Chronic Conditions in Childhood Obesity Subject: An Mixed Methods Research Approach

Childhood Obesity Clinical Trial

Official title:

Chronic Conditions in Childhood Obesity Subject: An Mixed Methods Research Approach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01987713
• Other study ID #: 201309023
• Status: Recruiting
• Phase: N/A
• First received: November 13, 2013
• Last updated: May 27, 2014
• Start date: November 2013
• Est. completion date: July 2016

Study information

• Verified date: May 2014
• Source: National Taiwan University Hospital
• Contact: Bih-Shya Gau, Ph.D.
• Phone: 886+23123456
• Email: bsgau[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• lifestyle intervention
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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the body weight and height to calculate the body mass index (BMI)		evaluate after intervention in 3 months	No