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Trial registered on ANZCTR


Registration number
ACTRN12611000386932
Ethics application status
Approved
Date submitted
13/04/2011
Date registered
13/04/2011
Date last updated
20/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preventing childhood overweight by promoting healthy lifestyle behaviours from infancy - The extended Infant feeding, activity and nutrition trial. (InFANT Extend)
Scientific title
Preventing childhood overweight by promoting healthy lifestyle behaviours from infancy - The extended Infant feeding, activity and nutrition trial (InFANT Extend) for first time mothers
Secondary ID [1] 259823 0
Registration ID of the original InFANT Trial: ISRCTN81847050
Universal Trial Number (UTN)
Nil
Trial acronym
InFANT Extend
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diet and Nutrition

Obesity
265399 0
Condition category
Condition code
Diet and Nutrition 265557 265557 0 0
Obesity
Public Health 265558 265558 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We aim to assess the effectiveness of a 42-month parent- focused child obesity-prevention intervention (compared with a no-intervention control) delivered to first-time parents. This cluster RCT (InFANT-Extend) will replicate the InFANT study design. InFANT is a 15-month parent-focussed obesity-prevention intervention commencing when infants are three-months of age, and delivered in existing social networks (first-time parent groups). InFANT concluded in March 2010. Children are 18-months of age at program conclusion. This study, known as InFANT- Extend, will enable assessment of the effectiveness of a 42-month parent- focused child obesity-prevention intervention (compared with a no-intervention control). In summary, the InFANT intervention involves:
* delivery of six quarterly group-sessions (child aged 3-18 months) The sessions will run for approximately 1.5 hour each and will cover a different topic. The Tap into Water, Colour Every Meal with Fruit and Veg, Snack on Fruit and Veg and Off and Running and Parents Provide Kids Decide. topics will be Eat together Play Together.
* six between session mailed newsletters reinforcing session messages
* purpose-designed InFANT DVD used in sessions and as take-home resource
* control-group receive usual care plus quarterly generic child health newsletters

The intervention arm will receive the previously trialled InFANT intervention delivered in first-time parent groups until child is aged 18-months. Around this time parent capacity to participate in groups rapidly diminishes, reflecting recommencement of work for many mothers. As continued delivery via groups is no longer viable, InFANT-Extend will be delivered at the individual level for the additional 24-months of the intervention. This will be via newsletters sent out to the intervention group approximately quarterly.
Intervention code [1] 264313 0
Prevention
Comparator / control treatment
There will be a non intervention control group in the InFANT Extend project. These first time parents will not receive the intervention. The control-group receive usual care plus quarterly generic child health newsletters. Usual care will be that the mothers and children might still meet in their informal mothers groups however they will not be scheduled to meet with us to receive their intervention. The control group will remain the control group for the entire project including the extended intervention.
Control group
Active

Outcomes
Primary outcome [1] 262430 0
In comparison to the control group infants, intervention group infants will:
Demonstrate greater increases in consumption of fruits and vegetables, and smaller increases in consumption of cordials, soft-drinks, juices and energy-dense snack foods.
This will be assessed by a 24 hour dietery recall.
Timepoint [1] 262430 0
Measured when the child is 18 months and 3.5 years.
Primary outcome [2] 262431 0
In comparison to the control group infants, intervention group infants will:
Demonstrate greater increases in time spent being physically active and smaller increases in time spent in sedentary behaviours, specifically television viewing.
This will be assessed by the use of accelerometers, and a parent report survey assessing sedentariness and physical activity.
Timepoint [2] 262431 0
Accelerometer data will be measured when the child is 18 months and 3.5 years

Sedentary behaviour will be measured when the child is 3 months, 18 months and 3.5 years.
Primary outcome [3] 262432 0
In comparison to the control group infants, intervention group infants will:
Exhibit reduced incremental BMI and waist circumference gain.
This will be assessed using calibrated scales, length matts calibrated stadiometers and tape measures.
Timepoint [3] 262432 0
Measured when the child is 3 months, 18 months and 3.5 years.
Secondary outcome [1] 273757 0
In comparison to the control group parents, the intervention group parents will demonstrate greater increases in:
Knowledge regarding child eating, physical activity and sedentary behaviours and greater self-efficacy regarding their capacity to influence these behaviours.
This will be assessed by Purpose designed questions utilised in both the InFANT and other studies.
Timepoint [1] 273757 0
Measured at baseline (when the child is 3 months), 18 months and 3.5 years.
Secondary outcome [2] 273758 0
In comparison to the control group parents, the intervention group parents will demonstrate greater increases in:
The adoption of desired feeding strategies, including parental modelling of healthy eating, the division of responsibility in feeding, and increased availability of desired foods in the home.
This will be assessed by The validated Comprehensive Feeding Practices Questionnaire / the Cancer Council of Vic validated Food Frequency Questionnaire (FFQ).
Timepoint [2] 273758 0
Measured at baseline (when the child is 3 months), 18 months and 3.5 years.
Secondary outcome [3] 273759 0
In comparison to the control group parents, the intervention group parents will demonstrate greater increases in:
The adoption of strategies, including modelling, for increasing opportunities for physical activity and reducing opportunities for sedentary behaviours.
This will be assessed by Purpose designed questions utilised in both the InFANT and other studies and The validated Comprehensive Feeding Practices Questionnaire / the Cancer Council of Vic validated Food Frequency Questionnaire (FFQ).
Timepoint [3] 273759 0
Measured at baseline (when the child is 3 months), 18 months and 3.5 years.

