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Trial registered on ANZCTR


Registration number
ACTRN12611000622909
Ethics application status
Approved
Date submitted
15/06/2011
Date registered
20/06/2011
Date last updated
21/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The M.A.D.E (Mothers and Daughters Exercising) 4 LIFE Pilot Randomised Control Trial: A theory-based physical activity intervention targeting mothers and their daughters.
Scientific title
The M.A.D.E (Mothers and Daughters Exercising) 4 LIFE Pilot Randomised Control Trial: A theory-based physical activity intervention targeting mothers and their daughters.
Secondary ID [1] 262382 0
Nil
Universal Trial Number (UTN)
Trial acronym
M.A.D.E 4 Life
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical activity levels of women and girls 268086 0
Condition category
Condition code
Public Health 268234 268234 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The M.A.D.E 4 Life program will be conducted as a pilot randomised control trial (RCT) with a wait-list control group. All participants (mothers and daughters) will be assessed at baseline, with follow-up assessments at 10-weeks and 20-weeks. The intervention involves mothers and daughters attending 90 minute information and physical activity sessions once a week for eight weeks, lead by a qualified PD/H/PE teacher. The sessions will involve educational information and physical activity fun. The information sessions will focus on physical activity and behaviours to support and achieve physical activity and fitness goals for mothers and promote physical activity and healthy lifestyles for their daughters. The physical activity sessions will involve the mother and daughter engaging in a variety of fun physical activities to increase self-confidence, fitness, role modeling behaviours of mothers and bonding time between mother and daughter. The intervention is based on social cognitive theory (SCT); self-efficacy, goal setting, social support and outcome expectations.
Intervention code [1] 266773 0
Lifestyle
Intervention code [2] 266774 0
Behaviour
Comparator / control treatment
Wait-list control group for 6-months. The wait-list control group will be offered the intervention in the first school term following 20-week follow up assessment.
Control group
Active

Outcomes
Primary outcome [1] 268966 0
Mother and daughter physical activity using Actigraph GT3X accelerometers (activity, steps)
Timepoint [1] 268966 0
Baseline and at 10 and 20-weeks follow up
Secondary outcome [1] 276708 0
Weight for mothers and daughters (kg) using calibrated electronic scales
Timepoint [1] 276708 0
Baseline and at 10 and 20-weeks follow up
Secondary outcome [2] 276709 0
Waist circumference for mothers and daughters (cm) using non extensible steel tapes
Timepoint [2] 276709 0
Baseline and at 10 and 20-weeks follow up
Secondary outcome [3] 276710 0
Body Mass Index (BMI) for mothers using the formula: weight in kilograms divided by the square of height in meters.

BMI for daughters (BMI-z) will be calculated similarly using standard deviation for children's scores related to age and gender
Timepoint [3] 276710 0
Baseline and at 10 and 20-weeks follow up
Secondary outcome [4] 276711 0
Systolic and diastolic blood pressure for mothers and daughters using automated blood pressure cuffs
Timepoint [4] 276711 0
Baseline and at 10 and 20-weeks follow up
Secondary outcome [5] 276712 0
Body composition for mothers and daughters using InBody720 (multi-frequency bioimpedance device featuring an eight-point tactile electrode system)
Timepoint [5] 276712 0
Baseline and at 10 and 20-weeks follow up
Secondary outcome [6] 276713 0
Physical activity behaviours: Godin leisure time self report.
Timepoint [6] 276713 0
Baseline and at 10 and 20-weeks follow up
Secondary outcome [7] 276714 0
Physical activity mediators: Validated physical activity measures.
Timepoint [7] 276714 0
Baseline and at 10 and 20-weeks follow up
Secondary outcome [8] 276715 0
Sedentary Behaviour: As indicated by self report for mothers and parent proxy-report completed by mothers for their daughters
Timepoint [8] 276715 0
Baseline and at 10 and 20-weeks follow up
Secondary outcome [9] 276716 0
Parent support and modeling: Validated questionnaire completed by mother
Timepoint [9] 276716 0
Baseline and at 10 and 20-weeks follow up
Secondary outcome [10] 276717 0
Parenting for physical activity: questions adapted from various validated questionnaires
Timepoint [10] 276717 0
Baseline and at 10 and 20-weeks follow up
Secondary outcome [11] 276718 0
Parent support for children's physical activity: questions adapted from validated questionnaire for daughters to complete
Timepoint [11] 276718 0
Baseline and at 10 and 20-weeks follow up
Secondary outcome [12] 276726 0
Height of mothers and daughters (cm)
Timepoint [12] 276726 0
Baseline

Eligibility
Key inclusion criteria
Mothers (aged 21-60) of primary school aged girls and their daughter/s (aged 5-12)
Minimum age
21 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of major medical problems such as heart disease or diabetes, orthopedic or joint problems that would be a barrier to completing physical activities such as walking, a daughter who is extensively involved in competitive sport, mothers who are pregnant

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Voluntary, informed and written consent will be obtained from all mothers and their daughters. Participants will be instructed to call the study phone line if they are interested in the study and screened for eligibility via telephone. Participants over 40 years of age will be required to receive doctor's clearance prior to commencement of the study.
Once written consent is obtained, the participants will be invited to baseline assessments and randomized to one of the two study groups. To ensure concealment, the random allocation sequence will be generated by a statistician and given to the project manager. Randomization will be completed by a research assistant who is not involved in the assessment of participants and the allocation sequence will be concealed when enrolling participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation sequence will be generated by a computer-based random number producing algorithm in block lengths of six to ensure an equal chance of allocation to each group
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Assessors and participants will be blind at baseline assessment
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2011
Actual
18/07/2011
Date of last participant enrolment
Anticipated
22/07/2011
Actual
22/07/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267253 0
University
Name [1] 267253 0
Priority Research Centre in Physical Activity & Nutrition University of Newcastle
Country [1] 267253 0
Australia
Primary sponsor type
Individual
Name
Miss Alyce Cook
Address
Health and Physical Education Building
School of Education
University of Newcastle
Callaghan, NSW 2308
Country
Australia
Secondary sponsor category [1] 266318 0
University
Name [1] 266318 0
University of Newcastle
A/Prof Philip Morgan
Address [1] 266318 0
Advanced Technology Centre (ATC 301)
Priority Research Centre for Physical Activity and Nutrition
Callaghan Drive
University of Newcastle
Callaghan
NSW 2308
Country [1] 266318 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269243 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 269243 0
Research Services
Research Office
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [1] 269243 0
Australia
Date submitted for ethics approval [1] 269243 0
Approval date [1] 269243 0
13/04/2011
Ethics approval number [1] 269243 0
H-2011-0054

Summary
Brief summary
The major aim of this project is to evaluate the effectiveness of a program designed to increase physical activity participation, and to improve self efficacy, health and lifestyle behaviours in both mothers and their daughters. M.A.D.E 4 Life program is specifically designed to unite mothers and daughters in a fun, educational setting where both parties can experience positive behaviour change the improvements in self-efficacy and overall health and wellbeing. A secondary aim of our project is to determine whether having a mother participate in a physical activity program has an effect on their daughters health and lifestyle behaviours. Parents influence the physical activity behaviours in the home environment through their behaviours, attitudes, and approach to physical activity and by being a role model. Parents of primary school children, in particular, play a pivotal role in changing a child’s environment to facilitate healthy physical activity behaviours.
Trial website
Trial related presentations / publications
Cook, A. Plotnikoff, R., & Collins, C. Morgan, P. (2014). Feasibility and preliminary efficacy of the Mothers and Daughters Exercising (M.A.D.E) 4 Life pilot randomized controlled trial. 2014 Annual Meeting of the International Society for Behavioral Nutrition and Physical Activity, 15-18 May 2014. San Diego, California, USA. POSTER

Cook, A., Morgan, P., Collins, C., & Plotnikoff, R. (2012). An examination of the association between a mother’s parenting practices relating to physical activity and their daughter’s physical activity levels. 4th International Congress on Physical Activity and Public Health, Australian Conference of Science and Medicine in Sport, 31 October-3 November 2012, Sydney, Australia. Journal of Science and Medicine in Sport, 15(6) (Dec 2012 Suppl.), 126. POSTER

Collins, C., Cook, A., Morgan, P., Schumacher, T., & Plotnikoff, R. (2012). Associations between mother and daughter dietary intakes. Australian and New Zealand Obesity Society Annual Scientific Meeting, 18-20 October 2012, Auckland, New Zealand. Obesity Research & Clinical Practice, 6(Supplement1): 80. POSTER

Cook, A., Morgan, P., Plotnikoff, R., & Collins, C. (2011). The M.A.D.E (Mothers and Daughters Exercising) 4 LIFE feasibility study: Description of a theory-based physical activity intervention targeting mothers and their daughters. 2011 Annual Meeting of the International Society for Behavioral Nutrition and Physical Activity, 15-18 June 2011. Melbourne, Australia. POSTER

Cook, A.T., Morgan, P.J., Plotnikoff, R.C., Collins, C.E. (2010). Rational and intervention description of the M.A.D.E (Mothers and Daughters Eating /Exercising) 4 Fun feasibility study: An obesity prevention program for mothers and their daughters. Australian and New Zealand Obesity Society Annual Scientific Meeting, 21-23 October 2010, Sydney, Australia. Obesity Research & Clinical Practice, 4(Supplement 1): S16-S16. POSTER
Public notes

Contacts
Principal investigator
Name 32748 0
Miss Alyce Cook
Address 32748 0
Priority Research Centre in Physical Activity and Nutrition
University Drive
University of Newcaslte
Callaghan
NSW 2308
Country 32748 0
Australia
Phone 32748 0
+61 2 49216566
Fax 32748 0
Email 32748 0
[email protected]
Contact person for public queries
Name 15995 0
Philip Morgan
Address 15995 0
School of Education
Faculty of Education and Arts
University of Newcastle
University Drive
Callaghan NSW 2308
Country 15995 0
Australia
Phone 15995 0
+61 2 4921 7265
Fax 15995 0
+61 2 4921 7407
Email 15995 0
[email protected]
Contact person for scientific queries
Name 6923 0
Philip Morgan
Address 6923 0
School of Education
Faculty of Education and Arts
University of Newcastle
University Drive
Callaghan NSW 2308
Country 6923 0
Australia
Phone 6923 0
+61 2 4921 7265
Fax 6923 0
+61 2 4921 7407
Email 6923 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFeasibility and Preliminary Efficacy of the MADE4Life Program: A Pilot Randomized Controlled Trial.2015https://dx.doi.org/10.1123/jpah.2014-0331
N.B. These documents automatically identified may not have been verified by the study sponsor.