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

NCT01987713 | Unknown

• 1 other identifier: 201309023
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (1)

• the body weight and height to calculate the body mass index (BMI)

  evaluate after intervention in 3 months

Study Arms (1)

lifestyle intervention

EXPERIMENTAL

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.

Behavioral: lifestyle intervention

Interventions

lifestyle intervention BEHAVIORAL

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.

Also known as: amount, frequency, duration intervention

lifestyle intervention

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \~15years old child
• \~15years old child's caregiver
• \~15years old child's teacher
• \~15years old child's nurse

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bih-Shya Gau, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bih-Shya Gau, Ph.D.

CONTACT

886+23123456; bsgau@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 19, 2013
• Study Start: November 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 29, 2014

Record last verified: 2014-05

Locations

TW (1)