Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability

NCT01041989 | Unknown DMC

• 1 other identifier: THL/TUET 122/2009
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 5

Brief Summary

This multi-center (6 sites: Helsinki, Kuopio, Oulu, Seinäjoki, Turku, Vantaa) intervention study aims to prevent cognitive impairment, dementia and disability in 60-77 year old persons at an increased dementia risk. The 2-year multi-domain life-style intervention includes nutritional guidance, exercise, cognitive training, increased social activity, and intensive monitoring and management of metabolic and vascular risk factors. The primary outcome is cognitive impairment measured by a sensitive Neuropsychological Test Battery (NTB), and Stroop and Trail Making tests to capture early cognitive impairment typical for both Alzheimer's disease and vascular dementia. We hypothesize that the multi-domain intervention will reduce cognitive impairment in the study group compared to the control group during the initial 2-year intervention period and reduce dementia incidence after the extended follow-up (until at least 300 participants have developed dementia).

Conditions

Cognitive Impairment; Dementia

Keywords

dementia; cognitive impairment; disability; intervention; elderly; lifestyle counseling

Outcome Measures

Primary Outcomes (1)

• Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests.

  2 years

Secondary Outcomes (7)

• Depressive symptoms will be assessed using the Zung depression scale.

  2 years

• Disability will be assessed using the ADCS-ADL scale

  2 years

• Quality of Life will be assessed using the RAND-36 and 15D questionnaires.

  2 years

• Utilization of health resources will be assessed using questionnaire and register data.

  2 years

• Vascular and metabolic risk factors will be assessed with blood pressure and anthropometric measurements, and laboratory analyses of metabolic biomarkers.

  2 years

Study Arms (2)

Standard health counseling at baseline

NO INTERVENTION

Lifestyle counseling

EXPERIMENTAL

Multi-domain lifestyle counseling including nutritional guidance, increased physical activity, cognitive training, increased social activity and intensive monitoring of vascular and metabolic risk factors.

Behavioral: Nutritional guidance; Behavioral: Exercise; Behavioral: Cognitive training; Other: Reduction of vascular risk factors

Interventions

Nutritional guidance BEHAVIORAL

Individual counseling sessions and group meetings will be organized.

Lifestyle counseling

Exercise BEHAVIORAL

Guided muscle strength training and aerobic exercise.

Lifestyle counseling

Cognitive training BEHAVIORAL

Cognitive training will be implemented through 8 group sessions lead by a psychologist and a computer-based cognitive training program available to participants via the internet.

Lifestyle counseling

Reduction of vascular risk factors OTHER

Monitoring and maintenance of metabolic and vascular risk factors

Lifestyle counseling

Eligibility Criteria

• Age: 60 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 60-77 years
• dementia Risk Score 6 points or more
• fulfillment of at least one of the following CERAD criteria: i) MMSE: 20-26 points ii) word list memory task (3x10 words): 19 words or less iii) delayed recall: 75% or less

You may not qualify if:

• malignant diseases
• dementia
• substantial cognitive decline
• major depression
• symptomatic cardiovascular disease
• revascularisation within 1 year
• severe loss of vision, hearing or communicative ability
• other conditions inhibiting from safe engagement in the prescribed intervention as judged by the study physician
• other conditions preventing from cooperation as judged by the study physician

Sponsors & Collaborators

• Finnish Institute for Health and Welfare: lead
• Academy of Finland: collaborator
• University of Helsinki: collaborator
• University of Eastern Finland: collaborator
• University of Oulu: collaborator
• Kuopio Research Institute of Exercise Medicine: collaborator
• Western University, Canada: collaborator
• Karolinska Institutet: collaborator
• Umeå University: collaborator

Study Sites (5)

Finnish Institute for Health and Welfare

Helsinki, 00300, Finland

Location

University of Eastern Finland

Kuopio, 70211, Finland

Location

University of Oulu

Oulu, 90014, Finland

Location

Research Center Mediwest

Seinäjoki, 60220, Finland

Location

Finnish Institute for Health and Welfare

Turku, 20720, Finland

Location

Related Publications (34)

• Kivipelto M, Ngandu T, Laatikainen T, Winblad B, Soininen H, Tuomilehto J. Risk score for the prediction of dementia risk in 20 years among middle aged people: a longitudinal, population-based study. Lancet Neurol. 2006 Sep;5(9):735-41. doi: 10.1016/S1474-4422(06)70537-3.

  PMID: 16914401 BACKGROUND

• Kivipelto M, Helkala EL, Laakso MP, Hanninen T, Hallikainen M, Alhainen K, Soininen H, Tuomilehto J, Nissinen A. Midlife vascular risk factors and Alzheimer's disease in later life: longitudinal, population based study. BMJ. 2001 Jun 16;322(7300):1447-51. doi: 10.1136/bmj.322.7300.1447.

  PMID: 11408299 BACKGROUND

• Kivipelto M, Helkala EL, Hanninen T, Laakso MP, Hallikainen M, Alhainen K, Soininen H, Tuomilehto J, Nissinen A. Midlife vascular risk factors and late-life mild cognitive impairment: A population-based study. Neurology. 2001 Jun 26;56(12):1683-9. doi: 10.1212/wnl.56.12.1683.

  PMID: 11425934 BACKGROUND

• Kivipelto M, Helkala EL, Laakso MP, Hanninen T, Hallikainen M, Alhainen K, Iivonen S, Mannermaa A, Tuomilehto J, Nissinen A, Soininen H. Apolipoprotein E epsilon4 allele, elevated midlife total cholesterol level, and high midlife systolic blood pressure are independent risk factors for late-life Alzheimer disease. Ann Intern Med. 2002 Aug 6;137(3):149-55. doi: 10.7326/0003-4819-137-3-200208060-00006.

  PMID: 12160362 BACKGROUND

• Rovio S, Kareholt I, Helkala EL, Viitanen M, Winblad B, Tuomilehto J, Soininen H, Nissinen A, Kivipelto M. Leisure-time physical activity at midlife and the risk of dementia and Alzheimer's disease. Lancet Neurol. 2005 Nov;4(11):705-11. doi: 10.1016/S1474-4422(05)70198-8.

  PMID: 16239176 BACKGROUND

• Kivipelto M, Ngandu T, Fratiglioni L, Viitanen M, Kareholt I, Winblad B, Helkala EL, Tuomilehto J, Soininen H, Nissinen A. Obesity and vascular risk factors at midlife and the risk of dementia and Alzheimer disease. Arch Neurol. 2005 Oct;62(10):1556-60. doi: 10.1001/archneur.62.10.1556.

  PMID: 16216938 BACKGROUND

• Lindstrom J, Ilanne-Parikka P, Peltonen M, Aunola S, Eriksson JG, Hemio K, Hamalainen H, Harkonen P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Mannelin M, Paturi M, Sundvall J, Valle TT, Uusitupa M, Tuomilehto J; Finnish Diabetes Prevention Study Group. Sustained reduction in the incidence of type 2 diabetes by lifestyle intervention: follow-up of the Finnish Diabetes Prevention Study. Lancet. 2006 Nov 11;368(9548):1673-9. doi: 10.1016/S0140-6736(06)69701-8.

  PMID: 17098085 BACKGROUND

• Kivipelto M, Rovio S, Ngandu T, Kareholt I, Eskelinen M, Winblad B, Hachinski V, Cedazo-Minguez A, Soininen H, Tuomilehto J, Nissinen A. Apolipoprotein E epsilon4 magnifies lifestyle risks for dementia: a population-based study. J Cell Mol Med. 2008 Dec;12(6B):2762-71. doi: 10.1111/j.1582-4934.2008.00296.x. Epub 2008 Feb 8.

  PMID: 18318693 BACKGROUND

• Kivipelto M, Solomon A, Ahtiluoto S, Ngandu T, Lehtisalo J, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Nissinen A, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H. The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER): study design and progress. Alzheimers Dement. 2013 Nov;9(6):657-65. doi: 10.1016/j.jalz.2012.09.012. Epub 2013 Jan 17.

  PMID: 23332672 RESULT

• Ngandu T, Lehtisalo J, Levalahti E, Laatikainen T, Lindstrom J, Peltonen M, Solomon A, Ahtiluoto S, Antikainen R, Hanninen T, Jula A, Mangialasche F, Paajanen T, Pajala S, Rauramaa R, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. Recruitment and baseline characteristics of participants in the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER)-a randomized controlled lifestyle trial. Int J Environ Res Public Health. 2014 Sep 10;11(9):9345-60. doi: 10.3390/ijerph110909345.

  PMID: 25211775 RESULT

• Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.

  PMID: 25771249 RESULT

• Kulmala J, Ngandu T, Pajala S, Lehtisalo J, Levalahti E, Antikainen R, Laatikainen T, Oksa H, Peltonen M, Rauramaa R, Soininen H, Strandberg T, Tuomilehto J, Kivipelto M. Leisure-Time and Occupational Physical Activity in Early and Late Adulthood in Relation to Later Life Physical Functioning. J Phys Act Health. 2016 Oct;13(10):1079-1087. doi: 10.1123/jpah.2015-0664. Epub 2016 Aug 16.

