Plain English Summary
Not provided at time of registration
Trial website
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22818406
Publication citations
-
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.