Body Composition, Obesity, Older Adults, Overweight (BMI > 25), Sleep Quality
Conditions
Keywords
Older women, Lifestyle intervention, Nutrition counseling, Sleep quality, Body composition
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.
Interventions
BEHAVIORALMultimodal 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.
Sponsors
Saglik Bilimleri Universitesi
Study design
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.
Intervention model description
Single-arm, pre-post pilot study. All participants received a 12-week multimodal lifestyle intervention including individualized nutrition counseling, psychological support, and regular walking recommendations. Outcomes were assessed at baseline and at week 12.
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pittsburgh Sleep Quality Index total score | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight measured in kilograms | 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. |
| Change in body mass index (BMI) (kg/m²) | 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. |
| Change in muscle mass measured by bioelectrical impedance analysis (kg) | 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. |
| Change in body water percentage measured by bioelectrical impedance analysis | Baseline and week 12 | Body water percentage was assessed using bioelectrical impedance analysis. The change from baseline to week 12 was evaluated. |
| Change in fasting blood glucose concentration (mg/dL) | Baseline and week 12 | Fasting blood glucose was measured in mg/dL. The change from baseline to week 12 was evaluated. |
| Change in fasting serum insulin concentration (mIU/mL) | Baseline and week 12 | Fasting insulin was measured in mIU/mL. The change from baseline to week 12 was evaluated. |
| Change in total cholesterol concentration(mg/dL) | Baseline and week 12 | Total cholesterol was measured in mg/dL. The change from baseline to week 12 was evaluated. |
| Change in LDL cholesterol concentration (mg/dL) | Baseline and week 12 | LDL cholesterol was measured in mg/dL. The change from baseline to week 12 was evaluated. |
| Change in HDL cholesterol concentration (mg/dL) | Baseline and week 12 | HDL cholesterol was measured in mg/dL. The change from baseline to week 12 was evaluated. |
| Change in serum triglyceride concentration (mg/dL) | Baseline and week 12 | Triglycerides were measured in mg/dL. The change from baseline to week 12 was evaluated. |
| Change in thyroid-stimulating hormone concentration (mIU/L) | Baseline and week 12 | Thyroid-stimulating hormone was measured in mIU/L. The change from baseline to week 12 was evaluated. |
| Change in aspartate aminotransferase activity (IU/L) | Baseline and week 12 | Aspartate aminotransferase was measured in IU/L. The change from baseline to week 12 was evaluated. |
| Change in alanine aminotransferase activity (U/L) | Baseline and week 12 | Alanine aminotransferase was measured in U/L. The change from baseline to week 12 was evaluated. |
| Change in Psychological Well-Being Scale in the Elderly total score | 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. |
| Change in International Physical Activity Questionnaire-Short Form total score | Baseline and week 12 | Physical activity was assessed using the International Physical Activity Questionnaire-Short Form and reported as MET-minutes/week. |
Countries
Turkey (Türkiye)
Outcome results
None listed