Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/12/2018
Date assigned
27/12/2018
Last edited
27/12/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Lifestyle changes are the best way to prevent the main chronic diseases, through interventions that target sedentary lifestyle, eating habits, toxic habits and healthy sleeping. During the university period, changes in lifestyles may occur due to several factors: independence of the family home, coexistence with other students, the responsibility to decide what food to eat, the schedules, start or consolidation of toxic habits, and decreased physical activity. Therefore, this population group may be a risk group, which in the short or long term present risk factors related to the main chronic diseases. Because the University plays an important role in the acquisition and transmission of knowledge, this environment becomes an adequate space to carry out interventions to promote healthy lifestyles. Therefore, the aim of this study is to assess a lifestyle intervention in a sample of university students at the University of Valencia (Spain).

Who can participate?
University students aged 18 to 27 with at least two of the following: sedentary lifestyle, smoking habit, daily consumption of at least two energy drinks, number of daily sleep hours less than 7 hours or changes in their study shift

What does the study involve?
Participants are randomly allocated into two groups: the control group and the intervention group. The intervention group attend group and individual sessions focused on different aspects of lifestyle: healthy diet, physical activity, toxic habits, and sleeping. The education sessions are planned as follows: one group session of ten people per month and one individual session per month. No intervention is planned for the control group during the follow-up. The main lifestyle variables, including the profile of products consumed in vending machines, are assessed at the start of the study and after 3 months. In addition to the lifestyle questionnaires, body and blood pressure measurements are taken.

What are the possible benefits and risks of participating?
The participant will be notified of their risk factors and how to address them to improve their lifestyle and health. As this is an intervention study on lifestyles with scientifically proven recommendations that have been carried out for decades by different health organizations in the general population, no risks are foreseen.

Where is the study run from?
University of Valencia (Spain)

When is the study starting and how long is it expected to run for?
December 2018 to December 2019

Who is funding the study?
1. Delikia Fresh (Spain)
2. University of Valencia (Spain)

Who is the main contact?
Dr Olga Portoles

Trial website

Contact information

Type

Scientific

Primary contact

Dr Olga Portolés

ORCID ID

Contact details

Av. Blasco Ibáñez 15
Valencia
46010
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

OP-1

Study information

Scientific title

Lifestyles and profile of products consumed in vending machines by students of the university of Valencia: a randomized clinical trial of the effects of an intervention to promote healthy lifestyles

Acronym

DELIHEALTH

Study hypothesis

An intensive intervention to promote healthy lifestyles improves the risk profile associated with incorrect eating habits, reducing the consumption of toxic substances, as well as sedentary lifestyle, and improving sleep hygiene at the same time. As well as the profile of products consumed in vending machines by the students.

Ethics approval

Institutional Review Board of Valencia university (human subjects), 13/12/2018, ref: H1543655762101

Study design

Single-centre randomized controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

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

Condition

Nutrition and lifestyle for health promotion

Intervention

Participants will be randomly assigned to the control arm or to the intensive intervention arm using a computer program. The control group will not have any type of intervention. The intensive intervention group will receive health education once a month for three months. This will consist of advice about healthy lifestyles consisting of: dietary habits, promoting the Mediterranean diet, practicing aerobic physical activity and promoting good sleep habits. Smokers will be given advice to quit smoking, and for those who consume alcoholic beverages, they will be suggested to reduce it to a minimum. In addition to the group sessions, in parallel and monthly, individual interventions adapted to the specific needs of each person will be carried out.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Changes in main life-style variables, as indicated by adherence to Mediterranean diet, will be measured using the 14 item Mediterranean Diet Scale (PREDIMED) at baseline and after three months.
2. Toxic habits (tobacco smoking and alcohol consumption) will be measured using specific validated questionnaires at baseline.
3. Physical activity will be measured using the Minnesota physical activity al Questionnaire, at baseline.
4. Sleep habits will be measured using the Pittsburg Quality of Sleep Questionnaire and the Epworth Drowsiness Questionnaire at baseline and after three months.
5. Weight, height, body composition (by bioimpedance), and blood pressure will be determined by direct measurement at baseline and after three months.

Secondary outcome measures

In the preliminary sample of participants:
1. Changes in main life-style variables, as indicated by adherence to Mediterranean diet, will be measured using the 14 item Mediterranean Diet Scale (PREDIMED) at baseline and after three months.
2. Toxic habits (tobacco smoking and alcohol consumption) will be measured using specific validated questionnaires at baseline.
3. Physical activity will be measured using the Minnesota physical activity al Questionnaire, at baseline.
4. Sleep habits will be measured using the Pittsburg Quality of Sleep Questionnaire and the Epworth Drowsiness Questionnaire at baseline and after three months.
5. Weight and height will be measured using self-referred variables at baseline.

Overall trial start date

25/10/2018

Overall trial end date

31/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Students of the degree of Medicine
2. Both sexes
3. Aged between 18 and 27 years
4. Presenting at least two of the following conditions:
4.1. Sedentary lifestyle
4.2. Smoking habit
4.3. Daily consumption of at least two energy drinks
4.4. Number of daily sleep hours less than 7 hours or changes in their study shifts

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

From an initial sample of about 325 students 25% will be selected and randomly assigned to the two groups (41 students in control group and 41 in the intervention group)

Participant exclusion criteria

1. Perform a job that implies schedules with rotating shifts
2. People who cannot follow the intensive lifestyle intervention established in the trial

Recruitment start date

26/12/2018

Recruitment end date

01/03/2019

Locations

Countries of recruitment

Spain

Trial participating centre

University of Valencia
Av. Blasco Ibáñez 15
Valencia
46010
Spain

Sponsor information

Organisation

Delikia Fresh

Sponsor details

C/ Falconera 9
Gandía
46727
Spain

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Delikia Fresh

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Universitat de València

Alternative name(s)

University of Valencia

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Spain

Results and Publications

Publication and dissemination plan

The main results are planned to be published in international journals, when the trial has been completed. In addiction partial results will be presented in scientific meetings.

The study protocol is available under request. Researches who are interested in this study can contact the main investigator (Olga Portolés).

IPD sharing statement: in accordance with the ethics board, the informed consent form signed by participants will state that their individually identifiable data will not be publicly available. The data will be saved in a protected file with a key known only to the principal investigator.

Intention to publish date

02/02/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes