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Health Literacy-based Weight Control Intervention

NCT04759716 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2023-11-22

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Bih-Shya Gau · National Taiwan University, College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-09
Primary Completion
2023-10-30
Completion
2023-11-18

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04759716 on ClinicalTrials.gov