Obesity and OverweightSLEEP-OBNCT07255274
Overweight and Obesity in Adolescents - Sleep Behavioral Intervention
A study testing Sleep Behavioral Intervention and Standard Obesity Treatment in people with Obesity and Overweight and Sleep Disorder, run by University of Beira Interior at 2 sites in Portugal.
Trial summary
Sleep plays a crucial role in energy balance, alongside diet and physical activity. Research has linked poor sleep quality and short sleep duration to obesity and cardiometabolic risk, such as insulin resistance and hypertension. The nature of this association is complex, and several mechanims have been suggested. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Obesity and Overweight, Sleep Disorder
- What is being tested?
- Sleep Behavioral Intervention and Standard Obesity Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 2 sitesPortugal
- Study dates
- 3 Jun 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Informed consent from legal guardians and assent/consent from the adolescent;
- Age between 13 and 17 years at the time of consent;
- Diagnosis of overweight (BMI z-score > 1 and ≤ 2) or obesity (BMI z-score > 2), according to WHO criteria;
- Sleep deprivation or poor sleep quality, based on the initial screening questionnaire.
Who cannot join
- Secondary obesity (e.g., hypothalamic, genetic, or endocrine causes);
- Comorbid psychiatric or neurological disorders (e.g., epilepsy, autism spectrum disorder) that affect sleep;
- Current treatment with selective serotonin reuptake inhibitors (SSRIs) or other medications affecting sleep.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal2 sites, 2 recruiting
- Recruiting
Unidade Local de Saúde Cova da Beira
Covilha
Sofia Ferreira, MD, +351275330000, ana.sofia.ferreira@ubi.pt
Arminda Jorge, PhD in Medicine, ajorge@fcsaude.ubi.pt
- Not yet recruiting
Hospital CUF Porto
Porto
Carla Rêgo, PhD in Medicine, carlambssrego@gmail.com
Carla Rêgo, PhD in Medicine
About this study
Official title: Treatment of Overweight and Obesity in Adolescents - Impact of a Sleep Behavioral Intervention - SLEEP-OB
Sleep plays a crucial role in energy balance, alongside diet and physical activity. Research has linked poor sleep quality and short sleep duration to obesity and cardiometabolic risk, such as insulin resistance and hypertension. The nature of this association is complex, and several mechanims have been suggested.
Scientific evidence suggests that sleep interventions may provide additional benefits in optimizing the effectiveness of overweight/obesity treatment in pediatric populations. Although some studies have explored this hypothesis, methodological heterogeneity hampers clear interpretation of the results.
Read more
The main goal of this clinical trial is is to evaluate the efficacy of a sleep behavioral intervention, combined with standard obesity treatment, in reducing adiposity (measured by BMI z-score, fat mass percentage, or fat-free mass index) in adolescents with overweight or obesity.
This randomized controlled trial will compare a control group receiving treatment as usual (or standard obesity treatment) with an intervention group receiving treatment as usual plus a sleep behavioral intervention.
Participants will be randomized into two groups: intervention and control. Throughout the study period, all medical consultations will include standard interventions focused on nutrition, physical activity/sedentary behavior, and other lifestyle factors. The sleep-focused intervention will be delivered by psychologists.
Participants will attend clinic visits every two months during the 6-month intervention period, and every three months during the subsequent 6-month follow-up period.
Read the detailed description
A randomized controlled trial (open-label, behavioral intervention) will be conducted at ULS Cova da Beira and Hospital CUF Porto, enrolling 126 adolescents (ages 13-17) diagnosed with overweight or obesity and poor sleep quality. Participants will be randomized into two groups: the intervention group (sleep behavioral intervention plus treatment as usual) and the control group (treatment as usual).
In addition to the primary aim, the researchers will evaluate several secondary outcomes, including the efficacy of the intervention in relation to: cardiometabolic risk, sleep patterns, eating patterns, physical activity level, emotional well-being/self-compassion, quality of life, leptin and ghrelin levels, and tryptophan and melatonin metabolism.
Throughout the study period, all medical consultations will include standard multicomponent behavioral intervention. The sleep behavioral intervention will be conducted by psychologists.
The intervention consists of seven cognitive-behavioral therapy (CBT) sessions over six months, focusing on sleep hygiene, self-monitoring, stimulus control, cognitive therapy, and relaxation techniques.
Data collection and analysis will include objective sleep assessment using actigraphy and a level 3 ambulatory sleep study. Blood samples will be collected at baseline, six months, and twelve months to analyze metabolic markers. From the samples collected at months 0 and 6, a portion will be appropriately stored for additional analysis at an external facility to quantify leptin, ghrelin, and tryptophan pathway metabolites.
Anthropometric and clinical assessments will include measurements of body mass index (BMI), waist circumference, body composition, and blood pressure. Validated questionnaires will be used to evaluate sleep patterns, eating behaviors, physical activity, quality of life, emotional well-being, and self-compassion.
It is anticipated that the sleep behavioral intervention combined with standard treatment will be more effective than standard treatment alone not only in reducing adiposity, but also in improving cardiometabolic risk, sleep patterns, eating patterns, physical activity, emotional well-being, self-compassion, and in regulating hormonal and metabolic pathways including ghrelin, leptin, and the tryptophan-melatonin axis, as outlined in the study hypotheses
The study also aims to clarify the role of ghrelin and leptin levels, as well as the tryptophan pathway, in the interaction between sleep and obesity and in the effects of the intervention
Emotional well-being and self-compassion are expected to mediate the response to obesity intervention and the sleep-obesity relationship, potentially influencing or influenced by the tryptophan metabolic pathway, particularly serotonin levels.
By deepening the knowledge about the relationship between sleep and obesity, this research may contribute to optimize interventions for pediatric obesity, which would have an unequivocal positive impact.
- Conditions
- Obesity and Overweight, Sleep Disorder
- Being tested
- Sleep Behavioral Intervention, Standard Obesity Treatment
- Keywords
- Obesity, Sleep, Behavioral intervention, Adolescents
- Medical subject headings
- Obesity, Overweight, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Behavioral InterventionBehavioural
Also called Sleep intervention, Cognitive Behavioral Therapy for sleep disorders
Our research team, composed by pediatricians with experience in Obesity and Adolescent Medicine, and clinical psychologists with experience in Sleep, Obesity, and Cognitive Behavioral Therapy (CBT), developed a specific manual for this project: "Behavioral Sleep Intervention - SLEEP-OB - Therapist Support Manual." The manual was adapted based on CBT models for adults and adolescents with insomnia and on CBT for adolescents with other sleep disorders and comorbidities, namely obesity. The behavioral intervention aims to promote sustainable changes in sleep. It includes behavioral strategies (such as sleep restriction, stimulus control), cognitive strategies (cognitive reappraisal/restructuring, cognitive control, paradoxical intention), mixed strategies (sleep education/hygiene, relaxation), self-monitoring, and problem identification and resolution.
The intervention will take place over six months, with a total of seven sessions (in-person and by video call).
Standard Obesity TreatmentOther
Also called treatment as usual
Standard obesity treatment for pediatric obesity according to international guidelines. It comprises pediatric appointments, and usually also nutrition and nursing appointments, every 2 to 3 months. These appointments include an anthropometric evaluation, physical examination and personalized multicomponent behavioral intervention with focus on nutrition, physical activity/sedentary behavior and other lifestyle recommendations. This standard intervention is common for both groups/arms.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Standard interventions focused on nutrition, physical activity/sedentary behavior, and other lifestyle aspects. Receives: Other: Standard Obesity Treatment |
| Intervention group | Experimental | Standard intervention plus sleep-focused intervention. The sleep intervention will be conducted by psychologists. These monthly sessions, delivered in person or via video call, will be scheduled on the same day as the medical consultation whenever possible. The session planning and objectives are outlined in the study protocol. Receives: Behavioral: Sleep Behavioral Intervention; Other: Standard Obesity Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI z-score at 6 months
Variation between Visit 1 (baseline) and Visit 4 (end of the intervention). Weight (in kilograms) and height (in meters) will be used to calculate BMI in kg/m2. Then, BMI z-score will be calculated by WHO Anthroplus software 3.2.2.
Measured: 6 months
BMI at 6 months
Variation between Visit 1 (baseline) and Visit 4 (end of the intervention). Weight (in kilograms) and height (in meters) will be used to calculate BMI in kg/m2.
Measured: 6 months
Fat mass percentage at 6 months
Variation between Visit 1 (baseline) and Visit 4 (end of the intervention). Fat mass percentage (%FM) assessed using bioelectrical impedance analysis with InBody 270®.
Measured: 6 months
Fat-free mass index at 6 months
Variation between Visit 1 (baseline) and Visit 4 (end of the intervention). FFMI (kg/ m2) calculated using FFM (in kilograms) and height (in meters).
Measured: 6 months
Secondary outcomes (29)
Participants achieving a BMI reduction ≥5%
Percentage of participants achieving a BMI reduction ≥5% between Visit 1 and Visit 4, and between Visit 1 and Visit 6.
Measured: 6 months and 12 months
Participants achieving a BMI reduction ≥10%
Percentage of participants achieving a BMI reduction ≥10% between Visit 1 and Visit 4, and between Visit 1 and Visit 6.
Measured: 6 months and 12 months
Change in Waist circumference centile
Variation between Visit 1 and Visit 4, and between Visit 1 and Visit 6. waist circumference in centimeters, and centiles according to Sharma AK, et al. Pediatr Res. 2015.
Measured: 6 months and 12 months
Fat mass percentage at 12 months
Variation between Visit 1 (baseline) and Visit 6 (end of the follow-up). Fat mass percentage (%FM) assessed using bioelectrical impedance analysis with InBody 270®.
Measured: 12 months
Fat-free mass index at 12 months
Variation between Visit 1 (baseline) and Visit 6 (end of the follow-up). FFMI (kg/ m2) calculated using FFM (in kilograms) and height (in meters).
Measured: 12 months
BMI z-score at 12 months
Variation between Visit 1 (baseline) and Visit 6 (end of the follow-up). Weight (in kilograms) and height (in meters) will be used to calculate BMI in kg/m2. Then, BMI z-score will be calculated by WHO Anthroplus software 3.2.2.
Measured: 12 months
BMI at 12 months
Variation between Visit 1 (baseline) and Visit 6 (end of the follow-up). Weight (in kilograms) and height (in meters) will be used to calculate BMI in kg/m2.
Measured: 12 months
Change in Waist-to-height Ratio
Variation between Visit 1 and Visit 4, and between Visit 1 and Visit 6.
Measured: 6 months and 12 months
Change in C-reactive protein
Variation between Visit 1 and Visit 4, and between Visit 1 and Visit 6.
Measured: 6 months and 12 months
Change in Fasting Lipid: Total Cholesterol
Variation between Visit 1 and Visit 4, and between Visit 1 and Visit 6.
Measured: 6 months and 12 months
Change in Fasting Lipid: LDL-cholesterol
Variation between Visit 1 and Visit 4, and between Visit 1 and Visit 6.
Measured: 6 months and 12 months
Change in Fasting Lipid: HDL-cholesterol
Variation between Visit 1 and Visit 4, and between Visit 1 and Visit 6.
Measured: 6 months and 12 months
Change in Fasting Lipid: Triglycerides
Variation between Visit 1 and Visit 4, and between Visit 1 and Visit 6.
Measured: 6 months and 12 months
Change in centiles of Systolic and Diastolic Blood Pressure
Variation between Visit 1 and Visit 4, and between Visit 1 and Visit 6. Blood pressure measured and centiles according to the American Academy of Pediatrics.
Measured: 6 months and 12 months
Change in HbA1c
Variation between Visit 1 and Visit 4, and between Visit 1 and Visit 6.
Measured: 6 months and 12 months
Change in Glycaemic Category
Variation between Visit 1 and Visit 4, and between Visit 1 and Visit 6. Number of participants in glycaemic categories, "normoglycaemia, pre-diabetes and type 2 diabetes (T2DM)" 2 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: fasting plasma glucose (FPG) <100 mg/dL and/or HbA1c <5.7%. 2) Pre-diabetes: FPG 100-125 mg/dL (both inclusive) or HbA1c 5.7-6.4% (both inclusive). 3) Type 2 diabetes (T2DM): FPG ≥126 mg/dL and/or HbA1c ≥6.5%
Measured: 6 months and 12 months
Change in HOMA-B
Variation between Visit 1 and Visit 4 and between Visit and Visit 6. HOMA-B was calculated as: Beta-cell function (%) = 20·fasting insulin[mU/L]/(FPG[mmol/L]-3.5).
Measured: 6 months and 12 months
Change in HOMA-IR
Variation between Visit 1 and Visit 4 and between Visit and Visit 6. HOMA-IR was calculated as: Insulin resistance (%) = fasting insulin [mU/L] x FPG [mmol/L]/ 22.5. R
Measured: 6 months and 12 months
Change in Continuous metabolic syndrome score
Variation between Visit 1 and Visit 4 and between Visit and Visit 6. Calculation according to Vukovic R, et al. PLoS One. 2017 Dec 6;12(12):e0189232.
Measured: 6 months and 12 months
Change in Sleep quality
Sleep quality assessed by the Pittsburgh Sleep Quality Index, at Visit 1and Visit 4, and at Visit 6.
Measured: 6 months and 12 months
Change in sleep quality - actigrafy
Sleep quality assessed by actigraphy and sleep diary, at Visit 1and Visit 4.
Measured: 6 months
Change in Respiratory Sleep disorder
Respiratory sleep disorder assessed by the Pediatric sleep questionnaire at Visit 1and Visit 4.
Measured: 6 months
Change in Diet Quality
Mediterranean Diet Quality assessed with KIDMED questionnaire, at Visit 1 and Visit 4.
Measured: 6 months
Change in Eating behavior
MEating behavior assessed with Eating Attitudes Test questionnaire, at Visit 1 and Visit 4.
Measured: 6 months
Change in emotional well-being
At Visit 1 and Visit 4: Emotional well-being assessed through the WHO-5.
Measured: 6 months
Change in Quality of life
At Visit 1 and Visit 4: Quality of life evaluated with the KIDSCREEN 52 questionnaire.
Measured: 6 months
Change in self-compassion
At Visit 1 and Visit 4: Self-compassion evaluated with the Self-Compassion Scale for adolescents.
Measured: 6 months
Change in Physical activity
Physical activity assessed with International Physical Activity Questionnaire for Adolescents, at Visit 1 and Visit 4.
Measured: 6 months
Change in Physical activity - actigraphy
Physical activity assessed by actigraphy, at Visit 1 and Visit 4.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start3 Jun 2025
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-Label Randomized Clinical Study with a Behavioral Intervention
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Beira Interior
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ana sofia rodrigues ferreira, University of Beira Interior
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255274
- Sponsor's protocol ID
- TID 101794088
- Acronym
- SLEEP-OB
- Status last verified
- Nov 2025
- First submitted
- 14 Jun 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data may be shared upon request, provided that all identifying information is removed to safeguard participant anonymity. This process upholds the confidentiality and privacy of participants, fully complying with ethical and legal standards for data protection.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Overweight and Obesity in Adolescents - Impact of a Sleep Behavioral Intervention - SLEEP-OB
- ClinicalTrials.gov ID
- NCT07255274
- Acronym / sponsor ID
- SLEEP-OB / TID 101794088
- Conditions
- Obesity and Overweight, Sleep Disorder
- Keywords
- Obesity, Sleep, Behavioral intervention, Adolescents
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- University of Beira InteriorUniversity, hospital or other
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Dec 2025 (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.
Sleep plays a crucial role in energy balance, alongside diet and physical activity. Research has linked poor sleep quality and short sleep duration to obesity and cardiometabolic risk, such as insulin resistance and hypertension. The nature of this association is complex, and several mechanims have been suggested.
Scientific evidence suggests that sleep interventions may provide additional benefits in optimizing the effectiveness of overweight/obesity treatment in pediatric populations. Although some studies have explored this hypothesis, methodological heterogeneity hampers clear interpretation of the results.
The main goal of this clinical trial is is to evaluate the efficacy of a sleep behavioral intervention, combined with standard obesity treatment, in reducing adiposity (measured by BMI z-score, fat mass percentage, or fat-free mass index) in adolescents with overweight or obesity.
This randomized controlled trial will compare a control group receiving treatment as usual (or standard obesity treatment) with an intervention group receiving treatment as usual plus a sleep behavioral intervention.
Participants will be randomized into two groups: intervention and control. Throughout the study period, all medical consultations will include standard interventions focused on nutrition, physical activity/sedentary behavior, and other lifestyle factors. The sleep-focused intervention will be delivered by psychologists.
Participants will attend clinic visits every two months during the 6-month intervention period, and every three months during the subsequent 6-month follow-up period.
Detailed description
A randomized controlled trial (open-label, behavioral intervention) will be conducted at ULS Cova da Beira and Hospital CUF Porto, enrolling 126 adolescents (ages 13-17) diagnosed with overweight or obesity and poor sleep quality. Participants will be randomized into two groups: the intervention group (sleep behavioral intervention plus treatment as usual) and the control group (treatment as usual).
In addition to the primary aim, the researchers will evaluate several secondary outcomes, including the efficacy of the intervention in relation to: cardiometabolic risk, sleep patterns, eating patterns, physical activity level, emotional well-being/self-compassion, quality of life, leptin and ghrelin levels, and tryptophan and melatonin metabolism.
Throughout the study period, all medical consultations will include standard multicomponent behavioral intervention. The sleep behavioral intervention will be conducted by psychologists.
The intervention consists of seven cognitive-behavioral therapy (CBT) sessions over six months, focusing on sleep hygiene, self-monitoring, stimulus control, cognitive therapy, and relaxation techniques.
Data collection and analysis will include objective sleep assessment using actigraphy and a level 3 ambulatory sleep study. Blood samples will be collected at baseline, six months, and twelve months to analyze metabolic markers. From the samples collected at months 0 and 6, a portion will be appropriately stored for additional analysis at an external facility to quantify leptin, ghrelin, and tryptophan pathway metabolites.
Anthropometric and clinical assessments will include measurements of body mass index (BMI), waist circumference, body composition, and blood pressure. Validated questionnaires will be used to evaluate sleep patterns, eating behaviors, physical activity, quality of life, emotional well-being, and self-compassion.
It is anticipated that the sleep behavioral intervention combined with standard treatment will be more effective than standard treatment alone not only in reducing adiposity, but also in improving cardiometabolic risk, sleep patterns, eating patterns, physical activity, emotional well-being, self-compassion, and in regulating hormonal and metabolic pathways including ghrelin, leptin, and the tryptophan-melatonin axis, as outlined in the study hypotheses
The study also aims to clarify the role of ghrelin and leptin levels, as well as the tryptophan pathway, in the interaction between sleep and obesity and in the effects of the intervention
Emotional well-being and self-compassion are expected to mediate the response to obesity intervention and the sleep-obesity relationship, potentially influencing or influenced by the tryptophan metabolic pathway, particularly serotonin levels.
By deepening the knowledge about the relationship between sleep and obesity, this research may contribute to optimize interventions for pediatric obesity, which would have an unequivocal positive impact.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Open-Label Randomized Clinical Study with a Behavioral Intervention
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Standard Obesity TreatmentStandard interventions focused on nutrition, physical activity/sedentary behavior, and other lifestyle aspects. |
| Intervention group | Experimental | Behavioral: Sleep Behavioral Intervention, Other: Standard Obesity TreatmentStandard intervention plus sleep-focused intervention. The sleep intervention will be conducted by psychologists. These monthly sessions, delivered in person or via video call, will be scheduled on the same day as the medical consultation whenever possible. The session planning and objectives are outlined in the study protocol. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Informed consent from legal guardians and assent/consent from the adolescent;
- Age between 13 and 17 years at the time of consent;
- Diagnosis of overweight (BMI z-score > 1 and ≤ 2) or obesity (BMI z-score > 2), according to WHO criteria;
- Sleep deprivation or poor sleep quality, based on the initial screening questionnaire.
Key exclusion criteria (3 listed)
- Secondary obesity (e.g., hypothalamic, genetic, or endocrine causes);
- Comorbid psychiatric or neurological disorders (e.g., epilepsy, autism spectrum disorder) that affect sleep;
- Current treatment with selective serotonin reuptake inhibitors (SSRIs) or other medications affecting sleep.
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 |
|---|---|---|
| Sleep Behavioral InterventionAlso: Sleep intervention, Cognitive Behavioral Therapy for sleep disordersOur research team, composed by pediatricians with experience in Obesity and Adolescent Medicine, and clinical psychologists with experience in Sleep, Obesity, and Cognitive Behavioral Therapy (CBT), developed a specific manual for this project: "Behavioral Sleep Intervention - SLEEP-OB - Therapist Support Manual." The manual was adapted based on CBT models for adults and adolescents with insomnia and on CBT for adolescents with other sleep disorders and comorbidities, namely obesity. The behavioral intervention aims to promote sustainable changes in sleep. It includes behavioral strategies (such as sleep restriction, stimulus control), cognitive strategies (cognitive reappraisal/restructuring, cognitive control, paradoxical intention), mixed strategies (sleep education/hygiene, relaxation), self-monitoring, and problem identification and resolution. The intervention will take place over six months, with a total of seven sessions (in-person and by video call). | Behavioural | Intervention group |
| Standard Obesity TreatmentAlso: treatment as usualStandard obesity treatment for pediatric obesity according to international guidelines. It comprises pediatric appointments, and usually also nutrition and nursing appointments, every 2 to 3 months. These appointments include an anthropometric evaluation, physical examination and personalized multicomponent behavioral intervention with focus on nutrition, physical activity/sedentary behavior and other lifestyle recommendations. This standard intervention is common for both groups/arms. | Other | Control group, Intervention group |
Primary outcome
BMI z-score at 6 months
Time frame: 6 months
Variation between Visit 1 (baseline) and Visit 4 (end of the intervention). Weight (in kilograms) and height (in meters) will be used to calculate BMI in kg/m2. Then, BMI z-score will be calculated by WHO Anthroplus software 3.2.2.
BMI at 6 months
Time frame: 6 months
Variation between Visit 1 (baseline) and Visit 4 (end of the intervention). Weight (in kilograms) and height (in meters) will be used to calculate BMI in kg/m2.
Fat mass percentage at 6 months
Time frame: 6 months
Variation between Visit 1 (baseline) and Visit 4 (end of the intervention). Fat mass percentage (%FM) assessed using bioelectrical impedance analysis with InBody 270®.
Fat-free mass index at 6 months
Time frame: 6 months
Variation between Visit 1 (baseline) and Visit 4 (end of the intervention). FFMI (kg/ m2) calculated using FFM (in kilograms) and height (in meters).
29 secondary outcomes
Participants achieving a BMI reduction ≥5%
Time frame: 6 months and 12 months
Participants achieving a BMI reduction ≥10%
Time frame: 6 months and 12 months
Change in Waist circumference centile
Time frame: 6 months and 12 months
Fat mass percentage at 12 months
Time frame: 12 months
Fat-free mass index at 12 months
Time frame: 12 months
BMI z-score at 12 months
Time frame: 12 months
BMI at 12 months
Time frame: 12 months
Change in Waist-to-height Ratio
Time frame: 6 months and 12 months
Change in C-reactive protein
Time frame: 6 months and 12 months
Change in Fasting Lipid: Total Cholesterol
Time frame: 6 months and 12 months
Change in Fasting Lipid: LDL-cholesterol
Time frame: 6 months and 12 months
Change in Fasting Lipid: HDL-cholesterol
Time frame: 6 months and 12 months
Change in Fasting Lipid: Triglycerides
Time frame: 6 months and 12 months
Change in centiles of Systolic and Diastolic Blood Pressure
Time frame: 6 months and 12 months
Change in HbA1c
Time frame: 6 months and 12 months
Change in Glycaemic Category
Time frame: 6 months and 12 months
Change in HOMA-B
Time frame: 6 months and 12 months
Change in HOMA-IR
Time frame: 6 months and 12 months
Change in Continuous metabolic syndrome score
Time frame: 6 months and 12 months
Change in Sleep quality
Time frame: 6 months and 12 months
Change in sleep quality - actigrafy
Time frame: 6 months
Change in Respiratory Sleep disorder
Time frame: 6 months
Change in Diet Quality
Time frame: 6 months
Change in Eating behavior
Time frame: 6 months
Change in emotional well-being
Time frame: 6 months
Change in Quality of life
Time frame: 6 months
Change in self-compassion
Time frame: 6 months
Change in Physical activity
Time frame: 6 months
Change in Physical activity - actigraphy
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Individual participant dataSharing planned: Yes. Individual participant data may be shared upon request, provided that all identifying information is removed to safeguard participant anonymity. This process upholds the confidentiality and privacy of participants, fully complying with ethical and legal standards for data protection.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Behavioral Intervention and Standard Obesity Treatment in people with Obesity and Overweight and Sleep Disorder, run by University of Beira Interior at 2 sites in Portugal.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI z-score at 6 months (time frame: 6 months). The study lists 4 primary outcomes in all. 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 1 Dec 2025.