Implementing Strategies for Eating Behaviour Modification Based on Portion Control

NCT06519539 | Active Not Recruiting

• 1 other identifier: PC139-140
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Lifestyle, Healthy; Weight Management; Behavior Change

Keywords

Portion size; Portion control tool; Dietary energy density

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (34)

• 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)

Other Outcomes (30)

• Socio-demographic and lifestyle data

  Pre-screening

• Eating habits: Risk of eating disorders

  Pre-screening

• Eating habits: Eating habits profile

  Clinical investigation day 1 (week 0), Clinical investigation day 2 (week 12), clinical investigation day 3 (week 24)

Study Arms (1)

Adults with overweight or obesity

Healthy adults with a BMI of 27.5 kg/sq-m or above (26 or above for those of Asian descent), who will undertake a 6 month lifestyle intervention focused on improving dieary choices, physical activity and attitudes towards weight management.

Behavioral: PORTIONS-4 behaviour change strategies

Interventions

PORTIONS-4 behaviour change strategies BEHAVIORAL

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.

Adults with overweight or obesity

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

University of Navarra, Dept. of Food Science and Physiology, Center for Nutrition Research

Pamplona, Navarre, 31008, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum samples

Study Officials

• Eva Almiron-Roig, PhD

  University of Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: July 25, 2024
• Study Start: March 14, 2024
• Primary Completion: September 27, 2024
• Study Completion: March 31, 2025
• Last Updated: July 25, 2024

Record last verified: 2024-05

Locations

ES (1)