NCT01577134

Brief Summary

PREFER II aims at developing psychological targeted theory- and evidence-based intervention components, which support older people with multiple illnesses in performing more physical activity. Many studies provide evidence for the importance of physical activity as a central mediator of health. This means that determinants of physical activity such as personal resources constitute an ideal target for interventions. Within PREFER II, particularly positive views on ageing, attitudes, self-efficacy, planning and self-monitoring will be targeted in the interventions. These factors are important both for motivating older people with multiple illnesses to change their health behaviors and to translate such motivation into behavior.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2012

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 13, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

1.3 years

First QC Date

March 19, 2012

Last Update Submit

March 26, 2015

Conditions

Keywords

multimorbidityautonomyolder adultsphysical activityinterventionbehavior change

Outcome Measures

Primary Outcomes (1)

  • Change in physical activity

    Baseline, 6 weeks, 10 weeks, 8.5 months, 12 months

Secondary Outcomes (2)

  • Change in quality of Life

    Baseline, 6 weeks, 10 weeks, 8.5 months, 12 months

  • Change in self-reported perceived autonomy

    Baseline, 6 weeks, 10 weeks, 8.5 months, 12 months

Study Arms (3)

Intervention to enhance physical activity

EXPERIMENTAL

Participants in this arm have high motivation to be regularly physically active. Face-to-face group intervention includes behavior change techniques to enhance physical activity.

Behavioral: Social-cognitive resource intervention

Active control intervention

ACTIVE COMPARATOR

Face-to-face group intervention includes behavior change techniques to enhance volunteering and improve attitudes towards volunteering.

Behavioral: Social-cognitive resource intervention

Passive control intervention

OTHER

Waiting-list control group, who receives all information (that the active groups got) via mail after completion of 8.5 months follow-up.

Behavioral: no intervention

Interventions

Intervention group that receives a behavior change technique intervention to increase volitional strategies and physical activity.

Intervention to enhance physical activity
no interventionBEHAVIORAL

Passive control group that receives no intervention until the 8.5 months follow-up. Subsequently, they receive the information by mail the active groups received within the intervention.

Passive control intervention

Eligibility Criteria

Age64 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • community-residing

You may not qualify if:

  • regularly exercising

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Centre of Gerontology

Berlin, 12101, Germany

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Clemens Tesch-Römer, Prof. Dr.

    German Centre of Gerontology

    STUDY CHAIR
  • Ralf Schwarzer, Prof. Dr.

    Freie Universität Berlin

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2012

First Posted

April 13, 2012

Study Start

April 1, 2012

Primary Completion

August 1, 2013

Study Completion

December 1, 2014

Last Updated

March 31, 2015

Record last verified: 2015-03

Locations