Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-18 @ 2:35 AM
Study NCT ID:
NCT02320760
Status:
COMPLETED
Last Update Posted:
2014-12-19
First Post:
2014-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Activity on Prescription in Overweight Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056128', 'term': 'Obesity, Abdominal'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-16', 'studyFirstSubmitDate': '2014-12-16', 'studyFirstSubmitQcDate': '2014-12-16', 'lastUpdatePostDateStruct': {'date': '2014-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of life', 'timeFrame': '6 months'}], 'primaryOutcomes': [{'measure': 'physical activity level', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'cardiometabolic risk factors', 'timeFrame': '6 months'}]}, 'conditionsModule': {'conditions': ['Low Physical Activity Level', 'Central Obesity', 'Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '26193882', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\n200 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.\n\nAfter six months both groups go through the same health check-up as at baseline and follow-ups take place after 12 and 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '65 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 25 and 40\n* waist circumference over 88 cm for women and 102 cm for men\n* basically healthy\n* mostly sedentary in their leisure time\n\nExclusion Criteria:\n\n* current heart disease\n* tablet or insulin treated diabetes type 2\n* cancer\n* other chronic serious illness'}, 'identificationModule': {'nctId': 'NCT02320760', 'briefTitle': 'Physical Activity on Prescription in Overweight Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'KI65'}, 'secondaryIdInfos': [{'id': '04-520/2', 'type': 'OTHER', 'domain': 'The regional Ethical review board in Stockholm'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical activity on prescription', 'interventionNames': ['Behavioral: Physical activity on prescription']}, {'type': 'NO_INTERVENTION', 'label': 'Ordinary care'}], 'interventions': [{'name': 'Physical activity on prescription', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Physical activity on prescription']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Proffesor', 'investigatorFullName': 'Mai-Lis Hellénius, Professor', 'investigatorAffiliation': 'Karolinska Institutet'}}}}