NCT05280652

Brief Summary

Background: Different studies have shown that nutritional interventions can be effective in informing and educating the population about the need to follow a healthy diet to prevent obesity and other chronic diseases. However, sometimes this knowledge is difficult to apply in daily life, which is usually marked by lack of time and easy access to food alternatives that are not healthy but can be more comfortable. These difficulties may be greater in families today since the lack of time is greater and it is a greater challenge to get minors to consume a high amount (5 servings a day) of fruits and vegetables. Culinary medicine is an emerging discipline that combines nutrition and gastronomy to increase the prevention and treatment of chronic diseases. Objective: The main objective is to demonstrate whether a culinary-nutritional intervention in families reduces the risk of obesity and increases adherence to a healthy and sustainable diet. Methods: The present project will cover culinary medicine and home-cooking as innovative strategies to improve the eating habits of families through an intervention based on face-to-face nutricional-culinary workshops and online material, where apart from receiving nutritional education, they will be taught a series of culinary techniques (adapted to adults and children) so that they learn to cook in an easy, enjoyable and family-friendly way, with tools to eat healthier in a simple and quick way. The intervention will be carried out with 92 families (dyads 1 adult and 1 child) which will be randomized in a 1: 1: 2 ratio into three groups: group 1 (intervention with families) in which families will attend nutritional-culinary workshops with theoretical and practical information to follow a sustainable Mediterranean diet; group 2 (intervention with parents) in which only parents will attend nutritional-culinary workshops with theoretical and practical information to follow a sustainable Mediterranean diet; and group 3 (control) in which families will attend nutritional workshops with theoretical information to follow a sustainable Mediterranean diet. UPDATED NOTE AFTER RECRUITMENT: Due to financial and recruitment issues, a total of 29 families were recruited.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 15, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2024

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

2.1 years

First QC Date

March 4, 2022

Last Update Submit

December 23, 2024

Conditions

Keywords

culinary medicine; home cooking; family-based

Outcome Measures

Primary Outcomes (1)

  • Effect of the intervention on changes in body mass index (BMI)

    Weight will be measured with a Tanita RD-545 (Tanita Corp Tokyo Japan). Height will be measured to the nearest 0.1 cm using a portable stadiometer. Differences between intervention groups on changes on BMI between baseline and 10-months and baseline and 14-months follow up.

    At baseline, and 10 and 14 months follow-up

Secondary Outcomes (3)

  • Effect of the intervention on home cooking habits

    At baseline, and 10 and 14 months follow-up

  • Effect of the intervention on the adherence to the Mediterranean Diet (MedDiet)

    At baseline, and 10 and 14 months follow-up

  • Home cooking attitudes and self-confidence on cooking at home with the cooking attitudes and self-confidence questionnaire

    At baseline, and 10 and 14 months follow-up

Study Arms (3)

Family intervention group

EXPERIMENTAL

Families (dyads parent and child) will attend culinary-nutritional workshops with theoretical and practical nutritional and culinary information (knowledge and skills to prepare healthy and easy menus) to follow a sustainable Mediterranean diet.

Behavioral: Nutritional and culinary intervention

Parent-only intervention group

EXPERIMENTAL

Parents will attend culinary-nutritional workshops with theoretical and practical nutritional and culinary information (knowledge and skills to prepare healthy and easy menus) to follow a sustainable Mediterranean diet.

Behavioral: Nutritional and culinary intervention

Control

ACTIVE COMPARATOR

Families (dyads parent and child) will attend nutritional workshops with theoretical information to follow a sustainable Mediterranean diet.

Behavioral: Nutritional intervention

Interventions

Participants will attend 6 two-hours nutritional-culinary workshops between May 2022 and February 2023. All of the workshops will be held in a kitchen, and will be given in groups of 2 dyads or parents according to the intervention group. In addition, during the intervention families will be given access to a web page with nutrition and culinary education materials (infographics, videos).

Family intervention groupParent-only intervention group

Participants will attend 6 1-hour nutritional workshops between May 2022 and February 2023. The workshops will be held in person, and will be given in groups of 10-12 families. In addition, during the intervention families will be given access to a web page with nutrition education materials (infographics, videos).

Control

Eligibility Criteria

Age9 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • The child must be between 9-14 years old.
  • The child is at risk of obesity because it is over cut-offs of BMI according to their age or because it has a low level of adherence to the Mediterranean dietary pattern (an score ≤7 points in the Kidmed questionnaire).
  • There is at least 1 obesity risk factor in the household: one or both progenitors has overweight or obesity; one of both progenitors has only primary studies; one or both progenitors are unskilled workers; the total household number is ≤3; the child birthweight was \>4 kg; biological mother smoked during pregnancy; biological mother's weight gain during pregnancy was greater than the cut-offs of weight according to her BMI before pregnancy; biological mother's BMI before pregnancy was ≥30 kg/m2; one or both progenitors has a low adherence to the Mediterranean diet (17 points Mediterranean diet score ≤8); or the score for the family nutrition and physical activity screening tool is ≤50.

You may not qualify if:

  • The participant progenitor or child has any food allergies and intolerances incompatible with the Mediterranean diet (fruits, nuts).
  • The participant progenitor or child follow a specific dietary pattern incompatible with the intervention.
  • The participant progenitor or child has type 1 diabetes, severe diseases of the digestive system, kidney, cancer, other diseases that limit survival less than 1 year, or eating disorders.
  • The family has not access to a PC, tablet or telephone with internet.
  • The family has participated in cooking workshops in the past 3 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Navarra

Pamplona, Navarre, 31008, Spain

Location

Universidad de Alicante

Alicante, Spain

Location

Related Publications (2)

  • Enright G, Allman-Farinelli M, Redfern J. Effectiveness of Family-Based Behavior Change Interventions on Obesity-Related Behavior Change in Children: A Realist Synthesis. Int J Environ Res Public Health. 2020 Jun 8;17(11):4099. doi: 10.3390/ijerph17114099.

    PMID: 32521815BACKGROUND
  • Smith JD, Montano Z, Dishion TJ, Shaw DS, Wilson MN. Preventing weight gain and obesity: indirect effects of the family check-up in early childhood. Prev Sci. 2015 Apr;16(3):408-19. doi: 10.1007/s11121-014-0505-z.

    PMID: 25263212BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2022

First Posted

March 15, 2022

Study Start

September 1, 2022

Primary Completion

October 17, 2024

Study Completion

October 17, 2024

Last Updated

December 27, 2024

Record last verified: 2024-12

Locations