- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06794411
Promotion of Healthy Eating Habits and Physical Activity Among Children and Their Families. (ALIAFF)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Barcelona
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Vic, Barcelona, Spain, 08500
- Social Services of the Regional Council of Osona
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Intervention group
Food habits and physical activity program.
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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:
Other Names:
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Other: Control group
Usual care.
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They will be evaluated on baseline, final and follow up, and they will recieved basic nutritional and physical activity information.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Atitude towards healthy food habits and physical activity
Time Frame: Baseline (before study started) 5 weeks 8 weeks (through study completion)
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Lima-Serrano et al. (2012) questionnaire: 18 ítems.
5 point Likert scale where 1 is totally disagree and 5 is totally agree.
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Baseline (before study started) 5 weeks 8 weeks (through study completion)
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Physical activity practice
Time Frame: Baseline (before study started), up to 5 weeks (through study completion)
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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.
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Baseline (before study started), up to 5 weeks (through study completion)
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Adults adherence to the Mediterranean diet
Time Frame: Baseline (before study started), up to 5 weeks (through study completion)
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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.
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Baseline (before study started), up to 5 weeks (through study completion)
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Child adherence to the Mediterranean diet
Time Frame: Baseline (before study started), up to 5 weeks (through study completion)
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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. |
Baseline (before study started), up to 5 weeks (through study completion)
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Nutrition literacy
Time Frame: Baseline (before study started), up to 5 weeks (through study completion)
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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.
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Baseline (before study started), up to 5 weeks (through study completion)
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Physical activity literacy
Time Frame: Baseline (before study started), up to 5 weeks (through study completion)
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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.
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Baseline (before study started), up to 5 weeks (through study completion)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Socio-demographic
Time Frame: Baseline
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Sex/Gender (female, male, non binary) Age (month and year of birth) Country of birth (name) Education status
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Baseline
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Food allergies
Time Frame: Baseline
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No, yes.
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Baseline
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Limitations to practice physical activity
Time Frame: Baseline
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No, yes
|
Baseline
|
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Health perception
Time Frame: Baseline (before study started), up to 5 weeks (through study completion)
|
Visual analog scale, EuroQol (EQ-SD) were 0 means the worst health you can imagine, and 100 the best health you can imagine.
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Baseline (before study started), up to 5 weeks (through study completion)
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Cristina V Vaque Crusellas, Doctrate, University of Vic-University Central of Catalonia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 24/092
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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