Lifestyle, HealthyPORTIONS-4NCT06519539
Implementing Strategies for Eating Behaviour Modification Based on Portion Control
An observational study of Lifestyle, Healthy and Weight Management, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial 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/obesity will take part in a 6-month intervention featuring 4 components: a portion control toolset; a manual including… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lifestyle, Healthy, Weight Management, Behavior Change
- What is being tested?
- PORTIONS-4 behaviour change strategies
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 11 Dec 2023to 13 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy men and women living with overweight or obesity and willing to receive a 6-month intervention focused on changing their dietary habits
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of Navarra, Dept. of Food Science and Physiology, Center for Nutrition Research
Pamplona, Navarre, 31008
About this study
Official title: Implementing Strategies for Eating Behaviour Modification Based on Portion Control: Methodological Development and Pilot Study
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/obesity will take part in a 6-month intervention featuring 4 components: a portion control toolset; a manual including instructions for the use of the tools, dietary and activity recommendations, and behavioural strategies; a mobile app to motivate intervention engagement; and biweekly telephone support. The primary outcome will be Intervention adherence, assessed as the change in dietary energy density, meal nutrient composition and utilization of intervention components from start to end of trial. Other measurements (at baseline, 3 and 6 months from baseline) will include body composition, fasting biochemical parameters, inhibitory control, eating behaviour, portions size norms and acceptance of the intervention.
Read the 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 consistent use and a good integration with other lifestyle modification strategies around body weight control and overall health. The present pilot study was designed to evaluate the feasibility of a self-applied weight management intervention based on portion control and to identify factors influencing adherence. The sample will consist of 40 healthy volunteers with overweight/obesity who will engage in a pre-post intervetion study lasting six-months. The intervetion will include four components: (1) a portion control toolkit (serving spoon and oil dispenser); (2) a phsyical manual with instructions for using the tools, dietary and physical activity recommendations, and strategies to build habits and improve mental wellbeing; (3) a mobile app to motivate intervention engagement; and (4) biweekly short telephone support. Adherence to the intervention will be the primary outcome, assessed on a fortnightly basis as the change from baseline in dietary energy density and change in meal nutrient composition plus frequency of using the intervention components. Other measurements that will be taken at baseline, 3 and 6 months from baseline, will be: body composition, fasting biochemical parameters, inhibitory control (only baseline and 6 months), eating behaviour, portion size norms and intervention acceptance. After 3 months of taking part in the intervention, a subset of the sample will participate in a nominal group session aimed at identifying barriers to intervention adherence and strategies to overcome them. The study results will inform the design of a full-scale controlled trial featuring the most successful components.
- Conditions
- Lifestyle, Healthy, Weight Management, Behavior Change
- Being tested
- PORTIONS-4 behaviour change strategies
- Keywords
- Portion size, Portion control tool, Dietary energy density
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PORTIONS-4 behaviour change strategiesBehavioural
The intervention includes 4 components, including: a portion control tool set previously developed and tested in our laboratory; a supporting guide (physical book) with dietary, activity and behavioural recommendations; a mobile application aligned with the guide; and biweekly telephone calls from the psychologist and/or dietitian.
| Study group | Role | What they receive |
|---|---|---|
| Adults with overweight or obesity | Healthy adults with a BMI of 27.5 kg/sq-m or above (26 or above for those of Asian descent), who will undertake a 6 month lifestyle intervention focused on improving dieary choices, physical activity and attitudes towards weight management. Receives: Behavioral: PORTIONS-4 behaviour change strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in 24 h total dietary energy intake
24 h total dietary energy intake (in kcal) will be obtained from the 24 h dietary record
Measured: Clinical investigation day 1 (week 0); Phone call (week 2, week 4, week 6, week 8, week 10); Clinical investigation day 2 (week 12); Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
Change from baseline in 24 h total dietary volume intake
24 h total dietary volume intake (in g) will be obtained from the 24 h dietary record
Measured: Clinical investigation day 1 (week 0); Phone call (week 2, week 4, week 6, week 8, week 10); Clinical investigation day 2 (week 12); Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
Change from baseline in daily dietary energy density
24 h total dietary energy intake (kcal) and 24 h total dietary volumen intake (g) will be combined to report daily dietary energy density (in kcal/g). Daily dietary energy density is defined as the ratio of 24 h total dietary energy intake (in kcal) to the 24 h total dietary volume intake (in g)
Measured: Clinical investigation day 1 (week 0); Phone call (week 2, week 4, week 6, week 8, week 10); Clinical investigation day 2 (week 12); Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
Intervention adherence
Daily dietary energy density, meal nutrient composition and use of intervention components (spoon, oil dispenser, guide, app) will be combined to report intervention adherence (as a qualitative measure)
Measured: Clinical investigation day 1 (week 0); Phone call (week 2, week 4, week 6, week 8, week 10); Clinical investigation day 2 (week 12); Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
Secondary outcomes (34)
Change from baseline in meal dietary energy density
Meal (breakfast, lunch and dinner) dietary energy density (kcal/g) will be calculated as the ratio of meal total dietary energy intake (in kcal) to the 24 h total dietary volume intake (in g), obtained from the 24 h dietary record
Measured: Clinical investigation day 1 (week 0); Phone call (week 2, week 4, week 6, week 8, week 10); Clinical investigation day 2 (week 12); Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
Change from baseline in meal nutrient composition: Grams
Meal (breakfast, lunch and dinner) nutrient content (in g) will be defined as the meal's content of carbohydrate (g), protein (g), vegetables (g), fibre (g), and sodium (mg) obtained from the 24 h dietary record
Measured: Clinical investigation day 1 (week 0); Phone call (week 2, week 4, week 6, week 8, week 10); Clinical investigation day 2 (week 12); Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
Change from baseline in meal nutrient composition: % energy
Percent of daily energy from meals will be defined as the % energy provided by carbohydrate, protein and vegetables at each meal (breakfast, lunch and dinner), obtained from the 24 h dietary record
Measured: Clinical investigation day 1 (week 0); Phone call (week 2, week 4, week 6, week 8, week 10); Clinical investigation day 2 (week 12); Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
Use of serving spoon (24 h frequency)
Number of times the intervention spoon has been used in a period of 24 h
Measured: Phone call (week 2, week 4, week 6, week 8, week 10); Clinical investigation day 2 (week 12); Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
Use of oil dispenser (24 h frequency)
Number of times the intervention oil dispenser has been used in a period of 24 h
Measured: Phone call (week 2, week 4, week 6, week 8, week 10); Clinical investigation day 2 (week 12); Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
Use of intervention guide (24 h frequency)
Number of times the intervention guide has been consulted in a period of 24 h
Measured: Phone call (week 2, week 4, week 6, week 8, week 10); Clinical investigation day 2 (week 12); Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
Use of intervention app (24 h frequency)
Number of times the intervention app has been used in a period of 24 h
Measured: Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
Use of serving spoon (15 day frequency)
Number of times the intervention spoon has been used in a period of 15 days
Measured: Phone call (week 2, week 4, week 6, week 8, week 10); Clinical investigation day 2 (week 12); Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
Use of oil dispenser (15 day frequency)
Number of times the intervention oil dispenser has been used in a period of 15 days
Measured: Phone call (week 2, week 4, week 6, week 8, week 10); Clinical investigation day 2 (week 12); Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
Use of intervention guide (15 day frequency)
Number of times the intervention guide has been consulted in a period of 15 days
Measured: Phone call (week 2, week 4, week 6, week 8, week 10); Clinical investigation day 2 (week 12); Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
Use of intervention app (15 day frequency)
Number of times the intervention app has been used in a period of 15 days
Measured: Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
Anthropometric profile: Change from baseline in Body Weight
Weight will be measured in kg; Weight and height will be combined to report BMI in kg/m^2
Measured: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Anthropometric profile: Body Height
Height will be measured in m using a stadiometer; Weight and height will be combined to report BMI in kg/m^2
Measured: Clinical investigation day 1 (week 0)
Anthropometric profile: Change from baseline in Body Mass Index
Weight and height will be combined to report BMI in kg/m^2
Measured: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Anthropometric profile: Change from baseline in Waist circumference
Waist circumference will be measured in cm using a measuring tape. Waist circumference and hip circumference will be combined to report Waist-to-hip ratio.
Measured: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Anthropometric profile: Hip circumference
Hip circumference will be measured in cm using a measuring tape. Waist circumference and hip circumference will be combined to report Waist-to-hip ratio.
Measured: Clinical investigation day 1 (week 0)
Anthropometric profile: Change from baseline in Waist-to-hip ratio
Waist circumference and hip circumference will be combined to report Waist-to-hip ratio. Waist to hip ratio is defined as the ratio of the waist circumference (cm) to the hip circumference (cm)
Measured: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Anthropometric profile: Change from baseline in body fat composition
Body fat composition will be quantified as fat mass (in kg, %) from a body composition analyser
Measured: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Biochemical profile: Change from baseline in fasting blood glucose
Fasting blood glucose levels (mg/dL)
Measured: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Biochemical profile: Change from baseline in fasting blood insulin
Fasting blood insuliln levels (mIU/L)
Measured: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Biochemical profile: Change from baseline in fasting blood triglycerides
Fasting blood triglycerides levels (mg/dL)
Measured: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Biochemical profile: Change from baseline in fasting blood cholesterol
Fasting blood total cholesterol levels (mg/dL)
Measured: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Biochemical profile: Change from baseline in fasting blood ghrelin
Fasting blood total ghrelin levels (pg/mL)
Measured: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Biochemical profile: Change from baseline in fasting blood leptin
Fasting blood leptin levels (ng/mL)
Measured: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Meal eating behaviour: Change from baseline in Eating rate
Average amount of milkshake consumed per unit of time (g/min), based on validated methodology (Yeomans, 2000)
Measured: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Meal eating behaviour: Change from baseline in bite size
Average amount of milkshake consumed at each sip (g), based on validated methodology (Yeomans, 2000)
Measured: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Meal eating behaviour: Change from baseline in meal duration
Average time used to drink a milkshake (min), based on validated methodology (Yeomans, 2000)
Measured: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Meal eating behaviour: Change from baseline in deceleration rate
Average change in eating rate (g/sec-squared), based on validated methodology (Yeomans, 2000)
Measured: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Inhibitory control pattern: Change from baseline in N200 wave latency
N200 wave latency (milisec), based on the Go/No Go paradigm (Ochner et al., 2009)
Measured: Clinical investigation day 1 (week 0), clinical investigation day 3 (week 24)
Inhibitory control pattern: Change from baseline in N200 wave length
N200 wave length (microV), based on the Go/No Go paradigm (Ochner et al., 2009)
Measured: Clinical investigation day 1 (week 0), clinical investigation day 3 (week 24)
Inhibitory control pattern: Change from baseline in P300 wave latency
P300 wave latency (milisec), based on the Go/No Go paradigm (Ochner et al., 2009)
Measured: Clinical investigation day 1 (week 0), clinical investigation day 3 (week 24)
Inhibitory control pattern: Change from baseline in P300 wave length
P300 wave length (microV), based on the Go/No Go paradigm (Ochner et al., 2009)
Measured: Clinical investigation day 1 (week 0), clinical investigation day 3 (week 24)
Learning task: Change from baseline in learned meal portion size
% error in chosen portion sizes for starch, protein and vegetables of a virtual meal vs recommended portion sizes (based on Brunstrom \& Rogers, 2009)
Measured: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Learning task: Change from baseline in learned meal nutrient content
% error in chosen nutrient content of a virtual meal vs recommended nutrient content (based on Brunstrom \& Rogers, 2009)
Measured: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start11 Dec 2023
- Primary completion10 Oct 2024
- Study completion13 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lifestyle, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eva Almiron-Roig, PhD, Principal investigator, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519539
- Sponsor's protocol ID
- PC139-140
- Acronym
- PORTIONS-4
- Status last verified
- Aug 2026
- First submitted
- 16 May 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Strategies for Eating Behaviour Modification Based on Portion Control: Methodological Development and Pilot Study
- ClinicalTrials.gov ID
- NCT06519539
- Acronym / sponsor ID
- PORTIONS-4 / PC139-140
- Conditions
- Lifestyle, Healthy, Weight Management, Behavior Change
- Keywords
- Portion size, Portion control tool, Dietary energy density
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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/obesity will take part in a 6-month intervention featuring 4 components: a portion control toolset; a manual including instructions for the use of the tools, dietary and activity recommendations, and behavioural strategies; a mobile app to motivate intervention engagement; and biweekly telephone support. The primary outcome will be Intervention adherence, assessed as the change in dietary energy density, meal nutrient composition and utilization of intervention components from start to end of trial. Other measurements (at baseline, 3 and 6 months from baseline) will include body composition, fasting biochemical parameters, inhibitory control, eating behaviour, portions size norms and acceptance of the intervention.
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 consistent use and a good integration with other lifestyle modification strategies around body weight control and overall health. The present pilot study was designed to evaluate the feasibility of a self-applied weight management intervention based on portion control and to identify factors influencing adherence. The sample will consist of 40 healthy volunteers with overweight/obesity who will engage in a pre-post intervetion study lasting six-months. The intervetion will include four components: (1) a portion control toolkit (serving spoon and oil dispenser); (2) a phsyical manual with instructions for using the tools, dietary and physical activity recommendations, and strategies to build habits and improve mental wellbeing; (3) a mobile app to motivate intervention engagement; and (4) biweekly short telephone support. Adherence to the intervention will be the primary outcome, assessed on a fortnightly basis as the change from baseline in dietary energy density and change in meal nutrient composition plus frequency of using the intervention components. Other measurements that will be taken at baseline, 3 and 6 months from baseline, will be: body composition, fasting biochemical parameters, inhibitory control (only baseline and 6 months), eating behaviour, portion size norms and intervention acceptance. After 3 months of taking part in the intervention, a subset of the sample will participate in a nominal group session aimed at identifying barriers to intervention adherence and strategies to overcome them. The study results will inform the design of a full-scale controlled trial featuring the most successful components.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with overweight or obesity | – | Behavioral: PORTIONS-4 behaviour change strategiesHealthy adults with a BMI of 27.5 kg/sq-m or above (26 or above for those of Asian descent), who will undertake a 6 month lifestyle intervention focused on improving dieary choices, physical activity and attitudes towards weight management. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy men and women living with overweight or obesity and willing to receive a 6-month intervention focused on changing their dietary habits
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PORTIONS-4 behaviour change strategiesThe intervention includes 4 components, including: a portion control tool set previously developed and tested in our laboratory; a supporting guide (physical book) with dietary, activity and behavioural recommendations; a mobile application aligned with the guide; and biweekly telephone calls from the psychologist and/or dietitian. | Behavioural | Adults with overweight or obesity |
Primary outcome
Change from baseline in 24 h total dietary energy intake
Time frame: Clinical investigation day 1 (week 0); Phone call (week 2, week 4, week 6, week 8, week 10); Clinical investigation day 2 (week 12); Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
24 h total dietary energy intake (in kcal) will be obtained from the 24 h dietary record
Change from baseline in 24 h total dietary volume intake
Time frame: Clinical investigation day 1 (week 0); Phone call (week 2, week 4, week 6, week 8, week 10); Clinical investigation day 2 (week 12); Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
24 h total dietary volume intake (in g) will be obtained from the 24 h dietary record
Change from baseline in daily dietary energy density
Time frame: Clinical investigation day 1 (week 0); Phone call (week 2, week 4, week 6, week 8, week 10); Clinical investigation day 2 (week 12); Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
24 h total dietary energy intake (kcal) and 24 h total dietary volumen intake (g) will be combined to report daily dietary energy density (in kcal/g). Daily dietary energy density is defined as the ratio of 24 h total dietary energy intake (in kcal) to the 24 h total dietary volume intake (in g)
Intervention adherence
Time frame: Clinical investigation day 1 (week 0); Phone call (week 2, week 4, week 6, week 8, week 10); Clinical investigation day 2 (week 12); Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
Daily dietary energy density, meal nutrient composition and use of intervention components (spoon, oil dispenser, guide, app) will be combined to report intervention adherence (as a qualitative measure)
34 secondary outcomes
Change from baseline in meal dietary energy density
Time frame: Clinical investigation day 1 (week 0); Phone call (week 2, week 4, week 6, week 8, week 10); Clinical investigation day 2 (week 12); Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
Change from baseline in meal nutrient composition: Grams
Time frame: Clinical investigation day 1 (week 0); Phone call (week 2, week 4, week 6, week 8, week 10); Clinical investigation day 2 (week 12); Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
Change from baseline in meal nutrient composition: % energy
Time frame: Clinical investigation day 1 (week 0); Phone call (week 2, week 4, week 6, week 8, week 10); Clinical investigation day 2 (week 12); Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
Use of serving spoon (24 h frequency)
Time frame: Phone call (week 2, week 4, week 6, week 8, week 10); Clinical investigation day 2 (week 12); Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
Use of oil dispenser (24 h frequency)
Time frame: Phone call (week 2, week 4, week 6, week 8, week 10); Clinical investigation day 2 (week 12); Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
Use of intervention guide (24 h frequency)
Time frame: Phone call (week 2, week 4, week 6, week 8, week 10); Clinical investigation day 2 (week 12); Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
Use of intervention app (24 h frequency)
Time frame: Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
Use of serving spoon (15 day frequency)
Time frame: Phone call (week 2, week 4, week 6, week 8, week 10); Clinical investigation day 2 (week 12); Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
Use of oil dispenser (15 day frequency)
Time frame: Phone call (week 2, week 4, week 6, week 8, week 10); Clinical investigation day 2 (week 12); Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
Use of intervention guide (15 day frequency)
Time frame: Phone call (week 2, week 4, week 6, week 8, week 10); Clinical investigation day 2 (week 12); Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
Use of intervention app (15 day frequency)
Time frame: Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
Anthropometric profile: Change from baseline in Body Weight
Time frame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Anthropometric profile: Body Height
Time frame: Clinical investigation day 1 (week 0)
Anthropometric profile: Change from baseline in Body Mass Index
Time frame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Anthropometric profile: Change from baseline in Waist circumference
Time frame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Anthropometric profile: Hip circumference
Time frame: Clinical investigation day 1 (week 0)
Anthropometric profile: Change from baseline in Waist-to-hip ratio
Time frame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Anthropometric profile: Change from baseline in body fat composition
Time frame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Biochemical profile: Change from baseline in fasting blood glucose
Time frame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Biochemical profile: Change from baseline in fasting blood insulin
Time frame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Biochemical profile: Change from baseline in fasting blood triglycerides
Time frame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Biochemical profile: Change from baseline in fasting blood cholesterol
Time frame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Biochemical profile: Change from baseline in fasting blood ghrelin
Time frame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Biochemical profile: Change from baseline in fasting blood leptin
Time frame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Meal eating behaviour: Change from baseline in Eating rate
Time frame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Meal eating behaviour: Change from baseline in bite size
Time frame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Meal eating behaviour: Change from baseline in meal duration
Time frame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Meal eating behaviour: Change from baseline in deceleration rate
Time frame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Inhibitory control pattern: Change from baseline in N200 wave latency
Time frame: Clinical investigation day 1 (week 0), clinical investigation day 3 (week 24)
Inhibitory control pattern: Change from baseline in N200 wave length
Time frame: Clinical investigation day 1 (week 0), clinical investigation day 3 (week 24)
Inhibitory control pattern: Change from baseline in P300 wave latency
Time frame: Clinical investigation day 1 (week 0), clinical investigation day 3 (week 24)
Inhibitory control pattern: Change from baseline in P300 wave length
Time frame: Clinical investigation day 1 (week 0), clinical investigation day 3 (week 24)
Learning task: Change from baseline in learned meal portion size
Time frame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Learning task: Change from baseline in learned meal nutrient content
Time frame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Almiron-Roig, PhD principal investigator
University of Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lifestyle, Healthy and Weight Management, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in 24 h total dietary energy intake (time frame: Clinical investigation day 1 (week 0); Phone call (week 2, week 4, week 6, week 8, week 10); Clinical investigation day 2 (week 12); Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.