CHANGES IN SLEEP QUALITY AND BODY COMPOSITION FOLLOWING A MULTIMODAL LIFESTYLE INTERVENTION IN OLDER WOMEN
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Change in Pittsburgh Sleep Quality Index total score
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Masking Description
No masking was used because this was an open-label, single-arm lifestyle intervention study.
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- Change in body weight measured in kilograms(Baseline and week 12)
- Change in body mass index (BMI) (kg/m²)(Baseline and week 12)
- Change in muscle mass measured by bioelectrical impedance analysis (kg)(Baseline and week 12)
- Change in body water percentage measured by bioelectrical impedance analysis(Baseline and week 12)
- Change in fasting blood glucose concentration (mg/dL)(Baseline and week 12)
- Change in fasting serum insulin concentration (mIU/mL)(Baseline and week 12)
- Change in total cholesterol concentration(mg/dL)(Baseline and week 12)
- Change in LDL cholesterol concentration (mg/dL)(Baseline and week 12)
- Change in HDL cholesterol concentration (mg/dL)(Baseline and week 12)
- Change in serum triglyceride concentration (mg/dL)(Baseline and week 12)
- Change in thyroid-stimulating hormone concentration (mIU/L)(Baseline and week 12)
- Change in aspartate aminotransferase activity (IU/L)(Baseline and week 12)
- Change in alanine aminotransferase activity (U/L)(Baseline and week 12)
- Change in Psychological Well-Being Scale in the Elderly total score(Baseline and week 12)
- Change in International Physical Activity Questionnaire-Short Form total score(Baseline and week 12)
Investigators
Pınar Göbel
Assoc. Prof. Dr.
Saglik Bilimleri Universitesi