Improvement of a Physically Active Lifestyle

NCT ID: NCT00979719

Last Updated: 2012-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1377 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-09-30

Brief Summary

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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).

Detailed Description

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An experimental study with three groups is planned over a time period of 18 months. Patients in the intervention group receive an interactive, computerized expert system (Intervention Group, IG). Patients in the Active Control Group (ACG) get an interactive computerized standard program. This standard program has already been proven to be effective but which does not tailor treatment components to the individual needs of the patients. Patients in the Passive Control Group (PCG) are asked to answer the questionnaires only. Rehabilitation patients (N = 1000) will be recruited in three rehabilitation clinics and followed up over six measurement points: t1 and t2 with computer interventions during their rehabilitation stay; t3 and t4 with booster-sessions via telephone (6 weeks and 6 months after admission from rehabilitation). Furthermore, patients will be contacted at t5 per mail with motivational material (12 months after admission) and at t6 again per mail (only questionnaire, 18 months after admission).

The hypotheses are: In comparison to the PCG, both the IG and the ACG are expected to have a higher motivation, to adopt a healthy lifestyle, to perform more health behavior and to be less likely to relapse into previous unhealthy routines. Also, IG and ACG will be healthier as well as they will report more quality of life and rehabilitation satisfaction. In comparison to ACG, the IG is hypothesized to be more effective than the ACG regarding motivation, behavior and social-cognitive predictors of behavior. Moreover, the interventions (ACG and IG) are supposed to be equally effective for cardiac and orthopedic, as well as out-patient and stationary treated rehabilitation patients. After successful evaluation and some adoptions the intervention will be implemented as a self-help program in all eligible rehabilitation clinics and in the internet.

Conditions

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

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention Group (IG)

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

Group Type EXPERIMENTAL

Intervention Group (IG)

Intervention Type BEHAVIORAL

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

Active Control Group (ACG)

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.

Group Type PLACEBO_COMPARATOR

Active Control Group (ACG)

Intervention Type 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.)

Passive Control Group (PCG)

patients are asked to answer the questionnaires only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intervention Group (IG)

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

Intervention Type BEHAVIORAL

Active Control Group (ACG)

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.)

Intervention Type BEHAVIORAL

Other Intervention Names

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FaBA MoVo

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* the participant not be of age
* severe cognitive deficits
* visual impairments (patients have to read at the PC)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Deutsche Rentenversicherung

OTHER

Sponsor Role collaborator

Freie Universität Berlin

OTHER

Sponsor Role lead

Responsible Party

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Freie Universität Berlin

Principal Investigators

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Sonia Lippke, PhD

Role: PRINCIPAL_INVESTIGATOR

Freie Universitaet Berlin

Locations

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Freie Universitaet Berlin

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 30113201 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24894668 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21784096 (View on PubMed)

Other Identifiers

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0421/00-40-64-50-00

Identifier Type: -

Identifier Source: secondary_id

8011 - 106 - 31/31.91

Identifier Type: -

Identifier Source: org_study_id