IT-Based Training in Obesity - Full Text View

Sponsors and Collaborators:	Technische Universität München German Federal Ministry of Education and Research
Information provided by:	Technische Universität München
ClinicalTrials.gov Identifier:	NCT00899964

Purpose

Though possibly cost-saving, there is little scientific evidence for the effectiveness and reasonable modality of internet-delivered physical activity interventions in primary prevention. The aim of the study is to compare the influence of different personal and IT-based service levels on the activity outcome of obese, sedentary persons to evaluate the minimum level of service necessary for a maximum increase in activity and weight reduction.

Condition	Intervention
Obesity Inactivity	Behavioral: Physical activity

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
Official Title:	Influence of a Combined Personal and IT-Based Physical Activity Intervention in an Obese, Sedentary Population on Daily Activity and Metabolic Risk Profile

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

Further study details as provided by Technische Universität München:

Primary Outcome Measures:

Self-reported physical activity evaluated by questionnaire [ Time Frame: 6 months ]

Secondary Outcome Measures:

Body-Mass-Index [ Time Frame: 6 months ]
Body weight [ Time Frame: 6 months ]
Technology acceptance evaluated by questionnaire [ Time Frame: 6 months ]
Motivation analysis [ Time Frame: 6 months ]
Time spent on the internet [ Time Frame: 6 months ]
Metabolic equivalents [ Time Frame: 6 months ]

Estimated Enrollment:	400
Study Start Date:	May 2009
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator automated tailored feedback per E-mail	Behavioral: Physical activity 6-month physical activity intervention (endurance activities) delivered by internet with tailored training schedules
2: Active Comparator 1 + active contact per E-mail possible	Behavioral: Physical activity 6-month physical activity intervention (endurance activities) delivered by internet with tailored training schedules
3: Active Comparator 2 + active contact by trainer in case of exercise-related problems	Behavioral: Physical activity 6-month physical activity intervention (endurance activities) delivered by internet with tailored training schedules
4: Active Comparator 3 + regular active contact by trainer	Behavioral: Physical activity 6-month physical activity intervention (endurance activities) delivered by internet with tailored training schedules

Eligibility

Ages Eligible for Study:	35 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Physical activity of less than once per week
Body-Mass-Index 28-35 kg/m2
Age 35-65
Men and women

Exclusion Criteria:

CHD
Diabetes
Other chronic diseases with conditions prohibiting regular physical activity
Drug abuse
BMI < 28 or > 35
Regular physical activity
Pregnancy
Mental illness

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899964

Contacts

Contact: Axel Preßler, MD

+49 89 28924446

pressler@sport.med.tum.de

Locations

Germany, Bavaria
Department of Prevention and Sports Medicine	Recruiting
München, Bavaria, Germany, 80809
Contact: Axel Preßler, MD +49 89 28924446 pressler@sport.med.tum.de
Principal Investigator: Axel Preßler, MD

Sponsors and Collaborators

Technische Universität München

German Federal Ministry of Education and Research

More Information

Publications:

Hoffmann, H.; Leimeister, J. M.; Krcmar, H. (2007): A Framework for Developing Personalizeable Mobile Services in Automobiles. In: XVth European Conference on Information Systems (ECIS 2007). Hrsg.: Österle, H.; Schelp, J.; Winter, R. University of St. Gallen, St. Gallen 2007, S. 938-949

Knebel, U.; Leimeister, J. M.; Krcmar, H. (2007): Personal Mobile Sports Companion: Design and Evaluation of IT-supported Product-Service-Bundles in the Sports Industry. In: XVth European Conference on Information Systems (ECIS 2007). Hrsg.: Österle, H.; Schelp, J.; Winter, R. University of St. Gallen, St. Gallen 2007, S. 81-92

Köbler, F.; Leimeister, J.M.; Lugmayr, A. (2006): Framework for Systematic and Strategic Planning of Innovation-based Mobile Broadband Services. Paper presented at the 14th Euromicro International Conference on Parallel, Distributed, and Network-Based Processing (PDP'06), Montbéliard, France

Neil, L.; Hansen, D.; Lindgaard, G.; Kogan, S.; Leimeister, J.M.; Oakley, K.; Selker, T. (2006): SIG Online Health Communities. Proccedings of the Conference on Human Factors in Computer Systems (CHI 2006), Montreal, S. 445

Study ID Numbers:	2372/09
Study First Received:	May 5, 2009
Last Updated:	May 22, 2009
ClinicalTrials.gov Identifier:	NCT00899964 History of Changes
Health Authority:	Germany: Federal Ministry of Education and Research

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on September 11, 2009