  PMID: 27254853 RESULT

• Strandberg TE, Levälahti E, Ngandu T, Solomon A, M Kivipelto for FINGER Study Group. Health-Related Quality of Life in a Multidomain Intervention Trial to Prevent Cognitive Decline (FINGER). Eur Ger Med. 2017; 8: 164-167.

  RESULT

• Lehtisalo J, Ngandu T, Valve P, Antikainen R, Laatikainen T, Strandberg T, Soininen H, Tuomilehto J, Kivipelto M, Lindstrom J. Nutrient intake and dietary changes during a 2-year multi-domain lifestyle intervention among older adults: secondary analysis of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) randomised controlled trial. Br J Nutr. 2017 Aug;118(4):291-302. doi: 10.1017/S0007114517001982.

  PMID: 28875868 RESULT

• Marengoni A, Rizzuto D, Fratiglioni L, Antikainen R, Laatikainen T, Lehtisalo J, Peltonen M, Soininen H, Strandberg T, Tuomilehto J, Kivipelto M, Ngandu T. The Effect of a 2-Year Intervention Consisting of Diet, Physical Exercise, Cognitive Training, and Monitoring of Vascular Risk on Chronic Morbidity-the FINGER Randomized Controlled Trial. J Am Med Dir Assoc. 2018 Apr;19(4):355-360.e1. doi: 10.1016/j.jamda.2017.09.020. Epub 2017 Nov 3.

  PMID: 29108888 RESULT

• Solomon A, Handels R, Wimo A, Antikainen R, Laatikainen T, Levalahti E, Peltonen M, Soininen H, Strandberg T, Tuomilehto J, Kivipelto M, Ngandu T. Effect of a Multidomain Lifestyle Intervention on Estimated Dementia Risk. J Alzheimers Dis. 2021;82(4):1461-1466. doi: 10.3233/JAD-210331.

  PMID: 34151805 RESULT

• Lehtisalo J, Rusanen M, Solomon A, Antikainen R, Laatikainen T, Peltonen M, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M, Ngandu T. Effect of a multi-domain lifestyle intervention on cardiovascular risk in older people: the FINGER trial. Eur Heart J. 2022 Jun 1;43(21):2054-2061. doi: 10.1093/eurheartj/ehab922.

  PMID: 35051281 RESULT

• Wimo A, Handels R, Antikainen R, Eriksdotter M, Jonsson L, Knapp M, Kulmala J, Laatikainen T, Lehtisalo J, Peltonen M, Skoldunger A, Soininen H, Solomon A, Strandberg T, Tuomilehto J, Ngandu T, Kivipelto M. Dementia prevention: The potential long-term cost-effectiveness of the FINGER prevention program. Alzheimers Dement. 2023 Mar;19(3):999-1008. doi: 10.1002/alz.12698. Epub 2022 Jul 16.

  PMID: 35841619 RESULT

• Saaskilahti M, Aarnio E, Levalahti E, Lehtisalo J, Kivipelto M, Strandberg T, Antikainen R, Soininen H, Laatikainen T, Tuomilehto J, Solomon A, Mangialasche F, Ngandu T. Cardiovascular and glucose-lowering medication use among older adults: results from 9-year follow-up of the FINGER trial. Eur Geriatr Med. 2025 Dec 3. doi: 10.1007/s41999-025-01354-1. Online ahead of print.

  PMID: 41339545 DERIVED

• Lorenzon G, Marseglia A, Mohanty R, Lehtisalo J, Poulakis K, Ngandu T, Solomon A, Kivipelto M, Westman E. Brain patterns and risk factors in the FINGER RCT multimodal lifestyle intervention. J Prev Alzheimers Dis. 2025 Dec;12(10):100390. doi: 10.1016/j.tjpad.2025.100390. Epub 2025 Sep 24.

  PMID: 40998691 DERIVED

• Lorenzo T, Ngandu T, Lehtisalo J, Antikainen R, Gispert JD, Kemppainen N, Laatikainen T, Lindstrom J, Rinne J, Soininen H, Strandberg T, Torre R, Tuomilehto J, Solomon A, Kivipelto M. Associations of Prediabetes, Diabetes and Glucose-Related Markers With Cognition and Neuroimaging in a 2-Year Multidomain Lifestyle Randomised Controlled Trial. Diabetes Metab Res Rev. 2025 Jul;41(5):e70053. doi: 10.1002/dmrr.70053.

