|- candidate number||26758|
|- NTR Number||NTR6289|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-feb-2017|
|- Secondary IDs||163014 METC AzM/UM|
|- Public Title||Behaviour change as a result of genetic disease risk testing combined with lifestyle counselling|
|- Scientific Title||Stage of health-related behaviour change after receiving information on personal disease risks and lifestyle advice, based on genetic and lifestyle factors, combined with lifestyle counselling: Leef!-study part B|
|- ACRONYM||Leef!-study part B|
|- hypothesis||The hypothesis is that receiving additional counselling will lead to greater improvements in behaviour change compared to no additional counselling.|
|- Healt Condition(s) or Problem(s) studied||Healthy living, Life style, Diet, Physical activity, Genetic disease risk testing, Environmental exposures|
|- Inclusion criteria||In order to be eligible to participate in this study, a subject must participate in part A of the Leef!-study and have purchased the Health Potential and the current health check.|
|- Exclusion criteria||None|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2017|
|- planned closingdate||1-nov-2019|
|- Target number of participants||384|
|- Interventions||The intervention consists of four additional lifestyle counselling sessions with a counsellor of approximately 60 minutes. The sessions will take place at t=0 weeks, t=1 week, t=4 weeks, and t=12 weeks.|
|- Primary outcome||Stage of behaviour change|
|- Secondary outcome||Motivational regulation, Attitude, Behaviour-specific self-efficacy, Risk perception, Perceived stress, Discussion of test results with health professionals and/or family and friends, Test-related distress|
|- Timepoints||Outcome parameters are measured at t=-6w (baseline), t=0, t=1w, t=4w, t=12w, t=6m, and t=1y.|
|- Trial web site||Not available|
|- CONTACT FOR PUBLIC QUERIES||MSc Kelly Stewart|
|- CONTACT for SCIENTIFIC QUERIES||MSc Kelly Stewart|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+), Stofberg Preventie en Coaching|
(Source(s) of Monetary or Material Support)
|Maastricht University Interfaculty Program ‘Eatwell’|
|- Publications||• Wesselius, A., and M. P. Zeegers. "Direct-to-consumer genetic testing." oa Epidemiology 1.4 (2013).|
• Al-Zalabani, Abdulmohsen H., et al. "Modifiable risk factors for the prevention of bladder cancer: a systematic review of meta-analyses." European journal of epidemiology 31.9 (2016): 811-851.
• Stewart, K., et al. "Behavioural changes and psychological responses after receiving direct-to-consumer genetic test results: a systematic review and meta-analysis." Submitted.
Elahi, IRN, et al. “The association between soft drinks consumption and asthma: a systematic review and meta-analysis.” Submitted.
|- Brief summary||Rationale: With a rapidly ageing population it is essential to consolidate efforts to prevent disease from occurring in order to reduce the burden on the health care system and economy. Health Potential could contribute to this. Health Potential is a service that provides information on personal disease risks followed by lifestyle advice for 21 preventable common chronic diseases, based on an individual’s genetic background, lifestyle, medical history, occupational history and other characteristics. This information, which is delivered to the client in a face-to-face meeting, can be used to direct lifestyle decision making.|
Objective: The primary objective is to study the effect of additional lifestyle counselling after receiving Health Potential on stage of behaviour change. The secondary study objective is to study the effect of additional lifestyle counselling after receiving Health Potential to change determinants of behaviour change. The hypothesis is that additional lifestyle counselling will lead to better lifestyle choices compared to no additional lifestyle counselling.
Study design: The full Leef!-study consists of two integrated designs: (1) a two-armed non- randomised controlled pre-test/post-test trial (part A), followed by (2) a two-armed randomised controlled pre-test/post-test trial among participants in the exposed condition of part A for whom consent is obtained (part B). This registration refers only to Leef!-study part B.
Study population: Clients of the Stofberg Groep purchasing Health Potential and the Stofberg Health Check (together named Personalised Health Check; PHC) who are willing to participate in part B.
Intervention: Four additional lifestyle counselling sessions at 0 weeks, 1 week, 4 weeks and 12 weeks.
Primary study parameters: The primary outcome parameter is stage of behaviour change.
|- Main changes (audit trail)|
|- RECORD||24-feb-2017 - 14-mei-2017|