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Health Literacy-based Weight Control Intervention

Primary Purpose

Obesity, Overweight

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Health Literacy-based Weight Control Intervention
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obesity focused on measuring weight control, Adolescents, overweight, obesity, Mobile health

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 13-19 years old adolescents;
  • Could use their mobile phones to upload diet records and photos;
  • Adolescents and their parents or legal representatives agree to involve in the study and sign the consent.

Exclusion Criteria:

  • Severe diseases;
  • Participate in other weight control program.

Sites / Locations

  • National Taiwan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Health Literacy-based Weight Control Intervention arm

control arm

Arm Description

intervention arm will receive weight control program

routine care

Outcomes

Primary Outcome Measures

BMI(body mass index)
BMI = weight / height².

Secondary Outcome Measures

WHR(waist-to-hip ratio )
waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement ( W⁄H).

Full Information

First Posted
February 10, 2021
Last Updated
September 7, 2022
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04759716
Brief Title
Health Literacy-based Weight Control Intervention
Official Title
The Effectiveness of Health Literacy-based Weight Control Intervention Via Mobile Health Application for Overweight and Obese Adolescent: A Longitudinal Panel Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2021 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This research will be a continuation of 2015-2017 research projects of smart phone APP research granted by Ministry of Science and Technology. First of all, a four-wave-cross-sectional survey by cluster sampling is used to recruit 90 adolescents aged 13-19 from high school, vocational schools or colleges to test the feasibility of the health literacy-based weight-control program. In the second stage, a two-arm randomized controlled trial (RCT) will be applied to recruit 240 overweight or obese teenagers to receive health literacy-based mobile Health App, smart sports watch Fitbit versa during the 12 months weight control program. Based on the previous research evidences, the outcome follow up will be scheduled on 3 months, 9 months, 15 months, and 21 months after the mobile Health Apps intervention. Short-term outcome indicators include health literacy, diet pattern, and dietary behaviors; long-term outcome indicators include BMI z-score, waist circumference. Intention-to-treat analysis, generalized linear mixed models with repeated measures, multiple regression analysis model, and counterfactual causal Inference will be applied to analyze the effectiveness of the interventions.
Detailed Description
Adolescent overweight and obesity are major health issues and challenges worldwide. According to the estimate of World Health Organization, the number of obese people in the world has tripled since 1975. Overweight and obese children and adolescents increased from 124 million in 1975 to 340 million in 2016. The obese young children will have a negative impact on the physical, psychological and social health, and will increase the risk of obesity in adulthood. This study is a continuing project of the research funded by the Ministry of Science and Technology to explore the smartphone app, health literacy. Purposes of this study are to (1) validate the Health literacy based mobile Health Apps Interventions, (2) conduct the mobile health apps and smart sports watches to intervene in 12 months and evaluate the effectiveness by follow-up repeated measures. Eligibility criteria. The inclusion criteria are 13-19 years old adolescents; Could use their mobile phones to upload diet records and photos; and Adolescents and their parents agree to involve in the study and sign the consent form. Exclusion conditions are the adolescent who with severe diseases (such as tumors and other diseases); and they already participate in other weight control program. Methods This research will be a continuation of 2015-2017 research projects of smart phone APP research granted by Ministry of Science and Technology. First of all, a four-wave-cross-sectional survey by cluster sampling is used to recruit 90 adolescents aged 13-19 from high school, vocational schools or colleges to test the feasibility of the health literacy-based weight-control program. In the second stage, a two-arm randomized controlled trial (RCT) will be applied to recruit 240 overweight or obese teenagers to receive health literacy-based mobile Health App, smart sports watch Fitbit versa during the 12 months weight control program. Based on the previous research evidences, the outcome follow up will be scheduled on 3 months, 9 months, 15 months, and 21 months after the mobile Health Apps intervention. Short-term outcome indicators include health literacy, diet pattern, and dietary behaviors; long-term outcome indicators include BMI z-score, waist circumference. Intention-to-treat analysis, generalized linear mixed models with repeated measures, multiple regression analysis model, and counterfactual causal Inference will be applied to analyze the effectiveness of the interventions. Expected outcomes This study applies health literacy-based mobile Health Apps weight control program for the overweight and obese adolescents. By strengthening healthy lifestyle of healthy dietary pattern and physical activity for adolescents, we hope to effectively prevent adolescent obesity, so as to reduce the impacts of obesity to social, medical and economic burdens.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
weight control, Adolescents, overweight, obesity, Mobile health

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Health Literacy-based Weight Control Intervention arm
Arm Type
Experimental
Arm Description
intervention arm will receive weight control program
Arm Title
control arm
Arm Type
No Intervention
Arm Description
routine care
Intervention Type
Other
Intervention Name(s)
Health Literacy-based Weight Control Intervention
Intervention Description
intervention arm will be applied to receive health literacy-based mobile Health App, smart sports watch Fitbit versa during the 12 months weight control program
Primary Outcome Measure Information:
Title
BMI(body mass index)
Description
BMI = weight / height².
Time Frame
Change from baseline body mass index at 3 months, 9 months, 15 months, and 21 months.
Secondary Outcome Measure Information:
Title
WHR(waist-to-hip ratio )
Description
waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement ( W⁄H).
Time Frame
Change from baseline waist-to-hip ratio at 3 months, 9 months, 15 months, and 21 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 13-19 years old adolescents; Could use their mobile phones to upload diet records and photos; Adolescents and their parents or legal representatives agree to involve in the study and sign the consent. Exclusion Criteria: Severe diseases; Participate in other weight control program.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Hsia Chen
Phone
+886-963467617
Email
d03426001@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bih-Shya Gau
Organizational Affiliation
National Taiwan University, College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-Hsia Chen

12. IPD Sharing Statement

Plan to Share IPD
No

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Health Literacy-based Weight Control Intervention

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