ISRCTN ISRCTN79011784
DOI https://doi.org/10.1186/ISRCTN79011784
Secondary identifying numbers 10/S0501/59
Submission date
05/01/2011
Registration date
18/02/2011
Last edited
26/09/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Miss Alyssa Gilinsky
Scientific

University of Stirling
Stirling
FK9 4LA
United Kingdom

Phone +44 (0)1786 467345
Email a.s.gilinsky@stir.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titlePhysical activity intervention for postnatal women: a randomised controlled trial
Study acronymMAMMiS
Study objectivesThe intervention group will show increased participation in moderate-vigorous physical activity relative to the control group at three and six months follow-up.
Ethics approval(s)Fife and Forth Valley Research Ethics Committee approved on the 16th December 2010
Health condition(s) or problem(s) studiedPublic health
InterventionA motivational and behavioural management intervention consisting of two face-to-face physical activity (PA) consultations delivered at the start and end of a 10-week group pram-walking programme.

The intervention group will receive a motivational and behavioural management intervention consisting of two individual face-to-face physical activity consultations of 30-40 minutes in duration, a 10-week group pram-walking programme and a leaflet describing the benefits of physical activity. Physical activity consultations will be delivered by the Chief Investigator who is a Health Psychologist and trained physical activity counsellor. Consultations will be structured sessions using evidence-based behaviour change techniques to encourage physical activity participation amongst participants. This will include providing participants with feedback on physical activity levels, raising awareness of the benefits of physical activity, goal setting, weekly action planning and self-monitoring of physical activity, prompting environmental change, social support seeking, planning how to overcome barriers to physical activity and relapse prevention. The pram-walking programme will provide one session per week of up to 50 minutes of moderate physical activity in the local community and will be lead by the Chief Investigator who is a trained walk leader.

The control group will receive a leaflet describing the benefits of physical activity.
Intervention typeOther
Primary outcome measurePhysical activity behaviour change measured using accelerometers (Actigraph GT3X), pedometers (Omron Healthcare UK Ltd) and the 7-Day Physical Activity Recall (PAR) interview.

All primary and secondary outcome measures will be taken at baseline, 3 and 6 months from baseline.
Secondary outcome measures1. Psychological well-being
2. Fatigue
3. Cardiovascular fitness
4. Weight
5. Body mass index (BMI)
6. Body composition (e.g. percentage body fat, fat mass and fat-free mass)
7. Theoretical mediators of physical activity behaviour change

Added 24/02/2011: All primary and secondary outcome measures will be taken at baseline, 3 and 6 months from baseline.

Previous measures: All primary and secondary outcome measures will be taken at baseline, 3 and 6 months from baseline with the exception of a self-report questionnaire measuring theoretical mediators of physical activity behaviour change (baseline and 3 months only).
Overall study start date01/02/2011
Completion date30/06/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants76
Key inclusion criteria1.18 years of age or older
2. Have given birth in the last year
3. Has received 6 - 8 week postnatal check-up with a suitable health professional
4. Insufficiently active (e.g. participates in less than the recommended 30 minutes of moderate intensity physical activity on five days of the week)
5. Able to communicate verbally, and in written format, in English
Key exclusion criteria1. Medical contraindications to physical activity
2. Pregnant or planning to become pregnant in the next 6 months
Date of first enrolment01/02/2011
Date of final enrolment30/06/2012

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

University of Stirling
Stirling
FK9 4LA
United Kingdom

Sponsor information

University of Stirling (UK)
University/education

University of Stirling
Stirling
FK9 4LA
Scotland
United Kingdom

Phone +44 (0)1786 466444
Email deborah.miller@stir.ac.uk
Website http://www.stir.ac.uk/
ROR logo "ROR" https://ror.org/045wgfr59

Funders

Funder type

University/education

University of Stirling (UK) - Department of Nursing and Midwifery and Department of Sports Studies

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 20/07/2012 Yes No
Results article results 01/07/2016 Yes No

Editorial Notes

26/09/2018: Publication reference added.