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Completed

NCT Number: NCT01357304

10 Prescriptions an Hour. Group Treatment and Physical Activity Referral in a Primary Health Care Setting

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

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Key information

Conditions

Type 2 Diabetes Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Primary Health Care Research, Lund University/Region Skane

Malmö, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group treatment and PAR

Behavioral

Group treatment (8-12 patients per group) involving an empowerment-based process and the 5-A model and including PAR. Two group sessions, 6 months apart. The estimated total time for both group sessions together is 100 minutes.

Primary outcomes

  1. Physical activity level

    Time frame: Up to 1 year

    Physical activity level is measured with an Actigraph GTM1/3. Overall physical activity, and total accumulated time and bouts of time in different categories of physical activity, will be determined according to count thresholds. Additonally subjective measurements of physical acidity are made using a questionnaire were questions about self-reported physical activity are reported (the International Physical Activity Questionnaire; IPAQ). Subjectively measured physical activity will be expressed as MET-minutes/week.

Secondary outcomes

  1. Quality of life, measured using the EQ-5D questionnaire

    Time frame: 1 year

    EQ-5D, a validated instrument that classifies health according to five items (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), each of which has three alternatives ("no problem", "moderate problem" and "severe problem"). Combining the answers gives an index with a score of between 0.59 and 1.0.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

Randomized Controlled Trial of Group Treatment With Physical Activity Referral in a Primary Health Care Setting

Acronym: 10PAR

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 20, 2011
Registry last updated
Nov 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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