Lifestyle Interventions and Genetic Scores for Weight Management (ACTION)
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Attica
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Athens, Attica, Řecko, 11527
- National and Kapodistrian University of Athens, School of Medicine
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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. |
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Aktivní komparátor: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Percentage Reduction in Body Mass Index (BMI) From Baseline to Week 8
Časové okno: Baseline and Week 8
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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
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Kalliopi K Gkouskou, PhD, National and Kapodistrian University of Athens, School of Medicine
- Studijní židle: Aristides G Eliopoulos, PhD, National and Kapodistrian University of Athens, School of Medicine
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ACTION-NKUA-001
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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.
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Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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