 (actual). Primary completion is estimated for Dec 2029, 60 months after the start.
Of 378 non-industry interventional studies with no phase under Prediabetic State, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 39. This study's planned 60 months is above that.
Counting every sponsor, half of 424 studies reached it within 23 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
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Beneficência Portuguesa de São Paulo