Physical Activity on Prescription in Overweight Older Adults
Primary Purpose
Low Physical Activity Level, Central Obesity, Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical activity on prescription
Sponsored by
About this trial
This is an interventional prevention trial for Low Physical Activity Level
Eligibility Criteria
Inclusion Criteria:
- BMI between 25 and 40
- waist circumference over 88 cm for women and 102 cm for men
- basically healthy
- mostly sedentary in their leisure time
Exclusion Criteria:
- current heart disease
- tablet or insulin treated diabetes type 2
- cancer
- other chronic serious illness
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Physical activity on prescription
Ordinary care
Arm Description
Outcomes
Primary Outcome Measures
physical activity level
Secondary Outcome Measures
cardiometabolic risk factors
Full Information
NCT ID
NCT02320760
First Posted
December 16, 2014
Last Updated
December 16, 2014
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT02320760
Brief Title
Physical Activity on Prescription in Overweight Older Adults
Official Title
Physical Activity in Prevention and Treatment of Overweight, Central Obesity and the Metabolic Syndrome - a Randomised Controlled Study in Overweight 65 Year Old Women and Men
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
5. Study Description
Brief Summary
This randomized controlled study evaluates the effect of individualized physical activity on prescription (PAP) in older overweight adults. The primary hypothesis is that an individualized prescription of physical activity increases physical activity level in overweight older adults after 6 months. Secondary hypothesis are that the increased physical activity level will improve cardio metabolic risk factors and quality of life.
200 women and men, aged 65 with low physical activity level, overweight, and abdominal obesity, will be randomized to an intervention group or a control group. The control group receives general information about physical activity and registration of physical activity level for one week. The intervention group receives in addition an individualized physical activity on prescription with patient-centered counseling.
After six months both groups go through the same health check-up as at baseline and follow-ups take place after 12 and 24 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Physical Activity Level, Central Obesity, Metabolic Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical activity on prescription
Arm Type
Experimental
Arm Title
Ordinary care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Physical activity on prescription
Primary Outcome Measure Information:
Title
physical activity level
Time Frame
6 months
Secondary Outcome Measure Information:
Title
cardiometabolic risk factors
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Quality of life
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
69 Years
Eligibility Criteria
Inclusion Criteria:
BMI between 25 and 40
waist circumference over 88 cm for women and 102 cm for men
basically healthy
mostly sedentary in their leisure time
Exclusion Criteria:
current heart disease
tablet or insulin treated diabetes type 2
cancer
other chronic serious illness
12. IPD Sharing Statement
Citations:
PubMed Identifier
26193882
Citation
Olsson SJ, Borjesson M, Ekblom-Bak E, Hemmingsson E, Hellenius ML, Kallings LV. Effects of the Swedish physical activity on prescription model on health-related quality of life in overweight older adults: a randomised controlled trial. BMC Public Health. 2015 Jul 21;15:687. doi: 10.1186/s12889-015-2036-3.
Results Reference
derived
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Physical Activity on Prescription in Overweight Older Adults
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