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Completed

NCT Number: NCT07740902

CHANGES IN SLEEP QUALITY AND BODY COMPOSITION FOLLOWING A MULTIMODAL LIFESTYLE INTERVENTION IN OLDER WOMEN

This single-arm pilot study evaluated changes in sleep quality, body composition, biochemical parameters, physical activity, and psychological well-being following a 12-week multimodal lifestyle intervention in overweight and obese women aged 60 years and older. The intervention included individualized nutrition counseling, regular psychological support, and encouragement to walk for at least 150 minutes per week. Participants were assessed at baseline and at the end of week 12. Sleep quality was evaluated using the Pittsburgh Sleep Quality Index. Secondary outcomes included anthropometric measurements, biochemical parameters, physical activity level, and psychological well-being.

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Key information

Conditions

Obesity Body Composition Body Weight Dyssomnias Mental Disorders Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Older Adults Overnutrition Overweight Overweight (BMI > 25) Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Quality Sleep Wake Disorders

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Healthy Living Center, Karabük

Karabük, Turkey (Türkiye)

About this study

This study was designed as a single-arm, pre-post pilot study to evaluate the preliminary effects of a 12-week multimodal lifestyle intervention on sleep quality, body composition, biochemical parameters, physical activity, and psychological well-being in overweight and obese women aged 60 years and older.

The study was conducted at a Healthy Living Center in Karabük, Türkiye. Volunteer women aged 60 years and older who were overweight or obese and had access to healthy diet consultation and psychological support services were enrolled. The intervention consisted of individualized nutrition counseling delivered by a registered dietitian, regular psychological support provided every two weeks, and encouragement to perform walking activity for at least 150 minutes per week. Nutrition counseling was tailored according to individual body composition results, lifestyle, dietary habits, and estimated daily energy requirements. Participants attended weekly face-to-face consultations with the dietitian during the 12-week intervention period.

Participants were assessed at baseline and at week 12. The primary outcome was change in sleep quality, assessed using the Pittsburgh Sleep Quality Index. Secondary outcomes included changes in anthropometric measurements, including body weight, body mass index, muscle mass, and body water ratio; biochemical parameters, including fasting blood glucose, fasting insulin, lipid profile, thyroid-stimulating hormone, aspartate aminotransferase, and alanine aminotransferase; physical activity level assessed using the International Physical Activity Questionnaire-Short Form; and psychological well-being assessed using the Psychological Well-Being Scale in the Elderly.

The study aimed to provide preliminary evidence on whether a combined lifestyle approach involving nutrition counseling, psychological support, and regular walking may be associated with improvements in sleep quality and selected health-related outcomes in older women with overweight or obesity. Because this was a single-arm pilot study without a control group, the findings are intended to inform future controlled studies rather than to establish causal effectiveness.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 60 years or older
  • Being overweight or obese
  • Having access to nutrition counseling and psychological support services at the Healthy Living Center
  • Willingness to participate in the 12-week lifestyle intervention
  • Provision of informed consent

Exclusion criteria

  • Age under 60 years
  • Inability to adhere to the nutrition program
  • Inability to adhere to the walking program
  • Following a specific diet at the time of enrollment
  • Presence of serious chronic kidney, heart, or endocrine disease
  • Presence of severe depressive problems

Treatment and study plan

multimodal lifestyle intervention

Behavioral

The intervention consisted of individualized nutrition counseling provided by a registered dietitian, psychological support provided every two weeks, and recommendations for regular walking activity for at least 150 minutes per week over a 12-week period.

Primary outcomes

  1. Change in Pittsburgh Sleep Quality Index total score

    Time frame: Baseline and week 12

    Sleep quality was assessed using the Pittsburgh Sleep Quality Index. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.

Secondary outcomes

  1. Change in body weight measured in kilograms

    Time frame: Baseline and week 12

    Body weight was measured in kilograms at baseline and week 12. The change in body weight over the 12-week intervention period was evaluated.

  2. Change in body mass index (BMI) (kg/m²)

    Time frame: Baseline and week 12

    Body mass index was calculated as weight in kilograms divided by height in meters squared. The change in BMI from baseline to week 12 was evaluated.

  3. Change in muscle mass measured by bioelectrical impedance analysis (kg)

    Time frame: Baseline and week 12

    Muscle mass was assessed using bioelectrical impedance analysis and reported in kilograms. The change in muscle mass from baseline to week 12 was evaluated.

  4. Change in body water percentage measured by bioelectrical impedance analysis

    Time frame: Baseline and week 12

    Body water percentage was assessed using bioelectrical impedance analysis. The change from baseline to week 12 was evaluated.

  5. Change in fasting blood glucose concentration (mg/dL)

    Time frame: Baseline and week 12

    Fasting blood glucose was measured in mg/dL. The change from baseline to week 12 was evaluated.

  6. Change in fasting serum insulin concentration (mIU/mL)

    Time frame: Baseline and week 12

    Fasting insulin was measured in mIU/mL. The change from baseline to week 12 was evaluated.

  7. Change in total cholesterol concentration(mg/dL)

    Time frame: Baseline and week 12

    Total cholesterol was measured in mg/dL. The change from baseline to week 12 was evaluated.

  8. Change in LDL cholesterol concentration (mg/dL)

    Time frame: Baseline and week 12

    LDL cholesterol was measured in mg/dL. The change from baseline to week 12 was evaluated.

  9. Change in HDL cholesterol concentration (mg/dL)

    Time frame: Baseline and week 12

    HDL cholesterol was measured in mg/dL. The change from baseline to week 12 was evaluated.

  10. Change in serum triglyceride concentration (mg/dL)

    Time frame: Baseline and week 12

    Triglycerides were measured in mg/dL. The change from baseline to week 12 was evaluated.

  11. Change in thyroid-stimulating hormone concentration (mIU/L)

    Time frame: Baseline and week 12

    Thyroid-stimulating hormone was measured in mIU/L. The change from baseline to week 12 was evaluated.

  12. Change in aspartate aminotransferase activity (IU/L)

    Time frame: Baseline and week 12

    Aspartate aminotransferase was measured in IU/L. The change from baseline to week 12 was evaluated.

  13. Change in alanine aminotransferase activity (U/L)

    Time frame: Baseline and week 12

    Alanine aminotransferase was measured in U/L. The change from baseline to week 12 was evaluated.

  14. Change in Psychological Well-Being Scale in the Elderly total score

    Time frame: Baseline and week 12

    Psychological well-being was assessed using the Psychological Well-Being Scale in the Elderly. Higher scores indicate greater psychological well-being.

  15. Change in International Physical Activity Questionnaire-Short Form total score

    Time frame: Baseline and week 12

    Physical activity was assessed using the International Physical Activity Questionnaire-Short Form and reported as MET-minutes/week.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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