ObesityNCT07740902
CHANGES IN SLEEP QUALITY AND BODY COMPOSITION FOLLOWING A MULTIMODAL LIFESTYLE INTERVENTION IN OLDER WOMEN
A study testing Multimodal Lifestyle Intervention in people with Obesity and Overweight (BMI > 25), run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Obesity, Overweight (BMI > 25), Sleep Quality
- What is being tested?
- Multimodal Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 15 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Obesity, Overweight (BMI > 25), Sleep Quality, Body Composition, Older Adults
- Being tested
- Multimodal Lifestyle Intervention
- Keywords
- Older women, Lifestyle intervention, Nutrition counseling, Sleep quality, Body composition
- Medical subject headings
- Obesity, Overweight, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Lifestyle InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Multimodal Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week 12
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start15 Jan 2024
- Primary completion30 Jun 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Göbel, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740902
- Sponsor's protocol ID
- KBU-NICREC-2023-1607
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to participant privacy and ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHANGES IN SLEEP QUALITY AND BODY COMPOSITION FOLLOWING A MULTIMODAL LIFESTYLE INTERVENTION IN OLDER WOMEN
- ClinicalTrials.gov ID
- NCT07740902
- Acronym / sponsor ID
- KBU-NICREC-2023-1607
- Conditions
- Obesity, Overweight (BMI > 25), Sleep Quality, Body Composition, Older Adults
- Keywords
- Older women, Lifestyle intervention, Nutrition counseling, Sleep quality, Body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Multimodal Lifestyle Intervention Group | Experimental | Behavioral: Multimodal Lifestyle InterventionParticipants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal Lifestyle InterventionThe 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. | Behavioural | Multimodal Lifestyle Intervention Group |
Primary outcome
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.
15 secondary outcomes
Change in body weight measured in kilograms
Time frame: Baseline and week 12
Change in body mass index (BMI) (kg/m²)
Time frame: Baseline and week 12
Change in muscle mass measured by bioelectrical impedance analysis (kg)
Time frame: Baseline and week 12
Change in body water percentage measured by bioelectrical impedance analysis
Time frame: Baseline and week 12
Change in fasting blood glucose concentration (mg/dL)
Time frame: Baseline and week 12
Change in fasting serum insulin concentration (mIU/mL)
Time frame: Baseline and week 12
Change in total cholesterol concentration(mg/dL)
Time frame: Baseline and week 12
Change in LDL cholesterol concentration (mg/dL)
Time frame: Baseline and week 12
Change in HDL cholesterol concentration (mg/dL)
Time frame: Baseline and week 12
Change in serum triglyceride concentration (mg/dL)
Time frame: Baseline and week 12
Change in thyroid-stimulating hormone concentration (mIU/L)
Time frame: Baseline and week 12
Change in aspartate aminotransferase activity (IU/L)
Time frame: Baseline and week 12
Change in alanine aminotransferase activity (U/L)
Time frame: Baseline and week 12
Change in Psychological Well-Being Scale in the Elderly total score
Time frame: Baseline and week 12
Change in International Physical Activity Questionnaire-Short Form total score
Time frame: Baseline and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to participant privacy and ethical restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Lifestyle Intervention in people with Obesity and Overweight (BMI > 25), run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pittsburgh Sleep Quality Index total score (time frame: Baseline and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.