A feasibility cluster randomised controlled trial of a preschool obesity prevention intervention: ToyBox-Scotland

Stephen Malden, John Reilly, Ann-Marie Gibson, Farid Bardid, Carolyn Summerbell, Marieke De Craemer, Greet Cardon, Odysseas Androutsos, Yannis Manios, Adrienne Hughes

Research output: Contribution to journalArticle

Abstract

Background: High levels of childhood obesity have been observed globally over the last three decades. Preschools are promising settings to implement obesity prevention interventions in the early years. The aim of this study was to test the feasibility of a cluster randomised controlled trial of the ToyBox-Scotland preschool obesity prevention intervention. Methods: Six preschools in predominantly deprived areas of Glasgow, UK, were randomised to either the ToyBox intervention (n = 3) or usual curriculum control group (n = 3). The intervention ran for 18 weeks from March–June 2018, and consisted of practitioner-led physical activity and sedentary behaviour sessions in preschools, with an additional interactive home component. Primary outcome measures were intervention fidelity, recruitment rates, attrition rates, and compliance with trial procedures. Secondary outcomes were body mass index (BMI) z-score, bioelectrical impedance analysis (BIA), objectively measured physical activity and sedentary time via activPAL accelerometer, and parent-reported home eating, snacking, and water consumption. Results: The preschool component of the intervention was implemented with high fidelity (64%), while the home component was implemented with low fidelity (41%). A cluster-level recruitment rate of 10% was achieved, and the individual-level recruitment rate was 18% (42/233 children, mean age 4.4 years; 17 girls). The attrition rate was 14%, and compliance rates varied considerably by the outcome. Compliance was highest for BMI (86%), while 19% of the sample returned valid accelerometer data for both baseline and follow-up and the parental questionnaire response rate was 23%. Both intervention and control groups showed small increases in BMI z-scores at follow-up of 0.02 and 0.06, respectively. Both groups had small decreases in physical activity and increases in sedentary time at follow-up. Conclusions: Before progression to an effectiveness trial, additional procedures should be considered to improve recruitment rates, compliance with outcome measures, and implementation of the home-based component of the ToyBox-Scotland intervention.
LanguageEnglish
Article number128
Number of pages11
JournalPilot and Feasibiliity Studies
Volume5
DOIs
Publication statusPublished - 9 Nov 2019

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Scotland
Body Mass Index
Randomized Controlled Trials
Obesity
Exercise
Outcome Assessment (Health Care)
Control Groups
Snacks
Pediatric Obesity
Electric Impedance
Curriculum
Drinking
Compliance
Eating

Keywords

  • childhood obesity
  • obesity prevention
  • health interventions

Cite this

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title = "A feasibility cluster randomised controlled trial of a preschool obesity prevention intervention: ToyBox-Scotland",
abstract = "Background: High levels of childhood obesity have been observed globally over the last three decades. Preschools are promising settings to implement obesity prevention interventions in the early years. The aim of this study was to test the feasibility of a cluster randomised controlled trial of the ToyBox-Scotland preschool obesity prevention intervention. Methods: Six preschools in predominantly deprived areas of Glasgow, UK, were randomised to either the ToyBox intervention (n = 3) or usual curriculum control group (n = 3). The intervention ran for 18 weeks from March–June 2018, and consisted of practitioner-led physical activity and sedentary behaviour sessions in preschools, with an additional interactive home component. Primary outcome measures were intervention fidelity, recruitment rates, attrition rates, and compliance with trial procedures. Secondary outcomes were body mass index (BMI) z-score, bioelectrical impedance analysis (BIA), objectively measured physical activity and sedentary time via activPAL accelerometer, and parent-reported home eating, snacking, and water consumption. Results: The preschool component of the intervention was implemented with high fidelity (64{\%}), while the home component was implemented with low fidelity (41{\%}). A cluster-level recruitment rate of 10{\%} was achieved, and the individual-level recruitment rate was 18{\%} (42/233 children, mean age 4.4 years; 17 girls). The attrition rate was 14{\%}, and compliance rates varied considerably by the outcome. Compliance was highest for BMI (86{\%}), while 19{\%} of the sample returned valid accelerometer data for both baseline and follow-up and the parental questionnaire response rate was 23{\%}. Both intervention and control groups showed small increases in BMI z-scores at follow-up of 0.02 and 0.06, respectively. Both groups had small decreases in physical activity and increases in sedentary time at follow-up. Conclusions: Before progression to an effectiveness trial, additional procedures should be considered to improve recruitment rates, compliance with outcome measures, and implementation of the home-based component of the ToyBox-Scotland intervention.",
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A feasibility cluster randomised controlled trial of a preschool obesity prevention intervention : ToyBox-Scotland. / Malden, Stephen; Reilly, John; Gibson, Ann-Marie; Bardid, Farid; Summerbell, Carolyn; De Craemer, Marieke; Cardon, Greet; Androutsos, Odysseas; Manios, Yannis; Hughes, Adrienne.

In: Pilot and Feasibiliity Studies, Vol. 5, 128, 09.11.2019.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A feasibility cluster randomised controlled trial of a preschool obesity prevention intervention

T2 - Pilot and Feasibiliity Studies

AU - Malden, Stephen

AU - Reilly, John

AU - Gibson, Ann-Marie

AU - Bardid, Farid

AU - Summerbell, Carolyn

AU - De Craemer, Marieke

AU - Cardon, Greet

AU - Androutsos, Odysseas

AU - Manios, Yannis

AU - Hughes, Adrienne

PY - 2019/11/9

Y1 - 2019/11/9

N2 - Background: High levels of childhood obesity have been observed globally over the last three decades. Preschools are promising settings to implement obesity prevention interventions in the early years. The aim of this study was to test the feasibility of a cluster randomised controlled trial of the ToyBox-Scotland preschool obesity prevention intervention. Methods: Six preschools in predominantly deprived areas of Glasgow, UK, were randomised to either the ToyBox intervention (n = 3) or usual curriculum control group (n = 3). The intervention ran for 18 weeks from March–June 2018, and consisted of practitioner-led physical activity and sedentary behaviour sessions in preschools, with an additional interactive home component. Primary outcome measures were intervention fidelity, recruitment rates, attrition rates, and compliance with trial procedures. Secondary outcomes were body mass index (BMI) z-score, bioelectrical impedance analysis (BIA), objectively measured physical activity and sedentary time via activPAL accelerometer, and parent-reported home eating, snacking, and water consumption. Results: The preschool component of the intervention was implemented with high fidelity (64%), while the home component was implemented with low fidelity (41%). A cluster-level recruitment rate of 10% was achieved, and the individual-level recruitment rate was 18% (42/233 children, mean age 4.4 years; 17 girls). The attrition rate was 14%, and compliance rates varied considerably by the outcome. Compliance was highest for BMI (86%), while 19% of the sample returned valid accelerometer data for both baseline and follow-up and the parental questionnaire response rate was 23%. Both intervention and control groups showed small increases in BMI z-scores at follow-up of 0.02 and 0.06, respectively. Both groups had small decreases in physical activity and increases in sedentary time at follow-up. Conclusions: Before progression to an effectiveness trial, additional procedures should be considered to improve recruitment rates, compliance with outcome measures, and implementation of the home-based component of the ToyBox-Scotland intervention.

AB - Background: High levels of childhood obesity have been observed globally over the last three decades. Preschools are promising settings to implement obesity prevention interventions in the early years. The aim of this study was to test the feasibility of a cluster randomised controlled trial of the ToyBox-Scotland preschool obesity prevention intervention. Methods: Six preschools in predominantly deprived areas of Glasgow, UK, were randomised to either the ToyBox intervention (n = 3) or usual curriculum control group (n = 3). The intervention ran for 18 weeks from March–June 2018, and consisted of practitioner-led physical activity and sedentary behaviour sessions in preschools, with an additional interactive home component. Primary outcome measures were intervention fidelity, recruitment rates, attrition rates, and compliance with trial procedures. Secondary outcomes were body mass index (BMI) z-score, bioelectrical impedance analysis (BIA), objectively measured physical activity and sedentary time via activPAL accelerometer, and parent-reported home eating, snacking, and water consumption. Results: The preschool component of the intervention was implemented with high fidelity (64%), while the home component was implemented with low fidelity (41%). A cluster-level recruitment rate of 10% was achieved, and the individual-level recruitment rate was 18% (42/233 children, mean age 4.4 years; 17 girls). The attrition rate was 14%, and compliance rates varied considerably by the outcome. Compliance was highest for BMI (86%), while 19% of the sample returned valid accelerometer data for both baseline and follow-up and the parental questionnaire response rate was 23%. Both intervention and control groups showed small increases in BMI z-scores at follow-up of 0.02 and 0.06, respectively. Both groups had small decreases in physical activity and increases in sedentary time at follow-up. Conclusions: Before progression to an effectiveness trial, additional procedures should be considered to improve recruitment rates, compliance with outcome measures, and implementation of the home-based component of the ToyBox-Scotland intervention.

KW - childhood obesity

KW - obesity prevention

KW - health interventions

U2 - 10.1186/s40814-019-0521-7

DO - 10.1186/s40814-019-0521-7

M3 - Article

VL - 5

JO - Pilot and Feasibiliity Studies

JF - Pilot and Feasibiliity Studies

SN - 2055-5784

M1 - 128

ER -