Clinical trial NCT05689658: Brazilian Diabetes Prevention Program: Pilot Study
Official title: Brazilian Diabetes Prevention Program: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Prediabetic State
Lead sponsor: Beneficência Portuguesa de São Paulo
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To structure a Brazilian Diabetes Prevention Program based on guidance for changing lifestyle promoted by the American Diabetes Prevention Program, using materials already developed by the Brazilian Ministry of Health and contextualizing it to the Brazilian Public Health System (SUS) and evaluating its effectiveness in a multicentric randomized clinical trial with 220 pre-diabetic patients and a follow up of 3 months. Outcomes are diet quality and time of physical activity. Health care professionals' perceptions regarding its incorporation into clinical practice will also be evaluated.

Detailed description: This is a multicentric randomized clinical study coordinated by the Hospital Beneficência Portuguesa in São Paulo-Brazil and made possible by PROADI-SUS (SUS Institutional Development Support Program).

The study's objective is the Brazilian Diabetes Prevention Program development based on guidance for changing lifestyle promoted by the American Diabetes Prevention Program, using materials already developed by the Brazilian Ministry of Health and contextualizing it to the Brazilian Public Health System (SUS).

The program will not include a multidisciplinary orientation, but the prescription will have a multi-professional vision. The objective is to bring the multi-team together to discuss different aspects of the same intervention, such as accessibility, motivation, contexts, and needs, so that the program, to be guided by the nutritionist, can also be recognized and supported by the other teammates.

Once the program is defined, the research teams from the collaborating centers will be trained and qualified. 220 individuals with pre-diabetes will be included in the study and followed for 3 months. Outcomes are diet quality and time of physical activity. Health care professionals' perceptions regarding its incorporation into clinical practice will also be evaluated.

Eligibility criteria: Inclusion Criteria:

* Body mass index greater than or equal to 24kg/m2
* Have one of the following criteria: (CDC criteria for participating in the DPP)

  1. Diagnosis of prediabetes or
  2. Fasting blood glucose between 100-125mg/dl or blood glucose 2h after oral glucose tolerance test between 140 and 199mg/dl or HbA1c between 5.7 and 6.4% (maximum test date: last 3 months) or
  3. Previously diagnosed with gestational diabetes or
  4. High risk on the CDC prediabetes risk test
* With Internet access
* With personal cell phone access
* No prior nutritional monitoring (6 months)
* Live at least 60 minutes from the survey call center

Exclusion Criteria:

* Diagnosis of Diabetes Mellitus
* In secondary prevention for cardiovascular disease
* HIV patient with detectable viral load (amount of virus greater than 40 copies per ml of blood)
* Presence of illnesses that could seriously reduce your life expectancy or your ability to participate in the study
* Refuse to participate in the study (signing the Free and Informed Consent Form)
* Participation in another Randomized Clinical Trial whose objective interferes with the primary outcome of this research, such as diet quality and physical activity level
* Pregnant and lactating women

Primary outcomes:
measure: Quality of diet
timeFrame: 3 months
measure: Minutes of Moderate Physical activity
timeFrame: 3 months
Secondary outcomes:
measure: Implementation Barriers and Facilitators
timeFrame: 3 months
measure: Moderate or vigorous physical activity (according to IPAQ-short)
timeFrame: 3 months
measure: Cardioprotective diet adherence
timeFrame: 3 months
measure: Global DNA Methylation
timeFrame: Baseline and 3 months
measure: weight
timeFrame: 3 months
measure: HbA1c
timeFrame: 3 months
measure: Glycemia
timeFrame: 3 months
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Hospital Universitário Professor Edgard Santos - HUPES
state: Bahia
city: Goiânia
country: Brazil
facility: Hospital de Clínicas de Goiania
state: Goias
city: Viçosa
country: Brazil
facility: Universidade Federal de Viçosa
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
city: Palmas
country: Brazil
facility: Universidade Federal do Tocantins
state: Tocantins
Study officials:
References: