Testing the Effect of Exercise Intervention Using a SMART Design.

NCT ID: NCT04696614

Last Updated: 2022-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-10
• Study Completion Date: 2021-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

aerobic exercise to aerobic exercise

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

Group Type: EXPERIMENTAL

exercise

Intervention Type: BEHAVIORAL

intervention groups provided different sequential modality of exercise

aerobic exercise to interval training

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

Group Type: EXPERIMENTAL

exercise

Intervention Type: BEHAVIORAL

intervention groups provided different sequential modality of exercise

aerobic exercise to aerobic exercise +resistance exercise

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

Group Type: EXPERIMENTAL

exercise

Intervention Type: BEHAVIORAL

intervention groups provided different sequential modality of exercise

interval training to interval training

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

Group Type: EXPERIMENTAL

exercise

Intervention Type: BEHAVIORAL

intervention groups provided different sequential modality of exercise

interval training to aerobic exercise

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

Group Type: EXPERIMENTAL

exercise

Intervention Type: BEHAVIORAL

intervention groups provided different sequential modality of exercise

interval training to aerobic exercise+resistance exercise

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

Group Type: EXPERIMENTAL

exercise

Intervention Type: BEHAVIORAL

intervention groups provided different sequential modality of exercise

Interventions

exercise

intervention groups provided different sequential modality of exercise

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taiwan University

OTHER

Sponsor Role: lead

Responsible Party

Yu-Hsuan Chang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Community Center

Tainan City, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 40019278 (View on PubMed)

Other Identifiers

108466

Identifier Type: -

Identifier Source: org_study_id