Portion control tools and an app put to the test for weight management

NCT ID NCT06519539

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This pilot study tests a 6-month weight management program for 40 healthy adults with overweight or obesity. The program includes a portion control toolset, a guidebook with dietary and activity advice, a mobile app, and biweekly phone calls from a psychologist or dietitian. Researchers will measure changes in eating habits, body composition, and blood markers to see if the approach is feasible and worth studying further.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A behavioral intervention combining a portion control toolset, a guidebook, a mobile app, and biweekly telephone support from a psychologist or dietitian.
What this could lead to
If it works, this could offer a practical, self-guided approach to weight management that people can use at home without frequent clinic visits.
What could go wrong
This is a small pilot study with only 40 participants, so results may not apply broadly. Success depends on people sticking with the program, and the study does not yet prove long-term weight loss.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

40 people

The number who actually took part.

Started

Dec 2023

Finished

Nov 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Healthy men and women living with overweight or obesity and willing to receive a 6-month intervention focused on changing their dietary habits

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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).

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Navarra, Dept. of Food Science and Physiology, Center for Nutrition Research

    Pamplona, Navarre, 31008, Spain

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