The effect of nutritional intervention on the health of patients affected by type 2 diabetes mellitus in Naples, Italy

The Role of Nutrition Education in Treatment and Improvement of the quality of life of patients affected by Type 2 Diabetes mellitus

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11067689

Enrollment

279

Registered

2018-09-10

Start date

2013-12-01

Completion date

Unknown

Last updated

2018-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus

Interventions

Participants joined the study groups on a voluntary basis. Individuals who decided to take part in the nutritional motivational program formed the intervention group (IG) while recruited patients who

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. between 50 and 70 years old 2. living in the community 3. diagnosed with type 2 diabetes at least 1 year prior

Exclusion criteria

Exclusion criteria: major complications of diabetes

Design outcomes

Primary

Measure	Time frame
1. Dietary habits and behaviours were measured using a questionnaire pre-intervention, at time 0, and post-intervention at 9 months 1.1. Daily consumption of food 1.2. The types of food eaten at breakfast, lunch, dinner and snacks 2. Anthropometric parameters were measured pre-intervention, at time 0, and post-intervention at 9 months 2.1 BMI (kg/m2) was calculated using weight and height measurements 2.2. Waist circumference 2.3. Hip circumference 3. Endocrinal-metabolic parameters were measured pre-intervention, at time 0, during intervention at months 3 and 6 and post-intervention at 9 months. 3.1. Blood pressure 3.3. Glycaemia was measured using a fasting blood test 3.4. HbA1c was measured using a fasting blood test 3.5. Total cholesterol was measured using a fasting blood test 3.6. HDL was measured using a fasting blood test 3.7. LDL was measured using a fasting blood test 3.8. Triglycerides was measured using a fasting blood test 3.9. Creatinine was measured using a fasting blood test	—

Measure

Time frame

1. Dietary habits and behaviours were measured using a questionnaire pre-intervention, at time 0, and post-intervention at 9 months 1.1. Daily consumption of food 1.2. The types of food eaten at breakfast, lunch, dinner and snacks 2. Anthropometric parameters were measured pre-intervention, at time 0, and post-intervention at 9 months 2.1 BMI (kg/m2) was calculated using weight and height measurements 2.2. Waist circumference 2.3. Hip circumference 3. Endocrinal-metabolic parameters were measured pre-intervention, at time 0, during intervention at months 3 and 6 and post-intervention at 9 months. 3.1. Blood pressure 3.3. Glycaemia was measured using a fasting blood test 3.4. HbA1c was measured using a fasting blood test 3.5. Total cholesterol was measured using a fasting blood test 3.6. HDL was measured using a fasting blood test 3.7. LDL was measured using a fasting blood test 3.8. Triglycerides was measured using a fasting blood test 3.9. Creatinine was measured using a fasting blood test

—

Secondary

Measure	Time frame
Secondary outcomes were measured using the results of a questionnaire reporting daily food consumption at 0 and 9 months post-intervention and calculated using the dietary anamnesis software WinFood7 1. Average daily amount of food consumed 2. Average daily calories consumed 3. Distribution into micro and macro nutrients 4. Caloric breakdown between meals	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026