The Niche of n-of-1 Trials in Precision Medicine for Weight Loss and Obesity Treatment: Back to the Future

Grammatikopoulou, Maria G.; Gkouskou, Kalliopi; Gkiouras, Konstantinos; Bogdanos, Dimitrios P.; Eliopoulos, Aristides G.; Goulis, Dimitrios G.

doi:10.1007/s13668-022-00404-5

Cited by 6 publications

(5 citation statements)

References 62 publications

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“…To conclude, the TELE-BariACTIV study is innovative in its approach and design [76]. Feasibility and acceptability evidence would support proceeding with a larger trial that is sufficiently powered to test its effectiveness.…”

Section: Limitationsmentioning

confidence: 98%

“…The study results will be reported according to the recommendations for single-case protocols in behavioral interventions [75]. Owing to the objectives of the study (feasibility, acceptability, and effect size exploration) and recommendations [31,76], this study is a multicenter study with a single-case experimental design with multiple base levels (ABAB'A). It is an open-label trial in which research staff, researchers, and participants are not blinded to the study objectives, intervention, and allocation, given the nature of the intervention and measures.…”

Section: Study Design and Proceduresmentioning

confidence: 99%

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Acceptability and Feasibility of the Telehealth Bariatric Behavioral Intervention to Increase Physical Activity: Protocol for a Single-Case Experimental Study

Baillot¹,

St-Pierre²,

Lapointe³

et al. 2022

JMIR Res Protoc

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Background Regular physical activity (PA) is recommended to optimize weight and health outcomes in patients who have undergone metabolic and bariatric surgery (MBS). However, >70% of patients have low PA levels before MBS that persist after MBS. Although behavioral interventions delivered face-to-face have shown promise for increasing PA among patients who have undergone MBS, many may experience barriers, preventing enrollment into and adherence to such interventions. Delivering PA behavior change interventions via telehealth to patients who have undergone MBS may be an effective strategy to increase accessibility and reach, as well as adherence. Objective This paper reports the protocol for a study that aims to assess the feasibility and acceptability of the protocol or methods and the Telehealth Bariatric Behavioral Intervention (TELE-BariACTIV). The intervention is designed to increase moderate-to-vigorous intensity PA (MVPA) in patients awaiting bariatric surgery and is guided by a multitheory approach and a patient perspective. Another objective is to estimate the effect of the TELE-BariACTIV intervention on presurgical MVPA to determine the appropriate sample size for a multicenter trial. Methods This study is a multicenter trial using a repeated (ABAB’A) single-case experimental design. The A phases are observational phases without intervention (A1=pre-MBS phase; A2=length personalized according to the MBS date; A3=7 months post-MBS phase). The B phases are interventional phases with PA counseling (B1=6 weekly pre-MBS sessions; B2=3 monthly sessions starting 3 months after MBS). The target sample size is set to 12. Participants are inactive adults awaiting sleeve gastrectomy who have access to a computer with internet and an interface with a camera. The participants are randomly allocated to a 1- or 2-week baseline period (A1). Protocol and intervention feasibility and acceptability (primary outcomes) will be assessed by recording missing data, refusal, recruitment, retention, attendance, and attrition rates, as well as via web-based acceptability questionnaires and semistructured interviews. Data collected via accelerometry (7-14 days) on 8 occasions and via questionnaires on 10 occasions will be analyzed to estimate the effect of the intervention on MVPA. Generalization measures assessing the quality of life, anxiety and depressive symptoms, and theory-based constructs (ie, motivational regulations for PA, self-efficacy to overcome barriers to PA, basic psychological needs satisfaction and frustration, PA enjoyment, and social support for PA; secondary outcomes for a future large-scale trial) will be completed via web-based questionnaires on 6-10 occasions. The institutional review board provided ethics approval for the study in June 2021. Results Recruitment began in September 2021, and all the participants were enrolled (n=12). Data collection is expected to end in fall 2023, depending on the MBS date of the recruited participants. Conclusions The TELE-BariACTIV intervention has the potential for implementation across multiple settings owing to its collaborative construction that can be offered remotely. International Registered Report Identifier (IRRID) DERR1-10.2196/39633

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Section: Limitationsmentioning

confidence: 98%

Section: Study Design and Proceduresmentioning

confidence: 99%

Acceptability and Feasibility of the Telehealth Bariatric Behavioral Intervention to Increase Physical Activity: Protocol for a Single-Case Experimental Study

Baillot¹,

St-Pierre²,

Lapointe³

et al. 2022

JMIR Res Protoc

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“…According to an umbrella systematic review [48], highquality evidence supports the reduction in triglyceride concentrations, and moderatequality evidence vouches for reductions in body weight, respiratory exchange ratio (RER), glycosylated hemoglobin (HbA1c), and increased total cholesterol levels. Furthermore, N-of-1 studies suggest that patients with overweight and obesity show preference for the KD over the typical hypocaloric diets [50].…”

Section: Advantages Of the Kdmentioning

confidence: 99%

Ketone Bodies in Diabetes Mellitus: Friend or Foe?

Veneti,

Grammatikopoulou,

Kintiraki

et al. 2023

Nutrients

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In glucose-deprived conditions, ketone bodies are produced by the liver mitochondria, through the catabolism of fatty acids, and are used peripherally, as an alternative energy source. Ketones are produced in the body under normal conditions, including during pregnancy and the neonatal period, when following a ketogenic diet (KD), fasting, or exercising. Additionally, ketone synthesis is also augmented under pathological conditions, including cases of diabetic ketoacidosis (DKA), alcoholism, and several metabolic disorders. Nonetheless, diet is the main regulator of total body ketone concentrations. The KDs are mimicking the fasting state, altering the default metabolism towards the use of ketones as the primary fuel source. Recently, KD has gained recognition as a medical nutrition therapy for a plethora of metabolic conditions, including obesity and diabetes mellitus (DM). The present review aims to discuss the role of ketones, KDs, ketonemia, and ketonuria in DM, presenting all the available new evidence in a comprehensive manner.

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“…Different hypocaloric diets aimed at producing a negative energy balance and substantial weight loss are applied [ 16 ], but macronutrient recommendations vary widely among different professional societies [ 17 ]. These ‘one-size-fits-all’ approaches do not account for the diverse responses that occur due to the inherent heterogeneity of obesity [ 18 ]. As demonstrated by the POUNDS Lost study [ 19 ], these regimens exhibit significant variability in terms of their effectiveness in achieving weight loss, highlighting the inadequacy of current strategies in delivering comprehensive and personalized care to individuals suffering from obesity.…”

Section: Introductionmentioning

confidence: 99%

A genomics perspective of personalized prevention and management of obesity

Gkouskou,

Grammatikopoulou,

Lazou

et al. 2024

Hum Genomics

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This review discusses the landscape of personalized prevention and management of obesity from a nutrigenetics perspective. Focusing on macronutrient tailoring, we discuss the impact of genetic variation on responses to carbohydrate, lipid, protein, and fiber consumption. Our bioinformatic analysis of genomic variants guiding macronutrient intake revealed enrichment of pathways associated with circadian rhythm, melatonin metabolism, cholesterol and lipoprotein remodeling and PPAR signaling as potential targets of macronutrients for the management of obesity in relevant genetic backgrounds. Notably, our data-based in silico predictions suggest the potential of repurposing the SYK inhibitor fostamatinib for obesity treatment in relevant genetic profiles. In addition to dietary considerations, we address genetic variations guiding lifestyle changes in weight management, including exercise and chrononutrition. Finally, we emphasize the need for a refined understanding and expanded research into the complex genetic landscape underlying obesity and its management.

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The Niche of n-of-1 Trials in Precision Medicine for Weight Loss and Obesity Treatment: Back to the Future

Cited by 6 publications

References 62 publications

Acceptability and Feasibility of the Telehealth Bariatric Behavioral Intervention to Increase Physical Activity: Protocol for a Single-Case Experimental Study

Acceptability and Feasibility of the Telehealth Bariatric Behavioral Intervention to Increase Physical Activity: Protocol for a Single-Case Experimental Study

Ketone Bodies in Diabetes Mellitus: Friend or Foe?

A genomics perspective of personalized prevention and management of obesity

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