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.
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.
Study Type
OBSERVATIONAL
Enrollment
40
The intervention includes 4 components, including: a portion control tool set previously developed and tested in our laboratory; a supporting guide (physical book) with dietary, activity and behavioural recommendations; a mobile application aligned with the guide; and biweekly telephone calls from the psychologist and/or dietitian.
University of Navarra, Dept. of Food Science and Physiology, Center for Nutrition Research
Pamplona, Navarre, Spain
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
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)
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
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)
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)
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)
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)
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)
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
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)
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
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)
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
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)
Use of serving spoon (24 h frequency)
Number of times the intervention spoon has been used in a period of 24 h
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)
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