Program for the Promotion of Physical Exercise and Healthy Eating (PEFAS) Culturally and Linguistically Adapted to the Population of Pakistani Origin With Obesity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Gamma-glutamyl transferase (GGT)(UI/L)
Study Overview
Brief 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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Active
Life-style interventions (diet and exercise)
Intervention: Nutrition Education and Exercise (Behavioral)
Control
Usual care
Intervention: Usual Care Group (Behavioral)
Outcomes
Primary Outcomes
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
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.
Secondary Outcomes
- Sociodemographic data(Baseline)
- Clinical history(Baseline)
- Toxic habits(Baseline, 3 months and 6 months)
- Nutrition knowledge(Baseline, 3 months and 6 months)
- Nutrition skills(Baseline, 3 months and 6 months)
- Total sleep duration (minutes)(Baseline and 3 months)
- Sleep stages duration (minutes)(Baseline and 3 months)
- Sleep stages distribution (% of total sleep)(Baseline and 3 months)
- Degree of hepatic steatosis measured by CAP (dB/m)(Baseline and 6 months)
- Liver stiffness measured by transient elastography (kPa)(Baseline and 6 months)