ObesityPEFASNCT07009054
Program for the Promotion of Physical Exercise and Healthy Eating Among Population of Pakistani Origin With Obesity
A study testing Nutrition Education and Exercise in people with Obesity, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial summary
This randomized control trial aims to evaluate the effectiveness of a culturally and linguistically adapted nutrition education and physical exercise program on lifestyle (diet and exercise), metabolic parameters, and fat content and distribution of people of Pakistani origin with obesity residing in the North… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Nutrition Education and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 3 Mar 2024to 30 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being of Pakistani origin
- Being Aged over 18 years
- Having obesity, defined as BMI ≥ 27 Kg/m2
- Being attended at the Saint Roc or Gorg Primary Care Centers, Endocrinology and Nutrition External Consultations at the Germans Trias i Pujol University Hospital (HUGTiP) or at the Specialized Care Center (Dr. Barraquer in St. Adrià and Dr. Robert in Badalona)
- Voluntarily accepting participation in the study.
Who cannot join
- Presenting a physical or mental illness that could prevent participation in the study.
- Presenting any pathology that could limit life expectancy in the short term.
- Pregnancy.
- Having a close family member included in the project.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
About this study
Official title: Program for the Promotion of Physical Exercise and Healthy Eating (PEFAS) Culturally and Linguistically Adapted to the Population of Pakistani Origin With Obesity
This randomized control trial aims to evaluate the effectiveness of a culturally and linguistically adapted nutrition education and physical exercise program on lifestyle (diet and exercise), metabolic parameters, and fat content and distribution of people of Pakistani origin with obesity residing in the North Metropolitan health area of Barcelona. The betterment of the mentioned parameters is expected to be greater in individuals from the intervention group who will receive a total of 12 sessions of nutrition education and physical exercise compared to the control group who will participate in only 4 sessions.
Read the detailed description
This study aims to assess the impact of a culturally and linguistically adapted nutrition education and physical exercise program on the acquisition of heart-healthy habits (diet and exercise), various metabolic parameters (including glycemic and lipid markers), and the content and distribution of ectopic fat in individuals of Pakistani origin with obesity residing in the North Metropolitan Health Area of Barcelona.
A 6-week intensive randomized controlled trial (RCT) will be implemented with a total of 60 participants. Baseline data will be collected using both quantitative and qualitative methods by a multidisciplinary team of nutrition and nursing professionals. Quantitative methods will be employed to gather data on sociodemographic characteristics, health status, quality of life, clinical variables, body composition, eating habits, nutrition knowledge and skills, and physical activity. Qualitative methods will be used to adapt the intervention to the cultural and practical needs of participants and to explore variables such as eating habits and nutrition-related skills in greater depth.
Study data will be collected and managed using REDCap (Research Electronic Data Capture) tools hosted at Germans Trias i Pujol University Hospital.
Following baseline assessments, participants will be randomized into intervention (n=30) and control (n=30) groups using simple random assignment via a table of random numbers. The randomization sequence will be concealed in sealed, opaque envelopes labeled with participant codes.
The intervention group will receive one weekly theoretical-practical nutrition education session conducted in Urdu and one Nordic walking-based physical activity session per week, over a period of 6 weeks (totaling 6 nutrition sessions and 6 physical activity sessions). Nutrition education sessions will be conducted in the therapeutic kitchen of Germans Trias i Pujol University Hospital. Physical activity sessions will take place in public green spaces near participants' residential areas.
The control group will participate in two theoretical sessions of nutrition education and two sessions of physical activity.
After completion of the intervention (6 weeks), follow-up data collection will be conducted using the same quantitative and qualitative approaches applied at baseline. Follow-up assessments will also be repeated at 3 and 6 months post-intervention.
- Conditions
- Obesity
- Being tested
- Nutrition Education and Exercise, Usual Care Group
- Keywords
- obesity, metabolic syndrome, diet
- Medical subject headings
- Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition Education and ExerciseBehavioural
A 6-week intensive randomized controlled trial will be conducted with a total of 60 participants. Thirty participants will be assigned to the intervention group and thirty to the control group through simple randomization using a table of random numbers. The intervention group will receive one weekly theoretical-practical nutrition education session in Urdu and one physical activity session based on Nordic walking per week, for a total of six nutrition sessions and six physical activity sessions over the 6-week period.
Usual Care GroupBehavioural
Also called Usual care
The control group will participate in 2 theoretical sessions of nutrition education and 2 of physical exercise.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Life-style interventions (diet and exercise) Receives: Behavioral: Nutrition Education and Exercise |
| Control | Other | Usual care Receives: Behavioral: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat mass and total body mass measured by bioimpedance analysis
Body fat mass and total body mass will be quantified using bioimpedanciometry
Measured: Baseline, 3 months and 6 months
Thickness of superficial and pre-peritoneal fat (mm) measured by ultrasound of the rectus abdominis
Subcutaneous and pre-peritoneal fat thickness will be assessed using ultrasound imaging of the rectus abdominis muscle.
Measured: Baseline, 3 months, and 6 months
Quadriceps muscle thickness (mm) measured by ultrasound
Muscle mass will be evaluated through ultrasound measurements of the quadriceps muscl
Measured: Baseline, 3 months, and 6 months
Body Mass Index (BMI) in kg/m²
BMI will be calculated as weight in kilograms divided by height in meters squared (BMI = kg/m²). Weight will be measured using a calibrated digital scale, and height will be measured with a portable stadiometer.
Measured: Baseline, 3 months, and 6 months
Waist circumference (cm)
Waist circumference will be measured at the midpoint between the lowest rib and the iliac crest using non-stretchable tape, recorded to the nearest 0.1 cm with the participant standing.
Measured: Baseline, 3 months, and 6 months
Physical exercise
The information related to the physical exercise will be gathered through the validated Urdu version of the International Physical Activity Questionnaire (IPAQ). Results will be reported as a continuous variable (MET minutes a week). Furthermore, participants from both the control and the intervention group will be provided with a smartwatch that will register their daily physical activity. The results will be presented in total minutes of intense and moderate physical activity per week.
Measured: Baseline, 3 months and 6 months
Health-related quality of life
Perceived physical and mental health will be assessed using the 12-Item Short Form Survey (SF-12). The SF-12 is a self-reported outcome measure of health-related quality of life, widely used in various ethnic groups. It consists of 12 questions that are scored in various ways. The total score range is 12-47 (higher scores mean a worse outcome).
Measured: Baseline, 3 months and 6 months
Fasting glucose level (mg/dL)
Fasting glucose will be measured in serum samples using enzymatic methods.
Measured: Baseline, 3 months, and 6 months
Hemoglobin A1C (%)
HbA1c will be measured from whole blood using high-performance liquid chromatography (HPLC).
Measured: Baseline, 3 months, and 6 months
Insulin (mIU/L)
Fasting insulin concentration will be measured using electrochemiluminescence immunoassay.
Measured: Baseline, 3 months, and 6 months
Aspartate aminotransferase (AST)(UI/L)
AST will be measured via kinetic UV test using an automated analyzer.
Measured: Baseline, 3 months, 6 months
Alanine aminotransferase (ALT)(UI/L)
ALT will be measured via kinetic UV test using an automated analyzer.
Measured: Baseline, 3 months, 6 months
Gamma-glutamyl transferase (GGT)(UI/L)
GGT will be measured using enzymatic colorimetric methods.
Measured: Baseline, 3 months, 6 months
Total cholesterol (mg/dL)
Total cholesterol will be measured using enzymatic colorimetric methods.
Measured: Baseline, 3 months, 6 months
LDL cholesterol (mg/dL)
LDL-C will be measured directly via homogenous enzymatic assay.
Measured: Baseline, 3 months, 6 months
HDL cholesterol (mg/dL)
HDL-C will be measured directly via homogenous enzymatic assay.
Measured: Baseline, 3 months, 6 months
Adherence to Mediterranean Diet using modified MEDAS questionnaire
Adherence to the Mediterranean Diet will be assessed using a modified version of the 14-item Mediterranean Diet Adherence Screener (MEDAS), excluding the alcohol intake item (13 items total). Scores range from 0 to 13, with higher scores indicating better adherence. A score < 9 indicates low adherence; ≥ 9 indicates good adherence.. Unit of measure: score 0-13
Measured: Baseline, 3 months, 6 months
Nutrient intake measured by 24-hour Dietary Recall
Nutrient and food group intake will be assessed using a structured 24-hour Dietary Recall (24HR), administered by trained staff. Data will be analyzed using nutritional analysis software to estimate daily intake. Unit of measure: grams, Kcal
Measured: Baseline, 3 months, 6 months
Secondary outcomes (10)
Sociodemographic data
A survey will be administered in which the following data will be collected:place of birth, reason for migration, years of residence in Catalonia, members of the family unit, type of academic studies, occupation, languages known and spoken, religion practiced, center of origin, previous participation in similar programs.
Measured: Baseline
Clinical history
The following clinical data will be collected with the help of the medical history: age, sex, presence of arterial hypertension (year of diagnosis and treatment), dyslipidemia (year of diagnosis and treatment), cardiovascular disease (ischemic heart disease, cerebrovascular disease, peripheral arterial disease) (age at diagnosis), DM (year of diagnosis, usual treatment), microvascular complications (retinopathy, nephropathy, neuropathy).
Measured: Baseline
Toxic habits
Through the survey smoking habits and alcohol intake (UBEs/week) will be recorded.
Measured: Baseline, 3 months and 6 months
Nutrition knowledge
Dietary knowledge will be evaluated in an ad hoc questionnaire of 14 questions related to some dietary aspects that will have three possible answers: true, false and I don't know. The focus groups will also include questions related to the dietary knowledge of the participants.
Measured: Baseline, 3 months and 6 months
Nutrition skills
Dietary skills will be evaluated based on an ad hoc questionnaire of 13 questions that will analyze the degree of difficulty they have faced in carrying out different actions related to aspects of nutrition (planning, purchasing, preparation, etc.) during the last 15 days. These questions could be answered as follows: no difficulty (1 point), little difficulty (2 points), some difficulty (3 points), quite a bit of difficulty (4 points), and a lot of difficulty (5 points), with a minimum value of 13 points and maximum of 65 points. Higher scores will indicate greater difficulty in performing dietary tasks.
Measured: Baseline, 3 months and 6 months
Total sleep duration (minutes)
Sleep duration will be objectively measured using a smartwatch device. Total minutes of sleep during the night will be recorded.
Measured: Baseline and 3 months
Sleep stages duration (minutes)
Sleep stage data (light, deep, and REM sleep) will be recorded using a smartwatch, reporting the duration in minutes spent in each stage.
Measured: Baseline and 3 months
Sleep stages distribution (% of total sleep)
The percentage of total sleep time spent in each sleep stage (light, deep, REM) will be calculated and reported.
Measured: Baseline and 3 months
Degree of hepatic steatosis measured by CAP (dB/m)
Hepatic fat content will be assessed using the Controlled Attenuation Parameter (CAP) obtained via transient elastography (FibroScan®).
Measured: Baseline and 6 months
Liver stiffness measured by transient elastography (kPa)
Liver fibrosis will be evaluated by measuring liver stiffness using transient elastography (FibroScan®).
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start3 Mar 2024
- Primary completion30 Oct 2024
- Study completion30 Oct 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Vic - Central University of Catalonia
- Responsible party
- Sponsor
- Investigators
- Maria-Teresa Julian, MD, Principal investigator, Hospital Universitario Germans Trias i Pujol (Badalona)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009054
- Sponsor's protocol ID
- PEFAS
- Acronym
- PEFAS
- Status last verified
- May 2025
- First submitted
- 29 Nov 2024
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program for the Promotion of Physical Exercise and Healthy Eating (PEFAS) Culturally and Linguistically Adapted to the Population of Pakistani Origin With Obesity
- ClinicalTrials.gov ID
- NCT07009054
- Acronym / sponsor ID
- PEFAS / PEFAS
- Conditions
- Obesity
- Keywords
- obesity, metabolic syndrome, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Collaborators
- University of Vic - Central University of Catalonia
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 6 Jun 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.
This randomized control trial aims to evaluate the effectiveness of a culturally and linguistically adapted nutrition education and physical exercise program on lifestyle (diet and exercise), metabolic parameters, and fat content and distribution of people of Pakistani origin with obesity residing in the North Metropolitan health area of Barcelona. The betterment of the mentioned parameters is expected to be greater in individuals from the intervention group who will receive a total of 12 sessions of nutrition education and physical exercise compared to the control group who will participate in only 4 sessions.
Detailed description
This study aims to assess the impact of a culturally and linguistically adapted nutrition education and physical exercise program on the acquisition of heart-healthy habits (diet and exercise), various metabolic parameters (including glycemic and lipid markers), and the content and distribution of ectopic fat in individuals of Pakistani origin with obesity residing in the North Metropolitan Health Area of Barcelona.
A 6-week intensive randomized controlled trial (RCT) will be implemented with a total of 60 participants. Baseline data will be collected using both quantitative and qualitative methods by a multidisciplinary team of nutrition and nursing professionals. Quantitative methods will be employed to gather data on sociodemographic characteristics, health status, quality of life, clinical variables, body composition, eating habits, nutrition knowledge and skills, and physical activity. Qualitative methods will be used to adapt the intervention to the cultural and practical needs of participants and to explore variables such as eating habits and nutrition-related skills in greater depth.
Study data will be collected and managed using REDCap (Research Electronic Data Capture) tools hosted at Germans Trias i Pujol University Hospital.
Following baseline assessments, participants will be randomized into intervention (n=30) and control (n=30) groups using simple random assignment via a table of random numbers. The randomization sequence will be concealed in sealed, opaque envelopes labeled with participant codes.
The intervention group will receive one weekly theoretical-practical nutrition education session conducted in Urdu and one Nordic walking-based physical activity session per week, over a period of 6 weeks (totaling 6 nutrition sessions and 6 physical activity sessions). Nutrition education sessions will be conducted in the therapeutic kitchen of Germans Trias i Pujol University Hospital. Physical activity sessions will take place in public green spaces near participants' residential areas.
The control group will participate in two theoretical sessions of nutrition education and two sessions of physical activity.
After completion of the intervention (6 weeks), follow-up data collection will be conducted using the same quantitative and qualitative approaches applied at baseline. Follow-up assessments will also be repeated at 3 and 6 months post-intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Behavioral: Nutrition Education and ExerciseLife-style interventions (diet and exercise) |
| Control | Other | Behavioral: Usual Care GroupUsual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being of Pakistani origin
- Being Aged over 18 years
- Having obesity, defined as BMI ≥ 27 Kg/m2
- Being attended at the Saint Roc or Gorg Primary Care Centers, Endocrinology and Nutrition External Consultations at the Germans Trias i Pujol University Hospital (HUGTiP) or at the Specialized Care Center (Dr. Barraquer in St. Adrià and Dr. Robert in Badalona)
- Voluntarily accepting participation in the study.
Key exclusion criteria (4 listed)
- Presenting a physical or mental illness that could prevent participation in the study.
- Presenting any pathology that could limit life expectancy in the short term.
- Pregnancy.
- Having a close family member included in the project.
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 |
|---|---|---|
| Nutrition Education and ExerciseA 6-week intensive randomized controlled trial will be conducted with a total of 60 participants. Thirty participants will be assigned to the intervention group and thirty to the control group through simple randomization using a table of random numbers. The intervention group will receive one weekly theoretical-practical nutrition education session in Urdu and one physical activity session based on Nordic walking per week, for a total of six nutrition sessions and six physical activity sessions over the 6-week period. | Behavioural | Active |
| Usual Care GroupAlso: Usual careThe control group will participate in 2 theoretical sessions of nutrition education and 2 of physical exercise. | Behavioural | Control |
Primary outcome
Fat mass and total body mass measured by bioimpedance analysis
Time frame: Baseline, 3 months and 6 months
Body fat mass and total body mass will be quantified using bioimpedanciometry
Thickness of superficial and pre-peritoneal fat (mm) measured by ultrasound of the rectus abdominis
Time frame: Baseline, 3 months, and 6 months
Subcutaneous and pre-peritoneal fat thickness will be assessed using ultrasound imaging of the rectus abdominis muscle.
Quadriceps muscle thickness (mm) measured by ultrasound
Time frame: Baseline, 3 months, and 6 months
Muscle mass will be evaluated through ultrasound measurements of the quadriceps muscl
Body Mass Index (BMI) in kg/m²
Time frame: Baseline, 3 months, and 6 months
BMI will be calculated as weight in kilograms divided by height in meters squared (BMI = kg/m²). Weight will be measured using a calibrated digital scale, and height will be measured with a portable stadiometer.
Waist circumference (cm)
Time frame: Baseline, 3 months, and 6 months
Waist circumference will be measured at the midpoint between the lowest rib and the iliac crest using non-stretchable tape, recorded to the nearest 0.1 cm with the participant standing.
Physical exercise
Time frame: Baseline, 3 months and 6 months
The information related to the physical exercise will be gathered through the validated Urdu version of the International Physical Activity Questionnaire (IPAQ). Results will be reported as a continuous variable (MET minutes a week). Furthermore, participants from both the control and the intervention group will be provided with a smartwatch that will register their daily physical activity. The results will be presented in total minutes of intense and moderate physical activity per week.
Health-related quality of life
Time frame: Baseline, 3 months and 6 months
Perceived physical and mental health will be assessed using the 12-Item Short Form Survey (SF-12). The SF-12 is a self-reported outcome measure of health-related quality of life, widely used in various ethnic groups. It consists of 12 questions that are scored in various ways. The total score range is 12-47 (higher scores mean a worse outcome).
Fasting glucose level (mg/dL)
Time frame: Baseline, 3 months, and 6 months
Fasting glucose will be measured in serum samples using enzymatic methods.
Hemoglobin A1C (%)
Time frame: Baseline, 3 months, and 6 months
HbA1c will be measured from whole blood using high-performance liquid chromatography (HPLC).
Insulin (mIU/L)
Time frame: Baseline, 3 months, and 6 months
Fasting insulin concentration will be measured using electrochemiluminescence immunoassay.
Aspartate aminotransferase (AST)(UI/L)
Time frame: Baseline, 3 months, 6 months
AST will be measured via kinetic UV test using an automated analyzer.
Alanine aminotransferase (ALT)(UI/L)
Time frame: Baseline, 3 months, 6 months
ALT will be measured via kinetic UV test using an automated analyzer.
Gamma-glutamyl transferase (GGT)(UI/L)
Time frame: Baseline, 3 months, 6 months
GGT will be measured using enzymatic colorimetric methods.
Total cholesterol (mg/dL)
Time frame: Baseline, 3 months, 6 months
Total cholesterol will be measured using enzymatic colorimetric methods.
LDL cholesterol (mg/dL)
Time frame: Baseline, 3 months, 6 months
LDL-C will be measured directly via homogenous enzymatic assay.
HDL cholesterol (mg/dL)
Time frame: Baseline, 3 months, 6 months
HDL-C will be measured directly via homogenous enzymatic assay.
Adherence to Mediterranean Diet using modified MEDAS questionnaire
Time frame: Baseline, 3 months, 6 months
Adherence to the Mediterranean Diet will be assessed using a modified version of the 14-item Mediterranean Diet Adherence Screener (MEDAS), excluding the alcohol intake item (13 items total). Scores range from 0 to 13, with higher scores indicating better adherence. A score < 9 indicates low adherence; ≥ 9 indicates good adherence.. Unit of measure: score 0-13
Nutrient intake measured by 24-hour Dietary Recall
Time frame: Baseline, 3 months, 6 months
Nutrient and food group intake will be assessed using a structured 24-hour Dietary Recall (24HR), administered by trained staff. Data will be analyzed using nutritional analysis software to estimate daily intake. Unit of measure: grams, Kcal
10 secondary outcomes
Sociodemographic data
Time frame: Baseline
Clinical history
Time frame: Baseline
Toxic habits
Time frame: Baseline, 3 months and 6 months
Nutrition knowledge
Time frame: Baseline, 3 months and 6 months
Nutrition skills
Time frame: Baseline, 3 months and 6 months
Total sleep duration (minutes)
Time frame: Baseline and 3 months
Sleep stages duration (minutes)
Time frame: Baseline and 3 months
Sleep stages distribution (% of total sleep)
Time frame: Baseline and 3 months
Degree of hepatic steatosis measured by CAP (dB/m)
Time frame: Baseline and 6 months
Liver stiffness measured by transient elastography (kPa)
Time frame: Baseline and 6 months
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 6 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Maria-Teresa Julian, MD principal investigator
Hospital Universitario Germans Trias i Pujol (Badalona)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Education and Exercise in people with Obesity, run by Germans Trias i Pujol Hospital at 1 site in Spain.
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 4 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 6 Jun 2025. 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 Spain. 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?
Fat mass and total body mass measured by bioimpedance analysis (time frame: Baseline, 3 months and 6 months). The study lists 18 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 6 Jun 2025.