Clinical trial NCT04696614: Testing the Effect of Exercise Intervention Using a SMART Design.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fat Burn
Keywords: sequential multiple assignment randomized trial
exercise
visceral adipose tissue
Lead sponsor: National Taiwan University
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 116
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: visceral adipose tissue
timeFrame: three times (baseline, change visceral adipose tissue from Baseline to 8 week, change visceral adipose tissue from Baseline to 16 week)
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Community Center
Study officials:
References: