Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05506436 |
| Other study ID # |
IBYE2100001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2022 |
| Est. completion date |
March 1, 2023 |
Study information
| Verified date |
August 2022 |
| Source |
Fundacion para la Investigacion y Formacion en Ciencias de la Salud |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The translation of beneficial interventions for the population into professional practice
represents a constant challenge. Moreover, implementation of this evidence into clinical
practice has been limited to date. Therefore, the aim of this pilot study is to identify the
critical factors and barriers that may influence the implementation of a digital intervention
for the promotion of exercise and a healthy diet in primary care and its implementation
through a pilot study with a strategy agreed with nursing professionals in a health centre.
Description:
DESIGN: Pilot study with mixed methodology (quantitative and qualitative). A
pre-implementation visit was performed to evaluate the variables of the study. After
completion of this visit, intervention and control groups are randomly assigned. Training and
participatory sessions are carried out in the intervention group. After these sessions, the
EVIDENT 3 intervention is implemented for 6 months in the nursing offices. After this 6-month
period, the final evaluation will be carried out, as well as a focus group in the
intervention group.
STUDY POPULATION: The study participants are the nursing professionals working in the health
centers that have been working in one of the selected centers for at least 6 months prior to
the start of the study, with permanence in the same until the end of the study, who agree to
participate and who sign the informed consent form.
IMPLEMENTATION STRATEGY
1. Specific intervention in the intervention group: 4 training sessions on the following
topics: 1-Evident intervention, 2-Evidence-based clinical practice, 3- Main components
of Normalization Process Theory, 4- Implementation strategies.
2. Intervention to be implemented: The intervention to be explained to the professionals is
the EVIDENT 3 intervention, which proves its efficacy previously. It consists of brief
advice on nutrition, using the plate method (50), and advice on physical activity based
on the current recommendations of at least 30 minutes of moderate activity 5 days a
week, or 20 minutes of vigorous activity, 3 days a week. In addition, the EVIDENT 3
mobile app is included, which was designed to allow self-reporting of daily nutrition.
Once the user enters all the information, the app integrates all the data to create
personalized recommendations and weight loss goals.
3. Qualitative research: In the final evaluation of the study, a focus group discussion
will be conducted from a phenomenological perspective, only with participants from the
intervention group. The sampling will be theoretical in order to achieve maximum
discursive plurality. A random selection of the participants who have marked the option
to participate in the qualitative study in the consent form will be contacted.
STRUCTURE OF THE STUDY VISITS:
Pre-implementation visit: Inclusion criteria, explanation of the project, informed consent
and baseline assessment of the study variables.
Assignment of study groups (intervention and control). Implementation: 4 training sessions in
the intervention group . After these sessions, the implementation will be piloted in real
conditions for a 6-months period.
Final visit: Post-implementation evaluation will be done at the end of the implementation (6
months) to evaluate changes in the study variables in both groups. A discussion group will be
held in the intervention group to evaluate the experience of the implementation
