Effectiveness of the Brazilian Diabetes Prevention Program

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 short form

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 (South, Southeast, Midwest, West, and Northwest)

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 EPS-10 scores between groups: Delta = Mean EPS-10 score at the final measurement - Mean EPS-10 score at baseline The EPS-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 changes in average daily alcohol consumption across the groups over the study period, reflecting the inter 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