Pediatric ObesityNCT02375490
Healthy Start to Increase Physical Activity and Improve Healthy Eating in Early Childcare Centres
A study testing Healthy Start in people with Pediatric Obesity, run by Université de Sherbrooke at 2 sites in Canada.
Trial summary
Childhood obesity is one of the greatest challenges facing public health and recent evidence shows it begins in preschool aged children. It has been suggested that interventions be carried out to improve physical activity and healthy eating behaviour among young children. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Healthy Start
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 897 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2013to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Early childcare center must prepare and provide meals for lunch
Who cannot join
- Any early childcare center that has already received a physical activity or nutrition promoting intervention in the past to avoid underestimating the effect of the Healthy Start intervention
- For feasibility reasons, the number of children attending the early childcare center also serves as an exclusion criterion; centers with less than 20 children from the ages of 3 to 5 are not considered
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Centre de formation médicale du Nouveau-Brunswick
Moncton, New Brunswick, E1A 3E9
University of Saskatchewan
Saskatoon, Saskatchewan, S7K 2L7
About this study
Official title: A Multilevel Intervention to Increase Physical Activity and Improve Healthy Eating Among Young Children (Ages 3-5) Attending Early Childcare Centres: the Healthy Start Study
Childhood obesity is one of the greatest challenges facing public health and recent evidence shows it begins in preschool aged children. It has been suggested that interventions be carried out to improve physical activity and healthy eating behaviour among young children. This study aims to fully evaluate Healthy Start, a multilevel physical activity and healthy eating intervention for preschool aged children. It is hypothesized that the Healthy Start intervention will improve both eating and physical activity behaviors of children attending early childcare centers because of its influence on multiple factors.
Read the detailed description
Childhood obesity is one of the greatest challenges facing public health in the 21st century. In 2010, an estimated 43 million preschool aged children suffered from overweight or obesity and another 92 million were at risk of being overweight. From 1990 to 2010, the prevalence of overweight and obesity in children under the age of 5 increased from 4.2% to 6.7%, and it is estimated that 60 million children will suffer from being overweight by 2020. In Canada, the prevalence of obesity in preschool aged children is three times higher than the global average. Being overweight in childhood has been associated with compromised emotional health and social wellbeing. Much of the excess weight in obese children is gained before the age of 5 years and many studies indicate that adiposity tracks into childhood. Further, children who become obese before the age of 6 are at least four times more at risk of obesity in adulthood.
The problem of obesity is multifactorial, but is primarily influenced by energy intake and energy expenditure. Eating habits are established early in childhood and can be sustained for many years. Data show that only 29% of Canadian preschool aged children meet recommendations for fruit and vegetable intake and 23% for grain products. Further, 79% of 4-5 year olds consume food of little nutritional value (ex: chips, french fries, candy, chocolate, soft drinks, cake and cookies) at least once a week and other studies have demonstrated that empty calories are making up as much as 40% of their total caloric intake. Similarly, a recent review demonstrated that physical activity (PA) levels in early childcare centers (ECC) are generally low, and that time spent in sedentary state is elevated. It was estimated that children in ECC accumulate an average of 7 to 13 minutes of moderate-to-vigorous PA (MVPA) during the course of a 7 hour day. Correspondingly, recent data suggest that the prevalence of children with poor physical literacy is high and that low physical literacy competence is negatively associated with PA, cardiorespiratory fitness and weight status. These data are troubling given that sedentary and physical activity levels track over time.
Several organizations have recognized the need to counter pediatric obesity and to develop physical activity and nutrition-based interventions for pre-school populations. More than half of young Canadians between the ages of 6 months and 5 years spend around 29 hours a week in ECC, making them rich environments for implementing strategies to help children adopt healthy lifestyles. For example, one pilot study demonstrated an increase in fruit and vegetable intake following nutrition education and increased availability of healthy foods in ECC. Another intervention study integrating physical activity in all aspects of the preschool curriculum reported a 2 minute increase in classroom MVPA as assessed by accelerometer. However, both a systematic review on obesity prevention interventions in children under 5 years and another on obesity prevention policies, practice and interventions in ECC reported limited success of current interventions in positively influencing physical activity levels, dietary behaviour, or body composition. The authors suggest that the least successful interventions were unidimensional, while the most successful interventions were those with a positive impact on knowledge, abilities and competence, suggesting that interventions should be conceived based on comprehensive behaviour change models. It was also found that few interventions focused on physical activity and eating behaviour in combination, and that future interventions should target both behaviours simultaneously.
