Association of a ‘three meals and sleep routine’ life-style intervention with weight and metabolic well being in youngsters with weight problems: a potential, single-arm pilot examine – Long

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Introduction

Childhood weight problems has emerged as some of the pressing world public well being challenges (1). Over the previous few many years, its prevalence has risen sharply throughout each developed and creating international locations (2). This pattern carries important long-term implications for metabolic and cardiovascular well being (3). The enhance in childhood weight problems has been notably pronounced in creating international locations. For instance, nationwide survey information from China revealed a dramatic enhance in weight problems prevalence amongst school-aged youngsters—from 1.1% in 1985 to twenty.4% by 2014, and additional to 21.6% by 2021 (1). Rapid financial development in these areas has been accompanied by important shifts in dietary patterns and life-style habits, together with elevated consumption of energy-dense, nutrient-poor meals and decreased ranges of bodily exercise (4,5). These modifications have contributed to a quicker acceleration of childhood weight problems than that noticed in high-income international locations, positioning weight problems as a big risk to little one well being in lots of creating areas (6–8).

Current pediatric weight problems care extends past easy recommendation to ‘eat less and exercise more’. Its basis is structured, intensive, family-centered well being conduct and life-style remedy that integrates diet, bodily exercise, behavior-change methods, and longitudinal assist (10,19). Access and sustained engagement stay tough, and partial weight regain after an early response is frequent. A routine targeted on meal and sleep timing may subsequently be evaluated as a doubtlessly low-burden adjunct to complete care, nevertheless it shouldn’t be offered as an alternative choice to established multicomponent remedy.

The ‘three meals and sleep routine’ (TMSR) intervention combines three structured, nutritionally full meals per day, avoidance of caloric consumption between meals, and an everyday nighttime routine (Figure 1) (14). The method emphasizes behavioral regularity quite than pharmacotherapy or an added train prescription.

The rationale is that meal timing and the light-sleep cycle act as time cues for central and peripheral circadian programs. Irregular consuming, late caloric consumption, and inadequate or irregular sleep might contribute to circadian misalignment, altered glucose regulation, urge for food signaling, and lipid metabolism (15–17). Accordingly, regularizing these behaviors may plausibly affect the anthropometric and metabolic outcomes measured right here. However, the mechanisms weren’t measured immediately, and sustained profit relies on sustained adherence. We subsequently aimed to explain feasibility and longitudinal within-cohort modifications throughout TMSR, whereas treating the findings as hypothesis-generating quite than confirmatory. We current this text in accordance with the STROBE reporting guidelines (accessible at ).

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Methods

Study design and setting

This was a potential, single-center, single-arm, nonrandomized pilot intervention examine embedded in routine care on the Department of Clinical Nutrition, Children’s Hospital, Zhejiang University School of Medicine. Children with weight problems aged 5–18 years had been consecutively enrolled between January 2022 and December 2023 and acquired the TMSR behavioral routine. There was no usual-care or untreated comparator. This examine was carried out in accordance with the Declaration of Helsinki and its subsequent amendments. The examine was authorised by the Institutional Review Board of the Children’s Hospital, Zhejiang University School of Medicine (No. 2024-IRB-0011-P-01). Written knowledgeable consent was obtained from the authorized guardians of all members. The examine was registered on the Chinese Clinical Trial Registry (ChiCTR2500097737).

Participants and eligibility standards

Participants had been eligible in the event that they met all the following standards: aged 5–18 years; weight problems is outlined as physique mass index (BMI)-for-age Z-score (BAZ) >2; little one and guardian prepared to obtain the TMSR counseling protocol.

Participants had been excluded for any of the next: presence of cardiovascular, pulmonary, renal, hepatic, or gastrointestinal illnesses; presence of persistent infectious illnesses; a psychiatric dysfunction or endocrine situation identified to have an effect on weight regulation, together with diabetes mellitus or hyperthyroidism; present use of medicines that have an effect on physique composition or metabolism; participation in different weight-loss applications throughout the previous 3 months; concurrent participation in a structured train or weight-management program that will materially alter recurring exercise or dietary publicity.

Baseline evaluation and measurement procedures

At baseline and follow-up visits, educated analysis coordinators and medical nutritionists used standardized procedures to measure peak and weight. Body composition, together with proportion physique fats (PBF), visceral fats space (VFA), and skeletal muscle index (SMI), was assessed by bioelectrical impedance evaluation (BIA). Fasting blood testing included glucose, insulin, whole ldl cholesterol, triglycerides, alanine aminotransferase, serum uric acid, and glycated hemoglobin. Staff acquired centralized coaching in measurement procedures and instrument calibration. Dietary consumption, sleep length, and bodily exercise weren’t measured with goal units or validated repeated devices.

Intervention procedures

Dietary and meal-routine counseling

At the preliminary outpatient session, a medical nutritionist reviewed the protocol with the kid and guardian and offered the written steerage proven in Figure 1. Families had been instructed to offer three structured meals every day and to keep away from caloric meals and drinks between meals. Daily vitality steerage ranged from 1,500 to 2,300 kcal in keeping with age, with tailor-made parts for main meals teams. Sugar-sweetened drinks and extremely processed snack meals had been discouraged; staple packaged meals corresponding to bread, steamed buns, and dumplings might be included inside meals. Exact clock occasions for the three meals weren’t mandated. Counseling was revisited throughout routine medical follow-up, however the quantity and spacing of contacts various with attendance.

Sleep and physical-activity elements

• The unique protocol specified at the very least 7.5 hours of nighttime sleep and lights off no later than 22:30. This was a uniform protocol-defined minimal, not an age-specific advice for enough sleep. It is decrease than consensus suggestions for a lot of the 5–18-year age vary and is addressed as a limitation.
• No extra train intervention was prescribed. Participants had been requested to take care of their recurring bodily exercise, however exercise was not objectively tracked and stability couldn’t be verified.

Follow-up, adherence evaluation, and participant disposition

Follow-up was deliberate at roughly 2-month intervals for 12 months; in follow, visits occurred in keeping with every household’s medical availability. At attended visits, anthropometry, BIA-derived physique composition, and accessible fasting metabolic measurements had been collected. No standardized dietary diary, sleep log, phone-based reminder report, wearable gadget, or formal adherence rating was used. Consequently, adherence and implementation constancy couldn’t be quantified or entered into the fashions. A contemporaneous screening log and standardized visit-disposition report weren’t accessible, stopping dependable retrospective reconstruction of numbers screened, excluded earlier than enrollment, finishing every deliberate time level, or misplaced to follow-up.

Outcomes

The main anthropometric outcomes analyzed on this report had been longitudinal modifications in BMI and BAZ. Secondary exploratory outcomes had been weight, peak, PBF, VFA, SMI, fasting glucose, insulin, triglycerides, whole ldl cholesterol, alanine aminotransferase, serum uric acid, and glycated hemoglobin. Because the pilot protocol didn’t designate a single confirmatory endpoint, this categorization is used for reporting readability and the secondary analyses shouldn’t be interpreted as confirmatory.

Sample measurement

No formal a priori energy calculation was carried out. The pattern comprised all 119 consecutive eligible members enrolled through the predefined recruitment window. The examine was exploratory and was not powered to determine medical efficacy or to estimate unusual opposed occasions.

Safety and opposed occasions

The supply data didn’t embody a prospectively outlined, standardized adverse-event surveillance dataset. Height and SMI had been evaluated as development and body-composition outcomes, however their trajectories weren’t handled as substitutes for systematic security evaluation. Counts of opposed occasions, unintended effects, and unintended penalties subsequently couldn’t be reported reliably.

Statistical evaluation

Continuous variables are summarized as imply ± customary deviation when roughly symmetric and as median (interquartile vary) when visibly skewed; categorical variables are summarized as n (%). No formal normality take a look at was prespecified. Longitudinal associations between examine time and anthropometric, metabolic, and body-composition outcomes had been assessed with generalized linear combined fashions utilizing all accessible repeated measurements; lacking observations weren’t imputed. Study go to time was entered as the only real fastened predictor. Thus, the reported coefficient is a mean month-to-month within-cohort affiliation and doesn’t mannequin the nonlinear rebound obvious in a number of visit-specific trajectories. No separate paired t-tests, Wilcoxon signed-rank checks, or month-to-month pairwise comparisons had been carried out. All checks had been two-tailed with α=0.05. No adjustment was made for a number of secondary outcomes; these P values are exploratory. Analyses had been carried out in R model 4.2.0 and EmpowerStats (X&Y Solutions, Inc., Boston, MA, USA).

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Results

Demographic and medical traits of the examine inhabitants

A complete of 119 members had been included. Their imply age was 10.24±2.33 years (median, 10 years); 82 (68.9%) had been male and 37 (31.1%) had been feminine. Baseline anthropometric, body-composition, and metabolic traits are proven in Table 1.

Participant disposition and information completeness

The analytic cohort comprised 119 enrolled youngsters. Because screening and visit-disposition logs weren’t accessible in a kind that permitted dependable reconstruction, the numbers screened, excluded earlier than enrollment, finishing every nominal follow-up time level, and misplaced to follow-up couldn’t be reported. We subsequently didn’t create a circulate diagram with inferred counts. Longitudinal fashions used the measurements accessible at attended visits with out imputation.

Standardized adverse-event information had been additionally unavailable; absence of a recorded adverse-event rely shouldn’t be interpreted as proof that no opposed occasions occurred.

Anthropometric modifications

Mean weight confirmed a U-shaped trajectory: it decreased from roughly 58 kg at baseline to 56 kg through the first 4 months after which elevated to roughly 60 kg by month 12 (Figure 2). Because youngsters had been rising and there was no comparator, the rise in absolute weight can’t be separated from anticipated development or different time-varying influences.

Mean BMI decreased from 26.0 kg/m² at baseline to 24.0 kg/m² at month 4, then rose to roughly 24.5 kg/m² by month 12; BAZ adopted the identical sample, lowering from 2.8 to 2.3 earlier than growing to 2.5 (Figures 3,4). Height elevated from roughly 146 cm at baseline to 152 cm at month 12 (Figure 5). Height achieve is anticipated throughout childhood and adolescence and shouldn’t be interpreted as an impact or security proof of the intervention.

Body-composition modifications

VFA and PBF additionally confirmed U-shaped patterns. VFA decreased from roughly 95 cm² at baseline to 78 cm² at month 4 after which elevated to roughly 88 cm² at month 12. PBF decreased from roughly 38% to 34% and subsequently elevated to roughly 35% (Figures 6,7). SMI modified from roughly 6.2 kg/m² at baseline to six.1 kg/m² at month 4 and 6.5 kg/m² at month 12 (Figure 8).

Changes in metabolic parameters

Longitudinal developments in metabolic parameters had been assessed over a 12-month follow-up interval.

Glucose and insulin

Fasting insulin decreased from roughly 150 pmol/L at baseline to 70 pmol/L at month 4 after which elevated to roughly 100 pmol/L at month 12 (Figure 9). Fasting glucose decreased from roughly 6.5 mmol/L at baseline to five.5 mmol/L at month 6 after which elevated to roughly 6.0 mmol/L by month 12 (Figure 10).

Lipid profile

Triglycerides decreased from roughly 1.2 mmol/L at baseline to 0.7 mmol/L by month 12 (Figure 11). Total ldl cholesterol decreased from roughly 4.2 mmol/L to 4.0 mmol/L at month 4 after which elevated to roughly 4.4 mmol/L at month 12 (Figure 12).

Serum uric acid

Serum uric acid ranges confirmed a sustained discount, lowering steadily from 400 to 340 μmol/L (Figure 13).

Average longitudinal associations

With go to time modeled as a steady predictor, common month-to-month coefficients had been adverse for BMI [−0.183 kg/m²; 95% confidence interval (CI): −0.241 to −0.125; P<0.001], BAZ (−0.069; 95% CI: −0.083 to −0.056; P<0.001), VFA (−2.17 cm²; 95% CI: −2.94 to −1.40; P<0.001), PBF (−0.60 proportion factors; 95% CI: −0.76 to −0.44; P<0.001), fasting insulin (−12.51 pmol/L; 95% CI: −17.94 to −7.07; P<0.001), fasting glucose (−0.053 mmol/L; 95% CI: −0.094 to −0.012; P=0.01), triglycerides (−0.042 mmol/L; 95% CI: −0.073 to −0.011; P=0.01), serum uric acid (−6.01 μmol/L; 95% CI: −9.35 to −2.68; P<0.001), and alanine aminotransferase (−4.35 U/L; 95% CI: −6.47 to −2.23; P<0.001) (Table 2). The SMI coefficient was −0.007 kg/m² (95% CI: −0.023 to 0.009; P=0.38). These estimates summarize common within-cohort change over time; they don’t set up an intervention impact and might obscure the nonlinear rebound proven in Figures 2–10.

