Motivation for Physical Activity Clinical Trial
— DALICOOfficial title:
A Multi-professional Team Intervention on Physical Activity Referrals in Primary Care Patients With Cardiovascular Risk factors-the Dalby Lifestyle Intervention Cohort Study (DALICO) Study
| NCT number | NCT01187576 |
| Other study ID # | CPF FaR 001 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | November 2010 |
| Est. completion date | November 2010 |
| Verified date | August 2018 |
| Source | Region Skane |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Background The present study protocol describes the trial design of a primary care
intervention cohort study, which examines whether an extended, multi-professional physical
activity referral (PAR) intervention is more effective in enhancing and maintaining
self-reported physical activity than ordinary physical activity recommendations. The study
targets patients with newly diagnosed hypertension and/or type 2 diabetes.
Secondary outcomes include: need of pharmacological therapy; blood pressure/plasma glucose;
physical fitness and anthropometric variables; mental health; health related quality of life;
and cost-effectiveness. Methods/Design The study is designed as a long-term intervention.
Three primary care centres are involved in the study, each constituting one of three
treatment groups: 1) Intervention group (IG): multi-professional team intervention with PAR,
lifestyle brochure; 2) Control group A (CA): ordinary recommendations on health behaviours,
lifestyle brochure; and 3) Control group B: treatment as usual (retrospective data
collection).
The intervention is based on self-determination theory and follows the principles of
motivational interviewing. Physical activity is measured with the International Physical
Activity Questionnaire (IPAQ) and expressed as metabolic equivalent of task (MET)-minutes per
week. Physical fitness is estimated with the 6-minute walk test in IG only. Variables such as
health behaviours; health-related quality of life; motivation to change; mental health;
demographics and socioeconomic characteristics are assessed with an electronic study
questionnaire that submits all data to a patient database, which automatically provides
instant feed-back on the patients' health status.
Cost-effectiveness of the intervention is evaluated continuously and the intermediate
- 3 - outcomes of the intervention are extrapolated by economic modelling. The first
statistical analyses and compilation of results will be performed one year after inclusion of
the first patient or when the IG and CA have included 60 and 30 eligible patients
respectively. Discussion By helping patients to overcome practical, social and cultural
obstacles and increase their internal motivation for physical activity we aim to improve
their physical health in a long-term perspective. The targeted patients belong to a patient
category that is supposed to benefit from increased physical activity in terms of improved
physiological values, mental status and quality of life, decreased risk of complications and
maybe a decreased need of medication.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | November 2010 |
| Est. primary completion date | November 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 95 Years |
| Eligibility |
Inclusion Criteria:newly diagnosed type 2 diabetes or hypertension or both and consecutive
primary care patients with suspected type 2 diabetes or hypertension will be screened for
inclusion. The diagnose criterion for type 2 diabetes in both the Intervention and the
Control groups is defined as a 2 x fasting plasma glucose (fP-glu) = 7.0 mmol/l according
to WHO guidelines [29]. The diagnose criterion for hypertension is defined as a resting
systolic blood pressure = 140 mmHg or a diastolic blood pressure = 90 mmHg. Hypertension is
confirmed by a 24-hour ambulatory blood pressure monitoring: a systolic blood pressure =
135 mmHg and/or a - 13 - diastolic blood pressure = 85 mmHg Exclusion Criteria: |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Dalby Vårdcentral | Dalby |
| Lead Sponsor | Collaborator |
|---|---|
| Region Skane | Swedish Council for Working Life and Social Research |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | to examine whether an extended multi-professional PAR intervention, based on SDT, is effective in increasing and maintaining the self-reported physical activity level in patients with newly diagnosed type 2 diabetes or hypertension or both. | every 6 months |