  PMID: 40478656 DERIVED

• Lehtisalo J, Saaskilahti M, Harkanen T, Kulmala J, Hemio K, Siltanen S, Zhi Z, Mangialasche F, Laatikainen T, Strandberg T, Antikainen R, Tuomilehto J, Soininen H, Kivipelto M, Ngandu T. Changes in older persons' lifestyle and perceived health over time and during the COVID-19 pandemic: findings from the extended follow-up of the FINGER randomized controlled trial from 2009 to 2020. BMC Geriatr. 2025 May 3;25(1):308. doi: 10.1186/s12877-025-05979-6.

  PMID: 40319270 DERIVED

• Kekkonen E, Hall A, Antikainen R, Havulinna S, Kivipelto M, Kulmala J, Laatikainen T, Paajanen TI, Sindi S, Soininen H, Strandberg T, Tuomilehto J, Ngandu T, Solomon A. Impaired sleep, depressive symptoms, and pain as determinants of physical activity and exercise intervention adherence: an exploratory analysis of a randomized clinical trial. BMC Geriatr. 2025 Mar 29;25(1):211. doi: 10.1186/s12877-025-05830-y.

  PMID: 40158087 DERIVED

• Vaskivuo L, Hokkanen L, Levalahti E, Hanninen T, Antikainen R, Backman L, Laatikainen T, Paajanen T, Stigsdotter Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M, Ngandu T. Subjective Memory Complaints and the Effect of a Multidomain Lifestyle Intervention on Cognition: The FINGER Trial. J Gerontol B Psychol Sci Soc Sci. 2024 Dec 11;80(1):gbae179. doi: 10.1093/geronb/gbae179.

  PMID: 39450437 DERIVED

• Goikolea J, Gerenu G, Daniilidou M, Mangialasche F, Mecocci P, Ngandu T, Rinne J, Solomon A, Kivipelto M, Cedazo-Minguez A, Sandebring-Matton A, Maioli S. Serum Thioredoxin-80 is associated with age, ApoE4, and neuropathological biomarkers in Alzheimer's disease: a potential early sign of AD. Alzheimers Res Ther. 2022 Feb 24;14(1):37. doi: 10.1186/s13195-022-00979-9.

  PMID: 35209952 DERIVED

• Alenius M, Ngandu T, Koskinen S, Hallikainen I, Hanninen T, Karrasch M, Kivipelto M, Raivio MM, Laakkonen ML, Kruger J, Suhonen NM, Hokkanen L. Education-Based Cutoffs for Cognitive Screening of Alzheimer's Disease. Dement Geriatr Cogn Disord. 2022;51(1):42-55. doi: 10.1159/000521982. Epub 2022 Feb 23.

  PMID: 35196653 DERIVED

• Neuvonen E, Lehtisalo J, Solomon A, Antikainen R, Havulinna S, Hanninen T, Laatikainen T, Lindstrom J, Rautio N, Soininen H, Strandberg T, Tuomilehto J, Kivipelto M, Ngandu T. Psychosocial determinants for adherence to a healthy lifestyle and intervention participation in the FINGER trial: an exploratory analysis of a randomised clinical trial. Aging Clin Exp Res. 2022 Aug;34(8):1793-1805. doi: 10.1007/s40520-022-02088-x. Epub 2022 Feb 19.

  PMID: 35182352 DERIVED

• Ngandu T, Lehtisalo J, Korkki S, Solomon A, Coley N, Antikainen R, Backman L, Hanninen T, Lindstrom J, Laatikainen T, Paajanen T, Havulinna S, Peltonen M, Neely AS, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. The effect of adherence on cognition in a multidomain lifestyle intervention (FINGER). Alzheimers Dement. 2022 Jul;18(7):1325-1334. doi: 10.1002/alz.12492. Epub 2021 Oct 20.

  PMID: 34668644 DERIVED

• Sandebring-Matton A, Goikolea J, Bjorkhem I, Paternain L, Kemppainen N, Laatikainen T, Ngandu T, Rinne J, Soininen H, Cedazo-Minguez A, Solomon A, Kivipelto M. 27-Hydroxycholesterol, cognition, and brain imaging markers in the FINGER randomized controlled trial. Alzheimers Res Ther. 2021 Mar 6;13(1):56. doi: 10.1186/s13195-021-00790-y.

