NCT07675486

Brief Summary

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 Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
36mo left

Started Jul 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026Jul 2029

First Submitted

Initial submission to the registry

June 18, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 30, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

3 years

First QC Date

June 18, 2026

Last Update Submit

June 26, 2026

Conditions

Outcome Measures

Primary Outcomes (7)

  • Fat Mass Index (FMI)

    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)

    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)

    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)

    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)

    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)

    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)

    Assessed at a single study visit during enrollment

Secondary Outcomes (4)

  • SARC-F Score

    Assessed at a single study visit during enrollment

  • Rapid Eating Assessment for Participants - dietary quality score

    Assessed at a single study visit during enrollment

  • IPAQ-SF Physical Activity (International Physical Activity Questionnaire - Short Form)

    Assessed at a single study visit during enrollment

  • Pittsburgh Sleep Quality Index (PSQI) Global Score

    Assessed at a single study visit during enrollment

Eligibility Criteria

Age20 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be identified from the pool of women attending clinically-ordered DEXA examinations.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Tairkhan Dautov

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Central Asia Food Innovation Lab, School of Medicine

Study Record Dates

First Submitted

June 18, 2026

First Posted

June 30, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2029

Last Updated

June 30, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share