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The effectiveness of a information graph-based life-style intervention advice system in bettering physique composition, muscle energy, and bodily operate in sarcopenic weight problems: Study protocol for a randomized managed trial

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Citation: Liu X, Lu Y, Fu M, Huang Z, Shi T, Zou J, et al. (2026) The effectiveness of a information graph-based life-style intervention advice system in bettering physique composition, muscle energy, and bodily operate in sarcopenic weight problems: Study protocol for a randomized managed trial. PLoS One 21(7):
e0353945.

https://doi.org/10.1371/journal.pone.0353945

Editor: Alessandra Coin, University of Padua: Universita degli Studi di Padova, ITALY

Received: January 14, 2026; Accepted: June 24, 2026; Published: July 27, 2026

Copyright: © 2026 Liu et al. This is an open entry article distributed underneath the phrases of the Creative Commons Attribution License, which allows unrestricted use, distribution, and copy in any medium, supplied the unique writer and supply are credited.

Data Availability: Data availability assertion: Data availabilitystatement: No datasets have been generated or analysed through the present examine. All related datafrom this examine will probably be made obtainable uponstudy completion.

Funding: Guangzhou University of Chinese Medicine “Double First-Class” Discipline High-Quality Development “Peak-Building and Excellence-Forging” Action Plan (2024–2027) [No. GZY2025GB0925]. Futian Healthcare Research Project [No. FTWS2025038]. Chronic Disease Management Research Project of National Health Commission Capacity Building and Continuing Education Center [No. GWJJMB202510024225].

Competing pursuits: The authors have declared that no competing pursuits exist.

Introduction

Sarcopenic weight problems (SO) is characterised by the coexistence of sarcopenia and weight problems, representing a definite scientific situation fairly than a easy mixture of the 2 issues. The interplay between extra adiposity and impaired muscle mass or operate will increase the danger of hostile well being outcomes. In 2022, the European Society for Clinical Nutrition and Metabolism (ESPEN) and the European Association for the Study of Obesity (EASO) printed an professional consensus defining SO as a scientific and purposeful dysfunction characterised by elevated physique fats mass accompanied by diminished skeletal muscle mass or operate [1]. Sedentary life-style, dysregulated fats metabolism, and metabolic adjustments related to acute or power comorbidities are necessary contributors to the event of SO [2]. Research signifies that sarcopenia impacts roughly 43% of chubby or overweight ladies and 42% of chubby or overweight males [3]. In the United States, the prevalence of SO was reported to be 8.1% amongst people aged 20–59 years and 28.3% amongst these aged ≥60 years. The prevalence additional elevated within the presence of metabolic abnormalities, reaching 19.7% in prediabetes, 34.5% in kind 2 diabetes, and 25.4% in metabolic-associated fatty liver illness with fibrosis [4]. In a examine involving 730 kids and adolescents aged 4–14 years, utilizing the muscle mass-to-fat mass ratio primarily based on the third BMI quintile because the diagnostic cutoff (1.22 kg/kg for females and 1.35 kg/kg for males), the prevalence of SO was 9.3% in women and seven.2% in boys [5].

The metabolic influence of SO exceeds that of sarcopenia or weight problems alone. In SO, extra adipose tissue shops massive quantities of fatty acids, selling the buildup of proinflammatory cells inside adipose tissue and creating an inflammatory milieu that induces insulin resistance, mitochondrial dysfunction, and oxidative stress [6]. In skeletal muscle, these processes set off inflammatory and oxidative stress responses, speed up muscle protein degradation and myocyte apoptosis, and promote muscle catabolism and impaired regeneration, finally resulting in sarcopenia. Muscle cell damage additional reduces bodily efficiency and bodily exercise, worsening weight problems and establishing a vicious cycle that will increase the danger of metabolic ailments and purposeful impairment [2]. SO considerably raises the danger of coronary heart illness, metabolic syndrome, dementia, and postoperative problems. It additionally considerably elevates the danger of frailty, incapacity, and despair, with 2.7-fold and a couple of.9-fold increased dangers of falls and incapacity, respectively [7–9], and a 24% enhance in all-cause mortality [10]. Consequently, SO imposes a substantial burden on public well being, households, and society. Once established, SO might persist all through life, underscoring the significance of early recognition and intervention to scale back hostile metabolic outcomes. However, most sufferers with SO are recognized solely after extreme purposeful impairment attributable to muscle loss has already occurred [11], leading to missed alternatives for optimum early remedy.

