Ireland
--:--IST
Recruiting Not applicable

Comprehensive Intervention for Changing Eating Habits Through Portion Control

NCT07932977 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2026-10-15
Last updated
2026-11-12

Condition(s) studied

Lifestyle InterventionWeight ManagementBehaviour ChangePortion Size

Investigational drug(s) / intervention(s)

Portion controlHealthy lifestyle

Portion control: Self-applied, multicomponent intervention with a previously validated portion control toolset

Healthy lifestyle: Active comparator with same level of follow-up as experimental group

Study summary

This is a 12-month randomized controlled trial designed to evaluate the effectiveness of a comprehensive self-applied lifestlye intervention for weight loss, based on portion control. A total of 181 volunteers with overweight/obesity will be randomly allocated to an experimental intervention group or an active control group. The experimental intervention will include 4 components: (1) a portion control toolset (eating utensils); (2) a manual including instructions for the use of the tools, dietary and activity recommendations, and behavioural strategies; (3) a mobile app to motivate intervention engagement; and (4) a recipe book to help integrate the intervention in daily life. The control group will receive standard guidelines for healthy living, including diet and physical activity. Both groups will attend 4 clinical investigation days, 2 group sessions and will receive periodic telephone support. The primary outcome will be the change in waist circumference from baseline, assessed at 3, 9 and 12 months. Other measurements will include body composition, fasting biochemical parameters, eating behaviour, gut microbiota, functional magnetic resonance, portion size norms, intervention adherence and acceptance. The study will test the hypothesis that a comprehensive intervention focused on portion control can promote changes in eating habits and reduce waist circumference over 12 months compared with receving standard healthy living advice (active control group).

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Body mass index equal or above 27.5 kg/m2 (26.0 kg/m2 for those of Asian descent), or waist circumference above 84 cm (female) or above 90 cm (male) * 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 and consume the study foods * Being able to attend in person on 4 clinical investigation days and 2 compulsory group sessions during working hours * Being able to understand and agree to sign the informed consent form Exclusion Criteria: * Being a regular smoker (i.e., smoking more than 4 cigarettes a month) * Being pregnant, breastfeeding or planning a pregnancy * Exceed the weekly alcohol consumption limit for the corresponding sex (more than 14 units in women and more than 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 * 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 malformation, angiodysplasia, active peptic ulcer, chronic inflammatory or malabsorption disease, or history of intestinal or bariatric surgery * Suffering from any 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") * Active mental health conditions, including dementia, that could interfere with the participant's ability to adequately follow the study protocol, or current use of psychiatric medications that may affect appetite (e.g., antidepressants). For stable-dose participants, cases will be evaluted on a one-to-one basis with the study medical team. * Engaging in 10 or more hours of vigorous physical activity per week. * Being allergic, or being intolerant to the study foods or their ingredients (regular or lactose-free yogurt and granola) * History of anaphylactic reaction to any food * Taking nutritional supplements as a prescription medication that may affect the results of the study * Taking over-the-counter nutritional supplements (that is, without a medical prescription) that may affect the results of the study, unless the person is willing to stop it during the 12 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 * Previous participation in PORTIONS-3 (preclinical study) or PORTIONS-4 (pilot trial) * For the body composition analysis, wearing a pacemaker or certain metallic implants. ADDITIONAL EXCLUSION CRITERIA FOR SUB-STUDIES Functional MRI sub-study - Additional Exclusion Criteria: * Claustrophobia * Presence of metallic implants, pacemakers, defibrillators, or other devices incompatible with functional magnetic resonance imaging (fMRI) * Body weight greater than 180 kg * Neck circumference greater than 62.8 cm * Any contraindication to undergoing magnetic resonance imaging identified through the MRI safety screening questionnaire * A score of 50% or lower for four or more of the food items included in the auditory stimuli in the food liking questionnaire, indicating insufficient familiarity with the stimuli * Allocation to the trial's focus group discussions, unless the participant explicitly expresses a willingness to participate in both the fMRI assessment and the focus group discussions Gut microbiota sub-study - Additional Exclusion Criteria During the 15 days preceding stool sample collection: * Use of antibiotics * Use of fiber supplements * Use of supplements that may affect the gut microbiota, such as probiotics or biotin

Primary outcome measure(s)

  • Change in Waist Circumference From Baseline — Week -1, Week 0, Week 12, Week 36, Week 48
    Change in waist circumference (cm) from baseline will be assessed over the 12-month intervention period. Waist circumference will be measured using standardized anthropometric procedures

Trial sites (1)

FacilityCityRegionStatus
University of Navarra, Centre for Nutrition Research Pamplona Navarre Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07932977 on ClinicalTrials.gov ↗ ← All trials in Spain