Overweight and ObesityNCT05622149
Is Strength Training a Viable Exercise Modality for Fat Loss?
A study testing Diet Only, Training Only and Diet plus Training in people with Overweight and Obesity, run by George Washington University.
Trial summary
The purpose of this study is to determine whether strength training can be used as a viable exercise modality for the purpose of inducing fat loss. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Diet Only, Training Only and Diet plus Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 18 Mar 2016to 1 Oct 2016
- 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 25 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 25-29.9 normally menstruating bodyfat >30%
Who cannot join
- currently dieting to lose weight currently engaged in structured exercise using dietary weight loss supplements Resting Metabolic Rate not within 10% of predicted value
About this study
The purpose of this study is to determine whether strength training can be used as a viable exercise modality for the purpose of inducing fat loss.
Read the detailed description
Aerobic exercise (AE) is commonly recommended as the most effective exercise modality for weight loss. The Centers for Disease Control (CDC) recommends 150 minutes of AE for weight maintenance, and an unspecified greater amount required for weight loss. Similarly, the American College of Sports Medicine (ACSM) position stand on physical activity for weight loss recommends 150-250 minutes per week of moderate intensity physical activity. While the ACSM promotes resistance training (RT) as a means of increasing fat free mass, which should lead to improved body composition, it does not promote RT for losing significant amounts of body fat. Similarly, the CDC physical activity guidelines for weight loss do not mention RT at all as a viable exercise modality for weight loss. This is not surprising, as there is a paucity of research examining the effects of RT on weight loss. Furthermore, the few studies that have explored RT for weight loss generally show that it is ineffective. The effectiveness of any weight loss program is dependent on the size of the caloric deficit that is created over time, and since AE generally burns more calories per unit of time than RT, it stands to reason that AE would be the most commonly prescribed type of exercise for weight loss. Contributing to the exclusion of RT for weight loss is a widespread belief among dietitians, nutritionists and exercise professionals that it is not possible to induce muscle growth while in a caloric deficit, and since the creation of a caloric deficit is essential for fat loss, the use of RT for muscle growth in a caloric deficit is counter intuitive.
However, RT has been shown to elevate resting metabolism for an extended period of time following cessation of the training session. Additionally, having a greater muscle mass should lead to a greater resting metabolism. Unlike RT, chronic AE performed in a caloric deficit (which is often the recommendation for effective weight loss) has the potential to lead to significant decreases in muscle mass, thereby hampering improvements in body composition. Ideally, a program designed to improve body composition should do so through fat losses alone, with muscle mass being maintained or increased.
Several reasons could exist for the lack of effectiveness of RT shown in most studies. These reasons include, but are not limited to, 1) Body mass being the measured outcome and not body composition, 2) lack of control and/or measurement of caloric intake, 3) failure to adjust dietary protein needs to support muscle growth, 4) ineffective RT program design. Case studies of clients from our lab have routinely shown that profound decreases in bodyfat can be induced with RT as the exclusive form of exercise. Furthermore, these decreases in bodyfat occur with concomitant increases in muscle mass, while in a caloric deficit. Therefore, the specific aims of this proposal are:
- To determine whether RT combined with dietary intervention (RT+DIET) results in greater decreases in fat mass than (RT) or dietary intervention (DIET) alone.
- To determine whether RT combined with dietary intervention (RT+DIET) results in greater improvements in body composition than (RT) or dietary intervention (DIET) alone.
- To determine whether concomitant increases in muscle mass and decreases in fat mass can occur while in a caloric deficit.
The goal of this project is to serve to generate pilot data to determine whether RT can be used as a viable exercise mode for fat loss and muscle gain. We will then pursue funding for a subsequent study that compares the effects of RT versus AE on body composition and fat loss when 1) the caloric intake is monitored to ensure the creation of a caloric deficit, and 2) dietary protein is appropriately increased to support muscle retention/growth.
- Conditions
- Overweight and Obesity
- Being tested
- Diet Only, Training Only, Diet plus Training
- Keywords
- resistance training; metabolism
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet OnlyBehavioural
Food tracking based on macronutrient goals.
Training OnlyBehavioural
Subjects completed 16 weeks of supervised resistance training
Diet plus TrainingBehavioural
Food tracking plus resistance training.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention |
| Diet Only | Experimental | Subjects were given calorie and macronutrient intake goals and were told to hit those goals as closely as possible on a daily basis for 16 weeks. Receives: Behavioral: Diet Only |
| Training Only | Experimental | Subjects were given a 3 times per week supervised resistance training program for 16 weeks Receives: Behavioral: Training Only |
| Diet plus Training | Experimental | Subjects were given calorie and macronutrient intake goals and were told to hit those goals as closely as possible on a daily basis for 16 weeks. Subjects were given a 3 times per week supervised resistance training program for 16 weeks Receives: Behavioral: Diet plus Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fat Free Mass
Fat Free Mass as measured from DXA and recorded in Kg
Measured: 0 and 16 weeks
Change in Fat Mass
Fat Mass as measured from DXA and recorded in Kg
Measured: 0, 4, 8, 12, 16 weeks
Change in Resting Metabolic Rate
Resting Metabolic Rate measured via indirect calorimetry and recorded in kcal / day
Measured: 0 and 16 weeks
Change in Visceral Fat
Fat in the Visceral Depot measured from DXA and recorded in Kg
Measured: 0, 4, 8, 12, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start18 Mar 2016
- Primary completion1 Oct 2016
- Study completion1 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- City University of New York
- Responsible party
- Principal investigator, Todd Miller, George Washington University
- Investigators
- Todd A Miller, PhD, Principal investigator, George Washington University SPH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622149
- Sponsor's protocol ID
- 011638
- Status last verified
- Nov 2022
- First submitted
- 19 Mar 2018
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Strength Training a Viable Exercise Modality for Fat Loss?
- ClinicalTrials.gov ID
- NCT05622149
- Acronym / sponsor ID
- 011638
- Conditions
- Overweight and Obesity
- Keywords
- resistance training; metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- City University of New York
- Study start
- 18 Mar 2016 (actual)
- Primary completion
- 1 Oct 2016 (actual)
- Study completion
- 1 Oct 2016 (actual)
- First posted
- 18 Nov 2022 (actual)
- 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.
The purpose of this study is to determine whether strength training can be used as a viable exercise modality for the purpose of inducing fat loss.
Detailed description
Aerobic exercise (AE) is commonly recommended as the most effective exercise modality for weight loss. The Centers for Disease Control (CDC) recommends 150 minutes of AE for weight maintenance, and an unspecified greater amount required for weight loss. Similarly, the American College of Sports Medicine (ACSM) position stand on physical activity for weight loss recommends 150-250 minutes per week of moderate intensity physical activity. While the ACSM promotes resistance training (RT) as a means of increasing fat free mass, which should lead to improved body composition, it does not promote RT for losing significant amounts of body fat. Similarly, the CDC physical activity guidelines for weight loss do not mention RT at all as a viable exercise modality for weight loss. This is not surprising, as there is a paucity of research examining the effects of RT on weight loss. Furthermore, the few studies that have explored RT for weight loss generally show that it is ineffective. The effectiveness of any weight loss program is dependent on the size of the caloric deficit that is created over time, and since AE generally burns more calories per unit of time than RT, it stands to reason that AE would be the most commonly prescribed type of exercise for weight loss. Contributing to the exclusion of RT for weight loss is a widespread belief among dietitians, nutritionists and exercise professionals that it is not possible to induce muscle growth while in a caloric deficit, and since the creation of a caloric deficit is essential for fat loss, the use of RT for muscle growth in a caloric deficit is counter intuitive.
However, RT has been shown to elevate resting metabolism for an extended period of time following cessation of the training session. Additionally, having a greater muscle mass should lead to a greater resting metabolism. Unlike RT, chronic AE performed in a caloric deficit (which is often the recommendation for effective weight loss) has the potential to lead to significant decreases in muscle mass, thereby hampering improvements in body composition. Ideally, a program designed to improve body composition should do so through fat losses alone, with muscle mass being maintained or increased.
Several reasons could exist for the lack of effectiveness of RT shown in most studies. These reasons include, but are not limited to, 1) Body mass being the measured outcome and not body composition, 2) lack of control and/or measurement of caloric intake, 3) failure to adjust dietary protein needs to support muscle growth, 4) ineffective RT program design. Case studies of clients from our lab have routinely shown that profound decreases in bodyfat can be induced with RT as the exclusive form of exercise. Furthermore, these decreases in bodyfat occur with concomitant increases in muscle mass, while in a caloric deficit. Therefore, the specific aims of this proposal are:
- To determine whether RT combined with dietary intervention (RT+DIET) results in greater decreases in fat mass than (RT) or dietary intervention (DIET) alone.
- To determine whether RT combined with dietary intervention (RT+DIET) results in greater improvements in body composition than (RT) or dietary intervention (DIET) alone.
- To determine whether concomitant increases in muscle mass and decreases in fat mass can occur while in a caloric deficit.
The goal of this project is to serve to generate pilot data to determine whether RT can be used as a viable exercise mode for fat loss and muscle gain. We will then pursue funding for a subsequent study that compares the effects of RT versus AE on body composition and fat loss when 1) the caloric intake is monitored to ensure the creation of a caloric deficit, and 2) dietary protein is appropriately increased to support muscle retention/growth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention |
| Diet Only | Experimental | Behavioral: Diet OnlySubjects were given calorie and macronutrient intake goals and were told to hit those goals as closely as possible on a daily basis for 16 weeks. |
| Training Only | Experimental | Behavioral: Training OnlySubjects were given a 3 times per week supervised resistance training program for 16 weeks |
| Diet plus Training | Experimental | Behavioral: Diet plus TrainingSubjects were given calorie and macronutrient intake goals and were told to hit those goals as closely as possible on a daily basis for 16 weeks. Subjects were given a 3 times per week supervised resistance training program for 16 weeks |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 25-29.9 normally menstruating bodyfat >30%
Key exclusion criteria (1 listed)
- currently dieting to lose weight currently engaged in structured exercise using dietary weight loss supplements Resting Metabolic Rate not within 10% of predicted value
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 |
|---|---|---|
| Diet OnlyFood tracking based on macronutrient goals. | Behavioural | Diet Only |
| Training OnlySubjects completed 16 weeks of supervised resistance training | Behavioural | Training Only |
| Diet plus TrainingFood tracking plus resistance training. | Behavioural | Diet plus Training |
Primary outcome
Change in Fat Free Mass
Time frame: 0 and 16 weeks
Fat Free Mass as measured from DXA and recorded in Kg
Change in Fat Mass
Time frame: 0, 4, 8, 12, 16 weeks
Fat Mass as measured from DXA and recorded in Kg
Change in Resting Metabolic Rate
Time frame: 0 and 16 weeks
Resting Metabolic Rate measured via indirect calorimetry and recorded in kcal / day
Change in Visceral Fat
Time frame: 0, 4, 8, 12, 16 weeks
Fat in the Visceral Depot measured from DXA and recorded in Kg
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 18 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Todd A Miller, PhD principal investigator
George Washington University SPH
Questions about this trial
What is this clinical trial studying?
A study testing Diet Only, Training Only and Diet plus Training in people with Overweight and Obesity, run by George Washington University.
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 1 inclusion and 1 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 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Fat Free Mass (time frame: 0 and 16 weeks). The study lists 4 primary outcomes in all. 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 18 Nov 2022.