Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000433606
Ethics application status
Not yet submitted
Date submitted
9/04/2014
Date registered
29/04/2014
Date last updated
29/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The relationships between obesity, lifestyle behaviours, and cardiovascular health in children.
Scientific title
PACMAC Study: Analyzing the relationships between obesity, lifestyle behaviours, and cardio-metabolic health in children ages 8-10.
Secondary ID [1] 284381 0
Nil known
Universal Trial Number (UTN)
U1111-1155-2586
Trial acronym
PACMAC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease 291548 0
Obesity Correlates 291549 0
Condition category
Condition code
Cardiovascular 291929 291929 0 0
Normal development and function of the cardiovascular system
Diet and Nutrition 291930 291930 0 0
Obesity
Public Health 291931 291931 0 0
Health promotion/education

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Phase one: The study will investigate the relationships between obesity, lifestyle behaviours (nutrition, physical activity/fitness, sleep behaviour, psychosocial influences) and cardiovascular health in a sample of 400 children ages 8-10. Participants are assessed at one timepoint only because this is a cross-sectional study. Phase one of the study will be conducted at primary school locations in the greater Wellington area.

Phase two: In a sub-group of 100 children, additional measurements of cardiovascular health, life style behaviours, and fatness will be obtained to provide objective and detailed data to determine whether the strongest correlate of cardiovascular disease risk is similar for Maori and Caucasian children. Some participants that are involved in phase one of the study will be involved in phase two of the research. Phase two of the study will be done subsequent phase one at a later date. Phase two of the study will be conducted in the research lab at Massey University.
Intervention code [1] 289120 0
Not applicable
Comparator / control treatment
This is a cross sectional study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291852 0
Cardio-metabolic health

Phase 1: Biochemical markers will be collected by finger prick procedure and analysed using portable lipid/glucose (CardioChek PA) and HbA1c (Afinion HbA1c) analyzers.
Timepoint [1] 291852 0
One-off measurement
Primary outcome [2] 291905 0
Cardio-Metabolic Health

Phase 2: Flow Mediated Dilation will be used to assess endothelial function.
Timepoint [2] 291905 0
One-off measurement
Secondary outcome [1] 307669 0
Fatness

Phase 1: Body composition will be estimated using body mass index (BMI), waist circumference, waist: hip ratio (WHR), and body composition (fat mass, fat-free mass) using bio-impedance analysis.
Timepoint [1] 307669 0
One-off measurement
Secondary outcome [2] 307694 0
Physical Activity

Phase 1: The Youth Physical Activity Questionnaire (YPAQ) will be used to measure physical activity type, frequency, and duration on a daily basis. The 47 item YPAQ asks students to quantify the frequency and duration of a range of physical and sedentary activities for both week and weekend days over the past 7 days.
Timepoint [2] 307694 0
One-off measurement
Secondary outcome [3] 307695 0
Physical Fitness

Phase 1: A 20-m maximal multistage shuttle run test.
Timepoint [3] 307695 0
One-off measurement
Secondary outcome [4] 307696 0
Sleep

Phase 1: The Children’s Sleep Habits Questionnaire (CSHQ) will be used to measure sleep habits and sleep disturbances.
Timepoint [4] 307696 0
One-off measurement
Secondary outcome [5] 307697 0
Nutritional Behavior

Phase 1: Food choice will be assessed using a specially modified, short version of New Zealand Adolescent Food Frequency Questionnaire (NZAFFQ), the New Zealand Children’s Food Frequency Questionnaire (NZCFFQ), designed for use in this age group. This FFQ is based on the Health Behaviour in School Children (HBSC) FFQ, which is suitable for use in this age group.
Timepoint [5] 307697 0
One-off measurement
Secondary outcome [6] 307786 0
Fatness

Phase 2: Intra-abdominal tissue thickness (IAT) and abdominal wall fat index (AFI) will be measured by an ultrasound device.
Timepoint [6] 307786 0
One-off measurement
Secondary outcome [7] 307787 0
Physical Activity

Phase 2: Accelerometry will be used to objectively measure moderate to vigorous physical activity levels.
Timepoint [7] 307787 0
One-off measurement
Secondary outcome [8] 307788 0
Physical Fitness

Phase 2: A continuous, incremental maximal exercise test on a cycle ergometer will be used to measure cardiorespiratory fitness.
Timepoint [8] 307788 0
One-off measurement
Secondary outcome [9] 307789 0
Sleep

Phase 2: Accelerometry and a paper-based sleep diary will be used to measure sleep behavior.
Timepoint [9] 307789 0
One-off measurement
Secondary outcome [10] 307790 0
Nutritional Behavior

Phase 2: A four day estimated food diary will be used to measure food intake over a four day period.
Timepoint [10] 307790 0
One-off measurement

Eligibility
Key inclusion criteria
Children will be deemed eligible if they are ages 8-10, reside in the greater Wellington area, and do not have any sign of injury or illness. This will be determined by a standardized health screening questionnaire, and a physical activity readiness-questionnaire (PAR-Q) that will be completed by a parent or guardian.
Minimum age
8 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children will be ineligible to participate if they have had an orthopaedic injury or surgery that has prohibited full function within the previous four weeks, have been prescribed any cardiovascular medications, or if the parent or guardian consent form and child assent form are not returned signed.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
For research Question 1: Investigate the associations of physical activity, physical fitness, nutrition, and sleep habits with fatness.
Partial correlations will be used to compare physical activity, physical fitness, nutrition, and sleep habits with fatness.
Two separate multiple regression models will be used to examine the association of the predictor variables with fatness.

For research Question 2:Investigate the strongest correlate of physical activity: physical environment (walkability, playability index) or psychosocial (attraction to physical activity).
Partial correlations will be used to compare physical environment and psychosocial with physical activity.
Two separate multiple regression models will be used to examine the association of the predictor variables with physical activity.

For research Question 3:Investigate the strongest correlate of nutritional behaviour: physical environment (local built food environment), psychosocial (preferences for and attitudes towards healthy foods) or hereditary (genetic variability of taste receptors).
Partial correlations will be used to compare physical environment, psychosocial, and hereditary with independent variables which will include food environment variables, psychosocial variables, and taste response (taste/non-taste) to 6-n-propylthiouracil (PROP).
A two-way (environment index x taste response) analysis of co-variance will be used to examine environment-gene interaction, adjusting for psychosocial variables.

For research Question 4: Investigate the association of fatness, nutrition, physical activity, physical fitness, and sleep with cardio-metabolic health.
Partial correlations will be used to compare fatness, physical activity, physical fitness, nutrition,and sleep behaviour with cardio-metabolic health.
Two separate multiple regression models will be used to examine the association of the predictor variables with cardio-metabolic health.

Research question 5: Investigate the association of fatness, nutrition, physical activity, physical fitness, and sleep with cardiovascular disease risk, and (b) determine whether the strongest correlate of cardiovascular disease risk is similar for Maori and Caucasian children.
Partial correlations will be used to compare fatness, nutrition, physical activity, physical fitness, and sleep with cardiovascular disease risk score.
Two separate multiple regression models will be used to examine the association of the predictor variables with cardiovascular disease risk score.

Sample Size Calculations

Phase one: Using magnitude-based inferences to estimate the sample size required to detect the smallest beneficial (or detrimental) effect in a cross-sectional study (in this case a correlation of 0.10 which is set lower than the estimated correlation of 0.20 found in previous research between fitness and fatness, with the maximum chances of a Type 1 and 2 error set at 5% (i.e. very unlikely), approximately 272 children are required. To allow for an approximate 30% non-completion rate across all study measures, 400 children will be recruited to the study.

Phase two: Using the same method described above, but changing the smallest beneficial effect to match that found previously between flow-mediated dilation and physical activity (i.e. r = 0.40), approximately 20 subjects are required per group (Caucasian or Maori). We will over sample to accommodate for setbacks.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment outside Australia
Country [1] 5956 0
New Zealand
State/province [1] 5956 0
Wellington
Country [2] 5999 0
New Zealand
State/province [2] 5999 0
Canterbury
Country [3] 6000 0
New Zealand
State/province [3] 6000 0
Otago

Funding & Sponsors
Funding source category [1] 289027 0
University
Name [1] 289027 0
Massey University
Country [1] 289027 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Massey University
College of Health
School of Sport and Exercise
Private Bag 756
Wellington 6140
Country
New Zealand
Secondary sponsor category [1] 287700 0
None
Name [1] 287700 0
Address [1] 287700 0
Country [1] 287700 0
Other collaborator category [1] 277908 0
Individual
Name [1] 277908 0
Dr. Lee Stoner
Address [1] 277908 0
Massey University
College of Health
School of Sport and Exercise
Private Bag 756
Wellington 6140
Country [1] 277908 0
New Zealand
Other collaborator category [2] 277909 0
Individual
Name [2] 277909 0
Dr. James Faulkner
Address [2] 277909 0
Massey University
College of Health
School of Sport and Exercise
Private Bag 756
Wellington 6140
Country [2] 277909 0
New Zealand
Other collaborator category [3] 277910 0
Individual
Name [3] 277910 0
Dr. Sally Lark
Address [3] 277910 0
Massey University
College of Health
School of Sport and Exercise
Private Bag 756
Wellington 6140
Country [3] 277910 0
New Zealand
Other collaborator category [4] 277911 0
Individual
Name [4] 277911 0
Dr. Michelle Williams
Address [4] 277911 0
Harvard School of Public Health
Department of Epidemiology
Boston, Massachusetts 02115
Country [4] 277911 0
United States of America

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290831 0
Health & Disability Ethics Committees
Ethics committee address [1] 290831 0
Ethics committee country [1] 290831 0
New Zealand
Date submitted for ethics approval [1] 290831 0
15/05/2014
Approval date [1] 290831 0
Ethics approval number [1] 290831 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47450 0
Mr Nicholas Castro
Address 47450 0
Massey University
College of Health
School of Sport and Exercise
Private Bag 756
Wellington 6140
Country 47450 0
New Zealand
Phone 47450 0
+64.06.356.9099 ext 62284
Fax 47450 0
+64.4.801.4994
Email 47450 0
[email protected]
Contact person for public queries
Name 47451 0
Nicholas Castro
Address 47451 0
Massey University
College of Health
School of Sport and Exercise
Private Bag 756
Wellington 6140
Country 47451 0
New Zealand
Phone 47451 0
+64.06.356.9099 ext 62284
Fax 47451 0
+64.4.801.4994
Email 47451 0
[email protected]
Contact person for scientific queries
Name 47452 0
Lee Stoner
Address 47452 0
Massey University
College of Health
School of Sport and Exercise
Private Bag 756
Wellington 6140
Country 47452 0
New Zealand
Phone 47452 0
+64.4.801.5799 ext 62403
Fax 47452 0
+64.4.801.4994
Email 47452 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSleep and Adiposity in Preadolescent Children: The Importance of Social Jetlag.2018https://dx.doi.org/10.1089/chi.2017.0272
EmbaseFood consumption patterns and body composition in children: Moderating effects of prop taster status.2019https://dx.doi.org/10.3390/nu11092037
EmbaseFitness and Fatness Are Both Associated with Cardiometabolic Risk in Preadolescents.2020https://dx.doi.org/10.1016/j.jpeds.2019.09.076
EmbaseA Cross-Sectional Investigation of Preadolescent Cardiometabolic Health: Associations with Fitness, Physical Activity, Sedentary Behavior, Nutrition, and Sleep.2023https://dx.doi.org/10.3390/children10020336
N.B. These documents automatically identified may not have been verified by the study sponsor.