|- candidate number||8017|
|- NTR Number||NTR2297|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-apr-2010|
|- Secondary IDs||200110006 ZonMW|
|- Public Title||The Active Plus project: A tailored advice to enhance physical activity among the over-fifties.|
|- Scientific Title||The Active plus project: (Cost-)effectiveness and feasibility of innovative tailoring interventions to enhance physical activity among the over-fifties.|
|- ACRONYM||Active Plus|
|- hypothesis||Regular physical activity reduces the risk of developing several health problems, especially for the still growing population of older adults.|
A tailored advice (especially with an additional environmental approach) is hypothesized to enhance the physical activity level of older adults.
|- Healt Condition(s) or Problem(s) studied||Prevention, Older adults, Physical exercise|
|- Inclusion criteria||1. Over 50 years;|
2. Recruited in region GGD Zuid Holland Zuid, GGD Kennemerland, GGD Zaanstreek-Waterland, GGD Amsterdam and region GGD Zeeland.
|- Exclusion criteria||If a physican advised against participating in physical activity.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2010|
|- planned closingdate||31-dec-2011|
|- Target number of participants||1250|
|- Interventions||Four intervention conditions will be provided:|
1. Basic print-delivered intervention: Subjects in this condition will three times receive tailored advice on their psychosocial determinants of physical activity by written letters. The intervention will tailor on three levels: awareness of physical activity, initiation of PA, and maintenance of PA behavioural change;
2. Basic web-based intervention: Subjects in this condition will three times receive tailored advice online via the internet on their psychosocial determinants of physical activity. The intervention will tailor on three levels: awareness of physical activity, initiation of PA, and maintenance of PA behavioural change. Each feedback time subjects will get an email to alert them to log in by using a provided link in the mail. Subjects will get their advice online, with an option to print the advice. Additionally, they will also get their advice enclosed in an email;
3. Print-delivered intervention with environmental approach: Subjects in this condition will three times receive tailored advice by written letters on their psychosocial determinants of physical activity (equal to the first condition), and additionally they receive tailored information on environmental determinants;
4. Web-based intervention with environmental approach: Subjects in this condition will three times receive tailored advice online via the internet on their psychosocial determinants of physical activity (equal to the second condition), and additional they receive tailored information on environmental determinants.
|- Primary outcome||Physical activity level (SQUASH).|
|- Secondary outcome||Changes on socio-cognitive determinants of changing and maintaining physical activity behaviour. Further more, subjective health, Quality of Life; experienced fitness, BMI, number of sick days, number of visits to the general practitioner or specialist in past 6 months will be assessed. These measurements will also be taken into account in the cost-effectiveness study as resource use and cost factors. Effects on productivity are measured in terms of absence from work due to illness.|
|- Timepoints||Baseline, 3 months, 6 months, 1 year.|
|- Trial web site||Website CCMO|
|- CONTACT FOR PUBLIC QUERIES||MSc. D. Peels|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. L. Lechner|
|- Sponsor/Initiator ||Open University the Netherlands, Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Rationale:|
Regular physical activity (PA) reduces the risks of health problems as overweight, obesity, CVD, cancer and diabetes; disorders that become more prevalent as people age.
Currently, less than 60% of the Dutch population meets PA guidelines, declining to less than 50% among older adults. Currently, in the Netherlands 32% of all residents are over fifty years of age. Stimulating physical activity for this large group is therefore of major relevance.
Previous, the Active Plus project systematically developed two tailored PA interventions: A basic tailored intervention and an intervention additionally targeting environmental factors. Both interventions haven proven effective in changing PA behaviour.
Both existing Active Plus interventions are improved by integrating (process) evaluation findings in the interventions, extending the environment intervention components, and by making a less costly and more interactive web-based version of both interventions. This resulted in four improved tailoring interventions: a basic print-delivered intervention, a basic web-based intervention, a print-delivered intervention with environmental approach, and a web-based version with environmental approach.
The adapted tailoring interventions will be implemented in a clustered randomized trial. Evaluation assessments will be taken at four times: At the start (also the data base for the first and second tailored advice), after three months (also the data base for the third tailored advice), after 6 months and after one year.
Persons aged 50 years or older.
The basic intervention is a tailored intervention targeted to raise awareness of lack of physical activity, and to stimulate initiation and maintenance of physical activity among the over fifties. The intervention additionally targeting environmental factors additionally tailors on environmental determinants by giving tailored personalised advice on local possibilities and initiatives for physical activity for the over fifties. Of both interventions, a print-delivered version and a web-based version will be tested.
Main study parameters/endpoints:
The main study parameters are changes on awareness, on determinants of changing and maintaining physical activity, and on physical activity behaviour.
|- Main changes (audit trail)|
|- RECORD||26-apr-2010 - 28-mei-2010|