Clinical trial NCT06794411: Promotion of Healthy Eating Habits and Physical Activity Among Children and Their Families.
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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Families
Children
Food Habits
Physical Activity
Keywords: intervention
Family-based intervention
health promotion
children
Nutrition and physical activity
Social Vulnerability
Lead sponsor: University of Vic - Central University of Catalonia
Sponsor class: OTHER
Collaborators: name: The Social Services Administration
First posted: 2025-01-27
Enrollment: 60
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quasi-experimental pilot study with control group, not randomized
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physical activity practice
timeFrame: Baseline (before study started) 5 weeks 8 weeks (through study completion)
measure: Adults adherence to the Mediterranean diet
timeFrame: Baseline (before study started) 5 weeks 8 weeks (through study completion)
measure: Child adherence to the Mediterranean diet
timeFrame: Baseline (before study started) 5 weeks 8 weeks (through study completion)
measure: Nutrition literacy
timeFrame: Baseline (before study started) 5 weeks 8 weeks (through study completion)
measure: Physical activity literacy
timeFrame: Baseline, up to 5 weeks, and 2 months post intervention.
measure: Atitude towards healthy food habits and physical activity
timeFrame: Baseline (before study started) 5 weeks 8 weeks (through study completion)
Secondary outcomes:
measure: Socio-demographic
timeFrame: Baseline
measure: Food allergies
timeFrame: Baseline
measure: Limitations to practice physical activity
timeFrame: Baseline
measure: Health perception
timeFrame: Baseline (before study started) 5 weeks 8 weeks (through study completion)
Other outcomes:
Locations:
city: Vic
country: Spain
facility: Social Services of the Regional Council of Osona
state: Barcelona
Study officials:
affiliation: University of Vic-University Central of Catalonia
name: Cristina V Vaque Crusellas, Doctrate
role: PRINCIPAL_INVESTIGATOR
References: