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Lifestyle Interventions and Genetic Scores for Weight Management (ACTION)

1 novembre 2026 aggiornato da: Kalliopi G, National and Kapodistrian University of Athens

Lifestyle Interventions and Genetic Susceptibility in Body Mass Index Management: The ACTION Study

The ACTION (Genotype-tAilored exerCise inTerventION) study investigated whether genetic information related to obesity susceptibility and endurance capacity could be used to inform personalized lifestyle interventions aimed at improving body mass index (BMI) and participation in physical activity programs.

Adults with increased genetic susceptibility to obesity and low habitual physical activity were invited to participate in an eight-week lifestyle intervention combining dietary counseling with physical activity recommendations.

The intervention initially compared structured jogging with recommendations to increase habitual physical activity. Following the evaluation of intervention completion, the exercise strategy was modified for a subsequent group of participants, incorporating a Genetic Endurance Score (GES) to guide allocation to jogging or yoga.

The study evaluated changes in BMI and completion of the assigned exercise programs, exploring the feasibility of integrating genetic information into personalized lifestyle recommendations.

Panoramica dello studio

Descrizione dettagliata

The ACTION (Genotype-tAilored exerCise inTerventION) study was designed to investigate the potential of integrating polygenic susceptibility to obesity and genetically predicted endurance capacity into lifestyle interventions for BMI management.

The study included an observational analysis of 918 genotyped Greek adults recruited during two consecutive study periods. A weighted BMI Genetic Risk Score (BMI-GRS), based on 97 genetic variants, was used to assess obesity susceptibility, while habitual physical activity was assessed using the International Physical Activity Questionnaire (IPAQ-Gr).

Adults with increased obesity-related genetic susceptibility were invited to participate in the intervention component. Enrollment was prioritized for individuals with BMI-GRS values above the 70th percentile and low habitual physical activity. A total of 198 participants were enrolled in eight-week lifestyle interventions across two sequential cohorts.

All intervention participants received a common genetic risk-adapted dietary program and individualized lifestyle counseling. Dietary recommendations emphasized healthy eating habits, reduced saturated fat and refined carbohydrate intake, increased dietary fiber and plant-based food consumption, and regular fish consumption.

In the initial intervention cohort (n=113), participants were systematically allocated according to enrollment order to structured jogging (n=77) or recommendations to increase habitual physical activity (n=36). The primary objective was to evaluate changes in BMI following eight weeks of intervention.

Following discontinuation of the initial intervention, exploratory analyses investigated the association between genetically predicted endurance capacity and exercise program completion. These observations motivated a modification of the intervention strategy.

In the subsequent cohort (n=85), exercise allocation was guided by a nine-variant Genetic Endurance Score (GES). Participants with GES ≥50 were assigned to structured jogging (n=35), while those with GES <50 were assigned to structured yoga (n=50). This phase assessed eight-week intervention completion and short-term BMI change.

BMI was calculated from measured weight and height. Intervention completion was defined by completion of the assigned eight-week program and attendance at the final assessment. Discontinuation of the intervention was recorded.

Comparisons between the sequential intervention cohorts were considered exploratory because the cohorts were recruited at different times and exercise allocation procedures differed. The genotype-guided allocation strategy was developed following observations from the initial intervention and was not part of the original intervention design.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

198

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Attica
      • Athens, Attica, Grecia, 11527
        • National and Kapodistrian University of Athens, School of Medicine

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:Inclusion Criteria:

  • Adults aged 18 years or older.
  • Greek residents who had previously undergone genome-wide genotyping and baseline anthropometric and lifestyle assessment.
  • Elevated genetic susceptibility to obesity, defined by the High or Max BMI Genetic Risk Score (BMI-GRS) categories.
  • Low habitual physical activity at baseline.
  • Voluntary agreement to participate in an eight-week lifestyle intervention.
  • Enrollment was prioritized for individuals with BMI-GRS values above the 70th percentile when the number of eligible volunteers exceeded the available intervention capacity.

