Status:
ACTIVE_NOT_RECRUITING
Implementing Strategies for Eating Behaviour Modification Based on Portion Control
Lead Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Conditions:
Lifestyle, Healthy
Weight Management
Eligibility:
All Genders
18-65 years
Brief Summary
This is a pre-post intervention study designed to evaluate the feasibility of a self-applied weight management intervention based on portion control. A total of 40 healthy volunteers with overweight/o...
Detailed Description
According to recent meta-analyses, portion control tools represent an acceptable and potentially effective strategy to aid in weight loss. However, how well these tools work depends on their consisten...
Eligibility Criteria
Inclusion
- Body mass index equal or above 27.5 kg/m2 (26.0 kg/m2 for those of Asian descent)
- Eating home-made meals at least 5 days a week
- Physically and mentally fit as assessed by the study researcher
- On-going pharmacological and hormonal treatment is accepted when this does not affect the study parameters (e.g. glucose response, appetite), and when the participant has been in a stable dose for at least 3 months
- Agreeing to undergo all the study procedures
- Being able to attend in person on 3 clinical investigation days during working hours
- Being able to understand and agree to sign the informed consent form
Exclusion
- Being a regular smoker (that is, smoke more than 4 cigarettes a month)
- Being pregnant, breastfeeding or planning a pregnancy
- Exceed the alcohol consumption limit marked for the corresponding sex (more than 14 units in women and 20 units in men)
- Having followed a meal plan for weight loss and/or muscle mass gain in the 3 months prior to the start of the study intervention
- Having used a portion measuring instrument (e.g. scale, calibrated plate, etc.) consistently (at least in one main meal for at least 5 days a week) during the 3 months prior to the start of the study intervention
- Experiencing a weight change greater than 5% in the last 3 months
- History of relevant functional or structural anomalies of the digestive system, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory or malabsorption diseases, or history of intestinal or bariatric surgery
- Suffer from some type of cancer, currently undergoing treatment for cancer, or when a period of at least 5 years has not elapsed since its eradication
- On-going chronic metabolic disease or obesity-related disease, or any systemic intestinal, liver or kidney disease such as type 1 or type 2 diabetes, severe dyslipidemia, uncontrolled thyroid function disorder, cirrhosis, inflammatory bowel disease, untreated anemia, etc. . (will not be excluded due to "fatty liver")
- Avoiding, being allergic, or being intolerant to the study foods or their ingredients (lactose free and regular chocolate milkshake)
- History of anaphylactic reaction to any food
- Taking any nutritional supplementation as a prescription medication that may affect the results of the study
- Taking over-the-counter nutritional supplementation (that is, without a medical prescription) that may affect the results of the study, unless the person is willing to stop it during the 6 months of the study duration and only when a minimum washout period of 14 days can be guaranteed prior to the basal measurements being taken
- A high incidence of attitudes and behaviors associated with eating disorders, expressed as a score greater than 20 on the 26-item Eating Attitudes Test scale (EAT - 26)
- Co-inhabiting with a study participant
- For former PORTIONS-3 study participants, when less than 3 months have passed since the last intervention visit (accepted if 3 or more months have elapsed).
Key Trial Info
Start Date :
March 14 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06519539
Start Date
March 14 2024
End Date
March 31 2025
Last Update
July 25 2024
Active Locations (1)
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1
University of Navarra, Dept. of Food Science and Physiology, Center for Nutrition Research
Pamplona, Navarre, Spain, 31008