Clinical trial NCT05539222: Food Vouchers and Educational Intervention on Promoting Healthy Eating in Vulnerable Groups.
Official title: The Effect of Food Vouchers and an Educational Intervention on Promoting Healthy Eating in Vulnerable Groups. A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Economic Problems
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 66
Sex: ALL
Minimum age (years): 3
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Cost has been reported as the main barrier to healthy eating in vulnerable groups. We aimed to evaluate the effect of food vouchers with a nutrition education intervention on diet quality (using NOVA classification) and health. This pilot study has a randomized pre-and post-test experimental design. We included 66 vulnerable users from the Red Cross of Zaragoza (Spain). Intervention and control group individuals received 120 eu-ros/month during 3 months in food vouchers to be spent in supermarkets (60 eu-ros/month if under 12y) plus a 10-week nutrition education for the intervention group. Family food purchases were assessed using electronically recorded supermarket-obtained transactions. We found the percentage of healthy food was higher in the in-tervention group than in the control group. Once the nutrition education was over, dif-ferences between groups dissipated. Health parameters improved in the intervention group, particularly weight-status, lipid, and liver enzymes. Control participants gained weight, although lipid and liver enzymes improved. Blood pressure and HbA1c did not improve in either the intervention or the control group. In conclusion, providing unrestricted food vouchers to vulnerable groups to increase healthy food consumption and reduce the intake of ultra-processed food appears to be insufficient and should be accompanied by medium-long term education.


Eligibility criteria: Inclusion Criteria: The inclusion criteria established were children and adults between 3 and 80 years of age with at least one adult per family unit that could speak and understand Spanish, French, or English.

Exclusion Criteria: Adults with severe illness or cognitive impairment were excluded from the study.

Primary outcomes:
measure: Diet quality (using NOVA classification)
timeFrame: 3 months
measure: Adherence Mediterranean diet
timeFrame: 10-week
Secondary outcomes:
measure: Weight
timeFrame: 10-week
measure: Height
timeFrame: 10-week
measure: Blood pressure
timeFrame: 10-week
measure: Uric acid
timeFrame: 10-week
measure: Blood urea nitrogen (BUN)
timeFrame: 10-week
measure: ALP (Alkaline phosphatase)
timeFrame: 10-week
measure: ALT (alanine transaminase)
timeFrame: 10-week
measure: AST (aspartate aminotransferase)
timeFrame: 10-week
measure: Gamma-glutamyl transferase (GGT)
timeFrame: 10-week
measure: Triglycerides
timeFrame: 10-week
measure: Total cholesterol (TC)
timeFrame: 10-week
measure: High-density lipoprotein cholesterol (HDL-C)
timeFrame: 10-week
measure: Low-density lipoprotein cholesterol (LDL-C)),
timeFrame: 10-week
measure: Fasting glucose
timeFrame: 10-week
measure: Glycated hemoglobin A1c (HbA1c)
timeFrame: 10-week
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: María Isabel Iguacel Azorín
Study officials:
References: