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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]

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

Condition category

Condition code

Public Health

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]

Lifestyle

Intervention code [2]

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]

Mother and daughter physical activity using Actigraph GT3X accelerometers (activity, steps)

Timepoint [1]

Baseline and at 10 and 20-weeks follow up

Secondary outcome [1]

Weight for mothers and daughters (kg) using calibrated electronic scales

Timepoint [1]

Baseline and at 10 and 20-weeks follow up

Secondary outcome [2]

Waist circumference for mothers and daughters (cm) using non extensible steel tapes

Timepoint [2]

Baseline and at 10 and 20-weeks follow up

Secondary outcome [3]

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]

Baseline and at 10 and 20-weeks follow up

Secondary outcome [4]

Systolic and diastolic blood pressure for mothers and daughters using automated blood pressure cuffs

Timepoint [4]

Baseline and at 10 and 20-weeks follow up

Secondary outcome [5]

Body composition for mothers and daughters using InBody720 (multi-frequency bioimpedance device featuring an eight-point tactile electrode system)

Timepoint [5]

Baseline and at 10 and 20-weeks follow up

Secondary outcome [6]

Physical activity behaviours: Godin leisure time self report.

Timepoint [6]

Baseline and at 10 and 20-weeks follow up

Secondary outcome [7]

Physical activity mediators: Validated physical activity measures.

Timepoint [7]

Baseline and at 10 and 20-weeks follow up

Secondary outcome [8]

Sedentary Behaviour: As indicated by self report for mothers and parent proxy-report completed by mothers for their daughters

Timepoint [8]

Baseline and at 10 and 20-weeks follow up

Secondary outcome [9]

Parent support and modeling: Validated questionnaire completed by mother

Timepoint [9]

Baseline and at 10 and 20-weeks follow up

Secondary outcome [10]

Parenting for physical activity: questions adapted from various validated questionnaires

Timepoint [10]

Baseline and at 10 and 20-weeks follow up

Secondary outcome [11]

Parent support for children's physical activity: questions adapted from validated questionnaire for daughters to complete

Timepoint [11]

Baseline and at 10 and 20-weeks follow up

Secondary outcome [12]

Height of mothers and daughters (cm)

Timepoint [12]

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]

University

Name [1]

Priority Research Centre in Physical Activity & Nutrition University of Newcastle

Address [1]

PRC in Physical Activity and Nutrition
Health and Physical Education Building
University of Newcastle
Callaghan, NSW 2308

Country [1]

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]

University

Name [1]

University of Newcastle
A/Prof Philip Morgan

Address [1]

Advanced Technology Centre (ATC 301)
Priority Research Centre for Physical Activity and Nutrition
Callaghan Drive
University of Newcastle
Callaghan
NSW 2308

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Newcastle Human Research Ethics Committee

Ethics committee address [1]

Research Services
Research Office
The University of Newcastle
Callaghan NSW 2308

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

13/04/2011

Ethics approval number [1]

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

Miss Alyce Cook

Address

Priority Research Centre in Physical Activity and Nutrition
University Drive
University of Newcaslte
Callaghan
NSW 2308

Country

Australia

Phone

+61 2 49216566

Fax

Email

[email protected]

Contact person for public queries

Name

Philip Morgan

Address

School of Education
Faculty of Education and Arts
University of Newcastle
University Drive
Callaghan NSW 2308

Country

Australia

Phone

+61 2 4921 7265

Fax

+61 2 4921 7407

Email

[email protected]

Contact person for scientific queries

Name

Philip Morgan

Address

School of Education
Faculty of Education and Arts
University of Newcastle
University Drive
Callaghan NSW 2308

Country

Australia

Phone

+61 2 4921 7265

Fax

+61 2 4921 7407

Email

[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

Source	Title	Year of Publication	DOI
Embase	Feasibility and Preliminary Efficacy of the MADE4Life Program: A Pilot Randomized Controlled Trial.	2015	https://dx.doi.org/10.1123/jpah.2014-0331

N.B. These documents automatically identified may not have been verified by the study sponsor.