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21 March 2013
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| [ Print-friendly version ] |
| Activity Begins in Childhood – a study to inspire healthy active behaviour in preschoolers |
| ISRCTN | ISRCTN94022291 |
| DOI | 10.1186/ISRCTN94022291 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Activity Begins in Childhood – a study to inspire healthy active behaviour in preschoolers |
| Scientific title | Activity Begins in Childhood – a randomized controlled trial to inspire healthy active behaviour in preschoolers |
| Acronym | ABC |
| Serial number at source | MOP 123326 |
| Study hypothesis |
Our primary hypothesis is to evaluate the efficacy of the ABC intervention protocol delivered in licensed daycare settings alone (intervention- DC) versus standard daycare curriculum (control-CON) to increase preschoolers overall physical activity (PA) levels and specifically time spent in moderate to vigorous PA (MVPA).
Our secondary hypotheses are to: 1. To evaluate the potential additive contribution of a parent/guardian-driven home PA - promotion in addition to the daycare-provider facilitated intervention on its own (i.e. intervention- DC + HOME). 2. To evaluate the efficacy of the ABC intervention arms to decrease the amount of time spent in sedentary behaviour. 3. To evaluate the effects of the ABC intervention arms on fundamental and gross motor skills in preschoolers attending daycare. 4. To evaluate the effects of the ABC intervention arms on preschool children’s anthropometrics, such as height, weight, body mass index, lean body mass, fat mass, and percent body fat. 5. To assess the effects of the ABC intervention on daycare providers’ attitudes, control beliefs, perceived competency and intentions toward incorporating PA into the daycare curriculum, and examine whether these social-cognitive variables impact PA in children. |
| Lay summary | Lay summary under review 2 |
| Ethics approval | CHEO Research Ethics Board, 24 November 2012, ref: 12/158X |
| Study design | Cluster randomized controlled trial |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Promoting healthy active behaviour in preschoolers for prevention of downstream chronic disease |
| Participants - inclusion criteria |
1. Male or female
2. English or French 3. Preschool children between age 3-5 years 4. Preschool children enrolled full-time in licensed daycares in Canada’s National Capital Region 5. Preschool children enrolled in daycares for the duration of this 6 month study 6. At least 10 or more children enrolled in the preschool program |
| Participants - exclusion criteria |
1. Parents/guardians of children that do not sign informed consent
2. Inability of children/parents/guardians to communicate in English or French |
| Anticipated start date | 28/01/2013 |
| Anticipated end date | 29/03/2014 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a participant information sheet |
| Target number of participants | 18 daycares (9 daycares in Winter cohort and 9 daycares in Summer/Fall cohort) and 306 children (153 per cohort). |
| Interventions |
Intervention 1: ABC intervention protocol delivered in licensed daycare settings alone (intervention- DC).
Intervention 2: ABC intervention protocol delivered in licensed daycare settings + parent/guardian home component (intervention- DC + HOME). Comparator: Standard daycare curriculum (control- CON). This group will receive all ABC programming and related resources after completion of the study. The ABC intervention will last approximately 6 months, with baseline assessment prior to ABC implementation and follow-up assessments at 3 and 6 months. After assessing if daycare and parent/guardian environments (DC + HOME group only) are suitable to administer ABC program, daycare providers will learn ABC program by attending 2 3-hour workshops provided by a Master Trainer and parents/guardians will learn ABC intervention by viewing 2 45-minute webinars. To ensure ABC understanding and compliance, 1-hour bi-weekly ‘pep’ sessions will take place at the daycares by a Master Trainer and bi-weekly post cards will be mailed to the parents/guardians. Workshop/webinar related questionnaires will also be administered. All consenting parents/guardians from each group will be asked to complete socio-demographic and quality of life questionnaires. As well, mothers of participating children will be asked to fill out a pregnancy and lifestyle questionnaire. All consenting children from each group: 1. Will be expected to wear an accelerometer for 1 week at a time to measure physical activity levels 2. Will have their fundamental gross motor development skills tested; and 3. Will have their anthropometric and body composition taken |
| Primary outcome measure(s) | Physical activity will be measured using an Actical accelerometer which is an omni-directional sensor that measures the occurrence and intensity of motion. Accelerometers will be worn on 3 separate time points- baseline, 3- and 6- months post workshop intervention. Activity data will be summarized and reported as activity minutes per hour, computed from tallied counts for each activity level average across wear time. |
| Secondary outcome measure(s) |
1. Fundamental/gross motor skills: The test of Gross Motor Development –2 (TGMD-2) will be used to evaluate the effects of the intervention on children’s movement skills. The TGMD-2 is a validated standardized norm-referenced measure of 12 common gross motor skills of children ages 3 to 11 years. This test will be conducted at baseline, 3- and 6-months post intervention.
2. Anthropometry and body composition: Height, weight, body mass index, lean body mass, fat mass, and percent body fat will be measured. Height will be measured using a wall-mounted stadiometer (Seca GmBH & Co Kg, Hamburg Germany). Body weight will be assessed using a standard weight scale. Body Mass Index (kg/m2) and body composition (lean body mass, fat mass, percent body fat) will be assessed using a RJL Quantum IV bioelectrical impedance analyzer system (RJL Quantum IV, RJL Systems, Michigan, 48035). These assessment will be conducted at baseline, 3- and 6-months post intervention. 3. Questionnaire data: Daycare providers/parents/guardians personal beliefs and self-efficacy towards incorporating a physical activity program into the regular daycare programming or home environment will be assessed using a short questionnaire before and after workshops/webinars. Daycare/home environments will be assessed at baseline, 3- and 6-months post intervention. Quality of life will be assessed using the pediatric quality of life (PedsQL) questionnaire at baseline, 3- and 6- month post intervention. Socio-demographic and pregnancy and lifestyle information will be collected from parents/guardian at baseline. |
| Sources of funding | Canadian Institute of Health Research (Canada) (ref: OP 123326 |
| Trial website | |
| Publications | |
| Contact name | Dr Kristi Adamo |
| Address |
Children’s Hospital of Eastern Ontario Research Institute
Healthy Active Living and Obesity Research 401 Smyth Rd, Rm 215 |
| City/town | Ottawa |
| Zip/Postcode | K1H 8l1 |
| Country | Canada |
| kadamo@cheo.on.ca | |
| Sponsor | Canadian Institute of Health Research (Canada) |
| Address |
160 Elgin Street
9th Floor, Address Locator 4809A |
| City/town | Ottawa |
| Zip/Postcode | K1A 0W9 |
| Country | Canada |
| Tel | +1 613 941 2672 |
| Fax | +1 613 954 1800 |
| RC-Grants@cihr-irsc.gc.ca | |
| Sponsor website: | http://www.cihr-irsc.gc.ca |
| Date applied | 11/12/2012 |
| Last edited | 21/12/2012 |
| Date ISRCTN assigned | 21/12/2012 |
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