Interventions promoting healthy weight in children should encompass a broad spectrum of concerted actions and be based on best available knowledge from research and practice. Healthy Start, an intersectional multilevel physical activity and healthy eating promotion in preschool aged children, was developed on these bases. The aim of the current study is to lead a comprehensive evaluation of the Healthy Start intervention using an experimental research design.
The Intervention The population health approach is based on the concept that in order to positively influence population-level health outcomes, one needs to account for the wide range of health determinants [39], recognise the importance and complexity of potential interplay among these determinants, and reduce social and material inequities. Further, interventions adhering to principles of the population health approach rely on best evidence available, stimulate intersectoral collaborations, and provide opportunities for all potential stakeholders to be meaningfully engaged in its development. Several models based on the population health approach have been developed to help guide interventions. These models provide holistic conceptual frameworks which, similar to ecological models, suggest that interventions include a series of concerted actions capable of targeting all levels of influence, including the intrapersonal (biological and psychological), interpersonal (social and cultural), organizational, community, physical environment and political levels.
The conceptual development of Healthy Start is based on this population health approach; it includes strategies to guide each level of influence with the aim of improving children physical activity and dietary behaviours. The development of Healthy Start was a concerted action including academicians, community groups, educators, parents, and government representatives. Their effort, supported by Phase I of federal funding from the Public Health Agency of Canada (2007-2010), also involved pilot testing and improving the intervention which was designed to be multilevel, inclusive, intersectoral. It is also noteworthy, that Healthy Start was developed to be linguistically and culturally adapted to cater to both official linguistic groups in Canada, which is important since it has been documented that to be effective, it is not sufficient for interventions to be translated, they must also have been adapted for the target population.
Therefore, Healthy Start was designed to promote physical activity and healthy eating among Anglophone and Francophone 3-5 year old children in ECC (i.e. licenced daycares, preschools and pre-kindergarten programs). The vision of Healthy Start is to ensure young children eat healthily and are physically active every day. The mission is to encourage and enable families and educators to integrate physical activity and healthy eating in the daily lives of young children. Specifically, Healthy Start attempts to influence factors at the intrapersonal (ex: eating and physical activity behaviour of children), interpersonal (ex: educators and parents), organizational (ex. child care centres), community (ex: community organization involvement), and physical environment and political levels (ex: built environment and policies). These levels of influence are targeted such that from an operational stand point, Healthy Start is composed of six interlinked components (more details presented in Figure 1) : 1) intersectoral partnerships conducive to participatory action that leads to promoting healthy weights in communities and ECC; 2) The Healthy Start guide for educators on implementing healthy eating and physical activity in young children; 3) customized training, role modelling and monitoring of Healthy Start in early learning centres; 4) an evidence-based resource, LEAP-GRANDIR which contains material for both families and educators; 5) supplementary resources from governmental partners; and 6) a knowledge development and exchange (KDE), and communication strategy involving social media and web-resources to raise awareness and mobilize grassroots organizations and communities.
Study Objectives
It is hypothesized that, in comparison to usual practice, exposure to the Healthy Start intervention will lead to improved opportunities for physical activities and healthy eating and to increased physical activity and healthier eating among children. The specific study objectives are to:
- Investigate whether the Healthy Start intervention leads to increases in child care centre-provided opportunities for physical activity and healthy eating;
- Investigate whether the Healthy Start intervention leads to increases in physical activity levels and healthy eating behaviours among children; and
- Investigate whether the Healthy Start intervention leads to improvements in physical literacy among children.
- Conditions
- Pediatric Obesity
- Being tested
- Healthy Start
- Keywords
- Exercise, Eating Behavior, Preschool Child, Early Childcare Center, Obesity, Physical Literacy
- Medical subject headings
- Pediatric Obesity, Motor Activity, Feeding Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy StartBehavioural
Healthy Start was designed to promote physical activity and healthy eating among 3-5 year old children. Specifically, Healthy Start attempts to influence factors at the intrapersonal, interpersonal, organizational, community and physical environment and political levels. These levels of influence are targeted such that from an operational stand point, Healthy Start is composed of six interlinked components: 1) intersectoral partnerships that leads to promoting healthy weights in communities and ECC; 2) The Healthy Start guide for educators; 3) customized training, role modelling and monitoring; 4) an evidence-based resource for both families and educators; 5) supplementary resources from governmental partners; and 6) a knowledge development and exchange, and communication strategy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | The intervention arm will participate in Healthy Start. Receives: Behavioral: Healthy Start |
| Control arm | No intervention | Control arm will pursue daily activities at early childcare center as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Level
Children's physical activity levels are obtained using an Actical accelerometer worn during attendance of ECC for five consecutive days. Accelerometers represent an objective and valid method of measuring physical activity in preschool aged children.
Measured: The intervention spans a period of 6 months. Outcomes are measured before and after intervention.
Physical Literacy
Physical literacy and gross motor skills of children will be measured using the Test of Gross Motor Development (TGMD-II). The TGMD-II is a standardized test designed to assess the gross motor functioning in children aged 3 through 10 years
Measured: The intervention spans a period of 6 months. Outcomes are measured before and after intervention.
Dietary Intake
Intake analysis provides information on the intake of calories, macronutrients and micronutrients in children attending the centers. This method has been extensively used in studies concerning school-aged children and is considered the most precise measurement of dietary intake. In this study, intake analysis is done using the photography-assisted weighted plate waste method centers.
Measured: The intervention spans a period of 6 months. Outcomes are measured before and after intervention.
Secondary outcomes (1)
Early Childcare Center Practices and Policies for Physical Activity and Nutrition
Dietary and physical activity practices and policies in ECC are measured using the Nutrition and Physical Activity Self-Assessment of Child Care (NAP SACC), filled out independently by two research assistants in each ECC.
Measured: The intervention spans a period of 6 months. Outcomes are measured before and after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startSep 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (57)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 897 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- University of Saskatchewan
- Responsible party
- Principal investigator, Mathieu Bélanger, Université de Sherbrooke
- Investigators
- Anne Leis, PhD, Principal investigator, University of SaskatchewanMathieu Bélanger, PhD, Principal investigator, Université de SherbrookeLouise Humbert, PhD, Principal investigator, University of SaskatchewanHassan Vatanparast, PhD, Principal investigator, University of SaskatchewanNazeem Muhajarine, PhD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375490
- Sponsor's protocol ID
- 6282-15-2010/3381056-RSFS
- Status last verified
- Nov 2017
- First submitted
- 24 Feb 2015
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
de Onis M, Blossner M, Borghi E. Global prevalence and trends of overweight and obesity among preschool children. Am J Clin Nutr. 2010 Nov;92(5):1257-64. doi: 10.3945/ajcn.2010.29786. Epub 2010 Sep 22.
PubMed 20861173Shields M. Overweight and obesity among children and youth. Health Rep. 2006 Aug;17(3):27-42.
PubMed 16981484Reilly JJ, Methven E, McDowell ZC, Hacking B, Alexander D, Stewart L, Kelnar CJ. Health consequences of obesity. Arch Dis Child. 2003 Sep;88(9):748-52. doi: 10.1136/adc.88.9.748.
PubMed 12937090Gardner DS, Hosking J, Metcalf BS, Jeffery AN, Voss LD, Wilkin TJ. Contribution of early weight gain to childhood overweight and metabolic health: a longitudinal study (EarlyBird 36). Pediatrics. 2009 Jan;123(1):e67-73. doi: 10.1542/peds.2008-1292.
PubMed 19117849Nader PR, O'Brien M, Houts R, Bradley R, Belsky J, Crosnoe R, Friedman S, Mei Z, Susman EJ; National Institute of Child Health and Human Development Early Child Care Research Network. Identifying risk for obesity in early childhood. Pediatrics. 2006 Sep;118(3):e594-601. doi: 10.1542/peds.2005-2801.
PubMed 16950951Quattrin T, Liu E, Shaw N, Shine B, Chiang E. Obese children who are referred to the pediatric endocrinologist: characteristics and outcome. Pediatrics. 2005 Feb;115(2):348-51. doi: 10.1542/peds.2004-1452.
PubMed 15687443Guo SS, Huang C, Maynard LM, Demerath E, Towne B, Chumlea WC, Siervogel RM. Body mass index during childhood, adolescence and young adulthood in relation to adult overweight and adiposity: the Fels Longitudinal Study. Int J Obes Relat Metab Disord. 2000 Dec;24(12):1628-35. doi: 10.1038/sj.ijo.0801461.
PubMed 11126216Freedman DS, Khan LK, Serdula MK, Dietz WH, Srinivasan SR, Berenson GS. The relation of childhood BMI to adult adiposity: the Bogalusa Heart Study. Pediatrics. 2005 Jan;115(1):22-7. doi: 10.1542/peds.2004-0220.
PubMed 15629977Hill JO, Melanson EL. Overview of the determinants of overweight and obesity: current evidence and research issues. Med Sci Sports Exerc. 1999 Nov;31(11 Suppl):S515-21. doi: 10.1097/00005768-199911001-00005.
PubMed 10593521Birch LL, Fisher JO. Development of eating behaviors among children and adolescents. Pediatrics. 1998 Mar;101(3 Pt 2):539-49.
PubMed 12224660Pabayo R, Spence JC, Casey L, Storey K. Food consumption patterns in preschool children. Can J Diet Pract Res. 2012 Summer;73(2):66-71. doi: 10.3148/73.2.2012.66.
PubMed 22668839Reedy J, Krebs-Smith SM. Dietary sources of energy, solid fats, and added sugars among children and adolescents in the United States. J Am Diet Assoc. 2010 Oct;110(10):1477-84. doi: 10.1016/j.jada.2010.07.010.
PubMed 20869486Langlois K, Garriguet D. Sugar consumption among Canadians of all ages. Health Rep. 2011 Sep;22(3):23-7.
PubMed 22106786Reilly JJ, Kelly J. Long-term impact of overweight and obesity in childhood and adolescence on morbidity and premature mortality in adulthood: systematic review. Int J Obes (Lond). 2011 Jul;35(7):891-8. doi: 10.1038/ijo.2010.222. Epub 2010 Oct 26.
PubMed 20975725Temple VA, Naylor PJ, Rhodes RE, Higgins JW. Physical activity of children in family child care. Appl Physiol Nutr Metab. 2009 Aug;34(4):794-8. doi: 10.1139/H09-061.
PubMed 19767816
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multilevel Intervention to Increase Physical Activity and Improve Healthy Eating Among Young Children (Ages 3-5) Attending Early Childcare Centres: the Healthy Start Study
- ClinicalTrials.gov ID
- NCT02375490
- Acronym / sponsor ID
- 6282-15-2010/3381056-RSFS
- Conditions
- Pediatric Obesity
- Keywords
- Exercise, Eating Behavior, Preschool Child, Early Childcare Center, Obesity, Physical Literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 897 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- University of Saskatchewan
- Study start
- Sep 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Childhood obesity is one of the greatest challenges facing public health and recent evidence shows it begins in preschool aged children. It has been suggested that interventions be carried out to improve physical activity and healthy eating behaviour among young children. This study aims to fully evaluate Healthy Start, a multilevel physical activity and healthy eating intervention for preschool aged children. It is hypothesized that the Healthy Start intervention will improve both eating and physical activity behaviors of children attending early childcare centers because of its influence on multiple factors.
Detailed description
Childhood obesity is one of the greatest challenges facing public health in the 21st century. In 2010, an estimated 43 million preschool aged children suffered from overweight or obesity and another 92 million were at risk of being overweight. From 1990 to 2010, the prevalence of overweight and obesity in children under the age of 5 increased from 4.2% to 6.7%, and it is estimated that 60 million children will suffer from being overweight by 2020. In Canada, the prevalence of obesity in preschool aged children is three times higher than the global average. Being overweight in childhood has been associated with compromised emotional health and social wellbeing. Much of the excess weight in obese children is gained before the age of 5 years and many studies indicate that adiposity tracks into childhood. Further, children who become obese before the age of 6 are at least four times more at risk of obesity in adulthood.
