|- candidate number||2732|
|- NTR Number||NTR1068|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-sep-2007|
|- Secondary IDs||2200.0120 (ZonMw) |
|- Public Title||Vitalum: development and evaluation of two innovative health communication technologies aimed at a combination of diet and physical activity changes among patients with high blood pressure and the general population.|
|- Scientific Title||Vitalum: development and evaluation of two innovative health communication technologies aimed at a combination of diet and physical activity changes among patients with high blood pressure and the general population.|
|- hypothesis||1. Compared to participants in the control group, people receiving either Telephone Motivational Interviewing (TMI) or Tailored Print Communication (TPC): |
a) increase fruit and vegetable intake by 10% from the expected mean at baseline;
b) decrease fat intake by 5%;
c) increase physical activity by 13%.
2. People receiving TMI+TPC have resulting behavioural changes which exceed the sum of the changes that are expected given each intervention.
3. Lower socio economic status groups benefit most from TMI.
4. Hypertensive patients are expected to be more motivated to change compared to the general public.
|- Healt Condition(s) or Problem(s) studied||Hypertension|
|- Inclusion criteria||1. Participants aged 45-70;|
2. Maximal one person per address;
3. Not participating in other studies according to the database of general practitioners;
4. 50% of the participants is hypertensive;
5. 50% of the participants is male;
6. Participants who are included fail to meet at least two public health guidelines: one of them is physical activity, the other is fruit or vegetable consumption.
|- Exclusion criteria||1. Physically not able to comply with healthy lifestyle;|
2. Unknown address/removed;
3. Not able to speak/read Dutch;
4. Life threatening or malignant disorder;
5. Intellectual disability;
6. Cerebral vascular or cardiac event in the last 6 months;
7. Disorders in which the health of individuals will be harmed if they alter their lifestyle.
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-dec-2004|
|- planned closingdate||1-okt-2008|
|- Target number of participants||1500|
|- Interventions||The Vitalum study has 4 trialarms:|
1. Tailored Print Communication (TPC) group: this group receives four tailored letters;
2. Telephone Motivational Interviewing (TMI) group: this group receives four motivational interview phone calls;
3. Combined (TPC+TMI) group: this group receives two tailored letters and two telephone motivational interviews in turns;
4. Control group: this group receives a tailored letter after the second follow-up questionnaire.
Intervention activities are delivered in week 5, 13, 30 and 43 after the baseline questionnaire.
|- Primary outcome||Physical activity, fruit and vegetable consumption and fat intake will be assessed with self-report questionnaires. At baseline and 47 and 73 weeks after baseline questionnaires will be filled out.|
|- Secondary outcome||Quality of life will be assessed with the Short Form 36.|
Determinants of physical activity, fruit and vegetable consumption and fat intake will also be assessed in the baseline and 12 month follow-up questionnaires.
|- Trial web site|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| Hilde Keulen van |
|- CONTACT for SCIENTIFIC QUERIES||Phd. Ilse Mesters|
|- Sponsor/Initiator ||University Maastricht (UM) Department of Health Education and Health Promotion|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Tailored Print Communications (TPC) and Telephone Motivational Interviewing (TMI) are both innovative and promising communication technologies that are being used to change regular physical activity and diet behaviour. Altering these behaviours is usefull when aiming at the reduction of elevated blood pressure, which continues to be a widespread major impediment to health. The 2 strategies are applied as instruments in the primary and secondary prevention of cardiovascular disease, i.e. participants include a sample of the general population and patients with hypertension, all recruited from databases of General Practitioners. The RCT will use a factorial design to test the (cost-) effectiveness of TPC, TMI and the combined effects of TPC and TMI, compared to the control group, who will receive a tailored letter after follow-up data are collected. Furthermore, the potential surplus value of TMI for lower SES groups will be tested. Four interventino actions are spaced over a one-year period. Cost effectiveness analyses focus on the most cost-effective method for achieving at least 10% improvement in at least one behavior and for achieving at least 1 guideline. This data will help policy makers to decide which approach deserves future dissemination.|
|- Main changes (audit trail)|
|- RECORD||6-sep-2007 - 12-mrt-2008|