Exclusion Criteria:

  • Missing anthropometric measurements or essential baseline covariate data.
  • Body-weight change greater than 3% during the preceding three months.
  • Previous bariatric surgery.
  • Untreated psychiatric disorders.
  • Use of medications known to influence body weight.
  • For the initial intervention cohort, habitual participation in jogging at baseline.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Structured Jogging

Participants assigned to structured jogging followed an eight-week exercise program together with common genetic risk-adapted dietary counseling. This arm included 77 participants from the initial cohort, allocated systematically by enrollment order, and 35 participants from the subsequent cohort, allocated according to a Genetic Endurance Score (GES) ≥50. A total of 112 participants received the jogging intervention.

An eight-week structured jogging program aimed at increasing weekly physical activity relative to baseline. The intervention was implemented in both sequential cohorts: 77 participants in the initial cohort and 35 participants with a Genetic Endurance Score (GES) ≥50 in the subsequent cohort. All participants also received common dietary counseling.

All 198 intervention participants received a common eight-week genetic risk-adapted dietary counseling program designed to support gradual weight loss. Recommendations emphasized reducing saturated fat and refined carbohydrate intake, increasing dietary fiber and plant-based foods, regular fish consumption, and behavioral strategies to support dietary adherence. The same dietary protocol was applied in both sequential intervention cohorts.

Comparatore attivo: Cohort-Specific Physical Activity

This arm represents the alternative physical activity strategy used in each intervention cohort. In the initial cohort, 36 participants received recommendations to increase physical activity through their habitual activities. In the subsequent cohort, 50 participants with a Genetic Endurance Score (GES) <50 were assigned to structured yoga. Both groups received the common dietary counseling intervention for eight weeks. The two exercise strategies were implemented in separate, sequential cohorts and were not identical interventions.

All 198 intervention participants received a common eight-week genetic risk-adapted dietary counseling program designed to support gradual weight loss. Recommendations emphasized reducing saturated fat and refined carbohydrate intake, increasing dietary fiber and plant-based foods, regular fish consumption, and behavioral strategies to support dietary adherence. The same dietary protocol was applied in both sequential intervention cohorts.

Participants received individualized recommendations to increase their weekly physical activity through their habitual forms of exercise, without assignment to a structured jogging or yoga program. This eight-week intervention was implemented in the initial cohort (n=36), alongside the common genetic risk-adapted dietary counseling program. Physical activity recommendations aimed to increase weekly activity relative to baseline.

An eight-week structured yoga program assigned to participants with a Genetic Endurance Score (GES) below 50. The intervention was implemented in the subsequent cohort (n=50) as an alternative to structured jogging for individuals with lower genetically predicted endurance capacity. All participants also received the common genetic risk-adapted dietary counseling program.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage Reduction in Body Mass Index (BMI) From Baseline to Week 8
Lasso di tempo: Baseline and Week 8

Percentage BMI reduction was calculated as 100 × (baseline BMI - BMI at week 8) / baseline BMI, with positive values indicating a reduction in BMI. BMI was calculated from measured body weight (kg) divided by height squared (m²). The outcome was evaluated among participants who completed the eight-week intervention and had available follow-up anthropometric measurements.

Baseline and Week 8

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Kalliopi K Gkouskou, PhD, National and Kapodistrian University of Athens, School of Medicine
  • Cattedra di studio: Aristides G Eliopoulos, PhD, National and Kapodistrian University of Athens, School of Medicine

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

29 ottobre 2023

Completamento primario (Effettivo)

22 dicembre 2025

Completamento dello studio (Effettivo)

22 dicembre 2025

Date di iscrizione allo studio

Primo inviato

1 novembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 novembre 2026

Primo Inserito (Effettivo)

6 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 novembre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

There is currently no plan to share individual participant data. The study includes genetic and health-related information. Any future data sharing would be subject to applicable data protection requirements, participant consent provisions, and approval by the responsible institution.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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