Improvement of a Physically Active Lifestyle

NCT00979719 | Completed DMC

• 2 other identifiers: 8011 - 106 - 31/31.910421/00-40-64-50-00
• Study Type: interventional
• Target: 1,377
• Locations: 1 country
• Sites: 1

Brief Summary

To help rehabilitation patients to adopt and maintain a physically active lifestyle, it is imperative to increase self-management competencies. Aim of this research project is to evaluate an evidence- and theory-based computerized expert system in comparison to a well established standard program and a questionnaire-only group. Rehabilitation patients will be treated psychologically and followed up over 18 months. The computerized expert system is expected to help patients better than the standard program. Both interventions are hypothesized to improve self-management competencies over and above the rehabilitation treatment (i.e., questionnaire-only group).

Conditions

Pain; Osteoarthritis; Rheumatoid Arthritis; Heart Diseases; Diabetes Mellitus, Type 2; Behavior; Motivation

Keywords

Randomized Controlled Trial; evidence- and theory-based behavioral intervention; expert system; stages of change; motivational interviewing; tailoring; Self Care; Rehabilitation; Expert Systems

Outcome Measures

Primary Outcomes (1)

• physical activity

  18 months

Secondary Outcomes (5)

• subjective health

  18 months

• quality of life

  18 months

• rehabilitation satisfaction

  18 months

• motivation

  18 months

• social-cognitive predictors of behavior (self-efficacy, action control etc.)

  18 months

Study Arms (3)

Intervention Group (IG)

EXPERIMENTAL

Patients in the IG will receive an interactive, computerized expert system which tailors treatment components to the individual needs of the patients

Behavioral: Intervention Group (IG)

Active Control Group (ACG)

PLACEBO COMPARATOR

Patients in the ACG will get an interactive computerized standard program which has been proven to be effective (Göhner, \& Fuchs, 2007) Göhner, W. \& Fuchs, R. (2007). Änderung des Gesundheitsverhaltens. MoVo-Gruppenprogramme für körperliche Aktivität und gesunde Ernährung. Göttingen: Hogrefe.

Behavioral: Active Control Group (ACG)

Passive Control Group (PCG)

NO INTERVENTION

patients are asked to answer the questionnaires only

Interventions

Intervention Group (IG) BEHAVIORAL

patients will receive an interactive, computerized expert system which tailors treatment components to the individual needs of the patients

Also known as: FaBA

Intervention Group (IG)

Active Control Group (ACG) BEHAVIORAL

Patients in the ACG will get an interactive computerized standard program which has been proven to be effective (Göhner, W. \& Fuchs, R. (2007). Änderung des Gesundheitsverhaltens. MoVo-Gruppenprogramme für körperliche Aktivität und gesunde Ernährung. Göttingen: Hogrefe.)

Also known as: MoVo

Active Control Group (ACG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to be capable of exercising on their own at the minimum level recommended by the according rehabilitation clinic
• able to fill out a questionnaire (no illiteracy)
• adequate German language ability

You may not qualify if:

• the participant not be of age
• severe cognitive deficits
• visual impairments (patients have to read at the PC)

Sponsors & Collaborators

• Freie Universität Berlin: lead
• Deutsche Rentenversicherung: collaborator

Study Sites (1)

Freie Universitaet Berlin

Berlin, State of Berlin, 14195, Germany

Location

Related Publications (3)

• Lippke S, Pomp S, Fleig L. Rehabilitants' conscientiousness as a moderator of the intention-planning-behavior chain. Rehabil Psychol. 2018 Aug;63(3):460-467. doi: 10.1037/rep0000210.

  PMID: 30113201 DERIVED

• Fleig L, Kerschreiter R, Schwarzer R, Pomp S, Lippke S. 'Sticking to a healthy diet is easier for me when I exercise regularly': cognitive transfer between physical exercise and healthy nutrition. Psychol Health. 2014;29(12):1361-72. doi: 10.1080/08870446.2014.930146. Epub 2014 Jul 21.

  PMID: 24894668 DERIVED

• Fleig L, Lippke S, Pomp S, Schwarzer R. Intervention effects of exercise self-regulation on physical exercise and eating fruits and vegetables: a longitudinal study in orthopedic and cardiac rehabilitation. Prev Med. 2011 Sep;53(3):182-7. doi: 10.1016/j.ypmed.2011.06.019. Epub 2011 Jul 14.

  PMID: 21784096 DERIVED

MeSH Terms

Conditions

Pain; Osteoarthritis; Arthritis, Rheumatoid; Heart Diseases; Diabetes Mellitus, Type 2; Behavior

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sonia Lippke, PhD

  Freie Universitaet Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 17, 2009
• First Posted: September 18, 2009
• Study Start: October 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: September 1, 2012
• Last Updated: November 15, 2012

Record last verified: 2011-01

Locations

DE (1)