An interventional study of Multimodal Lifestyle Intervention in Obesity, Overweight (BMI > 25) and Sleep Quality, sponsored by Saglik Bilimleri Universitesi. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Other
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.
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.
6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.
This study's enrollment of 36 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
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Exclusion Criteria:
Participants received a 12-week multimodal lifestyle intervention including individualized nutrition counseling, psychological support every two weeks, and recommendations for regular walking activity for at least 150 minutes per week.
Behavioral: Multimodal Lifestyle Intervention
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.
Change in Pittsburgh Sleep Quality Index total score
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.
Time frame: Baseline and week 12
Change in body weight measured in kilograms
Body weight was measured in kilograms at baseline and week 12. The change in body weight over the 12-week intervention period was evaluated.
Time frame: Baseline and week 12
Change in body mass index (BMI) (kg/m²)
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.
Time frame: Baseline and week 12
Change in muscle mass measured by bioelectrical impedance analysis (kg)
Muscle mass was assessed using bioelectrical impedance analysis and reported in kilograms. The change in muscle mass from baseline to week 12 was evaluated.
Time frame: Baseline and week 12
Change in body water percentage measured by bioelectrical impedance analysis
Body water percentage was assessed using bioelectrical impedance analysis. The change from baseline to week 12 was evaluated.
Time frame: Baseline and week 12
Change in fasting blood glucose concentration (mg/dL)
Fasting blood glucose was measured in mg/dL. The change from baseline to week 12 was evaluated.
Time frame: Baseline and week 12
Change in fasting serum insulin concentration (mIU/mL)
Fasting insulin was measured in mIU/mL. The change from baseline to week 12 was evaluated.
Time frame: Baseline and week 12
Change in total cholesterol concentration(mg/dL)
Total cholesterol was measured in mg/dL. The change from baseline to week 12 was evaluated.
Time frame: Baseline and week 12
Change in LDL cholesterol concentration (mg/dL)
LDL cholesterol was measured in mg/dL. The change from baseline to week 12 was evaluated.
Time frame: Baseline and week 12
Change in HDL cholesterol concentration (mg/dL)
HDL cholesterol was measured in mg/dL. The change from baseline to week 12 was evaluated.
Time frame: Baseline and week 12
Change in serum triglyceride concentration (mg/dL)
Triglycerides were measured in mg/dL. The change from baseline to week 12 was evaluated.
Time frame: Baseline and week 12
Change in thyroid-stimulating hormone concentration (mIU/L)
Thyroid-stimulating hormone was measured in mIU/L. The change from baseline to week 12 was evaluated.
Time frame: Baseline and week 12
Change in aspartate aminotransferase activity (IU/L)
Aspartate aminotransferase was measured in IU/L. The change from baseline to week 12 was evaluated.
Time frame: Baseline and week 12
Change in alanine aminotransferase activity (U/L)
Alanine aminotransferase was measured in U/L. The change from baseline to week 12 was evaluated.
Time frame: Baseline and week 12
Change in Psychological Well-Being Scale in the Elderly total score
Psychological well-being was assessed using the Psychological Well-Being Scale in the Elderly. Higher scores indicate greater psychological well-being.
Time frame: Baseline and week 12
Change in International Physical Activity Questionnaire-Short Form total score
Physical activity was assessed using the International Physical Activity Questionnaire-Short Form and reported as MET-minutes/week.
Time frame: Baseline and week 12
Plan to share: No — Individual participant data will not be publicly shared due to participant privacy and ethical restrictions.
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Saglik Bilimleri Universitesi