Overweight and ObesityEXCELNCT05702840

EXerCise wEight Loss

A study testing Resistance exercise training + weight loss group and Weight loss only group (WL) in people with Overweight and Obesity, run by University of Glasgow at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The overall aim of this study is to investigate the effects of home-based resistance exercise programme on changes in body composition and strength during weight loss, in people living with obesity or overweight. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Overweight and Obesity
What is being tested?: Resistance exercise training + weight loss group and Weight loss only group (WL)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteUnited Kingdom
Study dates: 1 Feb 2023to 1 Feb 2024
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Obesity or overweight (BMI ≥ 25kg/m2).
Passing the Physical Activity Readiness Questionnaire (PAR-q+)

Who cannot join

Currently take part in more than 1.5 hours of structured exercise per week.
Having recently (<6 months) taken part in any resistance exercise training, taking any medications known to affect weight loss.
Actively engaged in a weight loss programme, having lost more than 2kg weight in the last 6 months.
Any other reason which would limit ability to perform the exercises and outcome measurements safely.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Stuart Robert Gray
Glasgow

Other trials in United Kingdom

About this study

Official title: The Effects of a Home-based Resistance Training Programme on Body Composition and Muscle Function During Weight Loss in People With Overweight or Obesity: a Randomised Controlled Pilot Trial

Conditions: Overweight and Obesity
Being tested: Resistance exercise training + weight loss group, Weight loss only group (WL)
Medical subject headings: Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Resistance exercise training + weight loss groupBehavioural
Doing resistance exercises as well as following the weight watchers weight loss programme for a 12-week period
Weight loss only group (WL)Behavioural
Only following the weight watchers weight loss programme for a 12-week period

Study groups in NCT05702840
Study group	Role	What they receive
Resistance exercise training + weight loss group (RT+WL)	Experimental	Participants (WL-RT) will be provided with a resistance exercise booklet containing instructions for exercises and links to demonstration videos. A demonstration and explanation of the exercises will be given at the beginning of the intervention, alongside a discussion of the principles of the programme such as starting level and progression. We will ask participants to perform the resistance exercises for 12-week period. Participants will be asked to perform exercises 3 times a week (3 sets reaching the RPE scale between 8 - 10 out of 10 (4-6 out of 10 in the first week)) for the intervention period. The exercises will include press-ups, band lateral raises, band seated low row, squat, lunge and calf raise. Receives: Behavioral: Resistance exercise training + weight loss group
Weight loss only group (WL)	Experimental	All participants (WL and WL-RT) will be provided with vouchers to access the weight watchers weight loss programme for a 12-week period. Weight Watchers is a commercially available programme and participants will set an initial goal to lose 5kg of body mass. If 5kg weight loss is achieved then the participant can chose further weight loss goals, as long as it would result in a body mass in the weight watchers healthy weight range (https://www.weightwatchers.com/uk/weight-loss/programme/tools/healthy-weight-chart).This plan works on the basis of an individualised points plan that can then be used by the participant to select foods/meals to consume throughout the day. Receives: Behavioral: Weight loss only group (WL)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in whole body lean mass
whole body lean mass measured via bio-electrical impedance
Measured: Change from baseline to 12 weeks

Secondary outcomes (6)

Change in whole body fat mass
whole body fat mass measured via bio-electrical impedance
Measured: Change from baseline to 12 weeks
Change in body mass
body mass measured on scales
Measured: Change from baseline to 12 weeks
Change in vastus lateralis muscle thickness
Muscle thickness of the vastus lateralis muscle measured via ultrasound
Measured: Change from baseline to 12 weeks
Change in knee extensor maximal isometric torque
Knee extensor maximal isometric torque measured during a maximal voluntary contraction
Measured: Change from baseline to 12 weeks
Change in grip strength
Grip strength measured with a hand held dynamometer
Measured: Change from baseline to 12 weeks
Change in functional physical abilities
A 30-second sit-to-stand test measured functional abilities
Measured: Change from baseline to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 20231 Feb 2024

First posted27 Jan 2023
Study start1 Feb 2023
Primary completion1 Feb 2024
Study completion1 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Overweight and 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomised controlled pilot trial with two groups, resistance exercise + weight loss group and weight loss only group.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05702840
Sponsor's protocol ID: EXerCise wEight Loss Study
Acronym: EXCEL
Status last verified: Feb 2024
First submitted: 18 Jan 2023
Last updated: 28 Feb 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Upadhyay J, Farr O, Perakakis N, Ghaly W, Mantzoros C. Obesity as a Disease. Med Clin North Am. 2018 Jan;102(1):13-33. doi: 10.1016/j.mcna.2017.08.004. Epub 2017 Oct 21.
PubMed 29156181
An R, Ji M, Zhang S. Global warming and obesity: a systematic review. Obes Rev. 2018 Feb;19(2):150-163. doi: 10.1111/obr.12624. Epub 2017 Oct 4.
PubMed 28977817
James PT, Leach R, Kalamara E, Shayeghi M. The worldwide obesity epidemic. Obes Res. 2001 Nov;9 Suppl 4:228S-233S. doi: 10.1038/oby.2001.123.
PubMed 11707546
Siervo M, Montagnese C, Mathers JC, Soroka KR, Stephan BC, Wells JC. Sugar consumption and global prevalence of obesity and hypertension: an ecological analysis. Public Health Nutr. 2014 Mar;17(3):587-96. doi: 10.1017/S1368980013000141. Epub 2013 Feb 18.
PubMed 23414749
Ge L, Sadeghirad B, Ball GDC, da Costa BR, Hitchcock CL, Svendrovski A, Kiflen R, Quadri K, Kwon HY, Karamouzian M, Adams-Webber T, Ahmed W, Damanhoury S, Zeraatkar D, Nikolakopoulou A, Tsuyuki RT, Tian J, Yang K, Guyatt GH, Johnston BC. Comparison of dietary macronutrient patterns of 14 popular named dietary programmes for weight and cardiovascular risk factor reduction in adults: systematic review and network meta-analysis of randomised trials. BMJ. 2020 Apr 1;369:m696. doi: 10.1136/bmj.m696.
PubMed 32238384
Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5.
PubMed 29221645
Cava E, Yeat NC, Mittendorfer B. Preserving Healthy Muscle during Weight Loss. Adv Nutr. 2017 May 15;8(3):511-519. doi: 10.3945/an.116.014506. Print 2017 May.
PubMed 28507015
Enriquez Guerrero A, San Mauro Martin I, Garicano Vilar E, Camina Martin MA. Effectiveness of an intermittent fasting diet versus continuous energy restriction on anthropometric measurements, body composition and lipid profile in overweight and obese adults: a meta-analysis. Eur J Clin Nutr. 2021 Jul;75(7):1024-1039. doi: 10.1038/s41430-020-00821-1. Epub 2020 Dec 9.
PubMed 33293678
Pellegrini M, Cioffi I, Evangelista A, Ponzo V, Goitre I, Ciccone G, Ghigo E, Bo S. Effects of time-restricted feeding on body weight and metabolism. A systematic review and meta-analysis. Rev Endocr Metab Disord. 2020 Mar;21(1):17-33. doi: 10.1007/s11154-019-09524-w.
PubMed 31808043
Wolfe RR. The underappreciated role of muscle in health and disease. Am J Clin Nutr. 2006 Sep;84(3):475-82. doi: 10.1093/ajcn/84.3.475.
PubMed 16960159
Sajoux I, Lorenzo PM, Gomez-Arbelaez D, Zulet MA, Abete I, Castro AI, Baltar J, Portillo MP, Tinahones FJ, Martinez JA, Crujeiras AB, Casanueva FF. Effect of a Very-Low-Calorie Ketogenic Diet on Circulating Myokine Levels Compared with the Effect of Bariatric Surgery or a Low-Calorie Diet in Patients with Obesity. Nutrients. 2019 Oct 4;11(10):2368. doi: 10.3390/nu11102368.
PubMed 31590286
Ashton RE, Tew GA, Aning JJ, Gilbert SE, Lewis L, Saxton JM. Effects of short-term, medium-term and long-term resistance exercise training on cardiometabolic health outcomes in adults: systematic review with meta-analysis. Br J Sports Med. 2020 Mar;54(6):341-348. doi: 10.1136/bjsports-2017-098970. Epub 2018 Jun 22.
PubMed 29934430
Cornelissen VA, Fagard RH, Coeckelberghs E, Vanhees L. Impact of resistance training on blood pressure and other cardiovascular risk factors: a meta-analysis of randomized, controlled trials. Hypertension. 2011 Nov;58(5):950-8. doi: 10.1161/HYPERTENSIONAHA.111.177071. Epub 2011 Sep 6.
PubMed 21896934
Plotnikoff RC, Eves N, Jung M, Sigal RJ, Padwal R, Karunamuni N. Multicomponent, home-based resistance training for obese adults with type 2 diabetes: a randomized controlled trial. Int J Obes (Lond). 2010 Dec;34(12):1733-41. doi: 10.1038/ijo.2010.109. Epub 2010 Jun 8.
PubMed 20531348
Mikesky AE, Topp R, Wigglesworth JK, Harsha DM, Edwards JE. Efficacy of a home-based training program for older adults using elastic tubing. Eur J Appl Physiol Occup Physiol. 1994;69(4):316-20. doi: 10.1007/BF00392037.
PubMed 7851367

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of a Home-based Resistance Training Programme on Body Composition and Muscle Function During Weight Loss in People With Overweight or Obesity: a Randomised Controlled Pilot Trial
ClinicalTrials.gov ID: NCT05702840
Acronym / sponsor ID: EXCEL / EXerCise wEight Loss Study
Conditions: Overweight and Obesity
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: University of GlasgowUniversity, hospital or other
Study start: 1 Feb 2023 (actual)
Primary completion: 1 Feb 2024 (actual)
Study completion: 1 Feb 2024 (actual)
First posted: 27 Jan 2023 (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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Randomised controlled pilot trial with two groups, resistance exercise + weight loss group and weight loss only group.

Arm	Type	Receives
Resistance exercise training + weight loss group (RT+WL)	Experimental	Behavioral: Resistance exercise training + weight loss groupParticipants (WL-RT) will be provided with a resistance exercise booklet containing instructions for exercises and links to demonstration videos. A demonstration and explanation of the exercises will be given at the beginning of the intervention, alongside a discussion of the principles of the programme such as starting level and progression. We will ask participants to perform the resistance exercises for 12-week period. Participants will be asked to perform exercises 3 times a week (3 sets reaching the RPE scale between 8 - 10 out of 10 (4-6 out of 10 in the first week)) for the intervention period. The exercises will include press-ups, band lateral raises, band seated low row, squat, lunge and calf raise.
Weight loss only group (WL)	Experimental	Behavioral: Weight loss only group (WL)All participants (WL and WL-RT) will be provided with vouchers to access the weight watchers weight loss programme for a 12-week period. Weight Watchers is a commercially available programme and participants will set an initial goal to lose 5kg of body mass. If 5kg weight loss is achieved then the participant can chose further weight loss goals, as long as it would result in a body mass in the weight watchers healthy weight range (https://www.weightwatchers.com/uk/weight-loss/programme/tools/healthy-weight-chart).This plan works on the basis of an individualised points plan that can then be used by the participant to select foods/meals to consume throughout the day.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Obesity or overweight (BMI ≥ 25kg/m2).
Passing the Physical Activity Readiness Questionnaire (PAR-q+)

Key exclusion criteria (4 listed)

Currently take part in more than 1.5 hours of structured exercise per week.
Having recently (<6 months) taken part in any resistance exercise training, taking any medications known to affect weight loss.
Actively engaged in a weight loss programme, having lost more than 2kg weight in the last 6 months.
Any other reason which would limit ability to perform the exercises and outcome measurements safely.

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
Resistance exercise training + weight loss groupDoing resistance exercises as well as following the weight watchers weight loss programme for a 12-week period	Behavioural	Resistance exercise training + weight loss group (RT+WL)
Weight loss only group (WL)Only following the weight watchers weight loss programme for a 12-week period	Behavioural	Weight loss only group (WL)

Primary outcome

Change in whole body lean mass
Time frame: Change from baseline to 12 weeks
whole body lean mass measured via bio-electrical impedance

6 secondary outcomes

Change in whole body fat mass
Time frame: Change from baseline to 12 weeks
Change in body mass
Time frame: Change from baseline to 12 weeks
Change in vastus lateralis muscle thickness
Time frame: Change from baseline to 12 weeks
Change in knee extensor maximal isometric torque
Time frame: Change from baseline to 12 weeks
Change in grip strength
Time frame: Change from baseline to 12 weeks
Change in functional physical abilities
Time frame: Change from baseline to 12 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 28 Feb 2024.
Background: PubMed 29156181Upadhyay J, Farr O, Perakakis N, Ghaly W, Mantzoros C. Obesity as a Disease. Med Clin North Am. 2018 Jan;102(1):13-33. doi: 10.1016/j.mcna.2017.08.004. Epub 2017 Oct 21.
Background: PubMed 28977817An R, Ji M, Zhang S. Global warming and obesity: a systematic review. Obes Rev. 2018 Feb;19(2):150-163. doi: 10.1111/obr.12624. Epub 2017 Oct 4.
Background: PubMed 11707546James PT, Leach R, Kalamara E, Shayeghi M. The worldwide obesity epidemic. Obes Res. 2001 Nov;9 Suppl 4:228S-233S. doi: 10.1038/oby.2001.123.
Background: PubMed 23414749Siervo M, Montagnese C, Mathers JC, Soroka KR, Stephan BC, Wells JC. Sugar consumption and global prevalence of obesity and hypertension: an ecological analysis. Public Health Nutr. 2014 Mar;17(3):587-96. doi: 10.1017/S1368980013000141. Epub 2013 Feb 18.
Background: PubMed 32238384Ge L, Sadeghirad B, Ball GDC, da Costa BR, Hitchcock CL, Svendrovski A, Kiflen R, Quadri K, Kwon HY, Karamouzian M, Adams-Webber T, Ahmed W, Damanhoury S, Zeraatkar D, Nikolakopoulou A, Tsuyuki RT, Tian J, Yang K, Guyatt GH, Johnston BC. Comparison of dietary macronutrient patterns of 14 popular named dietary programmes for weight and cardiovascular risk factor reduction in adults: systematic review and network meta-analysis of randomised trials. BMJ. 2020 Apr 1;369:m696. doi: 10.1136/bmj.m696.
Background: PubMed 29221645Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5.
Background: PubMed 28507015Cava E, Yeat NC, Mittendorfer B. Preserving Healthy Muscle during Weight Loss. Adv Nutr. 2017 May 15;8(3):511-519. doi: 10.3945/an.116.014506. Print 2017 May.
Background: PubMed 33293678Enriquez Guerrero A, San Mauro Martin I, Garicano Vilar E, Camina Martin MA. Effectiveness of an intermittent fasting diet versus continuous energy restriction on anthropometric measurements, body composition and lipid profile in overweight and obese adults: a meta-analysis. Eur J Clin Nutr. 2021 Jul;75(7):1024-1039. doi: 10.1038/s41430-020-00821-1. Epub 2020 Dec 9.
Background: PubMed 31808043Pellegrini M, Cioffi I, Evangelista A, Ponzo V, Goitre I, Ciccone G, Ghigo E, Bo S. Effects of time-restricted feeding on body weight and metabolism. A systematic review and meta-analysis. Rev Endocr Metab Disord. 2020 Mar;21(1):17-33. doi: 10.1007/s11154-019-09524-w.
Background: PubMed 16960159Wolfe RR. The underappreciated role of muscle in health and disease. Am J Clin Nutr. 2006 Sep;84(3):475-82. doi: 10.1093/ajcn/84.3.475.
Background: PubMed 31590286Sajoux I, Lorenzo PM, Gomez-Arbelaez D, Zulet MA, Abete I, Castro AI, Baltar J, Portillo MP, Tinahones FJ, Martinez JA, Crujeiras AB, Casanueva FF. Effect of a Very-Low-Calorie Ketogenic Diet on Circulating Myokine Levels Compared with the Effect of Bariatric Surgery or a Low-Calorie Diet in Patients with Obesity. Nutrients. 2019 Oct 4;11(10):2368. doi: 10.3390/nu11102368.
Background: PubMed 29934430Ashton RE, Tew GA, Aning JJ, Gilbert SE, Lewis L, Saxton JM. Effects of short-term, medium-term and long-term resistance exercise training on cardiometabolic health outcomes in adults: systematic review with meta-analysis. Br J Sports Med. 2020 Mar;54(6):341-348. doi: 10.1136/bjsports-2017-098970. Epub 2018 Jun 22.

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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 Resistance exercise training + weight loss group and Weight loss only group (WL) in people with Overweight and Obesity, run by University of Glasgow at 1 site in United Kingdom.

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 2 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 28 Feb 2024. 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 Kingdom. 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?

Change in whole body lean mass (time frame: Change from baseline to 12 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 NCT05702840, which also lists 18 linked publications.

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 28 Feb 2024.