Effect-evaluation of the intervention "Being active without Worries"

ISRCTN	ISRCTN42389025
DOI	https://doi.org/10.1186/ISRCTN42389025
Protocol serial number	ZonMw 4016.0004; NTR197
Sponsor	University Maastricht (UM) (The Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 13/11/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Judith van der Waerden
Scientific

Maastricht University
Department of Health Education and Promotion
P.O. Box 616
Maastricht
6200 MD
Netherlands

Study information

Primary study design	Interventional
Study design	Randomised, single-blind, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title	Effect-evaluation of the intervention "Being active without Worries": an intervention aimed at reducing depressive and stress symptomatology in adult low socioeconomic status (LSES) women from disfavourised communities
Study objectives	1. Can a larger percentage of low socioeconomic status (LSES) women with depressive and/or stress related symptomatology be reached with an intervention when this contains an exercise component? 2. How effective is exercise only (B) compared to a control group (C) and does exercise plus psycho-education (BP) offer a surplus value above B? 3. How do LSES women appreciate this new intervention?
Ethics approval(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	Depressive and stress related symptomatology
Intervention	1. B-condition: the eight week intervention is offered with only the exercise component 2. BP-condition: the eight week intervention is offered with the exercise and psycho-education components 3. AC-condition: a control condition with postponed intervention for 3 months
Intervention type	Other
Primary outcome measure(s)	Depressive and stress related symptomatology, as measured by the CES-D, perceived stress scale, daily hassles scale. These measures will be administered two weeks before subjects start the course, 1 week after ending the course and next 6, 12 and 18 months after ending the course.
Key secondary outcome measure(s)	1. Social support 2. Mastery 3. Self-esteem 4. Self-efficacy 5. Assertiveness 6. Neighborhood perception These will be measured two weeks before subjects start the course, 1 week after ending the course and next 6, 12 and 18 months after ending the course by means of questionnaires such as the Social Support List (SSL), personal mastery scale, the NPV, ALCOS and the SIG. Percentage of participating women will be determined by means of enrolment numbers for the course, satisfaction with the course will be determined by means of a questionnaire.
Completion date	31/08/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	240
Key inclusion criteria	1. The research population consists of adult women (20 - 55 years) with a LSES background 2. Furthermore, the women must have mild to moderate (sub-clinical) depressive symptomatology as measured with the Centre for Epidemiologic Studies Depression Scale (CES-D), or suffer from stress related complaints
Key exclusion criteria	Because of the design of the intervention, participants are not allowed to have severe hearing problems or severe physical handicaps
Date of first enrolment	30/08/2005
Date of final enrolment	31/08/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Maastricht University

Maastricht
6200 MD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan