ObesityNCT04680455
Strength Training for Men Living With Obesity
A study testing Online home-based strength training in people with Obesity, run by University of New Brunswick at 1 site in Canada.
Trial summary
Emerging evidence suggests that alternative obesity management strategies need to address barriers to engaging with regular physical activity to adopt healthier lifestyles. It is hypothesized that more men living with obesity who are exposed to an online home-based circuit strength training for 12 weeks will be more… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Online home-based strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 22 Sep 2020to 5 Jan 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men
- Body fat% of 25% or more
- Not reaching physical activity guidelines (150 min of moderate to vigorous intensity of aerobic exercises + two sessions of resistance training)
- being able to do weight training
Who cannot join
- Taking medications that can cause to change in heart rate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Potential Benefits of Strength Training for Men Living With Obesity
Emerging evidence suggests that alternative obesity management strategies need to address barriers to engaging with regular physical activity to adopt healthier lifestyles. It is hypothesized that more men living with obesity who are exposed to an online home-based circuit strength training for 12 weeks will be more physically active, 34 weeks after the intervention compared with people who are not exposed to the program.
Read the detailed description
Sixty men (age ≥ 18 years; body fat % ≥ 25) were randomly assigned to the intervention group (N=30) or the control condition (N=30) for 12 weeks. The intervention group did the online delivered circuit training, three sessions in a week. Adherence to the weekly physical activity guidelines was evaluated 46 weeks after being enrolled in the program using a heart rate tracker and an exercise log. Most variables (anthropometrics, body composition, resting heart rate, blood pressure, lipids profile, glucose) were measured at baseline and after 12, 24, and 46 weeks. Aerobic fitness and comfort with technology were measured at baseline. Perceived benefits/barriers of participation in exercise were captured at baseline and 12 weeks.
More participants in the intervention group adhered to the physical activity guidelines compared to the control group at 46 weeks (intervention 36.8% vs control 5.3%; p=0.021). However, the intervention group did not improve their health outcomes after 12, 24, and 46 weeks. Fewer barriers were reported after 12-week for the intervention group (p=0.02).
- Conditions
- Obesity
- Being tested
- Online home-based strength training
- Keywords
- Physical Activity, Men, Strength Training
- Medical subject headings
- Obesity, Motor Activity, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online home-based strength trainingOther
Body weight exercises (i.e., squats, tricep dips, lunges, and push-ups) delivered online through Teams
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants in the intervention group were asked to exercise three times per week while performing four basic bodyweight exercises in a circuit manner for 12 weeks while supervised online via the Microsoft TEAMs platform. Participants were eased into the program by completing 120 minutes of exercise in week one, 150 minutes in week two, and 180 minutes in the following weeks. Participants were supervised 3X/week for the first four weeks, then 2X/week for the next four weeks and 1X/week for the remaining four weeks. At each session, participants performed the four prescribed exercises (squats, tricep dips, lunges, and push-ups) for 45 seconds each, then switched immediately (15 seconds) to the next exercise followed by one minute of rest at the end of each circuit. Following this exercise program, men living with obesity were able to reach moderate intensity. Receives: Other: Online home-based strength training |
| Control | No intervention | Participants allocated to the control group received an online exercise resource for a 12-week workout plan covering fitness components required to reach both components of the weekly physical activity guidelines on their own. It was recommended that they do a minimum of 150 minutes of moderate to vigorous aerobic activities and two sessions of muscle-strengthening activities using an online program. No supervision was offered and no contact was permitted between the research team and participants from this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity Level
Adherence to the both components of the physical activity guidelines
Measured: 48 weeks
Secondary outcomes (6)
Cardiorespiratory fitness
Maximum volume of oxygen consumption (Vo2peak)
Measured: Baseline
BMI
Anthropometrics
Measured: 46 weeks
Waist circumference
Anthropometrics
Measured: 46 weeks
Body fat percentage
Body composition
Measured: 46 weeks
Muscle mass
Body composition
Measured: 46 weeks
Metabolic profile
High density lipoprotein, low density lipoprotein, triglyceride, resting heart rate, blood pressure
Measured: 46 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start22 Sep 2020
- Primary completion23 May 2021
- Study completion5 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Brunswick
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680455
- Sponsor's protocol ID
- UNew Brunswick
- Status last verified
- Nov 2021
- First submitted
- 1 Dec 2020
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keshavarz M, Senechal M, Bouchard DR. Online Circuit Training Increases Adherence to Physical Activity: A Randomized Controlled Trial of Men with Obesity. Med Sci Sports Exerc. 2023 Dec 1;55(12):2308-2315. doi: 10.1249/MSS.0000000000003270. Epub 2023 Aug 2.
PubMed 37535330
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Benefits of Strength Training for Men Living With Obesity
- ClinicalTrials.gov ID
- NCT04680455
- Acronym / sponsor ID
- UNew Brunswick
- Conditions
- Obesity
- Keywords
- Physical Activity, Men, Strength Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of New BrunswickUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 23 May 2021 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 23 Dec 2020 (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.
Emerging evidence suggests that alternative obesity management strategies need to address barriers to engaging with regular physical activity to adopt healthier lifestyles. It is hypothesized that more men living with obesity who are exposed to an online home-based circuit strength training for 12 weeks will be more physically active, 34 weeks after the intervention compared with people who are not exposed to the program.
Detailed description
Sixty men (age ≥ 18 years; body fat % ≥ 25) were randomly assigned to the intervention group (N=30) or the control condition (N=30) for 12 weeks. The intervention group did the online delivered circuit training, three sessions in a week. Adherence to the weekly physical activity guidelines was evaluated 46 weeks after being enrolled in the program using a heart rate tracker and an exercise log. Most variables (anthropometrics, body composition, resting heart rate, blood pressure, lipids profile, glucose) were measured at baseline and after 12, 24, and 46 weeks. Aerobic fitness and comfort with technology were measured at baseline. Perceived benefits/barriers of participation in exercise were captured at baseline and 12 weeks.
More participants in the intervention group adhered to the physical activity guidelines compared to the control group at 46 weeks (intervention 36.8% vs control 5.3%; p=0.021). However, the intervention group did not improve their health outcomes after 12, 24, and 46 weeks. Fewer barriers were reported after 12-week for the intervention group (p=0.02).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Online home-based strength trainingParticipants in the intervention group were asked to exercise three times per week while performing four basic bodyweight exercises in a circuit manner for 12 weeks while supervised online via the Microsoft TEAMs platform. Participants were eased into the program by completing 120 minutes of exercise in week one, 150 minutes in week two, and 180 minutes in the following weeks. Participants were supervised 3X/week for the first four weeks, then 2X/week for the next four weeks and 1X/week for the remaining four weeks. At each session, participants performed the four prescribed exercises (squats, tricep dips, lunges, and push-ups) for 45 seconds each, then switched immediately (15 seconds) to the next exercise followed by one minute of rest at the end of each circuit. Following this exercise program, men living with obesity were able to reach moderate intensity. |
| Control | No intervention | –Participants allocated to the control group received an online exercise resource for a 12-week workout plan covering fitness components required to reach both components of the weekly physical activity guidelines on their own. It was recommended that they do a minimum of 150 minutes of moderate to vigorous aerobic activities and two sessions of muscle-strengthening activities using an online program. No supervision was offered and no contact was permitted between the research team and participants from this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- men
- Body fat% of 25% or more
- Not reaching physical activity guidelines (150 min of moderate to vigorous intensity of aerobic exercises + two sessions of resistance training)
- being able to do weight training
Key exclusion criteria (1 listed)
- Taking medications that can cause to change in heart rate
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 |
|---|---|---|
| Online home-based strength trainingBody weight exercises (i.e., squats, tricep dips, lunges, and push-ups) delivered online through Teams | Other | Intervention |
Primary outcome
Physical activity Level
Time frame: 48 weeks
Adherence to the both components of the physical activity guidelines
6 secondary outcomes
Cardiorespiratory fitness
Time frame: Baseline
BMI
Time frame: 46 weeks
Waist circumference
Time frame: 46 weeks
Body fat percentage
Time frame: 46 weeks
Muscle mass
Time frame: 46 weeks
Metabolic profile
Time frame: 46 weeks
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 5 Jun 2023.
- Derived from this study: PubMed 37535330Keshavarz M, Senechal M, Bouchard DR. Online Circuit Training Increases Adherence to Physical Activity: A Randomized Controlled Trial of Men with Obesity. Med Sci Sports Exerc. 2023 Dec 1;55(12):2308-2315. doi: 10.1249/MSS.0000000000003270. Epub 2023 Aug 2.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online home-based strength training in people with Obesity, run by University of New Brunswick at 1 site in Canada.
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 4 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 5 Jun 2023. 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 Canada. 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?
Physical activity Level (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04680455, which also lists 1 linked publication.
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 5 Jun 2023.