STAR-C Digital Coaching Intervention

NCT05864001 | Not Yet Recruiting

• 1 other identifier: 2018-01461_Forte
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Lifestyle

Keywords

Prevention; Primary care; Digital intervention

Outcome Measures

Primary Outcomes (1)

• Self-reported readiness for behavioural change

  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

  3 months

Secondary Outcomes (6)

• 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

Other Outcomes (1)

• Costs

  3 months

Study Arms (2)

Intervention

EXPERIMENTAL

Immediate access to the digital coaching intervention

Behavioral: STAR-C mobile app

Control

NO INTERVENTION

Delayed access to the digital coaching intervention, three months

Interventions

STAR-C mobile app BEHAVIORAL

Digital coaching intervention for healthy lifestyle

Intervention

Eligibility Criteria

• Age: 39 Years - 61 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant in the Västerbotten Intervention Programme (VIP) who have received the VIP intervention.
• Has a smartphone.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umeå University: lead
• Region Västerbotten: collaborator

Study Sites (1)

Primary health care, Region Västerbotten

Umeå, Västerbotten County, Sweden

Location

Related Publications (1)

• Ng N, Eriksson M, Guerrero E, Gustafsson C, Kinsman J, Lindberg J, Lindgren H, Lindvall K, Lundgren AS, Lonnberg G, Sahlen KG, Santosa A, Richter Sundberg L, Weinehall L, Wennberg P. Sustainable Behavior Change for Health Supported by Person-Tailored, Adaptive, Risk-Aware Digital Coaching in a Social Context: Study Protocol for the STAR-C Research Programme. Front Public Health. 2021 Mar 1;9:593453. doi: 10.3389/fpubh.2021.593453. eCollection 2021.

  PMID: 33732674 BACKGROUND

Study Officials

• Patrik Wennberg, MD, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrik Wennberg, MD, PhD

CONTACT

+46907869450; patrik.wennberg@umu.se

Nawi Ng, MD, PhD

CONTACT

nawi.ng@gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One-sided crossover

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: May 18, 2023
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 20, 2025

Record last verified: 2024-12

Locations

SE (1)