Program for the Promotion of Physical Exercise and Healthy Eating Among Population of Pakistani Origin With Obesity
NCT ID: NCT07009054
Last Updated: 2025-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2024-03-03
2024-10-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Active
Life-style interventions (diet and exercise)
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.
Control
Usual care
Usual Care Group
The control group will participate in 2 theoretical sessions of nutrition education and 2 of physical exercise.
Interventions
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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.
Usual Care Group
The control group will participate in 2 theoretical sessions of nutrition education and 2 of physical exercise.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 any pathology that could limit life expectancy in the short term.
* Pregnancy.
* Having a close family member included in the project.
18 Years
ALL
No
Sponsors
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University of Vic - Central University of Catalonia
OTHER
Germans Trias i Pujol Hospital
OTHER
Responsible Party
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Principal Investigators
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Maria-Teresa Julian, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Germans Trias i Pujol (Badalona)
Locations
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Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Countries
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Other Identifiers
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PEFAS
Identifier Type: -
Identifier Source: org_study_id
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