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

NCT07740902 | Completed

• 1 other identifier: KBU-NICREC-2023-1607
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Overweight (BMI > 25); Sleep Quality; Older Adults; Body Composition

Keywords

Older women; Lifestyle intervention; Nutrition counseling; Sleep quality; Body composition

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and week 12

Secondary Outcomes (15)

• 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

Study Arms (1)

Multimodal Lifestyle Intervention Group

EXPERIMENTAL

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

Interventions

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.

Multimodal Lifestyle Intervention Group

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Healthy Living Center, Karabük

Karabük, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity; Overweight; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking was used because this was an open-label, single-arm lifestyle intervention study.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: August 3, 2026
• Study Start: January 15, 2024
• Primary Completion: June 30, 2024
• Study Completion: July 15, 2024
• Last Updated: August 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)