  PMID: 33676572 DERIVED

• Sindi S, Solomon A, Kareholt I, Hovatta I, Antikainen R, Hanninen T, Levalahti E, Laatikainen T, Lehtisalo J, Lindstrom J, Paajanen T, Peltonen M, Singh Khalsa D, Wolozin B, Strandberg T, Tuomilehto J, Soininen H, Ngandu T, Kivipelto M; FINGER Study Group. Telomere Length Change in a Multidomain Lifestyle Intervention to Prevent Cognitive Decline: A Randomized Clinical Trial. J Gerontol A Biol Sci Med Sci. 2021 Feb 25;76(3):491-498. doi: 10.1093/gerona/glaa279.

  PMID: 33175128 DERIVED

• Stephen R, Liu Y, Ngandu T, Antikainen R, Hulkkonen J, Koikkalainen J, Kemppainen N, Lotjonen J, Levalahti E, Parkkola R, Pippola P, Rinne J, Strandberg T, Tuomilehto J, Vanninen R, Kivipelto M, Soininen H, Solomon A; FINGER study group. Brain volumes and cortical thickness on MRI in the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER). Alzheimers Res Ther. 2019 Jun 4;11(1):53. doi: 10.1186/s13195-019-0506-z.

  PMID: 31164160 DERIVED

• Kulmala J, Ngandu T, Havulinna S, Levalahti E, Lehtisalo J, Solomon A, Antikainen R, Laatikainen T, Pippola P, Peltonen M, Rauramaa R, Soininen H, Strandberg T, Tuomilehto J, Kivipelto M. The Effect of Multidomain Lifestyle Intervention on Daily Functioning in Older People. J Am Geriatr Soc. 2019 Jun;67(6):1138-1144. doi: 10.1111/jgs.15837. Epub 2019 Feb 26.

  PMID: 30809801 DERIVED

• Lehtisalo J, Levalahti E, Lindstrom J, Hanninen T, Paajanen T, Peltonen M, Antikainen R, Laatikainen T, Strandberg T, Soininen H, Tuomilehto J, Kivipelto M, Ngandu T. Dietary changes and cognition over 2 years within a multidomain intervention trial-The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER). Alzheimers Dement. 2019 Mar;15(3):410-417. doi: 10.1016/j.jalz.2018.10.001. Epub 2018 Dec 4.

  PMID: 30527596 DERIVED

• Solomon A, Turunen H, Ngandu T, Peltonen M, Levalahti E, Helisalmi S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lehtisalo J, Lindstrom J, Paajanen T, Pajala S, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. Effect of the Apolipoprotein E Genotype on Cognitive Change During a Multidomain Lifestyle Intervention: A Subgroup Analysis of a Randomized Clinical Trial. JAMA Neurol. 2018 Apr 1;75(4):462-470. doi: 10.1001/jamaneurol.2017.4365.

  PMID: 29356827 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Interventions

Exercise; Cognitive Training

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Miia Kivipelto, professor

  Finnish Institute for Health and Welfare

  PRINCIPAL INVESTIGATOR

• Tiina K Laatikainen, professor

  Finnish Institute for Health and Welfare

  STUDY DIRECTOR

• Hilkka S Soininen, professor

  University of Eastern Finland

  STUDY DIRECTOR

• Jaakko Tuomilehto, professor

  University of Helsinki

  STUDY DIRECTOR

• Timo E Strandberg, professor

  University of Oulu

  STUDY DIRECTOR

• Raimo Sulkava, professor

  University of Eastern Finland

  STUDY DIRECTOR

• Rainer Rauramaa, professor

  Kuopio Research Institute of Exercise Medicine

  STUDY DIRECTOR

• Antti Jula, research prof

  Finnish Institute for Health and Welfare

  STUDY DIRECTOR

• Markku Peltonen, research professor

  Finnish Institute for Health and Welfare

  STUDY DIRECTOR

• Satu Havulinna, PhD

  Finnish Institute for Health and Welfare

  STUDY DIRECTOR

• Jaana Lindström, Adjunct prof.

  Finnish Institute for Health and Welfare

  STUDY DIRECTOR

• Riitta Antikainen, professor

  Oulu City Health Services

  STUDY DIRECTOR

• Tiia Ngandu, MD, PhD, Adjunct professor

  Finnish Institute for Health and Welfare

  STUDY DIRECTOR

• Tuomo Hänninen, Adjunct prof

  University of Eastern Finland

  STUDY DIRECTOR

• Jenni Lehtisalo, PhD

  Finnish Institute for Health and Welfare

  STUDY DIRECTOR

• Alina Solomon, MD, PhD, Adjunct professor

  University of Eastern Finland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2010
• First Posted: January 5, 2010
• Study Start: September 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2025
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

FI (5)