| - candidate number | 2320 |
| - NTR Number | NTR805 |
| - ISRCTN | ISRCTN40888582 |
| - Date ISRCTN created | 28-dec-2006 |
| - date ISRCTN requested | 18-dec-2006 |
| - Date Registered NTR | 14-nov-2006 |
| - Secondary IDs | N/A |
| - Public Title | Tailored physical activity intervention for the over-fifties. |
| - Scientific Title | Development, implementation and evaluation of two tailored based physical activity intervention for the over-fifties. |
| - ACRONYM | N/A |
| - hypothesis | 1. In the first intervention group, the % of subjects who meet the national physical activity guideline will significantly increase; 2. In the second intervention group the % of subjects who meet the national physical activity guideline will significantly increase more than the subjects in the first intervention group; 3. Feasibilty and appreciation of the interventions will be evaluated. |
| - Healt Condition(s) or Problem(s) studied | No condition, healthy person |
| - Inclusion criteria | Persons will be included if they are aged 50 or older. |
| - Exclusion criteria | Persons are excluded if a physician advised against participating in physical activity or exercise. |
| - mec approval received | no |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Not applicable |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 23-nov-2006 |
| - planned closingdate | 1-mrt-2006 |
| - Target number of participants | 50 |
| - Interventions | Two tailored physical activity interventions are developed. In the first intervention condition subjects will receive tailored advice three times on their psychosocial and environmental determinant of physical activity. The intervention will tailor on three levels: awareness of physical activity, behavioural change and maintenance of behavioural change. In the second intervention condition subjects will receive tailored advice three times on their psychosocial determinants of physical activity and in more details on environmental determinants. Additionally, there will be an extra intervention to stimulate participation in local activities that stimulate physical activity among the over-fifties. The two intervention conditions will receive tailored advice at three times: two weeks after baseline assessment, 1 month and 2 months after the first baseline assessment. During the implementation period, evaluation assessments will be taken at three times: at the start (T0: also the data base for the first and second tailored advice), after 1,5 month (T1: also the data base for the third tailored advice), and after 3 months (T2). |
| - Primary outcome | Change in physical activity behavior (0 months, 6 weeks, 3 months) using a validated questionnaire (SQUASH). |
| - Secondary outcome | Changes on awareness and on determinants of changing and maintaining physical activity behaviour (0 months, 6 weeks, 3 months) using validated questionnaires. |
| - Timepoints | N/A |
| - Trial web site | http://www.actief-plus.ou.nl |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | Maartje Stralen, van |
| - CONTACT for SCIENTIFIC QUERIES | Prof. Dr. L. Lechner |
| - Sponsor/Initiator | Open University the Netherlands |
| - Funding (Source(s) of Monetary or Material Support) | ZON-MW, The Netherlands Organization for Health Research and Development |
| - Publications | N/A |
| - Brief summary | In this study, the feasibility and appreciation of two tailored physical activity interventions are evaluated. The study will have a double-blind longitudinal design. Two conditions will be included, in which the participants will be randomly assigned to: 1. the first intervention condition: subjects receive tailored advice three times on their psychosocial and environmental determinant of physical activity. The intervention will tailor on three levels: awareness of physical activity, behavioural change and maintenance of behavioural change. 2. the second intervention condition: subjects receive tailored advice three times on their psychosocial determinants of physical activity and in more details on environmental determinants. Additionally, there will be an extra intervention to stimulate participation in local activities that stimulate physical activity among the over-fifties. The two intervention conditions will receive tailored advice at three times: two weeks after baseline assessment, 1 month and 2 months after the first baseline assessment. During the implementation period, evaluation assessments will be taken at three times: at the start (T0: also the data base for the first and second tailored advice), after 1,5 month (T1: also the data base for the third tailored advice), and after 3 months (T2). The results from the formative evaluation may guide the further development of the interventions. Topics are the feasibility and appreciation of the interventions by the participants. |
| - Main changes (audit trail) | |
| - RECORD | 14-nov-2006 - 11-nov-2008 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl