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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brazilian Diabetes Prevention Program (hybrid - a mix of in-person and remote support) | Experimental | 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. |
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| Brazilian Diabetes Prevention Program - TeleHealth (remote care) | Experimental | 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. |
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| Control Group | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROVEN-DIA Hybrid Lifestyle Intervention | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of type 2 diabetes mellitus (T2DM) | to analyze the incidence of type 2 diabetes mellitus | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean value of Glycated Hemoglobin level (HbA1c in %) | to compare mean HbA1c(%) obtained through laboratory exams/tests between groups | 6, 12, 24 and 36 months |
| Mean value of Fasting Blood Glucose (mg/dL) |
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Inclusion Criteria
Be 18 years or older (no maximum age for being eligible)
Have a body mass index (BMI) between 18,5 and 34,9kg/m²
Have, at least, one electronic device (includes any of the following devices):
Have access to internet (broadband, 3G, 4G, 5G, among others) Without previous nutritional counseling (within the 6 months prior to recruitment/randomization/intervention) Without supervision by a Physical Education Professional (Personal Trainer) in the past 6 months
Living near the research center (at maximum 60 minutes)
Diagnosis of prediabetes defined as two HbA1c measurements between 5.7% and 6.4% collected 7 to 90 days apart.
Exclusion Criteria:
Corticosteroids other than topical, ophthalmic, or inhaled preparations Antineoplastic agents Psychoactive agents Other medications.
• Participant from the pilot Randomized Clinical Trial (Brazilian Diabetes Prevention Program: Pilot Study (PROVEN-Dia), NCT05689658)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angela C Bersch-Ferreira, PhD | Contact | (55 11) 988295600 | angelacbferreira@gmail.com | |
| Raira Pagano | Contact | 5511954729698 | raira.pagano@bp.org.br |
| Name | Affiliation | Role |
|---|---|---|
| Angela C Bersch-Ferreira, PhD | Hospital Beneficência Portuguesa de São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clínicas de Goiás - UFG | Recruiting | Goiânia | Goiás | Brazil |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Usual Care Lifestyle Guidance | Behavioral | 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. |
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| TelePROVEN-DIA Lifestyle Intervention | Behavioral | 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. |
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to compare mean fasting blood glucose (mg/dL) obtained through laboratory exams/tests between groups
| 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 | 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 | 6, 12, 24 and 36 months |
| body weight | to compare mean weight (kg) between groups | 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 | 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 | 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 | 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 | 6, 12, 24 and 36 months |
| Sedentary behavior | to compare the proportion of sedentary individuals | 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 | 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 | 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 | 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 | 36 months |
| Scholarity | To analyze the correlation between years of study and the incidence of type 2 diabetes | 36 months |
| Geo-Stratified Analysis | T2DM incidence across Brazillian five geographic regions (North, Northeast, Central-West (Midwest), Southeast, South) | 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) | 36 months |
| Neighbourhood value | correlation between neighborhood value (as assessed using the Gini index) and incidence of type 2 diabetes (DM2) | 36 months |
| Mean value of BMI (kg/m2) | to compare mean BMI (kg/m2) between groups | 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 | 6, 12, 24 and 36 months |
| delta body weight | to compare mean delta weight (kg) between groups (delta = final mean weight - baseline mean weight) | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 6, 12, 24 and 36 months |
| Universidade Federal de Viçosa | Recruiting | Viçosa | Minas Gerais | Brazil |
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| D004700 | Endocrine System Diseases |
| D006943 | Hyperglycemia |