Chronic Conditions in Childhood Obesity Subject: An Mixed Methods Research Approach
Primary Purpose
Childhood Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
lifestyle intervention
Sponsored by
About this trial
This is an interventional prevention trial for Childhood Obesity
Eligibility Criteria
Inclusion Criteria:
- 7~15years old child
- 7~15years old child's caregiver
- 7~15years old child's teacher
- 7~15years old child's nurse
Exclusion Criteria:
- not 7~15years old child
- not 7~15years old child's caregiver
- not 7~15years old child's teacher
- not 7~15years old child's nurse
Sites / Locations
- National Taiwan UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
lifestyle intervention
Arm Description
the intervention strength (amount, frequency, duration) including a reduction in energy intake and an increase in physical activity level will be reported. The guidance/description of the treatment protocol, preparation and training of intervener, techniques to retain the research subjects will be covered to prevent the lack of intervention integrity. Besides, the schooler admitted in a university hospital will be invited to explore their health lifestyles and receive the intervention.
Outcomes
Primary Outcome Measures
the body weight and height to calculate the body mass index (BMI)
Secondary Outcome Measures
Full Information
NCT ID
NCT01987713
First Posted
November 13, 2013
Last Updated
May 27, 2014
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01987713
Brief Title
Chronic Conditions in Childhood Obesity Subject: An Mixed Methods Research Approach
Official Title
Chronic Conditions in Childhood Obesity Subject: An Mixed Methods Research Approach
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Methods: This study will be a three-year mixed methods study, including the identification of obesity issues among children with chronic conditions in the first phase study (2013/10/01-2014/07/31), development of an intervention protocol in the second phase study (2014/08/01-2015/07/31), and conduction/evaluation of an intervention of lifestyle intervention in the third phase study (2015/08/01-2016/07/31). Firstly, anthropometry, healthy lifestyles questionnaire survey on children aged 7-12 and school environment audit will be conducted. By using the literature review, meta-analysis and focus-research approaches to develop a healthy lifestyle intervention protocol in the second year program. The protocol will be tested on a sample of school-age children with asthma, to develop a school-based and family-involved healthy lifestyle intervention. Finally, the protocol will be undertaken on children with asthma aged 10-15, by using an experimental (pretest-posttest) design with repeated follow-ups. The research subjects will be randomly assign to condition of receiving intervention or control; the measurement of the outcome across 4 observations, to assess both group differences (experimental comparison), and changes within groups. The interventions consist of healthy diet (X1), regular exercise (X2), and booster energy balance-related behaviors (BEBRB) (X3). The observations start from baseline (O1), then have three observations (O2, O3, O4) at 3-month interval respectively. Outcome indicators include height, body weight, waist circumference as well as healthy life style modification present by diet record, exercise diary, healthy life environments. The research subjects will consist of randomly sampled school-age children and their fathers (or mothers), school teachers and school nurses. The approximate sample size is estimated by power analysis and dropout rate, the eligible sample size will be 200 and 160 pairs of children with their parents, school teachers and nurses in the first and third year respectively.
Detailed Description
Background: Childhood obesity is a global "public health crisis" with increasing prevalence rate in all racial, ethnic and gender groups, as well as across socioeconomic strata. Research findings indicate that over the past 30 years, the prevalence of chronic conditions in children and youths has increased. Childhood obesity impacts physical, psychological and social well-being, and also impacts the economy as well.
Purpose: The purpose of this study is to explore the healthy status, healthy lifestyles among school-age obese children of chronic conditions, then to examine the contextual factors affecting their healthy lifestyles, in order to develop a theory-informed and evidence-based intervention of school-based and family-involved intervention for obese children, and evaluate the effectiveness of interventions by using mixed methods (MM) research approach.
Methods: This study will be a three-year mixed methods study, including the identification of obesity issues among children with chronic conditions in the first phase study (2013/10/01-2014/07/31), development of an intervention protocol in the second phase study (2014/08/01-2015/07/31), and conduction/evaluation of an intervention of lifestyle intervention in the third phase study (2015/08/01-2016/07/31). Firstly, anthropometry, healthy lifestyles questionnaire survey on children aged 7-12 and school environment audit will be conducted. By using the literature review, meta-analysis and focus-research approaches to develop a healthy lifestyle intervention protocol in the second year program. The protocol will be tested on a sample of school-age children with asthma, to develop a school-based and family-involved healthy lifestyle intervention. Finally, the protocol will be undertaken on children with asthma aged 10-15, by using an experimental (pretest-posttest) design with repeated follow-ups. The research subjects will be randomly assign to condition of receiving intervention or control; the measurement of the outcome across 4 observations, to assess both group differences (experimental comparison), and changes within groups. The interventions consist of healthy diet (X1), regular exercise (X2), and booster energy balance-related behaviors (BEBRB) (X3). The observations start from baseline (O1), then have three observations (O2, O3, O4) at 3-month interval respectively. Outcome indicators include height, body weight, waist circumference as well as healthy life style modification present by diet record, exercise diary, healthy life environments. The research subjects will consist of randomly sampled school-age children and their fathers (or mothers), school teachers and school nurses. The approximate sample size is estimated by power analysis and dropout rate, the eligible sample size will be 200 and 160 pairs of children with their parents, school teachers and nurses in the first and third year respectively.
Expected outcomes: To recognize the risk factors and determinants, have an evidence-based development of school-based and family-involved lifestyle modification to better health outcomes for children with chronic conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
lifestyle intervention
Arm Type
Experimental
Arm Description
the intervention strength (amount, frequency, duration) including a reduction in energy intake and an increase in physical activity level will be reported. The guidance/description of the treatment protocol, preparation and training of intervener, techniques to retain the research subjects will be covered to prevent the lack of intervention integrity. Besides, the schooler admitted in a university hospital will be invited to explore their health lifestyles and receive the intervention.
Intervention Type
Behavioral
Intervention Name(s)
lifestyle intervention
Other Intervention Name(s)
amount, frequency, duration intervention
Intervention Description
the intervention strength (amount, frequency, duration) including a reduction in energy intake and an increase in physical activity level will be reported. The guidance/description of the treatment protocol, preparation and training of intervener, techniques to retain the research subjects will be covered to prevent the lack of intervention integrity. Besides, the schooler admitted in a university hospital will be invited to explore their health lifestyles and receive the intervention.
Primary Outcome Measure Information:
Title
the body weight and height to calculate the body mass index (BMI)
Time Frame
evaluate after intervention in 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
7~15years old child
7~15years old child's caregiver
7~15years old child's teacher
7~15years old child's nurse
Exclusion Criteria:
not 7~15years old child
not 7~15years old child's caregiver
not 7~15years old child's teacher
not 7~15years old child's nurse
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bih-Shya Gau, Ph.D.
Phone
886+23123456
Ext
88440
Email
bsgau@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bih-Shya Gau, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bih-Shya Gau, Ph.D
Phone
886+23123456
Ext
88440
Email
bsgau@ntu.edu.tw
12. IPD Sharing Statement
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Chronic Conditions in Childhood Obesity Subject: An Mixed Methods Research Approach
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