Economic ProblemsNCT05539222
Food Vouchers and Educational Intervention on Promoting Healthy Eating in Vulnerable Groups.
A study testing Food vouchers and education in people with Economic Problems, run by Universidad de Zaragoza at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Economic Problems
- What is being tested?
- Food vouchers and education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 14 Oct 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Food Vouchers and an Educational Intervention on Promoting Healthy Eating in Vulnerable Groups. A Pilot Study
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.
- Conditions
- Economic Problems
- Being tested
- Food vouchers and education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food vouchers and educationOther
Intervention and control group individuals received 120 euros/month during 3 months in food vouchers to be spent in supermarkets (60 euros/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.
| Study group | Role | What they receive |
|---|---|---|
| Food voucher plus health and nutritional education | Active comparator | Intervention and control group individuals received 120 euros/month during 3 months in food vouchers to be spent in supermarkets (60 euros/month if under 12y) plus a 10-week nutrition education for the intervention group. Receives: Other: Food vouchers and education |
| Food voucher | No intervention | Intervention and control group individuals received 120 euros/month during 3 months in food vouchers to be spent in supermarkets (60 euros/month if under 12y) plus a 10-week nutrition education for the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet quality (using NOVA classification)
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".
Measured: 3 months
Adherence Mediterranean diet
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).
Measured: 10-week
Secondary outcomes (15)
Weight
Anthropometric data included body weight and height presented to the nearest 0.01 kg and 0.01 mm, respectively. Body Mass Index (BMI) was also calculated as body weight in kilograms divided by body height in meters squared (kg/m2). and categorized into underweight (if BMI<18.5), normal weight (18.5-24.9), overweight (25-29.9) and obesity (30 or greater). BMI for children and adolescents was converted to an age- and sex-specific z-score using the extended IOTF criteria. To assess weight and body composition, the TANITA MC780SMA portable beam scale was used.
Measured: 10-week
Height
Anthropometric data included body weight and height presented to the nearest 0.01 kg and 0.01 mm, respectively. Body Mass Index (BMI) was also calculated as body weight in kilograms divided by body height in meters squared (kg/m2). and categorized into underweight (if BMI<18.5), normal weight (18.5-24.9), overweight (25-29.9) and obesity (30 or greater). BMI for children and adolescents was converted to an age- and sex-specific z-score using the extended IOTF criteria. To assess weight and body composition, the TANITA MC780SMA portable beam scale was used.
Measured: 10-week
Blood pressure
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) in mmHg were measured with an automatic oscillometric device (OMRON M6). All participants were asked to sit for at least 5 min before taken the measurement. Two measurements were taken with a 2-minute interval plus a further measurement in case of a >5% difference in blood pressure between the first two readings. The average of the two (or three) measurements was used for statistical analysis.
Measured: 10-week
Uric acid
Blood samples were taken by a hematologist after 8 hours of fasting. Blood sam-ples were obtained at 9 am at pre- and post-intervention. Further, all participants were required to fast for 8 hours before extracting their blood sample. Approximately 10 mL of blood was extracted from the median antecubital vein and stored in an EDTA tube. The plasma was centrifuged for 15 minutes at 3,000 rpm at 4°C. Thereafter, the samples were stored frozen for subsequent analysis. All samples were measured directly by an automatic hematology analyzer. The laboratory carries out quality control according to standard procedures.
Measured: 10-week
Blood urea nitrogen (BUN)
Blood samples were taken by a hematologist after 8 hours of fasting. Blood sam-ples were obtained at 9 am at pre- and post-intervention. Further, all participants were required to fast for 8 hours before extracting their blood sample. Approximately 10 mL of blood was extracted from the median antecubital vein and stored in an EDTA tube. The plasma was centrifuged for 15 minutes at 3,000 rpm at 4°C. Thereafter, the samples were stored frozen for subsequent analysis. All samples were measured directly by an automatic hematology analyzer. The laboratory carries out quality control according to standard procedures.
Measured: 10-week
ALP (Alkaline phosphatase)
Blood samples were taken by a hematologist after 8 hours of fasting. Blood sam-ples were obtained at 9 am at pre- and post-intervention. Further, all participants were required to fast for 8 hours before extracting their blood sample. Approximately 10 mL of blood was extracted from the median antecubital vein and stored in an EDTA tube. The plasma was centrifuged for 15 minutes at 3,000 rpm at 4°C. Thereafter, the samples were stored frozen for subsequent analysis. All samples were measured directly by an automatic hematology analyzer. The laboratory carries out quality control according to standard procedures.
Measured: 10-week
ALT (alanine transaminase)
Blood samples were taken by a hematologist after 8 hours of fasting. Blood sam-ples were obtained at 9 am at pre- and post-intervention. Further, all participants were required to fast for 8 hours before extracting their blood sample. Approximately 10 mL of blood was extracted from the median antecubital vein and stored in an EDTA tube. The plasma was centrifuged for 15 minutes at 3,000 rpm at 4°C. Thereafter, the samples were stored frozen for subsequent analysis. All samples were measured directly by an automatic hematology analyzer. The laboratory carries out quality control according to standard procedures.
Measured: 10-week
AST (aspartate aminotransferase)
Blood samples were taken by a hematologist after 8 hours of fasting. Blood sam-ples were obtained at 9 am at pre- and post-intervention. Further, all participants were required to fast for 8 hours before extracting their blood sample. Approximately 10 mL of blood was extracted from the median antecubital vein and stored in an EDTA tube. The plasma was centrifuged for 15 minutes at 3,000 rpm at 4°C. Thereafter, the samples were stored frozen for subsequent analysis. All samples were measured directly by an automatic hematology analyzer. The laboratory carries out quality control according to standard procedures.
Measured: 10-week
Gamma-glutamyl transferase (GGT)
Blood samples were taken by a hematologist after 8 hours of fasting. Blood sam-ples were obtained at 9 am at pre- and post-intervention. Further, all participants were required to fast for 8 hours before extracting their blood sample. Approximately 10 mL of blood was extracted from the median antecubital vein and stored in an EDTA tube. The plasma was centrifuged for 15 minutes at 3,000 rpm at 4°C. Thereafter, the samples were stored frozen for subsequent analysis. All samples were measured directly by an automatic hematology analyzer. The laboratory carries out quality control according to standard procedures.
Measured: 10-week
Triglycerides
Blood samples were taken by a hematologist after 8 hours of fasting. Blood sam-ples were obtained at 9 am at pre- and post-intervention. Further, all participants were required to fast for 8 hours before extracting their blood sample. Approximately 10 mL of blood was extracted from the median antecubital vein and stored in an EDTA tube. The plasma was centrifuged for 15 minutes at 3,000 rpm at 4°C. Thereafter, the samples were stored frozen for subsequent analysis. All samples were measured directly by an automatic hematology analyzer. The laboratory carries out quality control according to standard procedures.
Measured: 10-week
Total cholesterol (TC)
Blood samples were taken by a hematologist after 8 hours of fasting. Blood sam-ples were obtained at 9 am at pre- and post-intervention. Further, all participants were required to fast for 8 hours before extracting their blood sample. Approximately 10 mL of blood was extracted from the median antecubital vein and stored in an EDTA tube. The plasma was centrifuged for 15 minutes at 3,000 rpm at 4°C. Thereafter, the samples were stored frozen for subsequent analysis. All samples were measured directly by an automatic hematology analyzer. The laboratory carries out quality control according to standard procedures.
Measured: 10-week
High-density lipoprotein cholesterol (HDL-C)
Blood samples were taken by a hematologist after 8 hours of fasting. Blood sam-ples were obtained at 9 am at pre- and post-intervention. Further, all participants were required to fast for 8 hours before extracting their blood sample. Approximately 10 mL of blood was extracted from the median antecubital vein and stored in an EDTA tube. The plasma was centrifuged for 15 minutes at 3,000 rpm at 4°C. Thereafter, the samples were stored frozen for subsequent analysis. All samples were measured directly by an automatic hematology analyzer. The laboratory carries out quality control according to standard procedures.
Measured: 10-week
Low-density lipoprotein cholesterol (LDL-C)),
Blood samples were taken by a hematologist after 8 hours of fasting. Blood sam-ples were obtained at 9 am at pre- and post-intervention. Further, all participants were required to fast for 8 hours before extracting their blood sample. Approximately 10 mL of blood was extracted from the median antecubital vein and stored in an EDTA tube. The plasma was centrifuged for 15 minutes at 3,000 rpm at 4°C. Thereafter, the samples were stored frozen for subsequent analysis. All samples were measured directly by an automatic hematology analyzer. The laboratory carries out quality control according to standard procedures.
Measured: 10-week
Fasting glucose
Blood samples were taken by a hematologist after 8 hours of fasting. Blood sam-ples were obtained at 9 am at pre- and post-intervention. Further, all participants were required to fast for 8 hours before extracting their blood sample. Approximately 10 mL of blood was extracted from the median antecubital vein and stored in an EDTA tube. The plasma was centrifuged for 15 minutes at 3,000 rpm at 4°C. Thereafter, the samples were stored frozen for subsequent analysis. All samples were measured directly by an automatic hematology analyzer. The laboratory carries out quality control according to standard procedures.
Measured: 10-week
Glycated hemoglobin A1c (HbA1c)
Blood samples were taken by a hematologist after 8 hours of fasting. Blood sam-ples were obtained at 9 am at pre- and post-intervention. Further, all participants were required to fast for 8 hours before extracting their blood sample. Approximately 10 mL of blood was extracted from the median antecubital vein and stored in an EDTA tube. The plasma was centrifuged for 15 minutes at 3,000 rpm at 4°C. Thereafter, the samples were stored frozen for subsequent analysis. All samples were measured directly by an automatic hematology analyzer. The laboratory carries out quality control according to standard procedures.
Measured: 10-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start14 Oct 2021
- Primary completion30 Mar 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Economic ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Isabel Iguacel Azorín, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539222
- Sponsor's protocol ID
- PI20/541
- Status last verified
- Sep 2022
- First submitted
- 1 Sep 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Food Vouchers and an Educational Intervention on Promoting Healthy Eating in Vulnerable Groups. A Pilot Study
- ClinicalTrials.gov ID
- NCT05539222
- Acronym / sponsor ID
- PI20/541
- Conditions
- Economic Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food voucher plus health and nutritional education | Active comparator | Other: Food vouchers and educationIntervention and control group individuals received 120 euros/month during 3 months in food vouchers to be spent in supermarkets (60 euros/month if under 12y) plus a 10-week nutrition education for the intervention group. |
| Food voucher | No intervention | –Intervention and control group individuals received 120 euros/month during 3 months in food vouchers to be spent in supermarkets (60 euros/month if under 12y) plus a 10-week nutrition education for the intervention group. |
Who may qualify
- Ages
- 3 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food vouchers and educationIntervention and control group individuals received 120 euros/month during 3 months in food vouchers to be spent in supermarkets (60 euros/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. | Other | Food voucher plus health and nutritional education |
Primary outcome
Diet quality (using NOVA classification)
Time frame: 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".
Adherence Mediterranean diet
Time frame: 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).
15 secondary outcomes
Weight
Time frame: 10-week
Height
Time frame: 10-week
Blood pressure
Time frame: 10-week
Uric acid
Time frame: 10-week
Blood urea nitrogen (BUN)
Time frame: 10-week
ALP (Alkaline phosphatase)
Time frame: 10-week
ALT (alanine transaminase)
Time frame: 10-week
AST (aspartate aminotransferase)
Time frame: 10-week
Gamma-glutamyl transferase (GGT)
Time frame: 10-week
Triglycerides
Time frame: 10-week
Total cholesterol (TC)
Time frame: 10-week
High-density lipoprotein cholesterol (HDL-C)
Time frame: 10-week
Low-density lipoprotein cholesterol (LDL-C)),
Time frame: 10-week
Fasting glucose
Time frame: 10-week
Glycated hemoglobin A1c (HbA1c)
Time frame: 10-week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food vouchers and education in people with Economic Problems, run by Universidad de Zaragoza at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet quality (using NOVA classification) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.