Obesity & OverweightBambúNCT07529704
Evaluation of a Multicomponent Early Intervention for Childhood Obesity Prevention in Vulnerable Families
A study testing Bambú program in people with Obesity & Overweight and Vulnerable Families, run by Helena Vall Roqué at 4 sites in Spain.
Trial summary
Childhood obesity is a public health concern. Evidence-based, multicomponent, parenting interventions targeting early childhood and adapted to families' socioeconomic context are needed to prevent childhood obesity. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Obesity & Overweight, Vulnerable Families, Children
- What is being tested?
- Bambú program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 526 participants
- Where
- 4 sitesSpain
- Study dates
- 2 Mar 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mothers and/or fathers aged 18 years or older.
- Primary caregivers of a healthy child aged 6 months to 3 years, born at term (≥37 weeks of gestation).
- At least one parent with overweight or obesity (as defined by BMI criteria).
- Families in a situation of vulnerability, defined as meeting ≥1 of the following criteria: (1) Low educational level of at least one parent (≤ lower secondary education or equivalent); (2) Precarious employment situation during the past year, (3) Perceived financial difficulties during the past year; (4) Insecure or unstable housing conditions; (5) Single-parent family or prolonged absence of one of the primary caregivers; (6) Recent immigration (≤10 years) without a stable support network or with language barriers.
Who cannot join
- Parents of a child aged 6 months to 3 years with low birth weight (<2500 g)
- Parents of a child aged 6 months to 3 years from a multiple birth (e.g., twins, triplets)
- Parents/caregivers of a child aged 6 months to 3 years with congenital conditions, chronic diseases, or severe disabilities that may affect feeding, growth, or participation in the study
- Parents or caregivers with severe physical or mental health conditions that would limit their ability to participate in the intervention or assessments
- Families planning to move out of the study area during the study period
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nuria Hidalgo contact
Spain4 sites, 4 recruiting
- Recruiting
Fundación Avedis Donabedian Para la Mejora de la Calidad Asistencial
Barcelona, Catalonia, 08037
Helena Vall Roqué, PhD, +34 932076608, hvall@fadq.org
Carola Orrego, PhD, +34 932076608, corrego@fadq.org
- Not yet recruiting
Gerencia de Atención Primaria de Burgos
Burgos, Castille and León, 09006
Noelia Gallego-Ausín, 34947240013 ext. 33794, ngallego@saludcastillayleon.es
- Recruiting
Atenció Primària de Mallorca
Palma de Mallorca, 07002
Joana Ripoll Amengual, +34626748937, joana.ripoll@ibsalut.es
- Recruiting
Servicio Andaluz de Salud
Seville, 41008
Rosario Vigo Ortega, +34955016700, rosario.vigo.sspa@juntadeandalucia.es
About this study
Official title: Evaluation of a Tailored Multicomponent Early Intervention for Childhood Obesity Prevention in Vulnerable Families (Bambú Project): Randomized Controlled Trial With a Hybrid Type 1 Effectiveness-implementation Design
Childhood obesity is a public health concern. Evidence-based, multicomponent, parenting interventions targeting early childhood and adapted to families' socioeconomic context are needed to prevent childhood obesity.
This study aims to evaluate the effectiveness of an early intervention in primary care for the prevention of childhood obesity, targeting vulnerable families where the mother and/or the father has overweight or obesity.
Read more
More specifically, the primary aim of this study is to evaluate the effectiveness the intervention to maintain a healthy weight in children aged 6 months to 3 years, measured by the BMI-for-age z-score at baseline, 6, 12, and 18 months, compared to usual care.
The study also aims to evaluate the effectiveness of the intervention, compared to usual care, for: promoting responsive feeding, improving dietary intake, improving parents' and children's physical activity levels, improving parents' eating styles, and improving children's sleep.
Finally, the study aims to determine the feasibility of implementing the intervention, and to identify factors influencing change and contextual factors in the implementation process.
A pragmatic cluster randomized controlled trial will be conducted. Approximately 526 families (parent-child family dyads) will be recruited, belonging to approximately 76 primary care centers. Primary care centers will be randomly assigned to either an intervention or control group.
