STAR-C (Sustainable Behaviour Change for Health Supported by Person-Tailored, Adaptive, Risk-aware Digital Coaching in a Social Context) Digital Coaching Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Umeå University
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Self-reported readiness for behavioural change
Study Overview
Brief Summary
Objectives: The overall objective is to evaluate the effectiveness of the STAR-C digital coaching intervention for health-related lifestyle behavioural change.
Study design: This intervention is designed as a two-arm individual pragmatic one-sided crossover randomised controlled trial, with participants receiving immediate access to the digital coaching intervention (Arm 1) and no digital coaching intervention (Arm 2, delayed access three months).
Setting: The intervention is integrated into the Västerbotten Intervention Programme (VIP) in Västerbotten Region. In total, 1000 participants will be recruited from all VIP-participating primary healthcare centres in Västerbotten, proportional to the size of the VIP participants in each centre. All participants will receive regular VIP intervention with the VIP nurse before recruitment into the STAR-C intervention study.
The intervention is planned to run for six months in total, with in-person recruitment at the baseline and follow-up at one, three, and six months. Individuals who are bedridden, terminally ill or have severe communication problems and those who receive behavioural change treatment at the Behavioural Medicine Clinic will be excluded.
Measures: The primary outcome of the intervention is change in the readiness for behaviour change at three months. The secondary outcomes include: (i) actual changes in the behaviours, including use of tobacco cessation clinics, higher smoking and snus cessation rate, reduction in alcohol consumption, adoption of healthy food habits, increased level of physical activity and reduction of sedentary behaviours, self-rated health and well-being, comparing baseline and follow-up data; (ii) patterns and usage of the digital tool during the intervention period (for the intervention group).
These outcomes will be measured quantitatively using questionnaires. In addition, interviews and group interviews will be conducted to explore the barriers and facilitators for the adoption and maintenance of the STAR-C digital coaching intervention for VIP nurses and the adult population.
Detailed Description
Objectives:
To evaluate the effectiveness of the STAR-C digital coaching intervention for health-related lifestyle behavioural change.
The specific objectives are to:
- Investigate to what extent STAR-C digital coaching intervention leads to change in the readiness for behavioural change (sub-study 1).
- Evaluate the effect of the digital intervention on behavioural change, including visit to tobacco cessation clinic, higher smoking and snus cessation rate, reduction in alcohol consumption, adoption of healthy food habits, increased level of physical activity and reduction of sedentary behaviours (sub-study 1).
- Evaluate the effect of the digital intervention on self-rated health and well-being (sub-study 1).
- Evaluate the cost-effectiveness of STAR-C digital coaching intervention compared to the existing VIP intervention in promoting behavioural change among the adult population (sub-study 2).
- Evaluate barriers and facilitators for adopting and maintaining the utilisation of STAR-C digital coaching intervention among the adult population (sub-study 3) and health professionals (sub-study 5).
- Evaluate barriers and facilitators for adopting and maintaining health-related lifestyle behavioural change among the adult population (sub-study 4).
- Analyse the different patterns of digital tool usage that could explain the effectiveness of the different behaviour change techniques embedded in the intervention and their relation to the participants and their characteristics (readiness for change, motivation, barriers, etc.), observed across age groups, gender, education level and geographical area of residence (sub-study 6).
Overall Study Design:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Masking Description
Upon their consent to participate in the study, baseline measurement will be conducted for each participant before their random allocation to different treatment arms. The research group will be blinded to the treatment assignment. The treatment assignment key will be revealed only after the intervention has been concluded and the analysis has been conducted
Eligibility Criteria
- Ages
- 39 Years to 61 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participant in the Västerbotten Intervention Programme (VIP) who have received the VIP intervention.
- •Has a smartphone.
Exclusion Criteria
- •Individuals who are bedridden, terminally ill, have severe vision/hearing problems, or with other hindrances to fulfilling the study protocol.
- •Individuals who will be referred to the Behavioural medicine clinic (Beteendemedicin) for behavioural change treatment.
Arms & Interventions
Intervention
Immediate access to the digital coaching intervention
Intervention: STAR-C mobile app (Behavioral)
Control
Delayed access to the digital coaching intervention, three months
Outcomes
Primary Outcomes
Self-reported readiness for behavioural change
Time Frame: 3 months
The proportion of participants in different stages of behavioural change of (a) pre-contemplation; (b) contemplation; (c) preparation; (d) action; and (e) maintenance for different behaviours
Secondary Outcomes
- Change in tobacco habits(3 months)
- Change in alcohol consumption(3 months)
- Change in healthy food habits(3 months)
- Change in physical activity and sedentary behaviour(3 months)
- Change in health-related quality of life(3 months)
- Change in well-being(3 months)