Testing the Effect of Exercise Intervention Using a SMART Design.

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.

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 Overview

• Status: Completed
• Conditions: Fat Burn
• Intervention / Treatment: Behavioral: exercise

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan
    • Community center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: aerobic exercise to aerobic exercise; first 8-week: aerobic exercise second 8-week: aerobic exercise	Behavioral: exercise; intervention groups provided different sequential modality of exercise
Experimental: aerobic exercise to interval training; first 8-week: aerobic exercise second 8-week: interval training	Behavioral: exercise; intervention groups provided different sequential modality of exercise
Experimental: aerobic exercise to aerobic exercise +resistance exercise; first 8-week: aerobic exercise second 8-week: aerobic exercise +resistance exercise	Behavioral: exercise; intervention groups provided different sequential modality of exercise
Experimental: interval training to interval training; first 8-week: interval training second 8-week: interval training	Behavioral: exercise; intervention groups provided different sequential modality of exercise
Experimental: interval training to aerobic exercise; first 8-week: interval training second 8-week: aerobic exercise	Behavioral: exercise; intervention groups provided different sequential modality of exercise
Experimental: interval training to aerobic exercise+resistance exercise; first 8-week: interval training second 8-week: aerobic exercise +resistance exercise	Behavioral: exercise; intervention groups provided different sequential modality of exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: National Taiwan University

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2020
• Primary Completion (Actual): January 4, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: January 4, 2021
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (Actual): January 6, 2021

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: exercise; visceral adipose tissue; sequential multiple assignment randomized trial
• Other Study ID Numbers: 108466

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