Exploring Gender Differences in the Effects of Diet and Physical Activity on Metabolic Parameters
NCT06661330
Behavior, Body Composition Changes
Rome, Italy
View Trial DetailsNCT Number: NCT07675486
This study aims to investigate the association between dietary intake, physical activity, sleep quality, and body composition in women in Kazakhstan. The study will recruit approximately 200 women aged 20 years and older undergoing routine DEXA examinations in Astana. Participants will complete validated questionnaires assessing diet, physical activity, sleep quality, and sarcopenia risk, alongside functional assessments. DEXA scans will provide measurements of fat mass, lean mass, visceral adipose tissue, bone mineral density, and appendicular skeletal muscle mass. The primary objective is to evaluate associations between dietary quality and DEXA-derived outcomes. Secondary objectives include assessing sarcopenia prevalence and examining relationships between physical activity, sleep quality, supplement use, and body composition. An optional second stage will explore associations between body composition and existing inflammatory and metabolic biomarkers from medical records. The findings are expected to provide the first comprehensive DEXA-based dataset on women's body composition and lifestyle factors in Kazakhstan and inform public health strategies.
Trial opening soon.
Get Notified20 year and older
Female
Observational
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Assessed at a single study visit during enrollment
FMI in kg/m², measured by dual-energy X-ray absorptiometry (DEXA). Higher values indicate greater adiposity and a less favorable body composition profile.
Time frame: Assessed at a single study visit during enrollment
BMD in g/cm², measured using dual-energy X-ray absorptiometry (DEXA). Higher values indicate greater bone mineral density and generally better bone health, whereas lower values indicate reduced bone mineral density.
Time frame: Assessed at a single study visit during enrollment
FFMI in kg/m², calculated as total fat-free mass (kg) divided by height squared (m²), and measured using dual-energy X-ray absorptiometry (DEXA). Higher values indicate greater fat-free mass relative to height and a more favorable body composition profile.
Time frame: Assessed at a single study visit during enrollment
Measured using dual-energy X-ray absorptiometry (DEXA) and reported as visceral fat mass in grams (g) or kilograms (kg). Higher values indicate greater accumulation of visceral adipose tissue and a less favorable body composition profile.
Time frame: Assessed at a single study visit during enrollment
ALMI in kg/m², calculated as the sum of lean mass from both arms and legs (kg) divided by height squared (m²), and measured by dual-energy X-ray absorptiometry (DEXA). This is a continuous measure and does not have a predefined minimum or maximum value. Higher values indicate greater appendicular lean mass.
Time frame: Assessed at a single study visit during enrollment
ASMI in kg/m², calculated as the appendicular skeletal muscle mass (sum of lean soft tissue mass of the arms and legs, kg) divided by height squared (m²), and measured using dual-energy X-ray absorptiometry (DEXA). This is a continuous measure and has no predefined minimum or maximum value. Higher values indicate greater appendicular skeletal muscle mass.
Time frame: Assessed at a single study visit during enrollment
Time frame: Assessed at a single study visit during enrollment
A self-reported screening tool consisting of five items evaluating strength, assistance with walking, rising from a chair, climbing stairs, and falls. Each item is scored from 0 to 2, yielding a total score ranging from 0 to 10. Higher scores indicate greater risk of sarcopenia and poorer physical function, with scores ≥4 suggesting probable sarcopenia.
Time frame: Assessed at a single study visit during enrollment
A 19-item questionnaire evaluating food sufficiency, healthy eating patterns, foods to limit, salt intake, alcohol consumption, and dietary supplement use. Each item is rated on a 4-point frequency scale. Responses are summed to generate a total dietary quality score ranging from 19 to 76, with higher scores indicating better overall dietary quality and greater adherence to healthy dietary practices.
Time frame: Assessed at a single study visit during enrollment
Evaluates the frequency and duration of walking, moderate-intensity activity, and vigorous-intensity activity over the past 7 days. Responses are converted into metabolic equivalent task (MET)-minutes per week. Total physical activity score has no fixed minimum or maximum value, as it is a continuous measure. Higher scores indicate greater levels of physical activity.
Time frame: Assessed at a single study visit during enrollment
A 19-item questionnaire that evaluates sleep quality and disturbances over the past month across seven components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction). Each component is scored from 0 to 3, yielding a total global score ranging from 0 to 21. Higher scores indicate poorer sleep quality, with scores >5 generally indicating poor sleep quality.
Contact information is provided by the study sponsor or research team.
Nazarbayev University
Other
Understanding Women's Health in Kazakhstan: Body Composition as a Key Indicator for Precision Nutrition and Predictive Healthcare
Acronym: HER-KZ
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