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Discussion

This exploratory single-arm examine recognized early within-cohort decreases in BMI, BAZ, adiposity measures, and several other metabolic markers throughout TMSR. The central discovering shouldn’t be a sustained monotonic response: BMI, BAZ, PBF, VFA, fasting insulin, glucose, and whole ldl cholesterol confirmed partial rebound after their early nadirs. In the absence of a comparator, the noticed trajectories might replicate the intervention, pure development and pubertal change, regression to the imply, seasonal variation, concurrent behaviors, choice and follow-up processes, or combos of those elements. The information subsequently assist speculation technology quite than claims of efficacy.

The rebound after month 4 is clinically vital and suggests restricted sturdiness of the preliminary modifications. Plausible explanations embody declining adherence, behavioral fatigue, decreased household assist over time, compensatory urge for food or consuming, metabolic adaptation after early weight reduction, and modifications at school schedules or seasonal exercise. Because meals consumption, sleep, bodily exercise, and adherence weren’t objectively recorded, these explanations can’t be distinguished within the current dataset. The sample signifies that any future TMSR program ought to embody upkeep contacts, goal suggestions, and predefined methods for relapse prevention.

Early decreases in fasting insulin, glucose, triglycerides, and alanine aminotransferase had been in line with improved metabolic standing through the first months, however within-person change in an uncontrolled cohort can’t be attributed particularly to meal or sleep timing. The partial rebound in insulin and glucose additional argues in opposition to describing the metabolic response as uniformly sustained (19,22).

Meal timing, sleep, food plan high quality, and bodily exercise can every affect vitality steadiness and metabolic regulation. The early PBF and VFA patterns are broadly in line with literature on time-restricted consuming and chrononutrition (23–26), however TMSR mixed meal construction, vitality steerage, avoidance of between-meal energy, and a sleep routine. Without component-specific adherence measures, the contribution of every component can’t be remoted.

Height elevated and SMI didn’t present a big common linear decline throughout follow-up. These observations are reassuring descriptive findings, however they don’t set up security: regular linear development is anticipated on this age vary, the examine had no comparator, and opposed occasions weren’t systematically ascertained. Future research ought to prespecify pediatric development, dietary adequacy, eating-disorder signs, compensatory behaviors, and different opposed outcomes (27).

TMSR could also be cheap to guage as an adjunct to complete pediatric weight problems remedy as a result of its behavioral guidelines are easy. However, feasibility was not quantified, effectiveness was not established, and scalability can’t be inferred from a single-center cohort. Any medical implementation ought to stay inside age-appropriate, family-centered weight problems care. It mustn’t substitute established diet, exercise, behavioral, pharmacologic, or surgical choices when indicated (19,28).

Several mechanisms are biologically believable however weren’t measured on this examine:

• Circadian synchronization: common meal timing may act as a time cue for peripheral clocks concerned in glucose and lipid metabolism. Experimental and observational proof hyperlinks circadian disruption with impaired insulin sensitivity, however the current examine didn’t measure circadian part, melatonin, clock-gene expression, or chronotype (29–31).
• Overnight fasting and decreased snacking: avoiding energy between three meals might prolong the in a single day fasting interval and scale back alternatives for unplanned consumption. These pathways may affect fats oxidation and vitality consumption, however every day consumption and consuming home windows weren’t recorded, so an intermittent-fasting mechanism can’t be confirmed (32).
• Sleep and urge for food regulation: enough, common sleep might affect leptin, ghrelin, urge for food, and insulin sensitivity. However, the protocol’s 7.5-hour minimal was beneath beneficial length for a lot of members, and neither sleep length nor sleep high quality was measured objectively; improved sleep-hormone regulation subsequently stays a speculation quite than an noticed mediator (33,34).

Contemporary steerage identifies intensive well being conduct and life-style remedy as foundational pediatric weight problems care (35). Consensus sleep steerage recommends 10–13 hours per 24 hours for 5-year-olds, 9–12 hours for kids aged 6–12 years, and eight–10 hours for adolescents aged 13–18 years (36). Recent pediatric information additionally affiliate later meal timing or an extended consuming window with much less favorable food plan high quality and metabolic markers (37), whereas a current managed pediatric time-restricted-eating protocol illustrates the worth of a comparator, prespecified outcomes, common follow-up, meals diaries, adherence measures, and adverse-event surveillance (38). These developments assist additional testing of circadian-informed routines but in addition underscore the design options required earlier than causal or practice-changing claims might be made.

Limitations

First, the absence of a standard-care comparator is the central limitation. Natural development, puberty, regression to the imply, seasonal variation, maturation, and secular or concurrent behavioral modifications may account for half or all the noticed trajectories. The examine subsequently can not estimate a remedy impact or assist causal claims about TMSR.