The problem of obesity is multifactorial, but is primarily influenced by energy intake and energy expenditure. Eating habits are established early in childhood and can be sustained for many years. Data show that only 29% of Canadian preschool aged children meet recommendations for fruit and vegetable intake and 23% for grain products. Further, 79% of 4-5 year olds consume food of little nutritional value (ex: chips, french fries, candy, chocolate, soft drinks, cake and cookies) at least once a week and other studies have demonstrated that empty calories are making up as much as 40% of their total caloric intake. Similarly, a recent review demonstrated that physical activity (PA) levels in early childcare centers (ECC) are generally low, and that time spent in sedentary state is elevated. It was estimated that children in ECC accumulate an average of 7 to 13 minutes of moderate-to-vigorous PA (MVPA) during the course of a 7 hour day. Correspondingly, recent data suggest that the prevalence of children with poor physical literacy is high and that low physical literacy competence is negatively associated with PA, cardiorespiratory fitness and weight status. These data are troubling given that sedentary and physical activity levels track over time.
Several organizations have recognized the need to counter pediatric obesity and to develop physical activity and nutrition-based interventions for pre-school populations. More than half of young Canadians between the ages of 6 months and 5 years spend around 29 hours a week in ECC, making them rich environments for implementing strategies to help children adopt healthy lifestyles. For example, one pilot study demonstrated an increase in fruit and vegetable intake following nutrition education and increased availability of healthy foods in ECC. Another intervention study integrating physical activity in all aspects of the preschool curriculum reported a 2 minute increase in classroom MVPA as assessed by accelerometer. However, both a systematic review on obesity prevention interventions in children under 5 years and another on obesity prevention policies, practice and interventions in ECC reported limited success of current interventions in positively influencing physical activity levels, dietary behaviour, or body composition. The authors suggest that the least successful interventions were unidimensional, while the most successful interventions were those with a positive impact on knowledge, abilities and competence, suggesting that interventions should be conceived based on comprehensive behaviour change models. It was also found that few interventions focused on physical activity and eating behaviour in combination, and that future interventions should target both behaviours simultaneously.
Interventions promoting healthy weight in children should encompass a broad spectrum of concerted actions and be based on best available knowledge from research and practice. Healthy Start, an intersectional multilevel physical activity and healthy eating promotion in preschool aged children, was developed on these bases. The aim of the current study is to lead a comprehensive evaluation of the Healthy Start intervention using an experimental research design.
The Intervention The population health approach is based on the concept that in order to positively influence population-level health outcomes, one needs to account for the wide range of health determinants [39], recognise the importance and complexity of potential interplay among these determinants, and reduce social and material inequities. Further, interventions adhering to principles of the population health approach rely on best evidence available, stimulate intersectoral collaborations, and provide opportunities for all potential stakeholders to be meaningfully engaged in its development. Several models based on the population health approach have been developed to help guide interventions. These models provide holistic conceptual frameworks which, similar to ecological models, suggest that interventions include a series of concerted actions capable of targeting all levels of influence, including the intrapersonal (biological and psychological), interpersonal (social and cultural), organizational, community, physical environment and political levels.
The conceptual development of Healthy Start is based on this population health approach; it includes strategies to guide each level of influence with the aim of improving children physical activity and dietary behaviours. The development of Healthy Start was a concerted action including academicians, community groups, educators, parents, and government representatives. Their effort, supported by Phase I of federal funding from the Public Health Agency of Canada (2007-2010), also involved pilot testing and improving the intervention which was designed to be multilevel, inclusive, intersectoral. It is also noteworthy, that Healthy Start was developed to be linguistically and culturally adapted to cater to both official linguistic groups in Canada, which is important since it has been documented that to be effective, it is not sufficient for interventions to be translated, they must also have been adapted for the target population.
