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临床试验/NCT05539222
NCT05539222已完成不适用

The Effect of Food Vouchers and an Educational Intervention on Promoting Healthy Eating in Vulnerable Groups. A Pilot Study

Universidad de Zaragoza2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2021年10月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
2
主要终点
Adherence Mediterranean diet

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
3 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Adults with severe illness or cognitive impairment were excluded from the study.

结局指标

主要结局

Adherence Mediterranean diet

时间窗: 10-week

To determine the degree of adherence to the Mediterranean diet, a specific short questionnaire of fourteen items validated for the Spanish population and used by the Prevention with Mediterranean Diet (PREDIMED) group was used. To obtain the score, a value of +1 is assigned to each of the items with a positive connotation with re-spect to DM and -1 when the items have a negative connotation. In adults, from the sum of the values obtained in the 14 items, the degree of adherence is determined, establishing two levels, so that if the total score is greater than or equal to nine, it is a diet with a good level of adherence, and if the total sum is less than nine, the diet has a low level of adherence. In children, the questionnaire consist of 16 questions and two possible answer options (yes/no), with 12 positive and 4 negative questions. The levels of adherence to the Mediterranean diet were classified into three groups: poor (0-3), average (4-7) and good (8-12).

Diet quality (using NOVA classification)

时间窗: 3 months

For the analysis of the products purchased by the family unit, the NOVA food classification was used. This classification groups products according to their degree of manufacture so that Group 1 are those products that are unprocessed or minimally processed; Group 2 are culinary processed products or food industry ingredients (oil, sugar, honey, salt, butter); Group 3 are products processed from Group 1 foods, such as canned vegetables, nuts with salt or fish preserved in oil or water; and Group 4 are ultra-processed products \[23\]. The rationale and details on each NOVA food group have been described elsewhere \[24\]. Two investigators classified each food item according to the NOVA classification criteria, and for some items with discrepant classification, they were resolved by discussion. Non-food items (e.g. cleaning products and other products that were purchased with the non-food voucher) were classified as "Others".

次要结局

  • Height(10-week)
  • Glycated hemoglobin A1c (HbA1c)(10-week)
  • Weight(10-week)
  • High-density lipoprotein cholesterol (HDL-C)(10-week)
  • Uric acid(10-week)
  • Blood urea nitrogen (BUN)(10-week)
  • Gamma-glutamyl transferase (GGT)(10-week)
  • Triglycerides(10-week)
  • Total cholesterol (TC)(10-week)
  • Blood pressure(10-week)
  • ALP (Alkaline phosphatase)(10-week)
  • ALT (alanine transaminase)(10-week)
  • AST (aspartate aminotransferase)(10-week)
  • Low-density lipoprotein cholesterol (LDL-C)),(10-week)
  • Fasting glucose(10-week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

María Isabel Iguacel Azorín

Associate Professor

Universidad de Zaragoza

研究点 (2)

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