Clinical trial NCT07009054: Program for the Promotion of Physical Exercise and Healthy Eating Among Population of Pakistani Origin With Obesity
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
metabolic syndrome
diet
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
Collaborators: name: University of Vic - Central University of Catalonia
First posted: 2025-06-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fat mass and total body mass measured by bioimpedance analysis
timeFrame: Baseline, 3 months and 6 months
measure: Thickness of superficial and pre-peritoneal fat (mm) measured by ultrasound of the rectus abdominis
timeFrame: Baseline, 3 months, and 6 months
measure: Quadriceps muscle thickness (mm) measured by ultrasound
timeFrame: Baseline, 3 months, and 6 months
measure: Body Mass Index (BMI) in kg/m²
timeFrame: Baseline, 3 months, and 6 months
measure: Waist circumference (cm)
timeFrame: Baseline, 3 months, and 6 months
measure: Physical exercise
timeFrame: Baseline, 3 months and 6 months
measure: Health-related quality of life
timeFrame: Baseline, 3 months and 6 months
measure: Fasting glucose level (mg/dL)
timeFrame: Baseline, 3 months, and 6 months
measure: Hemoglobin A1C (%)
timeFrame: Baseline, 3 months, and 6 months
measure: Insulin (mIU/L)
timeFrame: Baseline, 3 months, and 6 months
measure: Aspartate aminotransferase (AST)(UI/L)
timeFrame: Baseline, 3 months, 6 months
measure: Alanine aminotransferase (ALT)(UI/L)
timeFrame: Baseline, 3 months, 6 months
measure: Gamma-glutamyl transferase (GGT)(UI/L)
timeFrame: Baseline, 3 months, 6 months
measure: Total cholesterol (mg/dL)
timeFrame: Baseline, 3 months, 6 months
measure: LDL cholesterol (mg/dL)
timeFrame: Baseline, 3 months, 6 months
measure: HDL cholesterol (mg/dL)
timeFrame: Baseline, 3 months, 6 months
measure: Adherence to Mediterranean Diet using modified MEDAS questionnaire
timeFrame: Baseline, 3 months, 6 months
measure: Nutrient intake measured by 24-hour Dietary Recall
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Sociodemographic data
timeFrame: Baseline
measure: Clinical history
timeFrame: Baseline
measure: Toxic habits
timeFrame: Baseline, 3 months and 6 months
measure: Nutrition knowledge
timeFrame: Baseline, 3 months and 6 months
measure: Nutrition skills
timeFrame: Baseline, 3 months and 6 months
measure: Total sleep duration (minutes)
timeFrame: Baseline and 3 months
measure: Sleep stages duration (minutes)
timeFrame: Baseline and 3 months
measure: Sleep stages distribution (% of total sleep)
timeFrame: Baseline and 3 months
measure: Degree of hepatic steatosis measured by CAP (dB/m)
timeFrame: Baseline and 6 months
measure: Liver stiffness measured by transient elastography (kPa)
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
Study officials:
affiliation: Hospital Universitario Germans Trias i Pujol (Badalona)
name: Maria-Teresa Julian, MD
role: PRINCIPAL_INVESTIGATOR
References: