Program for the Promotion of Physical Exercise and Healthy Eating Among Population of Pakistani Origin With Obesity

NCT07009054 | Completed

• 1 other identifier: PEFAS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

obesity; metabolic syndrome; diet

Outcome Measures

Primary Outcomes (18)

• Fat mass and total body mass measured by bioimpedance analysis

  Body fat mass and total body mass will be quantified using bioimpedanciometry

  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.

  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

  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.

  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.

  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.

  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).

  Baseline, 3 months and 6 months

• Fasting glucose level (mg/dL)

  Fasting glucose will be measured in serum samples using enzymatic methods.

  Baseline, 3 months, and 6 months

• Hemoglobin A1C (%)

  HbA1c will be measured from whole blood using high-performance liquid chromatography (HPLC).

  Baseline, 3 months, and 6 months

• Insulin (mIU/L)

  Fasting insulin concentration will be measured using electrochemiluminescence immunoassay.

  Baseline, 3 months, and 6 months

• Aspartate aminotransferase (AST)(UI/L)

  AST will be measured via kinetic UV test using an automated analyzer.

  Baseline, 3 months, 6 months

• Alanine aminotransferase (ALT)(UI/L)

  ALT will be measured via kinetic UV test using an automated analyzer.

  Baseline, 3 months, 6 months

• Gamma-glutamyl transferase (GGT)(UI/L)

  GGT will be measured using enzymatic colorimetric methods.

  Baseline, 3 months, 6 months

• Total cholesterol (mg/dL)

  Total cholesterol will be measured using enzymatic colorimetric methods.

  Baseline, 3 months, 6 months

• LDL cholesterol (mg/dL)

  LDL-C will be measured directly via homogenous enzymatic assay.

  Baseline, 3 months, 6 months

• HDL cholesterol (mg/dL)

  HDL-C will be measured directly via homogenous enzymatic assay.

  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

  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

  Baseline, 3 months, 6 months

Secondary Outcomes (10)

• 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

Study Arms (2)

Active

ACTIVE COMPARATOR

Life-style interventions (diet and exercise)

Behavioral: Nutrition Education and Exercise

Control

OTHER

Usual care

Behavioral: Usual Care Group

Interventions

Nutrition Education and Exercise BEHAVIORAL

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.

Active

Usual Care Group BEHAVIORAL

The control group will participate in 2 theoretical sessions of nutrition education and 2 of physical exercise.

Also known as: Usual care

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead
• University of Vic - Central University of Catalonia: collaborator

Study Sites (1)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Conditions

Obesity; Metabolic Syndrome

Interventions

Nutrition Assessment; Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Maria-Teresa Julian, MD

  Hospital Universitario Germans Trias i Pujol (Badalona)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: June 6, 2025
• Study Start: March 3, 2024
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)