FamiliesALIAFFNCT06794411
Promotion of Healthy Eating Habits and Physical Activity Among Children and Their Families.
A study testing Intervention group: Food habits and physical activity program in people with Families and Children, run by University of Vic - Central University of Catalonia at 1 site in Spain.
Trial summary
Eating habits and physical activity are key determinants of individual health. The family plays a relevant role in educating children about healthy lifestyles. In the Moroccan community, women are the reference for aspects related to family care. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Families, Children, Food Habits
- What is being tested?
- Intervention group: Food habits and physical activity program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSpain
- Study dates
- 23 Dec 2024to 3 Mar 2025
- 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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 9-12, along with their reference adult linked to the CCO's SIS (using the RUMI social diagnosis tool).
- Low adherence to the Mediterranean diet and/or low physical activity levels in either the child or the reference adult.
- For children <3 points of KIDMED indicate a low level of adherence to the Mediterranean diet.
- For adults <5 points of MEDAS indicate low adherence to the Mediterranean diet.
- Through IPAQ fewer than three days of vigorous physical activity, five days of moderate physical activity, or walking less than 30 minutes per day are considered low physical activity levels.
- Having an interest in participating in a group program.
- Ability to independently reach the municipal centre.
Who cannot join
- Basic diagnosis of a serious intellectual developmental disorder that could make it impossible to follow the proposed sessions.
- Clinical contraindications for the practice of physical activity.
- Following a medically established dietary guideline that is incompatible with the Mediterranean diet.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Social Services of the Regional Council of Osona
Vic, Barcelona, 08500
About this study
Official title: Co-design, Implementation, and Evaluation of a Program to Promote Healthy Eating and Physical Activity Among Families in Situations of Social Vulnerability Linked to the Socio-educational Intervention Services of the Osona County Council.
Eating habits and physical activity are key determinants of individual health. The family plays a relevant role in educating children about healthy lifestyles. In the Moroccan community, women are the reference for aspects related to family care. The main aim of this study is to evaluate the effect of the ALIAFF program on awareness and promotion of healthy eating and the practice of regular physical activity in families with a situation of social vulnerability linked to the socio-educational intervention services of the Osona County Council (CCO).
Children aged 9-12 years, along with their reference adult linked to the CCO's Socio-educational Intervention Services (SIS) with low adherence to the Mediterranean diet and/or low physical activity levels, with an interest to participate in the program who are able to independently reach the municipal centre.
The study involves participating in an initial meeting to co-create and culturally adapt the program. Following this, selected participants will complete the initial data collection with the help of a mediator of Moroccan origin. The intervention group will participate in five nutrition and physical activity sessions of 1.5 hours. After the intervention, both the control and the intervention group will participate in the final evaluation, which will also be repeated after two months to assess the longer-term impact. Upon completion of the evaluation, the control group will also receive the intervention as compensation for their participation.
Read the detailed description
The intervention will start with the dissemination and recruitment phase. During this phase, the research team will provide detailed information about the project to the staff of Osona County Council (CCO) and Socio-educational Intervention Services (SIS). These staff members will then assist in identifying and inviting eligible children and one adult of their family (primarily mothers) who comply with the study's eligibility criteria. The municipal team will organize a meeting at SIS headquarters with the selected participants to facilitate extended information about the research and outline what their participation will entail. Families who agree to participate will be asked to sign the informed consent. This meeting will also serve as a collaborative space where families from both the control and the intervention groups can discuss the suitability of the proposed activities, session content, timetables, and interest dynamics of the families in order to co-create and culturally adapt the program. After that, the initial assessment will be conducted by the research team with the help of a mediator from the Moroccan community and the municipal social team through the initial data collection questionnaire (QRD). The intervention consisted of 5 dynamic face-to-face sessions of 1.5 hours will be implemented first with the intervention group. The sessions will be conducted by the researcher with the support of the social teams and a mediator of Morrocan origin in the SIS spaces of the municipality. The support material of every session will be provided to the participants and at the end of each session, small tasks will be assigned to encourage the transfer of the topics discussed during the sessions into the families' daily routines. The control group will receive the same intervention after the final evaluation as compensation for their participation in the program. At the end of the educational sessions, the final evaluation will be carried out for both groups through the final QRD. The same evaluation procedure will be repeated after two months to assess the program's impact and sustainability over time.
