Implementing Strategies for Eating Behaviour Modification Based on Portion Control: Methodological Development and Pilot Study

Clinica Universidad de Navarra, Universidad de Navarra1 site in 1 country40 target enrollmentMarch 14, 2024

ConditionsLifestyle, Healthy Weight Management Behavior Change

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Lifestyle, Healthy
Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Enrollment: 40
Locations: 1
Primary Endpoint: Change from baseline in 24 h total dietary energy intake
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 14, 2024

End Date

March 31, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Responsible Party

Sponsor

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)

Outcomes

Primary Outcomes

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

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

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

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)

Secondary Outcomes

Change from baseline in meal dietary energy density(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(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(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)(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)(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)(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)(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)(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)(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))
Anthropometric profile: Change from baseline in body fat composition(Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24))
Anthropometric profile: Body Height(Clinical investigation day 1 (week 0))
Use of intervention guide (15 day frequency)(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)(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 Mass Index(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 Weight(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(Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24))
Anthropometric profile: Hip circumference(Clinical investigation day 1 (week 0))
Anthropometric profile: Change from baseline in Waist-to-hip ratio(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(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(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(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(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(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(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(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(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(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(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(Clinical investigation day 1 (week 0), clinical investigation day 3 (week 24))
Inhibitory control pattern: Change from baseline in N200 wave length(Clinical investigation day 1 (week 0), clinical investigation day 3 (week 24))
Inhibitory control pattern: Change from baseline in P300 wave latency(Clinical investigation day 1 (week 0), clinical investigation day 3 (week 24))
Inhibitory control pattern: Change from baseline in P300 wave length(Clinical investigation day 1 (week 0), clinical investigation day 3 (week 24))
Learning task: Change from baseline in learned meal portion size(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(Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24))