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.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
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 de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Attica
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Athens, Attica, Grecia, 11527
- National and Kapodistrian University of Athens, School of Medicine
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: 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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Comparador activo: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage Change in Body Mass Index (BMI) From Baseline to Week 8
Periodo de tiempo: Baseline and Week 8
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Percentage change in BMI was calculated as 100 × (baseline BMI - BMI at Week 8) / baseline BMI. Positive values indicate a decrease in BMI, whereas negative values indicate an increase. 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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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Kalliopi K Gkouskou, PhD, National and Kapodistrian University of Athens, School of Medicine
- Silla de estudio: Aristides G Eliopoulos, PhD, National and Kapodistrian University of Athens, School of Medicine
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Trastornos Nutricionales
- Atributos de la enfermedad
- Sobrenutrición
- Peso corporal
- Susceptibilidad a la enfermedad
- Predisposición genética a la enfermedad
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Puntuación de riesgo genético
- Exceso de peso
- Obesidad
Otros números de identificación del estudio
Otros números de identificación del estudio
- ACTION-NKUA-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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