Nutrition education groups for treating type 2 diabetes
Effect of Nutritional Education Groups Added in the Usual Care of Outpatients with Type 2 Diabetes: a Randomized Clinical Trial
This study is testing whether adding nutrition education groups to regular treatment can help people with type 2 diabetes manage their blood sugar better and improve their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 252 (estimated) |
| Sex | All |
| Sponsor | Hospital de Clinicas de Porto Alegre Academic / other |
| Locations | 2 sites (Porto Alegre, Rio Grande do Sul and 1 other locations) |
| Trial ID | NCT05598203 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of integrating nutrition education groups into the standard treatment for patients with type 2 diabetes. It aims to enhance glycemic control, reduce complications, and improve overall quality of life through a randomized clinical trial. Participants will receive either the usual care or the additional intervention of nutrition education in group settings. The outcomes measured will include glycemic control, lipid profiles, body mass, blood pressure, and adherence to dietary recommendations.
Who should consider this trial
Good fit: Ideal candidates are adult patients diagnosed with type 2 diabetes mellitus who are seeking to improve their health through lifestyle changes.
Not a fit: Patients with other types of diabetes, severe comorbidities, or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of type 2 diabetes and better health outcomes for patients.
How similar studies have performed: Previous studies have shown that lifestyle interventions, including nutritional education, can significantly improve diabetes management, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Adult patients with a previous diagnosis of type 2 diabetes mellitus Exclusion Criteria: * Patients with other types of diabetes * With HbA1C within the therapeutic target or with values greater than 12% * Severe neuropathy * Chronic kidney disease \[glomerular filtration rate \<30mL/min/1.73m²\] * Life expectancy \<6 months * Chemical dependence/alcoholism or use of antipsychotics * Autoimmune disease or chronic steroid use * Gastroparesis * Pregnant or lactating women * Patients who have had an Episode of Acute Coronary Syndrome (ACS) in the last 60 days * Wheelchair users * Cognitive, neurological or psychiatric condition
Where this trial is running
Porto Alegre, Rio Grande do Sul and 1 other locations
- Hospital de Clinicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)
- Universidade Federal do Rio Grande do Sul — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)
Study contacts
- Principal investigator: Jussara C De Almeida, PhD — Federal University of Rio Grande do Sul
- Study coordinator: Jussara C De Almeida, PhD
- Email: jcalmeida@hcpa.edu.br
- Phone: +555133598410
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.