Implementing Strategies for Eating Behaviour Modification Based on Portion Control
NCT Number: NCT06519539
Acronym: PORTIONS-4
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lifestyle, Healthy|Weight Management|Behavior Change
Interventions: BEHAVIORAL: PORTIONS-4 behaviour change strategies
Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-14
Completion Date: 2025-03-31
Locations: University of Navarra, Dept. of Food Science and Physiology, Center for Nutrition Research, Pamplona, Navarra, 31008, Spain

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 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.

Primary Outcome Measures: 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, 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, 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), 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), 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 Outcome Measures: 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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., 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., 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), 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, 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), 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), 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), 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), 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), 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), 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), 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), 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), 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), 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), 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), 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), 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), 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), 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), Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Other Outcome Measures: Socio-demographic and lifestyle data, Socio-demographic characteristics of the sample collected via self-reported questionnaire (age, sex, education, marital status, household composition, employment, physical activity level, smoking, alcohol intake), Pre-screening|Eating habits: Risk of eating disorders, Score in the Eating Attitudes Test-26, ranging from 0-78 points, validated by Garner et al., 1982. Scores above 20 suggest risk for presence of potential eating disorders., Pre-screening|Eating habits: Eating habits profile, Profile defined by the combined Restraint (0-21 points), Disihnibition (0-16 points) and Susceptibilty to hunger (0-14 points) sub-scales scores of the Three Factor Eating Questionnaire (TFEQ), validated by Stunkard \& Messick, 1985. Restraint values above 11, disinhibition values above 8 and susceptibility to hunger values above 4 are considered worse outcomes (i.e. risk for development of obesity and other eating disorders), Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)|Eating habits: Portion control tool usage, Previous usage of portion control tools (end of study interview), Clinical investigation day 3 (week 24)|Eating habits: Frequency of home made meals, Frequency of consuming home made meals via self-reported questionnaire, Pre-screening|Eating habits: Frequency of take away meals, Frequency of consuming take away meals via self-reported questionnaire, Pre-screening|Eating habits: Meal prep and serving, Responsible person for cooking at home, via self-reported questionnaire, Pre-screening|Eating habits: Liking for the intervention food (milkshake), Liking for the foods to be used in the intervention, via self-reported questionnaire (100 mm visual analogue scale), Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)|Eating habits: Familiarity with the intervention food (milkshake), Familiarity with the foods to be used in the intervention, via self-reported questionnaire (100 mm visual analogue scale), Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)|Eating habits: Appetite levels, Scores for hunger, fullness, thirst, prospective intake, nausea measured on a 100 mm visual analogue scale before consumption of a milkshake (validated questionnaire based on Hill \& Blundell, 1982), Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)|Eating habits: Beverage consumption habits, Self-reported questionnaire assessing caloric beverage intake, awareness of beverage portion sizes and acceptance of portioning tools for liquids currently on the market (pre-piloted on-line BPS survey, Vargas-Alvarez et al., 2021), Pre-screening (week 0), clinical investigation day 3 (week 24)|Eating habits: Problem eating behaviour questionnaire (PEBQ), Validated questionnaire (Carter \& Jansen, 2012) used to identify eating patterns associated with the risk for obesity. It consists of 25 items answered on a 5-Pt intensity scale. The information collected can be used qualitatively, to identify problematic behaviors, or quantitatively by adding the direct scores. Scores greater than 50 suggest a moderate to high frequency of behaviors associated with obesity., Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)|Medical history, Self-reported questionnaire based on previous studies (Almiron-Roig et al., 2023) asking about special dietary needs, pregnancy, lactation, menopause, history of eating disorders, history of mental illness, incompatible medical conditions (e.g. cancer, diabetes, memory loss), regular medication including nutritional and other supplements, Pre-screening (week 0)|Anthropometric profile: General body composition, Fat mass distribution (trunk, arms, legs), fat-free mass (kg, %), fat-free mass distribution, basal metabolic rate (kcal/day), Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)|Psychological profile: Personality, Score in the NEO-Five Factor Inventory (NEO-FFI) 60 item validated questionnaire (Costa \& McCrae, 1989). The score for each central domain of normal personality defined by the Five-Factor Model of personality (neuroticism, extraversion, conscientiousness, agreeableness, and openness to experience) is calculated. A higher score on a scale assessing a certain personality domain indicates a stronger expression of traits associated with this particular domain, Pre-screening|Psychological profile: Perceived stress, Score in the Perceived Stress Scale-14 (PSS-14) validated questionnaire (Cohen et al., 1983). Scores ranging from 0 to 13 suggest low stress, scores ranging from 14 to 24 suggest moderate stress, and scores above 27 suggest high perceived stress, Pre-screening|Psychological profile: Emotional intelligence, Score in the Trait Meta-Mood Scale-24 (TMMS-24) validated questionnaire (Salovey et al., 1995). The score for three different dimensions of emotional intelligence are calculated. To obtain a score for each factor, items 1 to 8 are added for the emotional attention factor, items 9 to 16 for the emotional clarity factor, and items 17 to 24 for the emotional repair factor., Pre-screening|Psychological profile: Mood, Score in the Profile of Mood States (POMS) validated questionnaire (McNair et al., 1971). The score for six different dimensions of mood (tension, anger, fatigue, depression, confusion, and vigour) is calculated. A higher score on a scale assessing a certain mood dimension indicates a stronger expression of associated feelings. The resulting scores will range from -24 to 177, with lower scores indicative of people with more stable mood profiles, Pre-screening|Attitude towards intervention: Intervention expectations, Self-constructed scale evaluated with the sum of scores (1-10) for 5 items (based on Nau \& Borkovec, 1972). The 5 items include rating the intervention's logic, satisfaction, recommendability, expected usefulness, and the respondent's readiness to follow it. A higher score reflects a more positive expectation towards the upcoming intervention., Clinical investigation day 1 (week 0)|Attitude towards intervention: Intervention opinion, Self-constructed scale evaluated with the sum of scores (1-10) for 5 items (based on Nau \& Borkovec, 1972). The 5 items include rating the intervention's logic, satisfaction, recommendability, usefulness, and the respondent's readiness/intention to continue with it. A higher score reflects a more positive opinion towards the experienced intervention., Clinical investigation day 2 (week 12), Clinical investigation day 3 (week 24)|Attitude towards intervention: Dietetic tool acceptance (serving spoon, oil dispenser), Previously piloted questionnaire (Almiron-Roig et al., 2016) including 5-Pt Likert scores for portion tool attractiveness, fits within lifestyle, embarrassment, ease of use, perceived effectiveness and resistant to use. An average score of 1 or 2 indicates low acceptance, 3 neutral, and 4 or 5 high acceptance., Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), Clinical investigation day 3 (week 24)|Attitude towards intervention: Intervention component acceptance (serving spoon, oil dispenser, intervention guide, intervention app), Single scale instrument measuring the level of intention to use each component from 0-100 on a 100 mm visual analogue scale (previously piloted questionnaire, Almiron-Roig et al., 2016)., Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), Clinical investigation day 3 (week 24)|Attitude towards intervention: Perceived app usability, System Usability Scale (SUS) (based on Brooke, 1996). Includes ten 5-Pt Likert questions of which 5 items are scored positively (pleasant, easy to use, good functionality, quick to learn, safe), and 5 items are scored reversedly (complex, requires support, inconsistent, complicated to use, requires learning). A higher overall score indicates higher perceived usability., Clinical investigation day 2 (week 12), Clinical investigation day 3 (week 24)|Attitude towards intervention: Intervention guide assessment, Self-constructed questionnaire including 20 items answered with a 5-Pt Likert scale. The first 10 items assess content of the guide (credibility, coherence, usefulness, applicability) and the second 10 items assess format (organisation, word choice and communication style). A score \<60 indicates poor assessment (the tool cannot be used in clinical practice as it stands); a score between 60-79 indicates the tool needs revision before implementation; a score of 80 or above indicates the tool is well rated by potential users and may be useful in clinical practice., Clinical investigation day 2 (week 12)|Intervention component usage: serving spoon, Types of meals in which the serving spoons were most frequently used, 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 component usage: oil dispenser, Types of meals in which the oil dispenser was most frequently used, 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 component usage: intervention guide, Guide sections most frequently checked, 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 component usage: intervention app, App functions most frequently used, 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)|Protocol compliance on clinical investigation days, Self-constructed interview to verify participants' compliance with arrival time, physical activity and dietary requirements and any change in medication occurred prior to each clinical investigation day, Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), Clinical investigation day 3 (week 24)|End of study survey, Self-constructed interview to assess participant's overall experience with the intervention at study end (items include previous tools/methods employed, satisfaction with intervention, consistency of use, barriers experienced and intention to continue using the components), Clinical investigation day 3 (week 24)