Evaluation of an Implementation Strategy of mHealth Intervention to Promote Healthy Lifestyles (E-VIDAPP Pilot Study)

NCT05506436 | Completed

• 1 other identifier: IBYE2100001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Lifestyle; Nursing

Keywords

Implementation science; Health Promotion; Primary Health Care; mHealth

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months

Secondary Outcomes (3)

• Level of nurses' self-efficacy in obesity management

  6 months

• Level of acceptance of the implementation of the intervention

  6 months

• Level of the willingness of healthcare organizations to change clinical practice

  6 months

Study Arms (2)

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.

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.

Device: Evident 3

Interventions

Evident 3 DEVICE

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.

Control group; Implementation group

Implementation strategy OTHER

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.

Implementation group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fundacion para la Investigacion y Formacion en Ciencias de la Salud: lead
• Instituto de Investigación Biomédica de Salamanca: collaborator

Study Sites (1)

Primary Care Research Unit of Salamanca

Salamanca, 37005, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 18, 2022
• Study Start: April 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: March 1, 2023
• Last Updated: May 1, 2023

Record last verified: 2022-08

Locations

ES (1)