Eligibility
Key inclusion criteria
Sixty two first time parent groups from Maternal and Child Health (MCH) centres in the Greater City of Geelong and within surrounding municipalities (Melton shire, Wyndham city, Surfcoast shire, Hobsons Bay, Ballarat) will be recruited. Groups with a minimum of 8 mothers willing to participate will be included in the study. In all, 62 groups will be recruited and randomly selected into the Intervention and Control groups. Children will be aged 3-4 months. Participation in this study would require participants to be a member of a 'first-time parents group'. More specifically, participation entails being a parent for the first time and regularly attending a first-time parents group which is linked to a Maternal and Child Health Centres (MCHC) within a randomly selected recruited Local Government Areas (LGA). Parents will also be eligible to participate if they are able to freely give informed consent and can communicate in English.
For the extended intervention, all parents must have been enrolled in the InFANT study before they receive the extended intervention.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents will be excluded from the study if:
1. They are unable to give informed consent
2. They are unable to communicate in English

Infants with chronic health problems that are likely to influence height, weight, levels of physical activity or eating habits will be excluded from analyses, but will be permitted to participate in the study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation of participants to either the control or intervention group will be through random computer generated allocation. The allocation of each group will be contained in a sealed opaque envelope and this will be opened in front of the group before their first intervention or control session. The researchers will be blinded as to the groups allocation until that point.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will identified through randomly selected first-time parent groups initiated by Maternal and Child Health Centres (MCHCs) selected from a convenience sample of LGAs in close proximity to Geelong where the research will be conducted.

Contact will be made with participants through the MCHCs. A member of the research team will visit parent group sessions, at a time arranged with the MCH nurse.

We plan to recruit first time mothers and their child. These methods have been used previously and successfully in the Melbourne InFANT study. In summary, recruitment will involve:
* selecting local government districts in Melbourne, Australia from predominantly low mid socio-economic areas
* randomly selecting (proportionately) first-time parents’ groups - the unit of randomisation (computer sequence generated)
* recruiting parents of infants aged approximately three-months participating in first-time parent’s groups (a minimum of eight first time parents per group)
* randomly assigning groups to intervention or control (computer sequence generated)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264825 0
Charities/Societies/Foundations
Name [1] 264825 0
World Cancer Research Fund (WCRF) International
Address [1] 264825 0
World Cancer Research Fund International
Second Floor, 22 Bedford Square
London WC1B 3HH
Country [1] 264825 0
United Kingdom
Primary sponsor type
University
Name
Deakin University
Address
Deakin University
Faculty of Health, School of Exercise and Nutrition Sciences
221 Burwood Highway
Burwood
Vic
3125
Country
Australia
Secondary sponsor category [1] 263981 0
None
Name [1] 263981 0
Address [1] 263981 0
Country [1] 263981 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266790 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 266790 0
Melbourne Burwood Campus
221 Burwood Highway
Burwood
Vic 3125
Australia
Ethics committee country [1] 266790 0
Australia
Date submitted for ethics approval [1] 266790 0
21/01/2011
Approval date [1] 266790 0
11/02/2011
Ethics approval number [1] 266790 0
20110-029

Summary
Brief summary
Aim:
This study aims to test the effectiveness of a childhood obesity prevention intervention delivered to first-time parents and focused on parenting skills which support the development of positive diet and Physical Activity (PA) behaviours, and reduced Sedentary Behaviours (SB) in infants.

Hypotheses:
In comparison to the control group infants, over the course of the intervention, the intervention group infants will:
1. Demonstrate greater increases in consumption of fruits and vegetables, and smaller increases in consumption of cordials, soft-drinks and juices and energy-dense snack foods
2. Demonstrate greater increases in time spent being physically active and smaller increases in time spent in sedentary behaviours, specifically Television (TV) viewing
3. Exhibit reduced incremental Body Mass Index (BMI) gain

In comparison to the control group parents, the intervention group parents will demonstrate greater increases in:
4. The frequency with which they offer fruit and vegetables, water and milk (rather than cordials, soft-drinks and juices), and smaller increases in the frequency with which they offer energy-dense snack foods to their child
5. Knowledge regarding infant eating, physical activity and sedentary behaviours and greater development of positive attitudes/beliefs regarding their capacity to influence these behaviours
6. The adoption of desired feeding strategies, including the division of responsibility in feeding and in providing opportunities for modelling of healthy eating
7. The adoption of strategies, including modelling, for increasing opportunities for physical activity and reducing opportunities for sedentary behaviours
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32362 0
Address 32362 0
Country 32362 0
Phone 32362 0
Fax 32362 0
Email 32362 0
Contact person for public queries
Name 15609 0
Lily Meloni
Address 15609 0
Deakin University
Faculty of Health, School of Exercise and Nutrition Sciences
1 Gheringhap St
Geelong,
Vic 3217
Country 15609 0
Australia
Phone 15609 0
+61 3 5227 8776
Fax 15609 0
+61 3 5227 8376
Email 15609 0
lily.meloni@deakin.edu.au
Contact person for scientific queries
Name 6537 0
Dr Karen Campbell
Address 6537 0
Deakin University
Faculty of Health, School of Exercise and Nutrition Sciences
1 Gheringhap St
Geelong
Vic 3217
Country 6537 0
Australia
Phone 6537 0
+61 3 5227 8414
Fax 6537 0
+61 3 9244 6017
Email 6537 0
karen.campbell@deakin.edu.au

No information has been provided regarding IPD availability
Summary results
No Results