Clinical trial NCT06519539: Implementing Strategies for Eating Behaviour Modification Based on Portion Control
Official title: Implementing Strategies for Eating Behaviour Modification Based on Portion Control: Methodological Development and Pilot Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lifestyle, Healthy
Weight Management
Behavior Change
Keywords: Portion size
Portion control tool
Dietary energy density
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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/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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change from baseline in 24 h total dietary energy intake
timeFrame: 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)
measure: Change from baseline in 24 h total dietary volume intake
timeFrame: 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)
measure: Change from baseline in daily dietary energy density
timeFrame: 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)
measure: Intervention adherence
timeFrame: 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:
measure: Change from baseline in meal dietary energy density
timeFrame: 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)
measure: Change from baseline in meal nutrient composition: Grams
timeFrame: 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)
measure: Change from baseline in meal nutrient composition: % energy
timeFrame: 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)
measure: Use of serving spoon (24 h frequency)
timeFrame: 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)
measure: Use of oil dispenser (24 h frequency)
timeFrame: 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)
measure: Use of intervention guide (24 h frequency)
timeFrame: 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)
measure: Use of intervention app (24 h frequency)
timeFrame: Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
measure: Use of serving spoon (15 day frequency)
timeFrame: 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)
measure: Use of oil dispenser (15 day frequency)
timeFrame: 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)
measure: Use of intervention guide (15 day frequency)
timeFrame: 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)
measure: Use of intervention app (15 day frequency)
timeFrame: Phone call (week 14, week 16, week 18, week 20, week 22); Clinical investigation day 3 (week 24)
measure: Anthropometric profile: Change from baseline in Body Weight
timeFrame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
measure: Anthropometric profile: Body Height
timeFrame: Clinical investigation day 1 (week 0)
measure: Anthropometric profile: Change from baseline in Body Mass Index
timeFrame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
measure: Anthropometric profile: Change from baseline in Waist circumference
timeFrame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
measure: Anthropometric profile: Hip circumference
timeFrame: Clinical investigation day 1 (week 0)
measure: Anthropometric profile: Change from baseline in Waist-to-hip ratio
timeFrame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
measure: Anthropometric profile: Change from baseline in body fat composition
timeFrame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
measure: Biochemical profile: Change from baseline in fasting blood glucose
timeFrame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
measure: Biochemical profile: Change from baseline in fasting blood insulin
timeFrame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
measure: Biochemical profile: Change from baseline in fasting blood triglycerides
timeFrame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
measure: Biochemical profile: Change from baseline in fasting blood cholesterol
timeFrame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
measure: Biochemical profile: Change from baseline in fasting blood ghrelin
timeFrame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
measure: Biochemical profile: Change from baseline in fasting blood leptin
timeFrame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
measure: Meal eating behaviour: Change from baseline in Eating rate
timeFrame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
measure: Meal eating behaviour: Change from baseline in bite size
timeFrame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
measure: Meal eating behaviour: Change from baseline in meal duration
timeFrame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
measure: Meal eating behaviour: Change from baseline in deceleration rate
timeFrame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
measure: Inhibitory control pattern: Change from baseline in N200 wave latency
timeFrame: Clinical investigation day 1 (week 0), clinical investigation day 3 (week 24)
measure: Inhibitory control pattern: Change from baseline in N200 wave length
timeFrame: Clinical investigation day 1 (week 0), clinical investigation day 3 (week 24)
measure: Inhibitory control pattern: Change from baseline in P300 wave latency
timeFrame: Clinical investigation day 1 (week 0), clinical investigation day 3 (week 24)
measure: Inhibitory control pattern: Change from baseline in P300 wave length
timeFrame: Clinical investigation day 1 (week 0), clinical investigation day 3 (week 24)
measure: Learning task: Change from baseline in learned meal portion size
timeFrame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
measure: Learning task: Change from baseline in learned meal nutrient content
timeFrame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
Other outcomes:
measure: Socio-demographic and lifestyle data
timeFrame: Pre-screening
measure: Eating habits: Risk of eating disorders
timeFrame: Pre-screening
measure: Eating habits: Eating habits profile
timeFrame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
measure: Eating habits: Portion control tool usage
timeFrame: Clinical investigation day 3 (week 24)
measure: Eating habits: Frequency of home made meals
timeFrame: Pre-screening
measure: Eating habits: Frequency of take away meals
timeFrame: Pre-screening
measure: Eating habits: Meal prep and serving
timeFrame: Pre-screening
measure: Eating habits: Liking for the intervention food (milkshake)
timeFrame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
measure: Eating habits: Familiarity with the intervention food (milkshake)
timeFrame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
measure: Eating habits: Appetite levels
timeFrame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
measure: Eating habits: Beverage consumption habits
timeFrame: Pre-screening (week 0), clinical investigation day 3 (week 24)
measure: Eating habits: Problem eating behaviour questionnaire (PEBQ)
timeFrame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
measure: Medical history
timeFrame: Pre-screening (week 0)
measure: Anthropometric profile: General body composition
timeFrame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
measure: Psychological profile: Personality
timeFrame: Pre-screening
measure: Psychological profile: Perceived stress
timeFrame: Pre-screening
measure: Psychological profile: Emotional intelligence
timeFrame: Pre-screening
measure: Psychological profile: Mood
timeFrame: Pre-screening
measure: Attitude towards intervention: Intervention expectations
timeFrame: Clinical investigation day 1 (week 0)
measure: Attitude towards intervention: Intervention opinion
timeFrame: Clinical investigation day 2 (week 12), Clinical investigation day 3 (week 24)
measure: Attitude towards intervention: Dietetic tool acceptance (serving spoon, oil dispenser)
timeFrame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), Clinical investigation day 3 (week 24)
measure: Attitude towards intervention: Intervention component acceptance (serving spoon, oil dispenser, intervention guide, intervention app)
timeFrame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), Clinical investigation day 3 (week 24)
measure: Attitude towards intervention: Perceived app usability
timeFrame: Clinical investigation day 2 (week 12), Clinical investigation day 3 (week 24)
measure: Attitude towards intervention: Intervention guide assessment
timeFrame: Clinical investigation day 2 (week 12)
measure: Intervention component usage: serving spoon
timeFrame: 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)
measure: Intervention component usage: oil dispenser
timeFrame: 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)
measure: Intervention component usage: intervention guide
timeFrame: 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)
measure: Intervention component usage: intervention app
timeFrame: 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)
measure: Protocol compliance on clinical investigation days
timeFrame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), Clinical investigation day 3 (week 24)
measure: End of study survey
timeFrame: Clinical investigation day 3 (week 24)
Locations:
city: Pamplona
country: Spain
facility: University of Navarra, Dept. of Food Science and Physiology, Center for Nutrition Research
state: Navarra
Study officials:
affiliation: University of Navarra
name: Eva Almiron-Roig, PhD
role: PRINCIPAL_INVESTIGATOR
References: