Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
425801
Study information
Scientific title
The Infant Feeding Activity and Nutrition Trial (INFANT) an early intervention to prevent childhood obesity: cluster-randomised controlled trial
Acronym
The Melbourne Infant Feeding, Activity and Nutrition Trial (InFANT) Program
Study hypothesis
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
Ethics approval
Deakin University Human Research Ethics Committee - Health Medicine Nursing and Behavioural Sciences Subcommittee, 21/09/2007, ref: EC 175-2007
Study design
Cluster-randomised controlled trial conducted with first-time parents
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Health promotion for infants and families in the area of obesity, nutrition and sedentary behaviour.
Intervention
Control:
Control no treatment, but the group will receive a generic health news letter every three months on child development.
Intervention:
The intervention will be delivered within the first-time parents' group scheduled meetings by a health worker with expertise in early childhood and in education. The development of intervention resources will be supported by the research team who collectively have extensive experience in the design of resources promoting healthy diet, physical activity, and reduced sedentariness, across childhood. The intervention will draw on parenting support theory, which emphasises children's psychological and behavioural goals, logical and natural consequences, mutual respect and encouragement techniques. Emphasis will be placed on parent understanding of how improved parenting skills can facilitate the development of appropriate eating and activity behaviours in children. The intervention will use an anticipatory guidance framework, to coincide with opportunities to support parents regarding feeding, physical activity and sedentary behaviour issues for children prior to their evolution. This involves the mapping of the period encompassed by the intervention - from 3 months to 18 months (intervention will run for 15 months). The intervention will incorporate a range of modes of delivery and educational strategies including brief didactic sessions, use of group discussion and peer support, use of visual and written messages, follow-up delivery of messages by text-messaging and mail-outs. See below for further details:
At 3 months:
Emerging Behaviours:
1. Early weaning and introduction of solids
2. Introduction of energy-dense, nutrient poor foods
3. Increased muscle control, strength and coordination
Anticipatory Guidance Intervention Aims:
1. To support parents to delay weaning/introduction of solids to 6 months
2. To provide advice regarding appropriate foods for weaning
3. To explore expectations regarding weaning and early feeding, movement and muscle control
4. To introduce basic concepts regarding parental feeding styles and how these might relate to beliefs about parenting
At 6 months:
Emerging Behaviours:
1. Adoption by parents of a feeding style
2. Food rejection by infants
3. Infant starts to:
3.1. Sit briefly unsupported
3.2. Reaches with one hand
3.3. Rolls over
4. Adoption by parents of TV viewing for infant
Anticipatory Guidance Intervention Aims:
To develop parents' understanding regarding:
1. Feeding styles and impact on children's eating
2. Basic nutrition principals
3. Sedentary behaviours in families and limits to acceptability
At 9 months:
Emerging Behaviours:
1. Increasing use of TV
2. Parents' increased awareness of child mobility
3. Infant crawls and pulls self upright and walks with handhold
Anticipatory Guidance Intervention Aims:
To develop understanding regarding:
1. Parental modeling of eating, sedentary and physical activity behaviours
2. Impact of eating, activity and sedentary behaviours on health of children and adults and the provision of opportunities
At 12, 15 and 18 months:
Emerging Behaviours:
1. Increasing autonomy of child in eating and activity
2. Infant stands without support and beginning to walk
Anticipatory Guidance Intervention Aims:
Continued development of themes/skills regarding:
1. Eating and moving for health - parents and children
2. How to feed/how to manage food rejection and demands
3. Providing fail-safe food and activity environments
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
Parent and infant data will be collected using parent self-completion questionnaires, apart from dietary intake data which will be collected by telephone interview. All data (appropriate to the age of the child) will be collected every three months, corresponding with the six intervention sessions. Repeated data collection is necessary given the rapid changes in height, weight, eating and activity behaviours in infants. The measures collected are detailed below:
1. Dietary intake: dietary intake for the mother and father will be assessed using The Cancer Councils Dietary Questionnaire for Epidemiological Studies (Version 3) at baseline and study conclusion. This questionnaire is an updated version of the semi-quantitative food frequency questionnaire specifically developed for the Melbourne Collaborative Cohort Study. Childs dietary intake will be assessed by telephone-administered multi-pass 24-hour recall with parents. Visual aids will be provided to primary carers in advance of interviews to help in the estimation of quantities of food consumes. Three days of dietary data will be collected (including one weekend day) at 9 and 18 months
2. Physical activity: parents will report their frequency and duration in physical activity during the previous week using the Active Australia Survey. Given the lack of validated measures of physical activity for infants, this outcome will be assessed using parent report of the:
2.1. Child's enjoyment of playing with parents
2.2. Child's enjoyment of physical activity (movement, play)
2.3. Childs enjoyment of playing with objects and toys
2.4. Child is curious and explores environment through a variety of physical activities
2.5. Child moves in new ways when challenged with interesting activities
In addition, at 12 and 18 months parents will be asked to report the number of hours their child typically spends playing outdoors on weekdays and weekend days
3. Sedentary behaviours: parents will be asked the amount of time the infant spends watching television on a typical weekday and on a typical weekend day, and to estimate the amount of time each day that the child spends immobile. Parents will also report the total time they spend watching television during their leisure-time in a typical week
4. Homefood environment: three aspects of the home food environment will be assessed. Aspects of nutrition knowledge focused around nutrition targets of the intervention will be assessed using modified subscales of the validated Nutrition Knowledge Questionnaire, Parent Feeding Style will be assessed using the Child Feeding Questionnaire (CFQ), the Caregivers Feeding Style Questionnaire CFSQ (Hughes 2005). Home food availability and accessibility will be assessed using a self-reported shelf inventory on the availability of foods and fluids
5. Family physical activity and sedentary environment: parents will be asked general questions relating to their knowledge about physical activity in early childhood, to estimate the time they spend playing with their child, the frequency with which they take their child to the park or playground and an audit checklist on the physical activity and sedentary home environment
6. Standard demographic and socio-economic information will be collected by parental report
7. Anthropometric measures (height/length and weight) on the infant and parents will be collected by trained staff
Secondary outcome measures
Current secondary outcome measures as of 22/08/2012:
The majority of questions relating to parent-child interaction will be assessed via the primary outcome measures. The study will, however attempt to assess parenting styles and its relationship with diet, physical activity and sedentary behaviour at baseline and the 18 month conclusion within scheduled questionnaires. In terms of knowledge and attitudes specific to obesity and acceptability of the intervention these will be assessed by questions developed by the team which are specific to content relating to the intervention and assessed at baseline, 9 months and 18 months.
Primary and secondary outcome measures will be reassessed 2 and 3.5 years post intervention.
Previous secondary outcome measures until 22/08/2012:
The majority of questions relating to parent-child interaction will be assessed via the primary outcome measures. The study will, however attempt to assess parenting styles and its relationship with diet, physical activity and sedentary behaviour at baseline and the 18 month conclusion within scheduled questionnaires. In terms of knowledge and attitudes specific to obesity and acceptability of the intervention these will be assessed by questions developed by the team which are specific to content relating to the intervention and assessed at baseline, 9 months and 18 months.
Overall trial start date
01/02/2008
Overall trial end date
31/03/2014
Reason abandoned
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
600 first-time parents participating in a first-time parents group (300 in each arm, control/ intervention) will be recruited. This will incorporate approximately 62 MCHC across 14 LGA.
Participant 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.
Recruitment start date
01/02/2008
Recruitment end date
31/03/2014
Locations
Countries of recruitment
Australia
Trial participating centre
221 Burwood Highway
Burwood, Victoria
3125
Australia
Sponsor information
Organisation
National Health and Medical Research Council (NHMRC) (Australia)
Sponsor details
GPO Box 9848
Canberra ACT
2601
Australia
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Intervention phase: National Health and Medical Research Council (NHMRC) (Australia) - Primary Health Care Project Grant (ref: 425801).
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Follow-up phase: National Health and Medical Research Council (NHMRC) (Australia) - Project Grant (ref: 1008879)
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. 2008 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18373877
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20679302
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21515115
4. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22040598
5. 2012 results in http://onlinelibrary.wiley.com/doi/10.1111/j.1747-0080.2012.01584.x/abstract
6. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22543738
7. 2013 follow-up protocol in http://www.ncbi.nlm.nih.gov/pubmed/23117076
8. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23460688
9. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/24201090
10. 2015 results in http://www.ncbi.nlm.nih.gov/pubmed/25366542
Publication citations
-
Protocol
Campbell K, Hesketh K, Crawford D, Salmon J, Ball K, McCallum Z, The Infant Feeding Activity and Nutrition Trial (INFANT) an early intervention to prevent childhood obesity: cluster-randomised controlled trial., BMC Public Health, 2008, 8, 103, doi: 10.1186/1471-2458-8-103.
-
Results
Cameron AJ, Hesketh K, Ball K, Crawford D, Campbell KJ, Influence of peers on breastfeeding discontinuation among new parents: the Melbourne InFANT Program., Pediatrics, 2010, 126, 3, e601-7, doi: 10.1542/peds.2010-0771.
-
Results
McLeod ER, Campbell KJ, Hesketh KD, Nutrition knowledge: a mediator between socioeconomic position and diet quality in Australian first-time mothers., J Am Diet Assoc, 2011, 111, 5, 696-704, doi: 10.1016/j.jada.2011.02.011.
-
Results
Lioret S, McNaughton SA, Crawford D, Spence AC, Hesketh K, Campbell KJ, Parents' dietary patterns are significantly correlated: findings from the Melbourne Infant Feeding Activity and Nutrition Trial Program., Br. J. Nutr., 2012, 108, 3, 518-526, doi: 10.1017/S0007114511005757.
-
Results
Hnatiuk J, Ridgers ND, Salmon J, Campbell K, McCallum Z, Hesketh K, Physical activity levels and patterns of 19-month-old children., Med Sci Sports Exerc, 2012, 44, 9, 1715-1720, doi: 10.1249/MSS.0b013e31825825c4.
-
Results
Campbell KJ, Lioret S, McNaughton SA, Crawford DA, Salmon J, Ball K, McCallum Z, Gerner BE, Spence AC, Cameron AJ, Hnatiuk JA, Ukoumunne OC, Gold L, Abbott G, Hesketh KD, A parent-focused intervention to reduce infant obesity risk behaviors: a randomized trial., Pediatrics, 2013, 131, 4, 652-660, doi: 10.1542/peds.2012-2576.
-
Results
Cameron AJ, Ball K, Hesketh KD, McNaughton SA, Salmon J, Crawford DA, Lioret S, Campbell KJ, Variation in outcomes of the Melbourne Infant, Feeding, Activity and Nutrition Trial (InFANT) Program according to maternal education and age., Prev Med, 2014, 58, 58-63, doi: 10.1016/j.ypmed.2013.10.021.
-
Hesketh KD, Campbell K, Salmon J, McNaughton SA, McCallum Z, Cameron A, Ball K, Gold L, Andrianopoulos N, Crawford D, The Melbourne Infant Feeding, Activity and Nutrition Trial (InFANT) Program follow-up., Contemp Clin Trials, 2013, 34, 1, 145-151, doi: 10.1016/j.cct.2012.10.008.
-
Results
Spence AC, Campbell KJ, Crawford DA, McNaughton SA, Hesketh KD, Mediators of improved child diet quality following a health promotion intervention: the Melbourne InFANT Program, Int J Behav Nutr Phys Act, 2014, 11, 137, doi: 10.1186/s12966-014-0137-5.