NCT07009054

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

Program for the Promotion of Physical Exercise and Healthy Eating (PEFAS) Culturally and Linguistically Adapted to the Population of Pakistani Origin With Obesity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Germans Trias i Pujol Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Nutrition Education and Exercise	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.
BEHAVIORAL	Usual Care Group	The control group will participate in 2 theoretical sessions of nutrition education and 2 of physical exercise.

Timeline

• Start date: 2024-03-03
• Primary completion: 2024-10-30
• Completion: 2024-10-30
• First posted: 2025-06-06
• Last updated: 2025-06-06

Locations

1 site across 1 country: Spain