Condition category
Not Applicable
Date applied
05/01/2011
Date assigned
18/02/2011
Last edited
08/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.mammis.weebly.com

Contact information

Type

Scientific

Primary contact

Miss Alyssa Gilinsky

ORCID ID

Contact details

University of Stirling
Stirling
FK9 4LA
United Kingdom
+44 (0)1786 467345
a.s.gilinsky@stir.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10/S0501/59

Study information

Scientific title

Physical activity intervention for postnatal women: a randomised controlled trial

Acronym

MAMMiS

Study hypothesis

The 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

Fife and Forth Valley Research Ethics Committee approved on the 16th December 2010

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Public health

Intervention

A 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Physical 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 measures

1. 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 trial start date

01/02/2011

Overall trial end date

30/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1.18 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

76

Participant exclusion criteria

1. Medical contraindications to physical activity
2. Pregnant or planning to become pregnant in the next 6 months

Recruitment start date

01/02/2011

Recruitment end date

30/06/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Stirling
Stirling
FK9 4LA
United Kingdom

Sponsor information

Organisation

University of Stirling (UK)

Sponsor details

University of Stirling
Stirling
FK9 4LA
United Kingdom
+44 (0)1786 466444
deborah.miller@stir.ac.uk

Sponsor type

University/education

Website

http://www.stir.ac.uk/

Funders

Funder type

University/education

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22818406

Publication citations

  1. Protocol

    Gilinsky AS, Hughes AR, McInnes RJ, More Active Mums in Stirling (MAMMiS): a physical activity intervention for postnatal women. Study protocol for a randomized controlled trial., Trials, 2012, 13, 112, doi: 10.1186/1745-6215-13-112.

Additional files

Editorial Notes