|- candidate number||26757|
|- NTR Number||NTR6288|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-feb-2017|
|- Secondary IDs||16-4-077 METC AzM/UM |
|- Public Title||Behaviour change as a result of genetic disease risk testing|
|- Scientific Title||Stage of health-related behaviour change after receiving information on personal disease risks and lifestyle advice, based on genetic and lifestyle factors: Leef!-study part A|
|- ACRONYM||Leef!-study part A|
|- hypothesis||The is that receiving Health Potential, in combination with a current health status check, the Stofberg Health Check, will lead to greater improvements in behaviour change compared to receiving the Stofberg Health Check only.|
|- Healt Condition(s) or Problem(s) studied||Diet, Life style, Healthy living, Physical activity, Environmental exposures, Genetic disease risk testing|
|- Inclusion criteria||Apparently healthy, both physically and psychologically|
Age ≥18 years
Dutch language level such that more complex texts can be understood (similar to language proficiency level B2)
Authorised to make autonomous decisions
Internet access and e-mail address for the filling in of questionnaires
Able to independently visit the counselling clinic
|- Exclusion criteria||Dietary or other guidelines that need to be followed by prescription of a health professional (such as gluten-free diet in case of coeliac disease)|
Pregnant or trying to become pregnant
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-nov-2017|
|- planned closingdate||1-nov-2019|
|- Target number of participants||350|
|- Interventions||The studied service is the genetic disease prevention service Health Potential. This service will estimate a personal disease risk of a carefully selected list of 12 preventable common chronic diseases that have both a genetic and a lifestyle component of development. Participants purchasing Personalised Health Check (Health Potential + current health check) are considered the exposed group; participants purchasing the current health check only are considered the control group.|
|- 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||N/A|
|- 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 Health Potential to change behaviour and intention to change behaviour. The secondary study objectives are (1) to study the effect of Health Potential to change determinants of behaviour change and (2) to study characteristics of the Health Potential customers. The hypothesis is that receiving Health Potential, in combination with a standard health check (i.e. the Stofberg Health Check), will lead to better lifestyle choices when compared to receiving the standard health check alone.
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 A.
Study population and exposures: Clients purchasing a personalised health check, consisting of Health Potential and a current health check, are considered the exposed group, and will be compared to clients purchasing a current health check only.
Primary study parameters: The primary outcome parameter is stage of behaviour change.
|- Main changes (audit trail)|
|- RECORD||24-feb-2017 - 14-mei-2017|