- Conditions
- Families, Children, Food Habits, Physical Activity
- Being tested
- Intervention group: Food habits and physical activity program, Usual Care Group
- Keywords
- intervention, Family-based intervention, health promotion, children, Nutrition and physical activity, Social Vulnerability
- Medical subject headings
- Feeding Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group: Food habits and physical activity programBehavioural
Also called Nutrition and physical activity education
5 dynamic face-to-face sessions to promote healthy eating and regular physical activity. The 5 sessions are structured based on the pedagogical approach of Seeing, Judging and Acting (Gibson, 1999; Rodríguez-Bailón, et al., 2016). This methodology provides a logical structure to achieve nutritional and physical activity self-analysis. It is applied based on 3 stages:
- 1st reflective stage: to raise awareness about the importance of following healthy eating and physical activity habits and identify to what extent families are close to the healthy recommendations in relation to these two habits (first two sessions).
- 2nd: more active stage, to acquire strategies and learn to put these recommendations into practice in their day-to-day lives (session 3th and 4th session).
- 3th: to plan specific actions to address and transform some aspects of improvement by freely assuming one's own commitment proposals with the aim of modifying the presented reality, if deemed appropriate (last session).
Usual Care GroupBehavioural
They will be evaluated on baseline, final and follow up, and they will recieved basic nutritional and physical activity information.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Food habits and physical activity program. Receives: Behavioral: Intervention group: Food habits and physical activity program |
| Control group | Other | Usual care. Receives: Behavioral: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity practice
The International Questionnaire of Physical Activity - short version (IPAQ-SF) is the short version of the IPAQ (Craig et al., 2003), validated in Spain by Roman-Viñas et al. (2010).It measures, through 7 questions, the physical activity (vigorous, moderate and light) and the sitting time, and provide data for the total minutes of physical activity per week and the amount of sitting time per day.
Measured: Baseline (before study started), up to 5 weeks (through study completion)
Adults adherence to the Mediterranean diet
Identified through a Mediterranean Diet Adherence Screener (MEDAS). Is a validated 14-item scale (Schröder et al., 2011) that assess questions related to food intake and frequency of consumption of foods that are typical and non-typical of the Mediterranean diet. The questions are dichotomous on habitual intakes of several food items. Responses that are favourable to the adoption of the Mediterranean diet score as 1 point, while response unfavourable are scored as 0. The final score ranges from 1 to 14. A score greater than 9 means high adherence to the Mediterranean diet.
Measured: Baseline (before study started), up to 5 weeks (through study completion)
Child adherence to the Mediterranean diet
The KIDMED test (Mediterranean Diet Quality Index for children and teenagers) is a tool to evaluate the adherence to the mediterranean diet for children and youths.
It was developed and validated by Serra-Majem et al. (2001). The index ranges from 0 to 12 and is based on a 16-questions test that can be self-administered or conducted by interview (pediatrician, dietitian, etc.). Questions denoting a negative connotation with respect to the MD are assigned a value of -1, and those with a positive aspect +1. The sums of the values from the administered test are classified into three levels: 1) >8, optimal Mediterranean Diet; 2) 4-7, improvement needed to adjust intake to Mediterranean patterns; 3) ≤3, very low diet quality.
Measured: Baseline (before study started), up to 5 weeks (through study completion)
Nutrition literacy
2-item about nutritional knowledge measured by: true, false, I don't know, and 2 about nutritional skills measured with 5 points Likert scale were 1 is very easy and 5 is strongly difficult.
Measured: Baseline (before study started), up to 5 weeks (through study completion)
Physical activity literacy
2-item about physical activity knowledge measured by: true, false, I don't know, and 2 about physical activity skills measured with 5 points Likert scale were 1 is very easy and 5 is strongly difficult.
Measured: Baseline (before study started), up to 5 weeks (through study completion)
Atitude towards healthy food habits and physical activity
Lima-Serrano et al. (2012) questionnaire: 18 ítems. 5 point Likert scale where 1 is totally disagree and 5 is totally agree.
Measured: Baseline (before study started) 5 weeks 8 weeks (through study completion)
Secondary outcomes (4)
Socio-demographic
Sex/Gender (female, male, non binary) Age (month and year of birth) Country of birth (name) Education status
Measured: Baseline
Food allergies
No, yes.
Measured: Baseline
Limitations to practice physical activity
No, yes
Measured: Baseline
Health perception
Visual analog scale, EuroQol (EQ-SD) were 0 means the worst health you can imagine, and 100 the best health you can imagine.
Measured: Baseline (before study started), up to 5 weeks (through study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start23 Dec 2024
- Primary completion20 Jan 2025
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FamiliesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experimental pilot study with control group, not randomized
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vic - Central University of Catalonia
- Sponsor type
- University, hospital or other
- Collaborators
- The Social Services Administration
- Responsible party
- Principal investigator, Cristina Vaqué, University of Vic - Central University of Catalonia
- Investigators
- Cristina V Vaque Crusellas, Doctrate, Principal investigator, University of Vic-University Central of Catalonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794411
- Sponsor's protocol ID
- 24/092
- Acronym
- ALIAFF
- Status last verified
- Jun 2025
- First submitted
- 11 Jan 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-design, Implementation, and Evaluation of a Program to Promote Healthy Eating and Physical Activity Among Families in Situations of Social Vulnerability Linked to the Socio-educational Intervention Services of the Osona County Council.
- ClinicalTrials.gov ID
- NCT06794411
- Acronym / sponsor ID
- ALIAFF / 24/092
- Conditions
- Families, Children, Food Habits, Physical Activity
- Keywords
- intervention, Family-based intervention, health promotion, children, Nutrition and physical activity, Social Vulnerability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of Vic - Central University of CataloniaUniversity, hospital or other
- Collaborators
- The Social Services Administration
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 27 Jan 2025 (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.
Eating habits and physical activity are key determinants of individual health. The family plays a relevant role in educating children about healthy lifestyles. In the Moroccan community, women are the reference for aspects related to family care. The main aim of this study is to evaluate the effect of the ALIAFF program on awareness and promotion of healthy eating and the practice of regular physical activity in families with a situation of social vulnerability linked to the socio-educational intervention services of the Osona County Council (CCO).
Children aged 9-12 years, along with their reference adult linked to the CCO's Socio-educational Intervention Services (SIS) with low adherence to the Mediterranean diet and/or low physical activity levels, with an interest to participate in the program who are able to independently reach the municipal centre.
The study involves participating in an initial meeting to co-create and culturally adapt the program. Following this, selected participants will complete the initial data collection with the help of a mediator of Moroccan origin. The intervention group will participate in five nutrition and physical activity sessions of 1.5 hours. After the intervention, both the control and the intervention group will participate in the final evaluation, which will also be repeated after two months to assess the longer-term impact. Upon completion of the evaluation, the control group will also receive the intervention as compensation for their participation.
Detailed description
The intervention will start with the dissemination and recruitment phase. During this phase, the research team will provide detailed information about the project to the staff of Osona County Council (CCO) and Socio-educational Intervention Services (SIS). These staff members will then assist in identifying and inviting eligible children and one adult of their family (primarily mothers) who comply with the study's eligibility criteria. The municipal team will organize a meeting at SIS headquarters with the selected participants to facilitate extended information about the research and outline what their participation will entail. Families who agree to participate will be asked to sign the informed consent. This meeting will also serve as a collaborative space where families from both the control and the intervention groups can discuss the suitability of the proposed activities, session content, timetables, and interest dynamics of the families in order to co-create and culturally adapt the program. After that, the initial assessment will be conducted by the research team with the help of a mediator from the Moroccan community and the municipal social team through the initial data collection questionnaire (QRD). The intervention consisted of 5 dynamic face-to-face sessions of 1.5 hours will be implemented first with the intervention group. The sessions will be conducted by the researcher with the support of the social teams and a mediator of Morrocan origin in the SIS spaces of the municipality. The support material of every session will be provided to the participants and at the end of each session, small tasks will be assigned to encourage the transfer of the topics discussed during the sessions into the families' daily routines. The control group will receive the same intervention after the final evaluation as compensation for their participation in the program. At the end of the educational sessions, the final evaluation will be carried out for both groups through the final QRD. The same evaluation procedure will be repeated after two months to assess the program's impact and sustainability over time.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quasi-experimental pilot study with control group, not randomized
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Behavioral: Intervention group: Food habits and physical activity programFood habits and physical activity program. |
| Control group | Other | Behavioral: Usual Care GroupUsual care. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged 9-12, along with their reference adult linked to the CCO's SIS (using the RUMI social diagnosis tool).
- Low adherence to the Mediterranean diet and/or low physical activity levels in either the child or the reference adult.
- Having an interest in participating in a group program.
- Ability to independently reach the municipal centre.
Key exclusion criteria (3 listed)
- Basic diagnosis of a serious intellectual developmental disorder that could make it impossible to follow the proposed sessions.
- Clinical contraindications for the practice of physical activity.
- Following a medically established dietary guideline that is incompatible with the Mediterranean diet.
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 |
|---|---|---|
| Intervention group: Food habits and physical activity programAlso: Nutrition and physical activity education5 dynamic face-to-face sessions to promote healthy eating and regular physical activity. The 5 sessions are structured based on the pedagogical approach of Seeing, Judging and Acting (Gibson, 1999; Rodríguez-Bailón, et al., 2016). This methodology provides a logical structure to achieve nutritional and physical activity self-analysis. It is applied based on 3 stages: * 1st reflective stage: to raise awareness about the importance of following healthy eating and physical activity habits and identify to what extent families are close to the healthy recommendations in relation to these two habits (first two sessions). * 2nd: more active stage, to acquire strategies and learn to put these recommendations into practice in their day-to-day lives (session 3th and 4th session). * 3th: to plan specific actions to address and transform some aspects of improvement by freely assuming one's own commitment proposals with the aim of modifying the presented reality, if deemed appropriate (last session). | Behavioural | Intervention group |
| Usual Care GroupThey will be evaluated on baseline, final and follow up, and they will recieved basic nutritional and physical activity information. | Behavioural | Control group |
Primary outcome
Physical activity practice
Time frame: Baseline (before study started), up to 5 weeks (through study completion)
The International Questionnaire of Physical Activity - short version (IPAQ-SF) is the short version of the IPAQ (Craig et al., 2003), validated in Spain by Roman-Viñas et al. (2010).It measures, through 7 questions, the physical activity (vigorous, moderate and light) and the sitting time, and provide data for the total minutes of physical activity per week and the amount of sitting time per day.
Adults adherence to the Mediterranean diet
Time frame: Baseline (before study started), up to 5 weeks (through study completion)
Identified through a Mediterranean Diet Adherence Screener (MEDAS). Is a validated 14-item scale (Schröder et al., 2011) that assess questions related to food intake and frequency of consumption of foods that are typical and non-typical of the Mediterranean diet. The questions are dichotomous on habitual intakes of several food items. Responses that are favourable to the adoption of the Mediterranean diet score as 1 point, while response unfavourable are scored as 0. The final score ranges from 1 to 14. A score greater than 9 means high adherence to the Mediterranean diet.
Child adherence to the Mediterranean diet
Time frame: Baseline (before study started), up to 5 weeks (through study completion)
The KIDMED test (Mediterranean Diet Quality Index for children and teenagers) is a tool to evaluate the adherence to the mediterranean diet for children and youths. It was developed and validated by Serra-Majem et al. (2001). The index ranges from 0 to 12 and is based on a 16-questions test that can be self-administered or conducted by interview (pediatrician, dietitian, etc.). Questions denoting a negative connotation with respect to the MD are assigned a value of -1, and those with a positive aspect +1. The sums of the values from the administered test are classified into three levels: 1) >8, optimal Mediterranean Diet; 2) 4-7, improvement needed to adjust intake to Mediterranean patterns; 3) ≤3, very low diet quality.
Nutrition literacy
Time frame: Baseline (before study started), up to 5 weeks (through study completion)
2-item about nutritional knowledge measured by: true, false, I don't know, and 2 about nutritional skills measured with 5 points Likert scale were 1 is very easy and 5 is strongly difficult.
Physical activity literacy
Time frame: Baseline (before study started), up to 5 weeks (through study completion)
2-item about physical activity knowledge measured by: true, false, I don't know, and 2 about physical activity skills measured with 5 points Likert scale were 1 is very easy and 5 is strongly difficult.
Atitude towards healthy food habits and physical activity
Time frame: Baseline (before study started) 5 weeks 8 weeks (through study completion)
Lima-Serrano et al. (2012) questionnaire: 18 ítems. 5 point Likert scale where 1 is totally disagree and 5 is totally agree.
4 secondary outcomes
Socio-demographic
Time frame: Baseline
Food allergies
Time frame: Baseline
Limitations to practice physical activity
Time frame: Baseline
Health perception
Time frame: Baseline (before study started), up to 5 weeks (through study completion)
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 1 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
Cristina V Vaque Crusellas, Doctrate principal investigator
University of Vic-University Central of Catalonia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group: Food habits and physical activity program in people with Families and Children, run by University of Vic - Central University of Catalonia 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?
The sponsor lists 7 inclusion and 3 exclusion criteria. 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 1 Jul 2025. 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?
Physical activity practice (time frame: Baseline (before study started), up to 5 weeks (through study completion)). The study lists 6 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 1 Jul 2025.