NCT04759716

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

March 9, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2023

Completed
Last Updated

November 22, 2023

Status Verified

April 1, 2022

Enrollment Period

2.6 years

First QC Date

February 10, 2021

Last Update Submit

November 21, 2023

Conditions

ObesityOverweight

Keywords

weight controlAdolescentsoverweightobesityMobile health

Outcome Measures

Primary Outcomes (1)

  • BMI(body mass index)

    BMI = weight / height².

    Change from baseline body mass index at 3 months, 9 months, 15 months, and 21 months.

Secondary Outcomes (1)

  • WHR(waist-to-hip ratio )

    Change from baseline waist-to-hip ratio at 3 months, 9 months, 15 months, and 21 months.

Study Arms (2)

Health Literacy-based Weight Control Intervention arm

EXPERIMENTAL

intervention arm will receive weight control program

Other: Health Literacy-based Weight Control Intervention

control arm

NO INTERVENTION

routine care

Interventions

Health Literacy-based Weight Control InterventionOTHER

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

Health Literacy-based Weight Control Intervention arm

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University

Taipei, 100, Taiwan

Location

Related Publications (1)

  • Chen YH, Tzeng YF, Gau BS. Mobile Health-Based Health Literacy Weight Management Intervention Using Smart Devices for Adolescents: A Convergent Mixed-Methods Pilot Study. Nurs Health Sci. 2024 Dec;26(4):e13172. doi: 10.1111/nhs.13172.

    PMID: 39428322DERIVED

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bih-Shya Gau

    National Taiwan University, College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2021

First Posted

February 18, 2021

Study Start

March 9, 2021

Primary Completion

October 30, 2023

Study Completion

November 18, 2023

Last Updated

November 22, 2023

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)