Management of SO focuses on bettering muscle mass whereas decreasing extra adiposity. However, sarcopenia and weight problems are presently handled as separate scientific situations [10]. In aged sufferers with SO, this separation creates challenges in dietary administration as a result of the necessity for elevated protein consumption might battle with calorie restriction targets [12]. Similar challenges come up when combining resistance coaching to extend muscle mass with cardio train aimed toward fats discount. In addition, substantial interindividual variations in bodily situation, illness standing, and metabolic price make it troublesome to design individualized dietary, dietary, and train interventions. Effective administration, subsequently, requires collaboration amongst a number of skilled groups, making scientific implementation complicated and time-consuming.

Internet-based advice methods supply a novel technique for customized well being interventions [13]. Health advice methods are specialised advice methods that present customers with customized well being data by mechanically figuring out and recommending acceptable content material primarily based on particular person well being situations and wishes [14]. In current years, information graph-based advice methods have been extensively utilized in domains equivalent to motion pictures, music, information, and product suggestions [15–17]. By incorporating information graphs as auxiliary data, these methods successfully deal with the sparsity and cold-start limitations of conventional advice methods. Knowledge graph-based fashions can mine relational information and combine it with current person and merchandise data, growing information dimensionality and bettering advice accuracy. Although advice methods have lengthy been studied in healthcare, their utility in SO administration stays restricted.

Based on this, we designed a randomized managed trial to judge the effectiveness of a knowledge-graph-based care advice system in bettering physique composition, muscle energy, and bodily operate amongst sufferers with SO. We hypothesize that sufferers receiving this clever system-based intervention will obtain higher scientific advantages than these receiving normal care, thereby offering new evidence-based help and a possible technique for precision and clever administration of power ailments within the aged.

Methods

Study design

This single-blind, two-arm randomized managed trial is designed to judge the consequences of a information graph-based life-style advice system on skeletal muscle mass, grip energy, skeletal muscle mass index, physique fats proportion, bodily operate, and high quality of life in sufferers with SO. Participants will probably be randomly assigned in a 1:1 ratio to both the intervention group or the management group. The intervention group will obtain a 24-week life-style intervention aimed toward growing muscle mass and decreasing weight, whereas the management group will obtain standard remedy and well being training with out customized suggestions from the system. The complete examine length is 48 weeks, comprising a 24-week intervention interval adopted by a 24-week follow-up interval. Assessments will probably be carried out at baseline and at weeks 8, 16, 24, and 48, with week 24 marking the tip of the intervention. Thereafter, each teams will enter a follow-up part with out systematic intervention and will probably be noticed till week 48. The randomization sequence will probably be generated by a statistician utilizing a computer-generated block randomization with block sizes of 4 or 6. Allocation concealment will probably be ensured via a password-protected centralized community system accessible solely to impartial registrars not concerned in consequence evaluation after completion of baseline assessments. Because of the character of the life-style intervention, blinding of individuals and intervention implementers shouldn’t be doable. However, consequence assessors and statistical analysts will stay blinded all through the examine. All consequence assessments will probably be accomplished by uniformly educated impartial assessors unaware of group allocation. Data managers and statistical analysts will stay blinded till database lock. Participants will probably be instructed to not disclose their group allocation to assessors, and an emergency unblinding process will probably be established if required. Intervention reporting will comply with the Template for Intervention Description and Replication (TIDieR) guidelines. The examine protocol is developed in accordance with the SPIRIT assertion (S1 File). Fig 1 and Fig 2 illustrate the proposed examine timeline and procedures.

Inclusion standards

Participants will probably be eligible in the event that they meet the entire following standards:

  1. 1) SO was recognized primarily based on the concurrent presence of sarcopenia, weight problems, and ample baseline purposeful capability [18]. Sarcopenia will probably be outlined based on the Asian Working Group for Sarcopenia (AWGS) 2019 standards, requiring low muscle energy alongside both diminished bodily efficiency or low muscle mass. Low muscle energy will probably be outlined as handgrip energy <28 kg for males and <18 kg for ladies. Reduced bodily efficiency or low muscle mass will probably be outlined as a Short Physical Performance Battery (SPPB) rating ≤9, or an appendicular skeletal muscle mass index (ASMI) <7.0 kg/m2 in males and <5.4 kg/m2 in ladies, assessed utilizing dual-energy X-ray absorptiometry (DXA) [19]. Obesity will probably be outlined as both a physique mass index (BMI) ≥28 kg/m2 or a physique fats proportion >25% in males and >30% in ladies, measured utilizing the InBody 770 system [20].
  2. 2) Age ≥ 60 years;
  3. 3) Ability to securely take part within the intervention;
  4. 4) Willingness to bear examine assessments and provision of written knowledgeable consent voluntarily.

Discontinuation of the intervention and withdrawal from the examine

Participants might discontinue the intervention or withdraw from the examine at any time. Discontinuation of the intervention won’t be considered withdrawal from the examine except the participant explicitly requests withdrawal or declines additional follow-up. Participants who discontinue the intervention will probably be inspired to finish all scheduled follow-up assessments each time doable. The intervention could also be briefly suspended or completely discontinued on the investigator’s discretion underneath any of the next circumstances:

  1. 1) incidence of a critical hostile occasion, an hostile occasion thought of associated to the intervention, or another situation that makes continued intervention unsafe;
  2. 2) vital deterioration in key well being indicators or the event of scientific situations that make continued intervention inappropriate;
  3. 3) persistent insufficient adherence regardless of reminders and evaluation of doable causes, outlined as weekly adherence of <50% for 2 consecutive weeks or general adherence of <50% through the examine interval;
  4. 4) incapacity to know or comply with the intervention suggestions or a newly recognized or beforehand undisclosed medical situation that will compromise intervention security;
  5. 5) a request by the participant to discontinue the intervention or withdraw from the examine.

For individuals who discontinue the intervention or withdraw from the examine, investigators will make affordable efforts, with the participant’s consent, to doc the rationale for and date of discontinuation or withdrawal and to finish possible security and consequence assessments. Appropriate scientific administration will probably be supplied if discontinuation is expounded to hostile occasions, deterioration in well being standing, or unsatisfactory remedy results.

All obtainable information collected earlier than discontinuation or withdrawal will probably be included within the evaluation except the participant withdraws consent for information use. No alternative individuals will probably be recruited. All randomized individuals will probably be analyzed based on the intention-to-treat (ITT) precept, no matter intervention discontinuation, protocol deviations, or adherence stage. Protocol deviations, unresolved data-quality points, and adherence-related points will probably be documented and thought of in sensitivity or per-protocol analyses, as acceptable.

Sample measurement

The pattern measurement was calculated utilizing G-power 3.1 software program. The calculation was primarily based on a two-sided comparability of the imply change in skeletal muscle mass (SMM) between the 2 teams, with SMM prespecified as the only real major confirmatory consequence. The anticipated impact measurement was derived from a earlier Internet-based diet and train intervention examine in older adults with sarcopenia [21]. In that examine, the imply change in SMM was −0.10 kg within the management group and 1.09 kg within the complete intervention group, comparable to a between-group distinction of 1.19 kg. Because the usual deviation of the SMM change rating was circuitously reported, it was conservatively estimated from the reported baseline and post-intervention normal deviations, assuming a pre-post correlation coefficient of 0.50. This yielded an estimated pooled normal deviation of roughly 2.70 kg and a Cohen’s d of roughly 0.44. Although the proposed intervention incorporates a information graph-based advice system that will improve intervention individualization, this reasonable impact measurement was adopted to keep away from overestimating the intervention impact. With a two-sided α stage of 0.05, energy of 0.80, and a 1:1 allocation ratio, 83 individuals have been required per group. Factoring an anticipated dropout price of 20%, 104 individuals will probably be enrolled in every group, leading to a complete pattern measurement of 208 individuals.

Procedure

Potential individuals will first bear screening to find out eligibility, together with evaluation of medical historical past and life-style habits. Individuals assembly the eligibility standards will probably be invited to an in-person go to, throughout which the examine procedures will probably be defined and written knowledgeable consent will probably be obtained.

All baseline assessments will probably be accomplished on a single day following participant enrolment. Upon arrival on the hospital, individuals will full questionnaires gathering demographic and scientific data, together with intercourse, age, peak, weight, marital standing, residence deal with, and get in touch with data. Body composition measurements and bodily health exams will then be carried out to evaluate mobility, muscle energy, and general bodily operate. Participants may even full supplementary questionnaires at residence masking dietary standing, high quality of life, and SO-related signs.

After baseline evaluation, educated analysis workers will help individuals within the intervention group with downloading and utilizing the SO-KGCS system. Based on baseline evaluation outcomes, the system will present customized plans for diet, train, and life-style modification. Participants within the intervention group will obtain common customized updates via the system, whereas these within the management group will obtain normal well being training. The intervention interval will final 24 weeks. During the examine, all individuals will probably be instructed to take care of a each day calorie consumption roughly 200 kcal beneath their baseline ranges, in accordance with the ESPEN and EASO Consensus Statement on SO. Daily protein consumption will probably be maintained at ≥1.2 g/kg physique weight.

All assessments will probably be carried out by uniformly educated skilled nurses utilizing standardized procedures. After baseline evaluation and randomization at week 0, consequence assessments will probably be carried out at weeks 8, 16, and 24, with week 24 outlined as the tip of the intervention. A last follow-up evaluation will probably be carried out at week 48, comparable to 24 weeks after completion of the intervention. Adherence, hostile occasions, and causes for withdrawal will probably be recorded all through the intervention interval.

Experimental group

Intervention implementation.

In addition to the routine life-style steering for SO, individuals within the intervention group will probably be instructed to make use of the Sarcopenic Obesity-Knowledge Graph Care System (SO-KGCS) for customized life-style intervention. SO-KGCS is a cellular utility developed particularly for sufferers with SO. Built on a information graph framework, the system integrates multisource information to establish patterns of coexisting low muscle mass and extra fats accumulation, and generates customized diet, train, and life-style suggestions aimed toward simultaneous fats discount and muscle achieve. After logging in, individuals will enter the remedy recommendation interface and full private data, together with demographic traits, purposeful indicators, physiological and biochemical parameters, medical historical past, treatment historical past, and life-style habits. Based on these information, the system will mechanically generate a personalised intervention plan comprising illness evaluation, remedy aims, train coaching, dietary modification, TCM interventions, life-style optimization, and crucial medical suggestions, along with anticipated outcomes and precautions. The suggestions part will enable sufferers to report their experiences, enabling medical workers to regulate suggestions when crucial. Participants will probably be required to comply with the beneficial life-style modifications and repeatedly report their progress via the platform. The system interface is proven in Fig 4.

To guarantee intervention constancy and reduce confounding, permitted and prohibited concomitant remedies through the examine interval have been outlined. Participants might proceed secure current medicines and obtain crucial emergency care. However, participation in different structured packages focusing on weight reduction, muscle achieve, or bodily operate enchancment, in addition to unauthorized use of medicines affecting muscle metabolism or physique composition, will probably be prohibited. Compliance will probably be monitored via common follow-up, and all related occasions will probably be documented and thought of within the evaluation.

Measures

Secondary consequence measures.

  1. 1) Grip Strength

Grip energy will probably be measured utilizing a dynamometer (Jamar Plus+, USA) and recorded in kilograms. Participants will regulate the grip width to a cushty place and carry out maximal voluntary contraction for 3 seconds. Three measurements will probably be obtained for every hand and the very best worth will probably be recorded. If the variation between measurements exceeds 10%, individuals will relaxation for 10–quarter-hour earlier than repeat testing.

  1. 2) Skeletal Muscle Mass Index

Skeletal muscle mass index (SMI, kg/m²) will probably be assessed as a secondary consequence. Appendicular skeletal muscle mass (ASM, kg) will probably be measured utilizing BIA with the identical analyzer used for SMM evaluation. Measurement procedures and precautions will probably be an identical to these described for the first consequence. SMI will probably be calculated as ASM divided by peak squared: SMI = ASM (kg)/ height² (m²). Results will probably be expressed in kg/m² and recorded to 2 decimal locations.

  1. 3) Body Fat Percentage

Body fats proportion will probably be measured utilizing the identical physique composition analyzer underneath standardized situations as described above. Results will probably be expressed as percentages (%) and recorded to 1 decimal place.

  1. 4) Physical Function Assessment

Physical operate will probably be assessed utilizing the Short Physical Performance Battery (SPPB), which features a steadiness take a look at, a 4-meter standard gait velocity take a look at, and a five-times sit-to-stand take a look at. These parts assess steadiness, strolling capacity, lower-limb muscle energy, and endurance, respectively. The steadiness take a look at contains side-by-side, semi-tandem, and tandem standing positions. Each element will probably be scored from 0 to 4, yielding a complete rating starting from 0 to 12, with increased scores indicating higher bodily operate.

  1. 5) Quality of Life

Quality of life will probably be assessed utilizing the MOS 36-item Short Form Health Survey (SF-36) [22]. The SF-36 evaluates eight domains of health-related high quality of life: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH). Scores for every area will probably be transformed to a 0–100 scale utilizing the next components: Converted Score = (Actual Score − Minimum Score for that Dimension)/ (Maximum Score for that Dimension − Minimum Score for that Dimension) × 100. The imply rating for the eight domains will probably be calculated because the composite rating, with increased scores indicating higher high quality of life.

Statistical evaluation

The major efficacy evaluation will probably be carried out based on the ITT precept, with all randomized individuals analyzed within the teams to which they have been initially assigned. Continuous variables will probably be summarized as means ± normal deviations or medians with interquartile ranges, as acceptable primarily based on distribution, and categorical variables will probably be offered as frequencies and percentages. Baseline traits will probably be summarized by remedy group. Between-group comparisons at baseline will probably be carried out utilizing independent-samples t exams or Mann-Whitney U exams for steady variables, and χ² exams or Fisher’s precise exams for categorical variables.

The major evaluation inhabitants would be the ITT inhabitants. A per-protocol set evaluation will probably be carried out as a sensitivity evaluation and can embrace individuals who full the intervention and follow-up assessments, meet prespecified adherence standards, and haven’t any main protocol deviations. Poor adherence will probably be outlined as an intervention adherence price of <50% per week for 2 consecutive weeks or an general intervention adherence price of <50% through the examine interval. The security evaluation inhabitants will embrace individuals who obtain at the least one intervention session or full at the least one post-randomization security evaluation.

The sole major confirmatory consequence will probably be SMM. The major intervention impact will probably be outlined because the adjusted between-group distinction in change in SMM from baseline to the tip of the 24-week intervention. The major consequence will probably be analyzed utilizing a linear mixed-effects mannequin, with post-randomization SMM measurements because the dependent variable. Fixed results will embrace group, time, the group-by-time interplay, and prespecified covariates, together with age, intercourse, physique weight, and baseline SMM. A participant-level random intercept will account for within-participant correlation arising from repeated measurements. Time will probably be modeled as a categorical variable to keep away from imposing a linear change trajectory. The major impact will probably be estimated from the group-by-time interplay at week 24, and the adjusted between-group imply distinction, 95% confidence interval, and two-sided P worth will probably be reported.

Secondary outcomes will embrace handgrip energy, skeletal muscle index, physique fats proportion, SPPB rating, and SF-36 quality-of-life rating. Each secondary consequence will probably be analyzed utilizing a linear mixed-effects mannequin analogous to that used for the first consequence. Fixed results will embrace group, time, the group-by-time interplay, and prespecified covariates, together with age, intercourse, physique weight, and the baseline worth of the corresponding consequence. Adjusted between-group variations, 95% confidence intervals, and two-sided P values will probably be reported. SMM would be the solely major confirmatory consequence, whereas secondary outcomes will present supportive proof relating to intervention results. For analyses involving a number of secondary outcomes and repeated time factors, the Benjamini–-Hochberg process will probably be utilized to manage the false discovery price.

All obtainable repeated-measures information will probably be included within the linear mixed-effects fashions utilizing most probability estimation underneath the missing-at-random assumption. The extent, timing, and sample of lacking information, along with causes for withdrawal or intervention discontinuation, will probably be summarized by group. For the first consequence, a sensitivity evaluation will probably be carried out utilizing a number of imputation by chained equations. The imputation mannequin will embrace randomized group, age, intercourse, peak, physique weight, BMI, baseline SMM, obtainable follow-up SMM measurements, and different variables probably related to missingness or the first consequence. Twenty imputed datasets will probably be generated and analyzed utilizing the first evaluation mannequin, with estimates pooled based on Rubin’s guidelines. If missingness within the major consequence is substantial or the missing-data mechanism stays unsure, a tipping-point evaluation primarily based on delta-adjusted a number of imputation will probably be carried out. In this evaluation, a collection of prespecified unfavorable shifts will probably be utilized to the imputed SMM values to evaluate the robustness of the first conclusions underneath believable missing-not-at-random assumptions.

Prespecified exploratory subgroup analyses will probably be carried out by age and intercourse via inclusion of group-by-time-by-subgroup interplay phrases within the linear mixed-effects mannequin. Model assumptions will probably be evaluated utilizing residual plots, regular Q-Q plots, and outlier diagnostics. If substantial heteroscedasticity or deviation from residual non-normality is detected, sturdy normal errors will probably be utilized in sensitivity analyses whereas retaining the first mannequin construction. Safety analyses will probably be primarily descriptive. Adverse occasions and critical hostile occasions will probably be summarized by group, severity, doable relationship to the intervention, and consequence. All statistical exams will probably be two-sided, and P < 0.05 for the first consequence will probably be thought of statistically vital. Statistical analyses will probably be carried out utilizing R software program, model 4.4.2 (R Foundation for Statistical Computing, Vienna, Austria).


This web page was created programmatically, to learn the article in its authentic location you possibly can go to the hyperlink bellow:
https://journals.plos.org/plosone/article%3Fid%3D10.1371/journal.pone.0353945
and if you wish to take away this text from our web site please contact us

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