The intervention has been previously co-designed with families and healthcare professionals, and consists of five weekly sessions and four monthly sessions, lasting two hours each. It will be delivered by previously trained healthcare professionals or by members of the research team, depending on the preferences and availability of the primary care center professionals. Approximately 38 intervention face-to-face groups will be conducted, one in each primary care center allocated to the intervention group.
The study will be conducted in Catalonia, Andalusia, the Balearic Islands and Castile and León (Spain).
Effectiveness outcomes include child body mass index (BMI) z-score, parent feeding practices (measured with the Feeding Practices and Structure Questionnaire), child dietary intake (measured with the multiple-pass 24-hour recall), parents' eating behaviours (measured with the Dutch Eating Behavior Questionnaire), child movement (measured with the Movement Behavior Questionnaire), parents' movement behaviours (measured with the Brief Physical Activity Assessment Tool), and child sleep (measured with selected items from the Brief Infant Sleep Questionnaire).
Implementation and feasibility outcomes will be assessed through interviews during and at the end of the intervention, and through attendance sheets and a final satisfaction questionnaire.
This study will provide pioneering insights into the implementation and effectiveness of this intervention within the public healthcare system in Spain. This will allow the potential implementation in the future at a larger scale.
- Being tested
- Bambú program
- Keywords
- Pediatric obesity, Prevention, Vulnerable populations, Randomized controlled trial, Primary health care, Early intervention, Parenting interventions
- Medical subject headings
- Obesity, Overweight, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bambú programBehavioural
The Bambú program is a face-to-face 9-session group-based intervention for parents of children aged 6 months - 3.11 years, where at least one parent has overweight or obesity. Sessions last 2 hours. The first five sessions are delivered weekly and the other four sessions are delivered monthly. Sessions are led by two trained co-leaders (training includes two online sessions and access to a virtual platform with all intervention materials).
The program covers six main topics: (1) nutrition: feeding practices and dietary recommendations; (2) physical activity and interactive play; (3) emotion regulation skills and techniques; (4) positive parenting; (5) child sleep; and (6) community support networks.
The intervention is structured and includes video visualization and interactive activities.
The program has been previously co-designed with families and healthcare professionals aiming to target it to the needs and preferences of vulnerable families with overweight or obesity.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (Bambú program) | Experimental | This arm will include all primary care centers assigned to the intervention group.
All participants (parents) within these centers will receive the Bambú intervention.
They will participate in a 9-session group-based face-to-face intervention. Sessions will last 2 hours. The first 5 sessions will be delivered weekly and the following 4 sessions will be delivered monthly. They will be delivered at primary care centers in Catalonia, Andalusia, the Balearic Islands and Castile and León. They will be led by two professionals, either healthcare professionals working at the primary care center (who will be previously trained) or by members of the research team.
The following main topics will be covered in the program: (1) nutrition; (2) physical activity and interactive play; (3) emotion regulation; (4) positive parenting; (5) child sleep; and (6) community support networks.
Approximately 38 groups will be conducted, and each of them will include around 7 families. Receives: Behavioral: Bambú program |
| Control group | No intervention | The control group will not receive the intervention. Families who are assigned to the control group will receive their usual care. No restrictions will be placed on families or primary care centers regarding access to other training and support services during the course of the study, but this information will be monitored as a potential confounder. Primary care centers who are assigned to the intervention group will be asked not to share the intervention contents with other centers who are in the control group before the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline to post-intervention and each follow-up in Body Mass Index (BMI) z-score
The BMI z-scored will be measured using the WHO Child Growth Standards. "At risk for overweight," "overweight," and "childhood obesity" for children under five are defined as BMI z-scores >1 and ≤2, >2 and ≤3, or >3 standard deviations above the median established by WHO growth standards, respectively.
Measured: Measured to the intervention and control group at baseline (prior to program initiation) and after the intervention (at 6, 12 and 18 months after baseline)
Secondary outcomes (10)
Changes from baseline to post-intervention and each follow-up in child dietary intake
Child dietary intake will be measured using the multiple-pass 24-hour recall, which is a brief interview that will be conducted by healthcare professionals who participate in the project.
Measured: Administered to the intervention and control group at baseline (prior to program initiation) and after the intervention (at 6, 12 and 18 months after baseline)
Changes from baseline to post-intervention and each follow-up in the Feeding Practices and Structure Questionnaire (FPSQ)
The Feeding Practices and Structure Questionnaire is a self-administered questionnaire that measures parental feeding practices, specifically maternal responsiveness to children's hunger/satiety signals facilitated by routine and structure in feeding.
Age- and feeding-stage-appropriate versions of the questionnaire will be administered: (a) the specific FPSQ-28 version for children aged ≥2 years; and (b) the FPSQ version for children aged <2 years, either the FPSQ milk-feeding version (for caregivers predominantly feeding their child with milk) or the FPSQ (semi-)solids version (for caregivers predominantly feeding their child with solid food.
Each subscale is scored separately (range 1-5). No overall total score is calculated. Higher scores indicate greater endorsement of the feeding practice represented by the subscale.
Measured: Administered to the intervention and control group at baseline (prior to program initiation) and after the intervention (at 6, 12 and 18 months after baseline)
Changes from baseline to post-intervention and each follow-up in the Movement Behavior Questionnaire (MBQ)
The Movement Behavior Questionnaire is a self-administered questionnaire that measures physical activity, screen time and sleep in infants, toddlers and preschoolers.
The two age-specific versions of the questionnaire will be used: the MBQ-Baby (MBQ-B) for infants who have not yet reached the walking milestone, and the MBQ-Child (MBQ-C) for children who are able to walk. The closed-ended versions of the MBQ will be used.
The questionnaire does not produce a total score. It assesses individual movement behaviours (e.g., tummy time, physical activity, screen time, restrained time, sleep duration). Interpretation depends on the behaviour measured and its alignment with age-specific movement guidelines.
Measured: Administered to the intervention and control group at baseline (prior to program initiation) and after the intervention (at 6, 12 and 18 months after baseline)
Changes from baseline to post-intervention and each follow-up in Brief Physical Activity Assessment Tool (BPAAT)
The Brief Physical Activity Assessment Tool is a self-administered 2-item questionnaire to identify "inactive" patients in primary care settings. Responses to the two items are combined into a total score ranging from 0 to 8. Higher scores indicate a better outcome, reflecting higher levels of physical activity and adherence to recommended activity guidelines.
Measured: Administered to the intervention and control group at baseline (prior to program initiation) and after the intervention (at 6, 12 and 18 months after baseline)
Changes from baseline to post-intervention and each follow-up in the Dutch Eating Behavior Questionnaire (DEBQ)
Parents' eating patterns will be measured with the self-administered Dutch Eating Behavior Questionnaire.
The questionnaire comprises three subscales (Restrained Eating, Emotional Eating, and External Eating), each scored separately by averaging item responses (range 1-5). No overall total score is calculated. Higher scores indicate greater endorsement of the eating behaviour measured by each subscale; the interpretation of whether this represents a more or less desirable outcome depends on the subscale.
Measured: Administered to the intervention and control group at baseline (prior to program initiation) and after the intervention (at 6, 12 and 18 months after baseline)
Changes from baseline to post-intervention and each follow-up in infant sleep
Selected items (applicable to the whole children's age range included in the study) from the Brief Infant Sleep Questionnaire (BISQ) will be used to measure child sleep.
The complete BISQ will not be administered because the original questionnaire is not appropriate for the full age range of the study population. Sleep parameters derived from selected BISQ items will be analyzed individually. No total sleep score will be calculated; therefore, there is no overall minimum or maximum score. The direction of interpretation depends on the specific sleep parameter assessed (e.g., longer sleep duration is generally considered favorable, whereas more frequent night awakenings or longer nocturnal wakefulness may indicate poorer sleep).
Measured: Administered to the intervention and control group at baseline (prior to program initiation) and after the intervention (at 6, 12 and 18 months after baseline)
Percentage of parents engaging with and finishing the program
Parents' attendance will be recorded after each session using attendance sheets. These data will be used to calculate overall compliance and engagement across the full intervention period.
Measured: Through intervention completion (9 sessions, approximately 6 months)
Parents' acceptability and satisfaction with the program (evaluated with a Final Participant Satisfaction Questionnaire)
Parents' acceptability and satisfaction with the program will be assessed with a Final Participant Satisfaction Questionnaire. Data will be collected after the last session of the intervention.
Higher scores indicate greater acceptability and satisfaction with the intervention.
Measured: Administered to the intervention group at intervention completion (approximately 6 months after baseline)
Group leaders' fidelity with the program (evaluated with the Leader Checklist)
Fidelity with the program will be assessed after each session using the Leader Checklist completed by group leaders. Fidelity will be summarized across all sessions to evaluate adherence to the intervention protocol.
Measured: Through intervention completion (9 sessions, approximately 6 months)
Parents' and group leaders' overall experiences with the program (evaluated with individual interviews and focus groups)
Semi-structured individual interviews and focus groups will be conducted with parents and group leaders during the intervention and after the final session to explore barriers and facilitators, as well as acceptability, adoption, appropriateness, feasibility, penetration, and sustainability of the intervention.
Measured: Through intervention completion (approximately 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start2 Mar 2026
- Primary completionJun 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obesity & OverweightStudies 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
- Parallel groups
- Model description
- This is a cluster randomized controlled trial in which primary care centers (clusters) are randomized to intervention or control arms, and outcomes are measured at the individual participant level.
- Masking
- None (open label)
- Enrolment
- 526 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helena Vall Roqué
- Sponsor type
- University, hospital or other
- Collaborators
- Loyola University, Andalusian Health Service, Hospital Costa del Sol, Hospital Universitari Son Espases (Palma de Mallorca. Spain), Primary Care Research Unit of Mallorca, Balearic Islands Health Service, Palma, Research Group on Primary Care and Promotion of the Balearic Islands Community (Grapp-CAIB), Health Research Institute of the Balearic Islands (IdISBa), Palma, General Directorate of Public Health, Balearic Island, Palma, Public health research group of the Balearic Islands (GISPIB), Universidad de Burgos, Instituto de Investigación Biosanitaria de Burgos (IBioBurgos), Gerencia de Atención Primaria de Burgos
- Responsible party
- Sponsor-investigator, Helena Vall Roqué, Avedis Donabedian Research Institute
- Investigators
- Carola Orrego, PhD, Principal investigator, Avedis Donabedian Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529704
- Sponsor's protocol ID
- PI24/01033
- Other IDs
- 24/291-P
- Acronym
- Bambú
- Status last verified
- Aug 2026
- First submitted
- 31 Mar 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Epstein LH, Wilfley DE, Kilanowski C, Quattrin T, Cook SR, Eneli IU, Geller N, Lew D, Wallendorf M, Dore P, Paluch RA, Schechtman KB. Family-Based Behavioral Treatment for Childhood Obesity Implemented in Pediatric Primary Care: A Randomized Clinical Trial. JAMA. 2023 Jun 13;329(22):1947-1956. doi: 10.1001/jama.2023.8061.
PubMed 37314275Guerra Toro HI, Jaramillo AP, Caceres VM. Family-Based Interventions for Pediatric Obesity: A Comprehensive Systematic Review and Meta-Analysis of Their Effectiveness. Cureus. 2024 Aug 1;16(8):e65919. doi: 10.7759/cureus.65919. eCollection 2024 Aug.
PubMed 39221382Ciampa PJ, Kumar D, Barkin SL, Sanders LM, Yin HS, Perrin EM, Rothman RL. Interventions aimed at decreasing obesity in children younger than 2 years: a systematic review. Arch Pediatr Adolesc Med. 2010 Dec;164(12):1098-104. doi: 10.1001/archpediatrics.2010.232.
