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Lifestyle Interventions and Genetic Scores for Weight Management (ACTION)

9 ноября 2026 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

198

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Нерандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Поведенческий: Structured Jogging Program

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.

Поведенческий: Genetic Risk-Adapted 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.
Активный компаратор: 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.
Поведенческий: Genetic Risk-Adapted 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.

Поведенческий: Habitual Physical Activity Recommendations

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.

Поведенческий: Structured Yoga Program

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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Percentage Change in Body Mass Index (BMI) From Baseline to Week 8
Временное ограничение: Baseline and Week 8

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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

National and Kapodistrian University of Athens

Следователи

  • Главный следователь: Kalliopi K Gkouskou, PhD, National and Kapodistrian University of Athens, School of Medicine
  • Учебный стул: Aristides G Eliopoulos, PhD, National and Kapodistrian University of Athens, School of Medicine

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

29 октября 2023 г.

Первичное завершение (Действительный)

22 декабря 2025 г.

Завершение исследования (Действительный)

22 декабря 2025 г.

Даты регистрации исследования

Первый отправленный

1 ноября 2026 г.

Впервые представлено, что соответствует критериям контроля качества

1 ноября 2026 г.

Первый опубликованный (Действительный)

6 ноября 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

13 ноября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

9 ноября 2026 г.

Последняя проверка

1 октября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • ACTION-NKUA-001

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Описание плана 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.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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