Effect of Nutritional Counseling Based on Diet Quality on Metabolic Control in Patients With Type 2 Diabetes Mellitus

NCT ID: NCT02488213

Last Updated: 2016-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-12-31

Brief Summary

Randomized clinical trial with outpatient patients with type 2 diabetes mellitus treated in Endocrinology Division, Hospital de Clinicas de Porto Alegre. The study aims to carry out a nutritional counseling directed to offer benefits in metabolic control in diabetic patients.

Detailed Description

Randomized clinical trial with outpatient patients with type 2 diabetes mellitus treated in Endocrinology Division, Hospital de Clinicas de Porto Alegre. The study aims to carry out a nutritional counseling directed to offer benefits in metabolic control in diabetic patients. The initial step will be performed analysis of composition and diet quality, and anthropometric and laboratory evaluation. After initial assessment and meeting the criteria eligibility, patients will be randomized to receive nutritional counseling from diet quality (intervention group) or usual diet in according to current nutritional recommendations (control group). Both the groups will receive adjust caloric intake as the nutritional needs of each patient. Patients will be followed over six months, on a monthly basis from hospital visits or telephone monitoring. The outcomes evaluated will be: the achievement of therapeutic targets (fasting blood glucose levels between 70-130 mg / dL, HbA1c<7%, LDL cholesterol <100 mg/dL and triglycerides <150 mg/dL); use of antidiabetic drugs, lipid-lowering and antihypertensive drugs, and adherence to necessary dietary changes.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual Diet Guidance

The patients will receive usual diet guidance from the current nutritional recommendations for diabetes, according to the routine performed in outpatient patients treated in Endocrinology Division, Hospital de Clinicas de Porto Alegre.

Group Type: ACTIVE_COMPARATOR

Usual Diet Guidance

Intervention Type: OTHER

The patients with type 2 diabetes mellitus treated in Endocrinology Division, Hospital de Clinicas de Porto Alegre will receive usual diet guidance from the current nutritional recommendations for diabetes, according to the routine performed. The patients will need to come to hospital for three more visits every two months throughout the study (2, 4, 6 months). They will also be contacted by telephone during the months when will not have query (1, 3 and 5 months). The study will total duration of six months.

Nutritional Counseling

The patients will receive nutritional counseling from the diet quality assessment with adopting some techniques of motivational interviewing, and delivery of educational support material.

Group Type: EXPERIMENTAL

Nutritional Counseling

Intervention Type: OTHER

The patients with type 2 diabetes mellitus treated in Endocrinology Division, Hospital de Clinicas de Porto Alegre will receive nutritional counseling from the diet quality assessment with adopting some techniques of motivational interviewing, and delivery of educational support material. The patients will need to come to hospital for three more visits every two months throughout the study (2, 4, 6 months). They will also be contacted by telephone during the months when will not have query (1, 3 and 5 months). The study will total duration of six months.

Interventions

Nutritional Counseling

The patients with type 2 diabetes mellitus treated in Endocrinology Division, Hospital de Clinicas de Porto Alegre will receive nutritional counseling from the diet quality assessment with adopting some techniques of motivational interviewing, and delivery of educational support material. The patients will need to come to hospital for three more visits every two months throughout the study (2, 4, 6 months). They will also be contacted by telephone during the months when will not have query (1, 3 and 5 months). The study will total duration of six months.

Intervention Type: OTHER

Usual Diet Guidance

The patients with type 2 diabetes mellitus treated in Endocrinology Division, Hospital de Clinicas de Porto Alegre will receive usual diet guidance from the current nutritional recommendations for diabetes, according to the routine performed. The patients will need to come to hospital for three more visits every two months throughout the study (2, 4, 6 months). They will also be contacted by telephone during the months when will not have query (1, 3 and 5 months). The study will total duration of six months.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Type 2 diabetes patients aged ≥ 30 years;
• Body mass index ≤ 40kg/m²;
• Serum creatinine <2 mg/dL;
• Serum triglycerides <400 mg/dL.

Exclusion Criteria

• Cognitive impairment (clinical suspicion);
• Illiterate;
• Liver function tests and abnormal thyroid;
• Urinary tract infection carriers, kidney disease and heart failure uncompensated (grade III or IV);
• Active wasting disease diagnosis (Cancer, Acquired Immune Deficiency Syndrome);
• Metabolic control within the therapeutic target;
• Patients with dietary guidance by nutritionist in less than three months.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jussara C de Almeida

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas de Porto Alegre

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Juliana P Antonio

Role: CONTACT

juantonio@hcpa.edu.br

+ 55 51 3359 8530

Facility Contacts

Juliana P Antonio

Role: primary

juantonio@hcpa.edu.br

+ 55 51 3359 8530

Other Identifiers

14-0585

Identifier Type: -

Identifier Source: org_study_id