NCT03913585: TOFpilot2

An Adjusted Preventive Program Against Lifestyle Related Diseases

Status unknown NA Last updated 16 April 2019

What this trial tests

NA trial testing Lifestyle intervention in Lifestyle-Related Disorder in 4,800 participants. Status unknown.

Timeline

22 October 2018

Primary endpoint
31 May 2020

31 August 2020

Quick facts

Lead sponsor	University of Southern Denmark
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	4,800
Start date	22 October 2018
Primary completion	31 May 2020
Estimated completion	31 August 2020
Sites	4 locations across Denmark

Drugs / interventions tested

• Lifestyle intervention

Conditions studied

• Lifestyle-Related Disorder — all drugs for Lifestyle-Related Disorder →

Sponsor

University of Southern Denmark

Who can join

Adults 29 to 59, any sex, with Lifestyle-Related Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A large proportion of the Danish population leads an unhealthy lifestyle. The associated surge in lifestyle-related disease (LRD) represents a significant health and economic burden for the individual as well as society. However, the reactive nature of the Danish national health-care system, complicates a comprehensive and concerted preventive response to this issue. The TOF project aims to remedy this situation by 1) Using digital support systems to systematically identify citizens at risk of LRD and 2) Target the preventive services at citizens with the highest need. Specifically, the ultimate goal of TOF is to integrate the clinical and municipal preventive primary health-care system into a targeted preventive service that facilitates lifestyle change in the at-risk population, and thus reduces LRD at a population level. To this end, we have developed a complex intervention in close collaboration with central stakeholders (health professionals, citizens). The initial feasibility of the intervention has been tested in a pilot study comprising two municipalities, 47 GPs, and 8814 citizens. The intervention has subsequently been adjusted in collaboration with the end users, focusing both on recruitment activities and implementation activities in general practice. The upcoming step involves testing of the adjusted intervention (Pilot2), before large-scale implementation and efficacy evaluation.

The feasibility, acceptability, and short-term effect of the adjusted intervention will be tested in two municipalities using quantitative as well as qualitative research methods. The evaluation will focus on the reach of the intervention, the implementation and acceptability of the intervention in general practice and municipality, the use and assessment of the digital support system and the possible short-term effects on patient lifestyle and risk of disease. We expect 15 general practitioners and 4800 patients to participate.

The intervention comprises four main components:

1. Participants will be screened for LRD-risk factors by survey
2. Survey information is linked with participants' medical history in order to stratify participants into designated risk groups
3. Depending on risk level, participants will be offered targeted interventions at the GP or municipality.
4. Throughout the intervention, a digital support system providing personalized feedback and advice (health profile) to participants will be accessible to both participants and health professionals.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of a Co-Design-Based Invitation Strategy on Participation in a Preventive Health Check Program: Randomized Controlled Trial.
   Thilsing T, Larsen LB, Sonderlund AL, Andreassen SS, et al · · 2021 · cited 7× · PMID 33688836 · DOI 10.2196/25617
2. Non-participation in a targeted prevention program aimed at lifestyle-related diseases: a questionnaire-based assessment of patient-reported reasons.
   Leick C, Larsen LB, Larrabee Sonderlund A, Svensson NH, et al · · 2022 · cited 4× · PMID 35562735 · DOI 10.1186/s12889-022-13382-8
3. The Association Between Individualised Religiosity and Health Behaviour in Denmark: Are Social Networks a Mediating Factor?
   Svensson NH, Larrabee Sonderlund A, Wehberg S, Hvidt NC, et al · · 2022 · cited 3× · PMID 36083523 · DOI 10.1007/s10943-022-01650-1