NCT02320760

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2014

Completed
Last Updated

December 19, 2014

Status Verified

December 1, 2014

Enrollment Period

2 years

First QC Date

December 16, 2014

Last Update Submit

December 16, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • physical activity level

    6 months

Secondary Outcomes (1)

  • cardiometabolic risk factors

    6 months

Other Outcomes (1)

  • Quality of life

    6 months

Study Arms (2)

Physical activity on prescription

EXPERIMENTAL
Behavioral: Physical activity on prescription

Ordinary care

NO INTERVENTION

Interventions

Physical activity on prescription

Eligibility Criteria

Age65 Years - 69 Years
Sexall
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • current heart disease
  • tablet or insulin treated diabetes type 2
  • cancer
  • other chronic serious illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Obesity, AbdominalMetabolic Syndrome

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Proffesor

Study Record Dates

First Submitted

December 16, 2014

First Posted

December 19, 2014

Study Start

January 1, 2005

Primary Completion

January 1, 2007

Study Completion

May 1, 2009

Last Updated

December 19, 2014

Record last verified: 2014-12