Nutrition Thinking® Trial
- Conditions
- Overweight
- Interventions
- Behavioral: Nutrition Thinking®Behavioral: Standard Nutritional Approach
- Registration Number
- NCT04719260
- Lead Sponsor
- Hospital de Clinicas de Porto Alegre
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 82
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nutrition Thinking® Nutrition Thinking® Nutrition Thinking® approach to promote weight loss and healthy diet pattern. Standard Nutritional Approach Standard Nutritional Approach The traditional nutritional prescriptive approach.
- Primary Outcome Measures
Name Time Method Weight 12 weeks Weight change from baseline to end of intervention
Quality of diet 12 weeks 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.
Dietary usability 12 weeks 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.
- Secondary Outcome Measures
Name Time Method Food literacy 12 weeks Food literacy changes from baseline to end of intervention will be defined by the Short Food Literacy Questionnaire (SQLF). The SQLF employed a Likert-type scale to measure individual item scores and summed to create a composite score minimum score 7 points, maximum 52 points. Higher scores are associated with a better level of literacy in food.
Body fat percentage 12 weeks Body fat percentage change from baseline to end of intervention will be measured with multi-frequency segmental bioelectrical impedance.
Carbon Footprint 12 weeks Carbon footprint (CF) change from baseline to end of intervention will be estimated through individual-level carbon footprints (ICF) are assessed as ICF = ΣCiEi where each term is the product of the degree of consumption © and the CO2 equivalent radiative forcing emission (E) of that input (i). Greenhouse gas emission (E) weightings applied to individual consumption levels (C) will be expressed in metric tons CO2-equivalent/year (CO2e).
Trial Locations
- Locations (1)
Hospital de Clínicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil