Clinical trial NCT04719260: Nutrition Thinking® Trial
Official title: Nutrition Thinking® Randomized Clinical Trial for Scientific Validation of a Nutritional Approach Based on the Values and Methodology of Design Thinking
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight
Keywords: nutrition thinking
nutritional approach
diet
design thinking
overweight
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Mauricio Kunz
name: Caroline Nespolo de David
name: Renato Gorga Bandeira de Mello
name: Aline Marcadenti de Oliveira
First posted: 2021-01-22
Enrollment: 82
Sex: ALL
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Weight
timeFrame: 12 weeks
measure: Quality of diet
timeFrame: 12 weeks
measure: Dietary usability
timeFrame: 12 weeks
Secondary outcomes:
measure: Food literacy
timeFrame: 12 weeks
measure: Body fat percentage
timeFrame: 12 weeks
measure: Carbon Footprint
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Francisca Mosele, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Clinicas de Porto Alegre
name: Muricio Kunz, PhD
role: STUDY_CHAIR
References: