NCT06794411

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 23, 2024

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2025

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2025

Completed
Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

28 days

First QC Date

January 11, 2025

Last Update Submit

June 26, 2025

Conditions

Keywords

interventionFamily-based interventionhealth promotionchildrenNutrition and physical activitySocial Vulnerability

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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.

    Baseline (before study started) 5 weeks 8 weeks (through study completion)

Secondary Outcomes (4)

  • Socio-demographic

    Baseline

  • Food allergies

    Baseline

  • Limitations to practice physical activity

    Baseline

  • Health perception

    Baseline (before study started), up to 5 weeks (through study completion)

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Food habits and physical activity program.

Behavioral: Intervention group: Food habits and physical activity program

Control group

OTHER

Usual care.

Behavioral: Usual Care Group

Interventions

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).

Also known as: Nutrition and physical activity education
Intervention group

They will be evaluated on baseline, final and follow up, and they will recieved basic nutritional and physical activity information.

Control group

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Social Services of the Regional Council of Osona

Vic, Barcelona, 08500, Spain

Location

MeSH Terms

Conditions

Feeding BehaviorMotor Activity

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Cristina V Vaque Crusellas, Doctrate

    University of Vic-University Central of Catalonia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Quasi-experimental pilot study with control group, not randomized
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 11, 2025

First Posted

January 27, 2025

Study Start

December 23, 2024

Primary Completion

January 20, 2025

Study Completion

March 3, 2025

Last Updated

July 1, 2025

Record last verified: 2025-06

Locations