Clinical trial NCT01357304: 10 Prescriptions an Hour. Group Treatment and Physical Activity Referral in a Primary Health Care Setting
Official title: Randomized Controlled Trial of Group Treatment With Physical Activity Referral in a Primary Health Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Hypertension
Keywords: Group treatment
Physical activity referral
Type 2 diabetes
Hypertension
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2011-05-20
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of group treatment including physical activity referral (PAR) on level of physical activity and quality of life in patients diagnosed with type 2 diabetes and/or hypertension in a primary health care setting

Detailed description: A sedentary lifestyle and low levels of physical activity in populations are major health problems today and contribute substantially to poor health and diseases such as type 2 diabetes and hypertension. An increased and systematic effort to increase physical activity in the Swedish population in general, and in patients with type 2 diabetes/hypertension in particular, is important. Written prescriptions of physical activity with follow-up (i.e., PAR), is a cost-efficient way to increase physical activity in individuals.

The aim of this trial is to study whether physical activity is increased by a group method involving PARs in patients with hypertension and/or type 2 diabetes compared with a control group that receives usual care in the same primary care setting. Follow-up will be performed at 6 and 12 months.

This trial is being conducted to determine whether it is possible to offer PARs to more patients in a way that requires less effort and resources. The intervention in this study requires 10 minutes of a health care worker's time per patient during a 6-month period. Each patient requires 100 minutes with an instructor who oversees the group intervention.

Group treatment is given 3 weeks after baseline and at 6 months. Follow-up at 12 months involves data collection, but no intervention.

An empowerment process, with the 5-A-model as framework, will be used in the clinical intervention.

All participants will be required to fill in questionnaires and wear an ActiGraph GTM1/GTM3 for 7 days at baseline and at 6 and 12 months.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of hypertension or type 2 diabetes since 10-09-2009 at St Hans Primary Health Care Center, Lund, Sweden

Exclusion criteria:

* Dementia
* Psychosis
* Drug abuse
* Mental retardation
* Inability to walk without assistance
* Inability to speak Swedish

Primary outcomes:
measure: Physical activity level
timeFrame: Up to 1 year
Secondary outcomes:
measure: Quality of life, measured using the EQ-5D questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Center for Primary Health Care Research, Lund University/Region Skane
Study officials:
References: