NCT03524521

Brief Summary

Body-weight based interval training (IT) performed 3 times per week will lead to reductions in abdominal adiposity and reduce overall body fat percentage in overweight and obese sedentary adults more effectively than moderate intensity continuous training (MICT). Body-weight interval training will improve exercise capacity (peak VO2) in overweight/obese adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 14, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

November 6, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2021

Completed
Last Updated

January 11, 2021

Status Verified

January 1, 2021

Enrollment Period

2.2 years

First QC Date

April 30, 2018

Last Update Submit

January 8, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Body fat percent

    DEXA derived body fat %

    12 weeks

Secondary Outcomes (4)

  • Change in Weight

    12 weeks

  • Change in peak VO2

    12 weeks

  • Visceral adipose tissue area

    12 weeks

  • Thigh adipose tissue area

    12 weeks

Study Arms (2)

Standard Walking

ACTIVE COMPARATOR

This arm is prescribed standard of care exercise prescription; 30 minutes of moderate intensity walking, 5 days/week.

Behavioral: Standard of Care

Interval Training

EXPERIMENTAL

This arm is prescribed body-weight based interval training 3 days per week with progressive increase in exercise intervals and sets.

Behavioral: Interval Training

Interventions

Interval training is prescribed 3 days per week using 5 body weight exercises in a progressive fashion.

Interval Training

Walking prescribed to meet current exercise guidelines; 150 minutes per week.

Standard Walking

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 18-65 years of age
  • Willing and able to provide informed consent
  • Sedentary, overweight and obese adults (\<90 minutes of moderate intensity exercise)
  • BMI 25≤35
  • Able to safely begin an exercise program
  • Have a smartphone, and willing and able to download and use the Fitbit app

You may not qualify if:

  • Unable to provide informed consent.
  • Known cardiovascular disease, or uncontrolled hypertension,
  • Diagnosed type 1 or 2 diabetes
  • Women who are pregnant or plan to become pregnant in the next 3-4 months
  • Orthopedic injury/limitation or any other contraindications to exercise.
  • Medications that cause weight gain (steroids, HIV-related medications, etc.), or glucose lowering medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Body Weight ChangesOverweightObesityMotor Activity

Interventions

High-Intensity Interval TrainingStandard of Care

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Amanda R Bonikowske

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Associate Consultant

Study Record Dates

First Submitted

April 30, 2018

First Posted

May 14, 2018

Study Start

November 6, 2018

Primary Completion

January 8, 2021

Study Completion

January 8, 2021

Last Updated

January 11, 2021

Record last verified: 2021-01

Locations