Therefore, Healthy Start was designed to promote physical activity and healthy eating among Anglophone and Francophone 3-5 year old children in ECC (i.e. licenced daycares, preschools and pre-kindergarten programs). The vision of Healthy Start is to ensure young children eat healthily and are physically active every day. The mission is to encourage and enable families and educators to integrate physical activity and healthy eating in the daily lives of young children. Specifically, Healthy Start attempts to influence factors at the intrapersonal (ex: eating and physical activity behaviour of children), interpersonal (ex: educators and parents), organizational (ex. child care centres), community (ex: community organization involvement), and physical environment and political levels (ex: built environment and policies). These levels of influence are targeted such that from an operational stand point, Healthy Start is composed of six interlinked components (more details presented in Figure 1) : 1) intersectoral partnerships conducive to participatory action that leads to promoting healthy weights in communities and ECC; 2) The Healthy Start guide for educators on implementing healthy eating and physical activity in young children; 3) customized training, role modelling and monitoring of Healthy Start in early learning centres; 4) an evidence-based resource, LEAP-GRANDIR which contains material for both families and educators; 5) supplementary resources from governmental partners; and 6) a knowledge development and exchange (KDE), and communication strategy involving social media and web-resources to raise awareness and mobilize grassroots organizations and communities.
Study Objectives
It is hypothesized that, in comparison to usual practice, exposure to the Healthy Start intervention will lead to improved opportunities for physical activities and healthy eating and to increased physical activity and healthier eating among children. The specific study objectives are to:
- Investigate whether the Healthy Start intervention leads to increases in child care centre-provided opportunities for physical activity and healthy eating;
- Investigate whether the Healthy Start intervention leads to increases in physical activity levels and healthy eating behaviours among children; and
- Investigate whether the Healthy Start intervention leads to improvements in physical literacy among children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Healthy StartThe intervention arm will participate in Healthy Start. |
| Control arm | No intervention | –Control arm will pursue daily activities at early childcare center as usual. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Early childcare center must prepare and provide meals for lunch
Key exclusion criteria (2 listed)
- Any early childcare center that has already received a physical activity or nutrition promoting intervention in the past to avoid underestimating the effect of the Healthy Start intervention
- For feasibility reasons, the number of children attending the early childcare center also serves as an exclusion criterion; centers with less than 20 children from the ages of 3 to 5 are not considered
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy StartHealthy Start was designed to promote physical activity and healthy eating among 3-5 year old children. Specifically, Healthy Start attempts to influence factors at the intrapersonal, interpersonal, organizational, community and physical environment and political levels. These levels of influence are targeted such that from an operational stand point, Healthy Start is composed of six interlinked components: 1) intersectoral partnerships that leads to promoting healthy weights in communities and ECC; 2) The Healthy Start guide for educators; 3) customized training, role modelling and monitoring; 4) an evidence-based resource for both families and educators; 5) supplementary resources from governmental partners; and 6) a knowledge development and exchange, and communication strategy. | Behavioural | Intervention arm |
Primary outcome
Physical Activity Level
Time frame: The intervention spans a period of 6 months. Outcomes are measured before and after intervention.
Children's physical activity levels are obtained using an Actical accelerometer worn during attendance of ECC for five consecutive days. Accelerometers represent an objective and valid method of measuring physical activity in preschool aged children.
Physical Literacy
Time frame: The intervention spans a period of 6 months. Outcomes are measured before and after intervention.
Physical literacy and gross motor skills of children will be measured using the Test of Gross Motor Development (TGMD-II). The TGMD-II is a standardized test designed to assess the gross motor functioning in children aged 3 through 10 years
Dietary Intake
Time frame: The intervention spans a period of 6 months. Outcomes are measured before and after intervention.
Intake analysis provides information on the intake of calories, macronutrients and micronutrients in children attending the centers. This method has been extensively used in studies concerning school-aged children and is considered the most precise measurement of dietary intake. In this study, intake analysis is done using the photography-assisted weighted plate waste method centers.
1 secondary outcome
Early Childcare Center Practices and Policies for Physical Activity and Nutrition
Time frame: The intervention spans a period of 6 months. Outcomes are measured before and after intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Background: PubMed 20861173de Onis M, Blossner M, Borghi E. Global prevalence and trends of overweight and obesity among preschool children. Am J Clin Nutr. 2010 Nov;92(5):1257-64. doi: 10.3945/ajcn.2010.29786. Epub 2010 Sep 22.
- Background: PubMed 16981484Shields M. Overweight and obesity among children and youth. Health Rep. 2006 Aug;17(3):27-42.
- Background: PubMed 12937090Reilly JJ, Methven E, McDowell ZC, Hacking B, Alexander D, Stewart L, Kelnar CJ. Health consequences of obesity. Arch Dis Child. 2003 Sep;88(9):748-52. doi: 10.1136/adc.88.9.748.
- Background: PubMed 19117849Gardner DS, Hosking J, Metcalf BS, Jeffery AN, Voss LD, Wilkin TJ. Contribution of early weight gain to childhood overweight and metabolic health: a longitudinal study (EarlyBird 36). Pediatrics. 2009 Jan;123(1):e67-73. doi: 10.1542/peds.2008-1292.
- Background: PubMed 16950951Nader PR, O'Brien M, Houts R, Bradley R, Belsky J, Crosnoe R, Friedman S, Mei Z, Susman EJ; National Institute of Child Health and Human Development Early Child Care Research Network. Identifying risk for obesity in early childhood. Pediatrics. 2006 Sep;118(3):e594-601. doi: 10.1542/peds.2005-2801.
- Background: PubMed 15687443Quattrin T, Liu E, Shaw N, Shine B, Chiang E. Obese children who are referred to the pediatric endocrinologist: characteristics and outcome. Pediatrics. 2005 Feb;115(2):348-51. doi: 10.1542/peds.2004-1452.
- Background: PubMed 11126216Guo SS, Huang C, Maynard LM, Demerath E, Towne B, Chumlea WC, Siervogel RM. Body mass index during childhood, adolescence and young adulthood in relation to adult overweight and adiposity: the Fels Longitudinal Study. Int J Obes Relat Metab Disord. 2000 Dec;24(12):1628-35. doi: 10.1038/sj.ijo.0801461.
- Background: PubMed 15629977Freedman DS, Khan LK, Serdula MK, Dietz WH, Srinivasan SR, Berenson GS. The relation of childhood BMI to adult adiposity: the Bogalusa Heart Study. Pediatrics. 2005 Jan;115(1):22-7. doi: 10.1542/peds.2004-0220.
- Background: PubMed 10593521Hill JO, Melanson EL. Overview of the determinants of overweight and obesity: current evidence and research issues. Med Sci Sports Exerc. 1999 Nov;31(11 Suppl):S515-21. doi: 10.1097/00005768-199911001-00005.
- Background: PubMed 12224660Birch LL, Fisher JO. Development of eating behaviors among children and adolescents. Pediatrics. 1998 Mar;101(3 Pt 2):539-49.
- Background: PubMed 22668839Pabayo R, Spence JC, Casey L, Storey K. Food consumption patterns in preschool children. Can J Diet Pract Res. 2012 Summer;73(2):66-71. doi: 10.3148/73.2.2012.66.
- Background: PubMed 20869486Reedy J, Krebs-Smith SM. Dietary sources of energy, solid fats, and added sugars among children and adolescents in the United States. J Am Diet Assoc. 2010 Oct;110(10):1477-84. doi: 10.1016/j.jada.2010.07.010.
- Individual participant dataSharing planned: Undecided
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Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
Enrolling by invitation
Impact of a Playful Family Education Strategy With ICT on Childhood Obesity Prevention
Pediatric Obesity, Childhood Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Leis, PhD principal investigator
University of Saskatchewan
Mathieu Bélanger, PhD principal investigator
Université de Sherbrooke
Louise Humbert, PhD principal investigator
University of Saskatchewan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Start in people with Pediatric Obesity, run by Université de Sherbrooke at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Level (time frame: The intervention spans a period of 6 months. Outcomes are measured before and after intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02375490, which also lists 57 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2017; AzTrials last refreshed its copy on 7 Nov 2026.