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STAR-C Digital Coaching Intervention

NCT05864001 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2025-08-20

No results posted yet for this study

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.

Conditions

  • Healthy Lifestyle

Interventions

BEHAVIORAL

STAR-C mobile app

Digital coaching intervention for healthy lifestyle

Sponsors & Collaborators

  • Region Västerbotten

    collaborator OTHER_GOV

  • Umeå University

    lead OTHER

Principal Investigators

  • Patrik Wennberg, MD, PhD · Umeå University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
39 Years
Max Age
61 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05864001 on ClinicalTrials.gov