Pre Diabetes, Prediabetic State
Conditions
Brief summary
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.
Detailed description
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).
Interventions
BEHAVIORALPROVEN-DIA Hybrid Lifestyle Intervention
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
BEHAVIORALUsual Care Lifestyle Guidance
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.
BEHAVIORALTelePROVEN-DIA Lifestyle Intervention
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.
Sponsors
Beneficência Portuguesa de São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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): * Computer * Laptop/notebook * Tablet * Smartphone * 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
* Diagnosis of Diabetes Mellitus (including current or recent use, within three months, of glucose-lowering medication) * Underlying disease likely to limit life expectancy and/or increase the risk of interventions influencing the risk of developing T2D * Diagnosis of Renal Disease * Diagnosis of Pulmonary Disease * Gastrointestinal Disease * Secondary prevention for Cardiovascular Disease * Endocrine Diseases * Weight loss exceeding 10% in the last 6 months (except postpartum-related) * Uncontrolled Hypertension * Diagnosis of Polycystic Ovary Syndrome (self-reported) * Patients undergoing treatment for Tuberculosis (except those using isoniazid \[INH\] as prophylaxis) * Presence of diseases that may severely reduce life expectancy or the ability to participate in the study * Pregnant or breastfeeding women * Severe psychiatric disorders that, in the opinion of the clinical team, hinder participation in the program * Acute or chronic excessive alcohol consumption * Congestive Heart Failure (CHF) with a New York Heart Association Functional Class (NYHA) \> 2 * Need for referral to a cardiologist according to the Physical Activity Readiness Questionnaire (PAR-Q) * Current or recent participation (within the last six months) in another clinical trial that impacts the interventions and/or is associated with the study outcomes (in case of doubt, contact the coordinating center) * Likely relocation away from the research collaborating center within the next 3 years * Another household member is a participant or a team member of the PROVEN-DIA study * Unwillingness to accept treatment assignment by randomization and/or refusal to participate in the study (signing the Informed Consent Form) * Continuous use of the following medications: 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of type 2 diabetes mellitus (T2DM) | 36 months | to analyze the incidence of type 2 diabetes mellitus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean value of Glycated Hemoglobin level (HbA1c in %) | 6, 12, 24 and 36 months | to compare mean HbA1c(%) obtained through laboratory exams/tests between groups |
| Mean value of Fasting Blood Glucose (mg/dL) | 6, 12, 24 and 36 months | to compare mean fasting blood glucose (mg/dL) obtained through laboratory exams/tests between groups |
| Number of Participants with controlled Fasting blood glucose (<126mg/dL) | 6, 12, 24 and 36 months | to compare the proportion of individuals with controlled blood glucose (\<126mg/dl) obtained through laboratory exams/tests without the use of hypoglycemic medication |
| Number of Participants with controlled Glycated Hemoglobin level (<6.4%) | 6, 12, 24 and 36 months | to compare the proportion of individuals with HbA1c (\<6.4%) obtained through laboratory exams/tests without the use of hypoglycemic medication |
| body weight | 6, 12, 24 and 36 months | to compare mean weight (kg) between groups |
| Number of Participants who performed, at least, 150 minutes of moderate-to-vigorous physical activity obtained by International Physical Activity Questionnaire | 6, 12, 24 and 36 months | 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 |
| Minutes spent on moderate-to-vigorous physical activity | 6, 12, 24 and 36 months | to compare mean time in minutes of practice of moderate/vigorous physical activity over a week between groups |
| Moderate-to-vigorous physical activity and sedentary behavior | 6, 12, 24 and 36 months | to compare the proportion of individuals engaging in moderate or vigorous physical activity and sedentary behavior |
| Physical activity | 6, 12, 24 and 36 months | to compare the proportion of individuals who engage in 150 minutes or more of physical activity per week |
| Sedentary behavior | 6, 12, 24 and 36 months | to compare the proportion of sedentary individuals |
| Quality of diet (Mean score of The Diet Quality Index Revised (DQI-R)) | 6, 12, 24 and 36 months | 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 |
| Mean of kcal from ultra processed food intake | 6, 12, 24 and 36 months | 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 |
| 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) | 6, 12, 24 and 36 months | 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 |
| Cost | 36 months | 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 |
| Scholarity | 36 months | To analyze the correlation between years of study and the incidence of type 2 diabetes |
| Geo-Stratified Analysis | 36 months | T2DM incidence across Brazillian five geographic regions (North, Northeast, Central-West (Midwest), Southeast, South) |
| Household income | 36 months | 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) |
| Neighbourhood value | 36 months | correlation between neighborhood value (as assessed using the Gini index) and incidence of type 2 diabetes (DM2) |
| Mean value of BMI (kg/m2) | 6, 12, 24 and 36 months | to compare mean BMI (kg/m2) between groups |
| Number of Participants in use of hypoglycemic medication | 6, 12, 24 and 36 months | to compare the proportion of individuals in use of hypoglycemic medication |
| delta body weight | 6, 12, 24 and 36 months | to compare mean delta weight (kg) between groups (delta = final mean weight - baseline mean weight) |
| delta glycemia | 6, 12, 24 and 36 months | 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. |
| delta HbA1c (%) | 6, 12, 24 and 36 months | 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. |
| delta Insulin (μU/mL) | 6, 12, 24 and 36 months | 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. |
| delta HOMA-IR (homeostasis model assessment-estimated insulin resistance) | 6, 12, 24 and 36 months | 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. |
| delta HOMA-Beta *homeostasis model assessment of β-cell function) | 6, 12, 24 and 36 months | 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. |
| delta PSQI-BR scores (Pittsburgh Sleep Quality Index - Brazilian version) | 6, 12, 24 and 36 months | 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. |
| delta PSS-10 (Perceived Stress Scale - 10-item Brazilian version) | 6, 12, 24 and 36 months | 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. |
| mean alcohol consumption (g/day) | 6, 12, 24 and 36 months | 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. |
| proportion of smokers | 6, 12, 24 and 36 months | 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. |
| mean number of cigarettes smoked per day | 6, 12, 24 and 36 months | 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. |
| mean scores of the eight SF-36 quality of life domains | 6, 12, 24 and 36 months | 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. |
Countries
Brazil
Contacts
CONTACTAngela C Bersch-Ferreira, PhD
CONTACTRaira Pagano
PRINCIPAL_INVESTIGATORAngela C Bersch-Ferreira, PhD
Hospital Beneficência Portuguesa de São Paulo
Outcome results
None listed