Second, implementation constancy and key time-varying confounders weren’t measured adequately. Dietary consumption, meal occasions, sleep length and high quality, bodily exercise, and adherence weren’t captured with diaries, validated questionnaires, reminders, wearables, or different goal instruments. Self-report was not accessible in a standardized longitudinal kind. Consequently, we couldn’t confirm publicity, modify for conduct modifications, carry out dose-response analyses, or decide whether or not declining adherence defined the rebound.

Third, the uniform 7.5-hour sleep minimal was beneath consensus suggestions for many of the age vary and should have launched publicity heterogeneity. Fourth, contemporaneous screening, visit-completion, dropout, and standardized adverse-event data had been inadequate to reconstruct a dependable participant circulate diagram or characterize attrition and security. Height achieve and a secure common SMI coefficient don’t substitute for systematic adverse-event evaluation.

Fifth, the single-center comfort cohort limits generalizability. No formal pattern measurement calculation or single confirmatory endpoint was specified, a number of exploratory outcomes had been examined with out multiplicity adjustment, and linear-time fashions summarized common slopes regardless of visibly nonlinear trajectories. Missing information weren’t imputed, and the assumptions underlying available-case combined modeling couldn’t be verified. Mechanistic outcomes, pubertal stage, socioeconomic elements, and seasonal exposures weren’t assessed.

Future analysis instructions

Future analysis ought to use potential multicenter managed designs, ideally randomized when possible, with a standard-care comparator; prespecified main outcomes and sample-size calculations; age-specific sleep targets; fastened follow-up home windows; full screening and retention logs; goal or validated measurement of meals consumption, meal timing, sleep, and bodily exercise; repeated adherence evaluation; and systematic adverse-event surveillance. Maintenance assist ought to be intensified earlier than and after month 4, and analyses ought to mannequin nonlinear trajectories and look at whether or not adherence mediates early response and later rebound.

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Conclusions

In this potential, single-center, single-arm pilot examine, a number of anthropometric and metabolic measures improved through the first 4–6 months of TMSR, adopted by partial rebound in BMI, BAZ, adiposity, insulin, and glucose. These preliminary within-cohort associations don’t set up efficacy, sturdiness, scalability, or security as a result of the examine lacked a comparator and goal monitoring of food plan, sleep, exercise, adherence, attrition, and opposed occasions. Larger managed multicenter trials with age-appropriate sleep targets and strong implementation and security measurement are required.

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Acknowledgments

We wish to thank Editage (www.editage.cn) for English-language enhancing. During the preparation of this work, the authors used ChatGPT to help with language and readability enhancements. After utilizing this software, the authors reviewed and edited the content material as wanted and took full accountability for the publication’s content material.

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Reporting Checklist: The authors have accomplished the STROBE reporting guidelines. Available at

Data Sharing Statement: Available at

Peer Review File: Available at

Funding: This work was supported by The Key R&D Program of Zhejiang (No. 2023C03047) and the ZJU-GENSCI Children’s Health Research & Development Center (No. ZJU-GENSCI2024YY010).

Conflicts of Interest: All authors have accomplished the ICMJE uniform disclosure kind (accessible at https://tp.amegroups.com/article/view/10.21037/tp-2026-0402/coif). The authors don’t have any conflicts of curiosity to declare.

Ethical Statement: The authors are accountable for all features of the work in guaranteeing that questions associated to the accuracy or integrity of any a part of the work are appropriately investigated and resolved. This examine was carried out in accordance with the Declaration of Helsinki and its subsequent amendments. The examine was authorised by the Institutional Review Board of the Children’s Hospital, Zhejiang University School of Medicine (No. 2024-IRB-0011-P-01). Written knowledgeable consent was obtained from the authorized guardians of all members.

Open Access Statement:This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which allows the non-commercial replication and distribution of the article with the strict proviso that no modifications or edits are made and the unique work is correctly cited (together with hyperlinks to each the formal publication via the related DOI and the license). See:https://creativecommons.org/licenses/by-nc-nd/4.0/.

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Cite this text as: Long Q, Ma M, Wang D, Chen F, Zhou X, Wu W, Dong G, Fu J. Association of a ‘three meals and sleep routine’ life-style intervention with weight and metabolic well being in youngsters with weight problems: a potential, single-arm pilot examine. Transl Pediatr 2026;15(9):369. doi: 10.21037/tp-2026-0402