Testing the Effect of Exercise Intervention Using a SMART Design.

NCT04696614 | Completed DMC

• 1 other identifier: 108466
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Fat Burn

Keywords

sequential multiple assignment randomized trial; exercise; visceral adipose tissue

Outcome Measures

Primary Outcomes (1)

• visceral adipose tissue

  measured using body composition analyzer

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

Study Arms (6)

aerobic exercise to aerobic exercise

EXPERIMENTAL

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

Behavioral: exercise

aerobic exercise to interval training

EXPERIMENTAL

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

Behavioral: exercise

aerobic exercise to aerobic exercise +resistance exercise

EXPERIMENTAL

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

Behavioral: exercise

interval training to interval training

EXPERIMENTAL

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

Behavioral: exercise

interval training to aerobic exercise

EXPERIMENTAL

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

Behavioral: exercise

interval training to aerobic exercise+resistance exercise

EXPERIMENTAL

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

Behavioral: exercise

Interventions

exercise BEHAVIORAL

intervention groups provided different sequential modality of exercise

aerobic exercise to aerobic exercise; aerobic exercise to aerobic exercise +resistance exercise; aerobic exercise to interval training; interval training to aerobic exercise; interval training to aerobic exercise+resistance exercise; interval training to interval training

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University: lead

Study Sites (1)

Community Center

Tainan, Taiwan

Location

Related Publications (1)

• Chang YH, Lee YH, Wu KL, Hsu WL, Hung H, Shun SC. Exercise Strategy for Reducing Visceral Adipose Tissue in Community Residents With Obesity: A Sequential Multiple Assignment Randomized Trial. J Nurs Res. 2025 Apr 1;33(2):e385. doi: 10.1097/jnr.0000000000000662.

  PMID: 40019278 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: singal blinding for the assessor
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized with 1:1 equal allocation at baseline to one of two first-stage interventions (8 weeks aerobic exercise (AE) or interval training). Those who exhibit early signs of nonresponse determined by a tailoring variable (reduced (visceral adipose tissue (VAT) \< 3%) will then be rerandomized to one of two second-stage interventions (AE + RE (resistance exercise) vs interval training or AE), also with 1:1 equal allocation, whereas those who have a significant response to the first-stage intervention will continue to receive the same exercise treatment until 16 weeks.

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 6, 2021
• Study Start: November 10, 2020
• Primary Completion: January 4, 2021
• Study Completion: July 31, 2021
• Last Updated: April 7, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)