Nutrition Thinking® Trial

NCT ID: NCT04719260

Last Updated: 2021-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-31
• Study Completion Date: 2022-02-28

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.

Detailed Description

The concept of nutrition has changed exponentially in recent decades to include a range of challenges that were not foreseen. The strength of this movement is based on the understanding of (1) the complexity with which people face their nutritional challenges; and (2) the interconnection between food systems and overlapping health risks associated with malnutrition, obesity, and climate change.

Maintaining an adequate weight, a healthy and sustainable diet pattern are complex well-established challenges. However, current nutritional approaches to lose weight, based on functional experiences, often fail to promote long-term adherence to dietary recommendations and maintaining lost weight.

The ambiguity and complexity that involves an interactional nutrition, based on the experiences involved in how people act at the individual level and their relationships with the environment and dynamic systems, brings up the challenge of designing meaningful learning experiences to promote a change of culture and positive impact.

Current social changes demand the search for novel nutritional approaches based on methodologies that result in meaningful experiences. We need new ways to build diets that balance the needs of individuals and society as a whole, new ideas that address global challenges, new strategies that result in differences that matter, and a sense of purpose that includes everyone involved.

With that in mind, Nutrition Thinking® arises as a nutritional approach based on the values and methodologies of Design Thinking, an abstraction of a mental model for addressing complex problems and conducting projects based on empathy, collaboration, and experimentation. Therefore, Nutrition Thinking® represents a new nutrition learning matrix based on experience for the co-creation of authentic and sustainable diets.

Conditions

Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Nutrition Thinking®

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

Group Type: EXPERIMENTAL

Nutrition Thinking®

Intervention Type: 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.

Standard Nutritional Approach

The traditional nutritional prescriptive approach.

Group Type: ACTIVE_COMPARATOR

Standard Nutritional Approach

Intervention Type: 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.

Interventions

Nutrition Thinking®

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.

Intervention Type: BEHAVIORAL

Standard Nutritional Approach

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mauricio Kunz

UNKNOWN

Sponsor Role: collaborator

Caroline Nespolo de David

UNKNOWN

Sponsor Role: collaborator

Renato Gorga Bandeira de Mello

UNKNOWN

Sponsor Role: collaborator

Aline Marcadenti de Oliveira

UNKNOWN

Sponsor Role: collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Francisca Mosele

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francisca Mosele, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas de Porto Alegre

Muricio Kunz, PhD

Role: STUDY_CHAIR

Hospital de Clinicas de Porto Alegre

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Central Contacts

Francisca Mosele, PhD

Role: CONTACT

franciscamosele@nutritionthinking.com

+55 51 98151-8638

Facility Contacts

Têmis Maria Felix, PhD

Role: primary

cep@hcpa.edu.br

+55 51 3359-7640

Other Identifiers

2019-0694

Identifier Type: -

Identifier Source: org_study_id