ObesityNCT01107691
Comparison of 1 vs 3 Sets of Resistance Training on Muscular Hypertrophy
A study testing Amount of resistance offered in training in people with Obesity, run by University of Kansas at 1 site in United States.
Trial summary
This study is designed to investigate the effects of two levels of resistance weight training on body composition, energy expenditure, and energy intake in men and women. The weight training will take about one hour to complete. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Amount of resistance offered in training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 22-<30
- 18- 30 years old
- sedentary
- no medications
- weight stable for at least 3 months
Who cannot join
- Tobacco/Drug user
- metabolism altering medication
- gain/lost 10lbs in the last 3 months
- current exerciser
Trial locations and contacts
1 site in 1 country.
United States1 site
Energy Balance Lab, The University of Kansas
Lawrence, Kansas, 66045
About this study
Official title: Resistance Training Energy Balance & Weight Management
This study is designed to investigate the effects of two levels of resistance weight training on body composition, energy expenditure, and energy intake in men and women. The weight training will take about one hour to complete. Participants will perform the training 3 days per week for 9 months in a private exercise room equipped with state of the art equipment and a personal trainer to help guide you through the exercises.
The project lasts 21 months total with one follow-up visit 1-year from your last training date. You will be required to stay in the Lawrence area and train 3 day/week over the summer \& holidays.
Read the detailed description
We propose to conduct a randomized controlled efficacy trial (RT-1 set vs. RT-3 sets vs. non exercise control) to evaluate the potential for a longer intervention (9 months RT with body composition assessments 1 yr post RT completion) with a higher volume of RT (3 sets) to enhance the effects on body composition and energy expenditure observed in the pilot, and to determine the impact of the 2 levels of RT on free-living energy balance (expenditure by doubly labeled water and intake by digital photography and 24-hr recalls). This investigation will be conducted in a sample of healthy, normal and overweight, sedentary, young adult men and women; a group at high risk for development of overweight and obesity. The specific aims of this project are to determine the impact of the volume (1 vs. 3 sets) of a progressive RT protocol for inducing muscular hypertrophy, as recommended by the American College of Sports Medicine, on body weight and body composition (fat mass, fat-free mass (FFM), % body fat) and energy balance. Our results will provide information relative to the minimum volume of RT that may be associated with body weight/fat gain which may inform the development of guidelines for RT to prevent weight gain or to alter body composition. If RT has a favorable impact on energy balance and body composition, it may provide an attractive alternative to aerobic exercise for weight management for busy young adults, as RT requires minimal time, and no need to change clothes or shower (i.e. minimal or no sweating).
- Conditions
- Obesity
- Being tested
- Amount of resistance offered in training
- Keywords
- resistance and weight loss training
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amount of resistance offered in trainingOther
to determine the impact of the volume (1 vs. 3 sets) of a progressive resistance training protocol for inducing muscular hypertrophy
| Study group | Role | What they receive |
|---|---|---|
| Resistance training | Experimental | 1 set of progressive resistance training per session Receives: Other: Amount of resistance offered in training |
| 3 sets per session | Experimental | 3 sets of progressive resistance training per session Receives: Other: Amount of resistance offered in training |
| Control | No intervention | Non exercise control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Composition
Changes in body composition will be evaluated by measuring the change in percent body fat, total fat mass, and total lean mass by dual energy x-ray absorptiometry (DEXA).
Measured: 21 Months
Secondary outcomes (3)
Resting Metabolic Rate
Resting metabolic rate as measured by indirect calorimetry as kcal/day will be evaluated. Also, substrate oxidation (fat and carbohydrate oxidation) will be evaluated at these time points.
Measured: 9 months
Muscular Strength
One rep max strength will be measured on the chest and leg press.
Measured: 9 months
Daily Energy Expenditure
Total daily energy expenditure over a 14 day period will be measured using doubly labeled water.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startApr 2009
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Washburn, University of Kansas
- Investigators
- Richard A Washburn, PhD, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107691
- Sponsor's protocol ID
- HSCL17623
- Other IDs
- NIDDKRO180832
- Status last verified
- May 2015
- First submitted
- 26 Mar 2010
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Training Energy Balance & Weight Management
- ClinicalTrials.gov ID
- NCT01107691
- Acronym / sponsor ID
- HSCL17623
- Conditions
- Obesity
- Keywords
- resistance and weight loss training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Apr 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 21 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to investigate the effects of two levels of resistance weight training on body composition, energy expenditure, and energy intake in men and women. The weight training will take about one hour to complete. Participants will perform the training 3 days per week for 9 months in a private exercise room equipped with state of the art equipment and a personal trainer to help guide you through the exercises.
The project lasts 21 months total with one follow-up visit 1-year from your last training date. You will be required to stay in the Lawrence area and train 3 day/week over the summer \& holidays.
Detailed description
We propose to conduct a randomized controlled efficacy trial (RT-1 set vs. RT-3 sets vs. non exercise control) to evaluate the potential for a longer intervention (9 months RT with body composition assessments 1 yr post RT completion) with a higher volume of RT (3 sets) to enhance the effects on body composition and energy expenditure observed in the pilot, and to determine the impact of the 2 levels of RT on free-living energy balance (expenditure by doubly labeled water and intake by digital photography and 24-hr recalls). This investigation will be conducted in a sample of healthy, normal and overweight, sedentary, young adult men and women; a group at high risk for development of overweight and obesity. The specific aims of this project are to determine the impact of the volume (1 vs. 3 sets) of a progressive RT protocol for inducing muscular hypertrophy, as recommended by the American College of Sports Medicine, on body weight and body composition (fat mass, fat-free mass (FFM), % body fat) and energy balance. Our results will provide information relative to the minimum volume of RT that may be associated with body weight/fat gain which may inform the development of guidelines for RT to prevent weight gain or to alter body composition. If RT has a favorable impact on energy balance and body composition, it may provide an attractive alternative to aerobic exercise for weight management for busy young adults, as RT requires minimal time, and no need to change clothes or shower (i.e. minimal or no sweating).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resistance training | Experimental | Other: Amount of resistance offered in training1 set of progressive resistance training per session |
| 3 sets per session | Experimental | Other: Amount of resistance offered in training3 sets of progressive resistance training per session |
| Control | No intervention | –Non exercise control group |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- BMI 22-<30
- 18- 30 years old
- sedentary
- no medications
- weight stable for at least 3 months
Key exclusion criteria (4 listed)
- Tobacco/Drug user
- metabolism altering medication
- gain/lost 10lbs in the last 3 months
- current exerciser
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amount of resistance offered in trainingto determine the impact of the volume (1 vs. 3 sets) of a progressive resistance training protocol for inducing muscular hypertrophy | Other | 3 sets per session, Resistance training |
Primary outcome
Body Composition
Time frame: 21 Months
Changes in body composition will be evaluated by measuring the change in percent body fat, total fat mass, and total lean mass by dual energy x-ray absorptiometry (DEXA).
3 secondary outcomes
Resting Metabolic Rate
Time frame: 9 months
Muscular Strength
Time frame: 9 months
Daily Energy Expenditure
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard A Washburn, PhD principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amount of resistance offered in training in people with Obesity, run by University of Kansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Composition (time frame: 21 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2015.