Clinical trial NCT05506436: Evaluation of an Implementation Strategy of mHealth Intervention to Promote Healthy Lifestyles (E-VIDAPP Pilot Study)
Official title: Evaluation of an Implementation Strategy of mHealth Intervention for the Promotion of Healthy Lifestyles in Primary Healthcare (E-VIDAPP Pilot Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Lifestyle
Nursing
Keywords: Implementation science
Health Promotion
Primary Health Care
mHealth
Lead sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Sponsor class: OTHER
Collaborators: name: Instituto de Investigación Biomédica de Salamanca
First posted: 2022-08-18
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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

Eligibility criteria: Inclusion Criteria:

* Nurses who have been working in one of the selected centers for at least 6 months prior to the start of the study, with permanence until the end of the study.
* Acceptance to participate and sign the informed consent form

Exclusion Criteria:

* Nurses who have been working at the center for less than 6 months.

Primary outcomes:
measure: Use of the intervention EVIDENT 3
timeFrame: 6 months
measure: Number of obesity-related activities in primary health care
timeFrame: 6 months
Secondary outcomes:
measure: Level of nurses' self-efficacy in obesity management
timeFrame: 6 months
measure: Level of acceptance of the implementation of the intervention
timeFrame: 6 months
measure: Level of the willingness of healthcare organizations to change clinical practice
timeFrame: 6 months
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Primary Care Research Unit of Salamanca
Study officials:
References: