NCT05702840

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

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

January 18, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

January 18, 2023

Last Update Submit

February 26, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in whole body lean mass

    whole body lean mass measured via bio-electrical impedance

    Change from baseline to 12 weeks

Secondary Outcomes (6)

  • Change in whole body fat mass

    Change from baseline to 12 weeks

  • Change in body mass

    Change from baseline to 12 weeks

  • Change in vastus lateralis muscle thickness

    Change from baseline to 12 weeks

  • Change in knee extensor maximal isometric torque

    Change from baseline to 12 weeks

  • Change in grip strength

    Change from baseline to 12 weeks

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Weight loss only group (WL)

Interventions

Doing resistance exercises as well as following the weight watchers weight loss programme for a 12-week period

Resistance exercise training + weight loss group (RT+WL)

Only following the weight watchers weight loss programme for a 12-week period

Weight loss only group (WL)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stuart Robert Gray

Glasgow, United Kingdom

Location

Related Publications (18)

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    PMID: 23414749BACKGROUND
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    PMID: 32238384BACKGROUND
  • 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.

    PMID: 29221645BACKGROUND
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    PMID: 28507015BACKGROUND
  • 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.

    PMID: 33293678BACKGROUND
  • 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.

    PMID: 31808043BACKGROUND
  • 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.

    PMID: 16960159BACKGROUND
  • 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.

    PMID: 31590286BACKGROUND
  • 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.

    PMID: 29934430BACKGROUND
  • 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.

    PMID: 21896934BACKGROUND
  • 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.

    PMID: 20531348BACKGROUND
  • 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.

    PMID: 7851367BACKGROUND
  • Zion AS, De Meersman R, Diamond BE, Bloomfield DM. A home-based resistance-training program using elastic bands for elderly patients with orthostatic hypotension. Clin Auton Res. 2003 Aug;13(4):286-92. doi: 10.1007/s10286-003-0117-3.

    PMID: 12955554BACKGROUND
  • NIH Consensus statement. Bioelectrical impedance analysis in body composition measurement. National Institutes of Health Technology Assessment Conference Statement. December 12-14, 1994. Nutrition. 1996 Nov-Dec;12(11-12):749-62.

    PMID: 8974099BACKGROUND
  • Binmahfoz A, Johnston L, Dunning E, Gray CM, Gray SR. The effects of a home-based resistance training programme on body composition and muscle function during weight loss in people living with overweight or obesity: a randomised controlled pilot trial. Nutr Metab (Lond). 2025 Aug 4;22(1):90. doi: 10.1186/s12986-025-00986-1.

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Members of the research team that perform measurements are blinded to group allocation.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Randomised controlled pilot trial with two groups, resistance exercise + weight loss group and weight loss only group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 18, 2023

First Posted

January 27, 2023

Study Start

February 1, 2023

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations