Health Literacy-based Weight Control Intervention

November 21, 2023 updated by: National Taiwan University Hospital

The Effectiveness of Health Literacy-based Weight Control Intervention Via Mobile Health Application for Overweight and Obese Adolescent: A Longitudinal Panel Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Health Literacy-based Weight Control Intervention arm
intervention arm will receive weight control program
Other: Health Literacy-based Weight Control Intervention
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
No Intervention: control arm
routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI(body mass index)
Time Frame: Change from baseline body mass index at 3 months, 9 months, 15 months, and 21 months.
BMI = weight / height².
Change from baseline body mass index at 3 months, 9 months, 15 months, and 21 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WHR(waist-to-hip ratio )
Time Frame: Change from baseline waist-to-hip ratio at 3 months, 9 months, 15 months, and 21 months.
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).
Change from baseline waist-to-hip ratio at 3 months, 9 months, 15 months, and 21 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Bih-Shya Gau, National Taiwan University, College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2021

Primary Completion (Actual)

October 30, 2023

Study Completion (Actual)

November 18, 2023

Study Registration Dates

First Submitted

February 10, 2021

First Submitted That Met QC Criteria

February 16, 2021

First Posted (Actual)

February 18, 2021

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201912048RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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