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Clinical Trials/NCT04696614
NCT04696614CompletedNot Applicable

Developing and Testing the Effect of Exercise Intervention Using a SMART Design on Reducing Visceral Adipose Tissue in Community Residents: A Mixed-Method, Longitudinal Study.

National Taiwan University1 site in 1 country116 target enrollmentStarted: November 10, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
116
Locations
1
Primary Endpoint
visceral adipose tissue

Study Overview

Brief Summary

Exercise is the most effective way on reducing visceral adipose tissue (VAT), which is strongly linked with obesity to hypertension, cardiovascular disease, and insulin resistance. However, the current exercise dosage for reducing VAT cannot be accurately quantified. The aims of this study are to develop and test the optimal exercise dosage and sequence for reducing VAT in overweight and obese community residents. Purposive sampling will be used to enroll at least 206 participants aged 40-65 years and body fat more than 30% without diet control from 2 community centers in southern Taiwan. The project will use the sequential multiple assignment randomized trial (SMART) design to conduct a 16-week 2-stage (each for 8-weeks) adaptive exercise intervention for community residents. In the first stage, participants will be randomized into groups performing 8 weeks either moderate intensity of aerobic exercise or interval training 3 times per week. Participants whose VAT does not decrease by over 3%, measured using a body composition analyzer, compared with the baseline will be 1:1 rerandomized into groups with aerobic exercise combined with resistance exercise or received the exchange of first stage treatment (interval training or aerobic exercise) in the second stage. Those with substantial response to the first-stage intervention (VAT reduction of more than 3%) will continue to receive the same exercise treatment until 16 weeks. Linear mixed model, weighted and replicated regression will be used to identify the optimal sequence of exercises for the greatest reduction in VAT. The findings can assist clinical health workers to develop exercise prescriptions for effectively reducing VAT, and help community residents reduce VAT through exercise to achieve the health promotion.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Masking Description

singal blinding for the assessor

Eligibility Criteria

Ages
40 Years to 64 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Community residents (a) who are 40-65 years old without diet control, (b) body fat ≧ 30% measured by body composition analyzer, and (c) can communicate in Mandarin or Taiwanese will be included.

Exclusion Criteria

  • •This study will exclude residents with (a) recent unstable condition involving stroke or those with heart disease, handicap, pregnancy, mental disorders, systolic BP > 200 mmHg, or diastolic BP >110 mmHg; and (b) those with contraindications in body composition analyzer measurement including people with pacemakers, artificial metal joints, amputated hands or feet, and those who cannot be cooperated with standing during testing.

Arms & Interventions

aerobic exercise to aerobic exercise

Experimental

first 8-week: aerobic exercise second 8-week: aerobic exercise

Intervention: exercise (Behavioral)

aerobic exercise to interval training

Experimental

first 8-week: aerobic exercise second 8-week: interval training

Intervention: exercise (Behavioral)

aerobic exercise to aerobic exercise +resistance exercise

Experimental

first 8-week: aerobic exercise second 8-week: aerobic exercise +resistance exercise

Intervention: exercise (Behavioral)

interval training to interval training

Experimental

first 8-week: interval training second 8-week: interval training

Intervention: exercise (Behavioral)

interval training to aerobic exercise

Experimental

first 8-week: interval training second 8-week: aerobic exercise

Intervention: exercise (Behavioral)

interval training to aerobic exercise+resistance exercise

Experimental

first 8-week: interval training second 8-week: aerobic exercise +resistance exercise

Intervention: exercise (Behavioral)

Outcomes

Primary Outcomes

visceral adipose tissue

Time Frame: three times (baseline, change visceral adipose tissue from Baseline to 8 week, change visceral adipose tissue from Baseline to 16 week)

measured using body composition analyzer

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yu-Hsuan Chang

Principal Investigator

National Taiwan University

Study Sites (1)

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