Healthy LifestyleE-VIDAPPNCT05506436
Evaluation of an Implementation Strategy of mHealth Intervention to Promote Healthy Lifestyles (E-VIDAPP Pilot Study)
A study testing Evident 3 and Implementation strategy in people with Healthy Lifestyle and Nursing, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Healthy Lifestyle, Nursing
- What is being tested?
- Evident 3 and Implementation strategy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2022to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Nurses who have been working at the center for less than 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of an Implementation Strategy of mHealth Intervention for the Promotion of Healthy Lifestyles in Primary Healthcare (E-VIDAPP Pilot Study)
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.
Read the 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
- 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.
- 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.
- 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
- Conditions
- Healthy Lifestyle, Nursing
- Being tested
- Evident 3, Implementation strategy
- Keywords
- Implementation science, Health Promotion, Primary Health Care, mHealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evident 3Device
It consists of brief 5-minute counselling on general physical activity recommendations and explaining the plate method for a balanced diet. Also, it includes the Evident 3 application, which is a daily dietary log that provides information on calories and diet composition and shows a reminder of the 10000 steps/day.
Implementation strategyOther
Four sessions have been designed to obtain the implementation strategy:
First session: Presentation of the Evident 3 application and its results in clinical trials. Training in the use of the application and identification of possible areas for improvement.
Second session: Presentation of evidence-based practices on the management of obesity in Primary Care. Consensus selection of those related to health promotion and mHealth. Sharing of possible lines of improvement of the care offered in the practice.
Third session (optional): Intervention on those components (coherence, cognitive participation, collective action and reflective follow-up) of the NOMAD questionnaire, if very low scores are obtained.
Fourth session: Brainstorming on possible strategies for the implementation of the Evident 3 intervention. Analysis and evaluation of these strategies and determination of a common strategy for their implementation.
| Study group | Role | What they receive |
|---|---|---|
| Implementation group | Experimental | Four sessions are conducted with the nurses of the center assigned to the intervention group to agree on the implementation strategy together with the professionals. Once the strategy is defined, the implementation of the intervention will be launched in this group for 6 months. After this period, the final evaluation will be carried out, as well as a qualitative evaluation through a focus group. Receives: Device: Evident 3; Other: Implementation strategy |
| Control group | Active comparator | A single session will be scheduled to introduce the nurses of the center assigned to this group to the EVIDENT 3 intervention, and access and downloading will be allowed for free use in their practice. Receives: Device: Evident 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of the intervention EVIDENT 3
It will be evaluated by the number of downloads of the application from the platform created for this purpose in RedCap per primary health centre.
Measured: 6 months
Number of obesity-related activities in primary health care
It will be evaluated with the clinical practice questionnaire in the management of obesity, which evaluates the frequency (weekly, monthly or never) of 7 activities that are performed in the office related to obesity. This questionnaire has no cut-off point.
Measured: 6 months
Secondary outcomes (3)
Level of nurses' self-efficacy in obesity management
It will be evaluated by the Self-efficacy in obesity management Questionnaire, with 23 items on a Likert scale with 4 possible answers. This questionnaire has no cut-off point.
Measured: 6 months
Level of acceptance of the implementation of the intervention
Measured with the Normalisation Measure Development questionnaire (NoMAD), which evaluates the implementation of complex health interventions. It consists of 23 questions grouped into four constructs: C1 Coherence (4 questions); C2 Cognitive involvement (4 questions); C3 Collective action (7 questions); C4 Reflective monitoring or "Evaluation"(5 questions) and 3 standardization questions.This questionnaire has no cut-off point.
Measured: 6 months
Level of the willingness of healthcare organizations to change clinical practice
It will be evaluated with the Organizational Readiness for Knowledge Translation (OR4KT) questionnaire. It assesses 6 domains (organizational climate for change, contextual and organizational factors, change content, leadership, organizational support and motivation) through 59 items with a 5-choice Likert scale. A score greater than 64 indicates a greater willingness to change clinical practice.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start1 Apr 2022
- Primary completion31 Dec 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigación Biomédica de Salamanca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506436
- Sponsor's protocol ID
- IBYE2100001
- Acronym
- E-VIDAPP
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2022
- Last updated
- 1 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Implementation Strategy of mHealth Intervention for the Promotion of Healthy Lifestyles in Primary Healthcare (E-VIDAPP Pilot Study)
- ClinicalTrials.gov ID
- NCT05506436
- Acronym / sponsor ID
- E-VIDAPP / IBYE2100001
- Conditions
- Healthy Lifestyle, Nursing
- Keywords
- Implementation science, Health Promotion, Primary Health Care, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la SaludUniversity, hospital or other
- Collaborators
- Instituto de Investigación Biomédica de Salamanca
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implementation group | Experimental | Device: Evident 3, Other: Implementation strategyFour sessions are conducted with the nurses of the center assigned to the intervention group to agree on the implementation strategy together with the professionals. Once the strategy is defined, the implementation of the intervention will be launched in this group for 6 months. After this period, the final evaluation will be carried out, as well as a qualitative evaluation through a focus group. |
| Control group | Active comparator | Device: Evident 3A single session will be scheduled to introduce the nurses of the center assigned to this group to the EVIDENT 3 intervention, and access and downloading will be allowed for free use in their practice. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Nurses who have been working at the center for less than 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evident 3It consists of brief 5-minute counselling on general physical activity recommendations and explaining the plate method for a balanced diet. Also, it includes the Evident 3 application, which is a daily dietary log that provides information on calories and diet composition and shows a reminder of the 10000 steps/day. | Device | Control group, Implementation group |
| Implementation strategyFour sessions have been designed to obtain the implementation strategy: First session: Presentation of the Evident 3 application and its results in clinical trials. Training in the use of the application and identification of possible areas for improvement. Second session: Presentation of evidence-based practices on the management of obesity in Primary Care. Consensus selection of those related to health promotion and mHealth. Sharing of possible lines of improvement of the care offered in the practice. Third session (optional): Intervention on those components (coherence, cognitive participation, collective action and reflective follow-up) of the NOMAD questionnaire, if very low scores are obtained. Fourth session: Brainstorming on possible strategies for the implementation of the Evident 3 intervention. Analysis and evaluation of these strategies and determination of a common strategy for their implementation. | Other | Implementation group |
Primary outcome
Use of the intervention EVIDENT 3
Time frame: 6 months
It will be evaluated by the number of downloads of the application from the platform created for this purpose in RedCap per primary health centre.
Number of obesity-related activities in primary health care
Time frame: 6 months
It will be evaluated with the clinical practice questionnaire in the management of obesity, which evaluates the frequency (weekly, monthly or never) of 7 activities that are performed in the office related to obesity. This questionnaire has no cut-off point.
3 secondary outcomes
Level of nurses' self-efficacy in obesity management
Time frame: 6 months
Level of acceptance of the implementation of the intervention
Time frame: 6 months
Level of the willingness of healthcare organizations to change clinical practice
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evident 3 and Implementation strategy in people with Healthy Lifestyle and Nursing, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of the intervention EVIDENT 3 (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.