Nutrition Thinking® Trial

NCT04719260 | Unknown DMC

• 1 other identifier: 2019-0694
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to scientifically validate Nutrition Thinking®, a novel nutritional approach based on the values and methodologies of Design Thinking.

Conditions

Overweight

Keywords

nutrition thinking; nutritional approach; diet; design thinking; overweight

Outcome Measures

Primary Outcomes (3)

• Weight

  Weight change from baseline to end of intervention

  12 weeks

• Quality of diet

  Changes in The Healthy Eating Index 2015 score (HEI-2015) from baseline to end of intervention. The Healthy Eating Index-2015 (HEI-2015) allows us to assess how well a set of foods aligns with the 2015-2020 Dietary Guidelines for Americans. The HEI-2015 includes 13 components that can be summed to a maximum total score of 100 points. The components capture adequacy components and moderation components. For the adequacy components, higher scores reflect higher intakes that meet or exceed the standards. For the moderation components, higher scores reflect lower intakes because lower intakes are more desirable. A higher total score indicates a diet that aligns better with the Dietary Guidelines. Adequacy components include total fruits, whole fruits, total vegetables, greens and beans, whole grains, dairy, total protein foods, seafood and plant proteins, fatty acids. Moderation components include refined grains, sodium, added sugars, and saturated fats.

  12 weeks

• Dietary usability

  Dietary usability will be measured by the System Usability Scale (SUS). The SUS consists of ten statements. For each statement, the participant gives his or her approval or rejection in the form of a scale ranging from 1=strong approval to 5=strong rejection of the statement. The results of the SUS questionnaire are used to calculate a numerical value (the so-called SUS score). The categories in the SUS questionnaire are coded with values from 0 to 4. The results can have a value between 0 (worst application imaginable) and 100 (best application imaginable): when the questionnaire is evaluated, the numbers obtained are added together - the sum is between 0 and 40 - and then multiplied by 2.5 and will be normalized to produce a percentile ranking.

  12 weeks

Secondary Outcomes (3)

• Food literacy

  12 weeks

• Body fat percentage

  12 weeks

• Carbon Footprint

  12 weeks

Study Arms (2)

Nutrition Thinking®

EXPERIMENTAL

Nutrition Thinking® approach to promote weight loss and healthy diet pattern.

Behavioral: Nutrition Thinking®

Standard Nutritional Approach

ACTIVE COMPARATOR

The traditional nutritional prescriptive approach.

Behavioral: Standard Nutritional Approach

Interventions

Nutrition Thinking® BEHAVIORAL

In the first session, the nutritionist will carry out the anamnesis through the Empathy Map and assessment of the nutritional status to define the Nutrition Briefing. The steps described by Design Thinking as understanding, observation, and point of view comprise the first phase of this session. The ideation process will proceed from the definition of the Nutrition Challenge. Prototyping is the final stage of the first session, where an initial prototype of the diet will be co-created based on visual thinking tools and the description underlying the creation of diets. Within 24 hours the individual will receive a summary of the material developed by email. The period between sessions will comprise the testing phase and the follow-up sessions the iteration phase where the experience and previous steps are revisited in order to create new insights, anthropometric measurements will be seen as reflections of the experience and not as primary outcomes of the intervention.

Nutrition Thinking®

Standard Nutritional Approach BEHAVIORAL

In the first session the nutritionist will carry out the food and nutritional anamnesis and assessment of the nutritional status. From this information, the nutritionist will generate the diagnostic hypothesis and determine the specific nutritional needs. The professional will be responsible for generating the dietary prescription defining the characteristics of the diet that will be delivered printed to the individual after a period of 15 days, in the second session of the protocol. The follow-up session will be based on adherence to the established conduct and monitoring of anthropometric variations.

Standard Nutritional Approach

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age between 25 and 35 years old of both sexes;
• nutritional diagnosis of overweight (BMI between 25-29.9 kg/m2);
• available to participate in the sessions proposed by the protocol (every 15 days for a period of 3 months).

You may not qualify if:

• presence of characteristics that make nutritional assessment impossible (eg. presence of metallic prostheses or amputated limbs);
• previous involvement in any clinical trial, nutritional or medical intervention for weight loss in the 6 months prior to recruitment;
• previous history of eating disorders (anorexia, bulimia, binge eating);
• presence of congenital diseases;
• presence of thyroid disease, hypertension, dyslipidemia and diabetes, defined through medical diagnosis associated with drug treatment and / or previous or current cardiovascular disease;
• pregnant or lactating women.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Mauricio Kunz: collaborator
• Caroline Nespolo de David: collaborator
• Renato Gorga Bandeira de Mello: collaborator
• Aline Marcadenti de Oliveira: collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Francisca Mosele, PhD

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

• Muricio Kunz, PhD

  Hospital de Clinicas de Porto Alegre

  STUDY CHAIR

Central Study Contacts

Francisca Mosele, PhD

CONTACT

+55 51 98151-8638; franciscamosele@nutritionthinking.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization sequence will be generated by computer in the data center using alphanumeric codes and implemented through the Research Electronic Data Capture (REDCap®) software. The professionals who will carry out the interventions during the protocol will be trained for one of the two interventions, without knowledge of the outcomes (except, bioimpedance results), evaluations performed during the study or comparison intervention. After the assignment to one of the groups, the participants, and those who will evaluate all the outcomes, will remain blind until the end of the study and results analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a parallel randomized clinical trial, where individuals will be allocated to one of the arms - experimental intervention (Nutrition Thinking®) or control (standard intervention) - in a 1:1 ratio. The sample size calculation suggests that 82 subjects (41/each arm) are required. At the end of the clinical trial, individuals will be part of a cohort study where they will be followed up every three months for 12 months.

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: January 22, 2021
• Study Start: August 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: February 1, 2022
• Last Updated: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)