Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/08/2018
Date assigned
10/09/2018
Last edited
23/10/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Background and study aims
Type 2 diabetes (T2D) is associated with a diminished quality of life. Changing dietary habits is an absolute priority, as well as implementing nutritional motivational programs. This longitudinal study is part of a health promotion intervention sponsored by the National Center for Prevention and Control of Diseases of the Italian Ministry of Health. It aimed to evaluate possible changes in food habits and health perception in a sample of individuals with T2D before and after a 9 month nutritional motivational program.

Participants
In the preliminary phase of the study (3 months), physicians and diabeticians of Naples city (ASL Na2 Nord and ASL Na1 Centro) identified patients who were eligible and invited them to participate in the investigation. Eligibility criteria were being between 50 and 70 years old, living in the community, having been diagnosed with T2D at least 1 year prior, absence of major complications of diabetes. All participants were informed about the purpose of the study and the use of resulting data, and signed an informed consent for being included in the intervention. 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 decided not to follow the program were included in the control group (CG).

The study
Anthropometric parameters (BMI, waist measurement, hip measurement) and endocrinal-metabolic data (blood pressure, heart rate, glycaemia, HbA1c, total cholesterol, HDL, LDL, triglycerides, creatinine) were assessed before and after the intervention. Dietary habits were also evaluated.
The intervention lasted 9 months. The nutritional program was structured in quarterly group meetings conducted by a trained nutritionist, who discussed with patients the role of diet in diabetes control, Mediterranean diet benefits, healthy food choices, and how to manage their own nutrition through an adequate daily distribution of meals, using photo books containing examples of meals, as well as to learn a correct interpretation of food labels. Detailed information about how to prevent and manage hypoglycemia was given.

Possible benefits and risks of participating
A nutritional motivational intervention may be useful in improving dietary habits and health status of patients with T2D. We hope that a similar intervention will be applied in Campania and in other Italian regions.
There were no adverse events associated with this trial.

Where is the study run from?
This study is part of a health promotion intervention sponsored by the National Center for Prevention and Control of Diseases of the Italian Ministry of Health. About 30 physicians and diabeticians of Naples city (ASL Na2 Nord and ASL Na1 Centro) identified patients who were eligible and invited them to participate in the investigation.

When is the study starting and how long is it expected to run for?
The study started on 01/01/2012, and ended on 01/10/2014.

Financial Support
This work was supported by the National Center for Prevention and Control of Diseases of the Italian Ministry of Health (CCM funding, 2012) and by the University of Naples Parthenope (funding for competitive research, 2016).

Main contact:
Valeria Di Onofrio
Researcher of General and Applied Hygiene
University of Naples “Parthenope”
Department of Science and Technology
Business District, Block C4, 80143, Naples, Italy.
Tel. +39 0815476542
e-mail: valeria.dionofrio@uniparthenope.it

Trial website

Contact information

Type

Scientific

Primary contact

Dr Valeria Di Onofrio

ORCID ID

http://orcid.org/0000-0001-9398-3496

Contact details

Business District
Block C4
Naples
80143
Italy
+ 39 081 547 65 42
valeria.dionofrio@uniparthenope.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CUP:B29E12001850001

Study information

Scientific title

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

Acronym

RNETIpatT2D

Study hypothesis

The health and quality of life of patients with type 2 diabetes will improve if they participate in a nutritional education intervention, but not if they do not participate in this intervention.

Ethics approval

Ethics committee: Università degli Studi della Campania “Luigi Vanvitelli” – Azienda Ospedaliera Universitaria “Luigi Vanvitelli” – AORN “Ospedale dei Colli”, Naples. Approval date: 21/03/2018. Reference number: N. Prot. 224/2018

Study design

Single-centre non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

type 2 diabetes mellitus

Intervention

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 decided not to follow the program were included in the control group (CG). The nutritional program lasted 9 months and was structured into quarterly group meetings conducted by a trained nutritionist. The meetings discussed the role of diet in diabetes control, Mediterranean diet benefits, healthy food choices, daily meal distribution. Participants were shown photo books containing examples of meals, learnt how to interpret food labels and were given detailed information about preventing and managing hypoglycemia.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

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 outcome measures

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

Overall trial start date

01/01/2012

Overall trial end date

01/10/2014

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

512

Participant exclusion criteria

major complications of diabetes

Recruitment start date

01/12/2013

Recruitment end date

31/08/2014

Locations

Countries of recruitment

Italy

Trial participating centre

ASL Napoli 1 Centro
Naples
80100
Italy

Sponsor information

Organisation

National Center for Prevention and Control of Diseases of the Italian Ministry of Health (CCM funding, 2012)

Sponsor details

Viale Giorgio Ribotta
5
Rome
00144
Italy
+39 06 5994 2878
segr.dgprev@sanita.it

Sponsor type

Government

Website

http://www.ccm-network.it/home.html

Funders

Funder type

Not defined

Funder name

National Center for Prevention and Control of Diseases of the Italian Ministry of Health (CCM funding, 2012)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD Sharing Statement
The datasets generated during the current study will be available upon request to Valeria Di Onofrio (valeria.dionofrio@uniparthenope.it). Individual patient data, respecting anonymity, will be available for six months, upon formal request by any interested parties.

Intention to publish date

01/09/2018

Participant level data

Available on request

Basic results (scientific)

See additional file (ISRCTN11067689_BasicResults_3Sep18.pdf)

Publication list

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30333012

Publication citations

Additional files

Editorial Notes

23/10/2018: Publication reference added. 13/09/2018: The basic results of this trial have been uploaded as an additional file.