Health, Body Composition, and Nutrition Research Among Women in Kazakhstan (HER-KZ)
26 giugno 2026 aggiornato da: Mei Yen Chan, Nazarbayev University
Understanding Women's Health in Kazakhstan: Body Composition as a Key Indicator for Precision Nutrition and Predictive Healthcare
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.
Panoramica dello studio
Stato
Non ancora reclutamento
Tipo di studio
Osservativo
Iscrizione (Stimato)
200
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Mei Yen Chan
- Numero di telefono: +7 7172 69 4968
- Email: yen.chan@nu.edu.kz
Backup dei contatti dello studio
- Nome: Tairkhan Dautov
- Email: tairkhan.dautov@gmail.com
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
- Adulto
- Adulto più anziano
Accetta volontari sani
N/A
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Participants will be identified from the pool of women attending clinically-ordered DEXA examinations.
Descrizione
Inclusion Criteria:
- Female sex
- Age ≥20 years at the time of consent
- Natural postmenopause (≥12 consecutive months of amenorrhoea not attributable to other pathological or pharmacological causes) OR surgical postmenopause (bilateral oophorectomy)
- Resident of Astana or the surrounding region with no planned relocation during the study period
- Able to provide written informed consent independently
- Able to complete the questionnaire in Kazakh, Russian, or English
Exclusion Criteria:
- Active malignancy or systemic anti-cancer treatment (chemotherapy, radiotherapy, immunotherapy) within the past 5 years
- Conditions causing secondary changes in muscle mass or body composition: hyperthyroidism (untreated), Cushing's syndrome, acromegaly, severe liver disease (Child-Pugh B or C), advanced chronic kidney disease (Stage 4 or 5, eGFR <30 ml/min/1.73 m²)
- Neuromuscular disorders that independently affect skeletal muscle mass (e.g., myopathy, motor neurone disease, multiple sclerosis)
- Long-term systemic corticosteroid therapy (>3 months in the past year, equivalent to ≥5 mg/day prednisolone)
- Severe skeletal deformity (kyphoscoliosis, limb absence) or presence of metallic implants (hip or knee prosthesis on both sides, bilateral rods) that would significantly compromise DEXA body composition validity
- Physical inability to stand or to complete the functional assessments safely
- Cognitive impairment or psychiatric condition precluding independent informed consent, as determined by the recruiting research team member
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
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Fat Mass Index (FMI)
Lasso di tempo: 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.
|
Assessed at a single study visit during enrollment
|
|
Bone mineral density (BMD)
Lasso di tempo: 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.
|
Assessed at a single study visit during enrollment
|
|
Fat-Free Mass Index (FFMI)
Lasso di tempo: 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.
|
Assessed at a single study visit during enrollment
|
|
Visceral Adipose Tissue (VAT)
Lasso di tempo: 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.
|
Assessed at a single study visit during enrollment
|
|
Appendicular lean mass index (ALMI)
Lasso di tempo: 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.
|
Assessed at a single study visit during enrollment
|
|
Appendicular skeletal muscle mass and index (ASMI)
Lasso di tempo: 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.
|
Assessed at a single study visit during enrollment
|
|
Body Mass Index (BMI)
Lasso di tempo: Assessed at a single study visit during enrollment
|
Assessed at a single study visit during enrollment
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
SARC-F Score
Lasso di tempo: 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.
|
Assessed at a single study visit during enrollment
|
|
Rapid Eating Assessment for Participants - dietary quality score
Lasso di tempo: 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.
|
Assessed at a single study visit during enrollment
|
|
IPAQ-SF Physical Activity (International Physical Activity Questionnaire - Short Form)
Lasso di tempo: 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.
|
Assessed at a single study visit during enrollment
|
|
Pittsburgh Sleep Quality Index (PSQI) Global Score
Lasso di tempo: 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.
|
Assessed at a single study visit during enrollment
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
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 (Stimato)
1 luglio 2026
Completamento primario (Stimato)
1 luglio 2029
Completamento dello studio (Stimato)
1 luglio 2029
Date di iscrizione allo studio
Primo inviato
18 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
26 giugno 2026
Primo Inserito (Effettivo)
30 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
30 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
26 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 201223FD2603
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
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 .