PubMed 21135337Blake-Lamb TL, Locks LM, Perkins ME, Woo Baidal JA, Cheng ER, Taveras EM. Interventions for Childhood Obesity in the First 1,000 Days A Systematic Review. Am J Prev Med. 2016 Jun;50(6):780-789. doi: 10.1016/j.amepre.2015.11.010. Epub 2016 Feb 22.
PubMed 26916260
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Tailored Multicomponent Early Intervention for Childhood Obesity Prevention in Vulnerable Families (Bambú Project): Randomized Controlled Trial With a Hybrid Type 1 Effectiveness-implementation Design
- ClinicalTrials.gov ID
- NCT07529704
- Acronym / sponsor ID
- Bambú / PI24/01033
- Keywords
- Pediatric obesity, Prevention, Vulnerable populations, Randomized controlled trial, Primary health care, Early intervention, Parenting interventions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 526 participants (estimated)
- Lead sponsor
- Helena Vall RoquéUniversity, hospital or other
- Collaborators
- Loyola University, Andalusian Health Service, Hospital Costa del Sol, Hospital Universitari Son Espases (Palma de Mallorca. Spain), Primary Care Research Unit of Mallorca, Balearic Islands Health Service, Palma, Research Group on Primary Care and Promotion of the Balearic Islands Community (Grapp-CAIB), Health Research Institute of the Balearic Islands (IdISBa), Palma, General Directorate of Public Health, Balearic Island, Palma, Public health research group of the Balearic Islands (GISPIB), Universidad de Burgos, Instituto de Investigación Biosanitaria de Burgos (IBioBurgos), Gerencia de Atención Primaria de Burgos
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 14 Apr 2026 (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.
Childhood obesity is a public health concern. Evidence-based, multicomponent, parenting interventions targeting early childhood and adapted to families' socioeconomic context are needed to prevent childhood obesity.
This study aims to evaluate the effectiveness of an early intervention in primary care for the prevention of childhood obesity, targeting vulnerable families where the mother and/or the father has overweight or obesity.
More specifically, the primary aim of this study is to evaluate the effectiveness the intervention to maintain a healthy weight in children aged 6 months to 3 years, measured by the BMI-for-age z-score at baseline, 6, 12, and 18 months, compared to usual care.
The study also aims to evaluate the effectiveness of the intervention, compared to usual care, for: promoting responsive feeding, improving dietary intake, improving parents' and children's physical activity levels, improving parents' eating styles, and improving children's sleep.
Finally, the study aims to determine the feasibility of implementing the intervention, and to identify factors influencing change and contextual factors in the implementation process.
A pragmatic cluster randomized controlled trial will be conducted. Approximately 526 families (parent-child family dyads) will be recruited, belonging to approximately 76 primary care centers. Primary care centers will be randomly assigned to either an intervention or control group.
The intervention has been previously co-designed with families and healthcare professionals, and consists of five weekly sessions and four monthly sessions, lasting two hours each. It will be delivered by previously trained healthcare professionals or by members of the research team, depending on the preferences and availability of the primary care center professionals. Approximately 38 intervention face-to-face groups will be conducted, one in each primary care center allocated to the intervention group.
The study will be conducted in Catalonia, Andalusia, the Balearic Islands and Castile and León (Spain).
Effectiveness outcomes include child body mass index (BMI) z-score, parent feeding practices (measured with the Feeding Practices and Structure Questionnaire), child dietary intake (measured with the multiple-pass 24-hour recall), parents' eating behaviours (measured with the Dutch Eating Behavior Questionnaire), child movement (measured with the Movement Behavior Questionnaire), parents' movement behaviours (measured with the Brief Physical Activity Assessment Tool), and child sleep (measured with selected items from the Brief Infant Sleep Questionnaire).
Implementation and feasibility outcomes will be assessed through interviews during and at the end of the intervention, and through attendance sheets and a final satisfaction questionnaire.
This study will provide pioneering insights into the implementation and effectiveness of this intervention within the public healthcare system in Spain. This will allow the potential implementation in the future at a larger scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a cluster randomized controlled trial in which primary care centers (clusters) are randomized to intervention or control arms, and outcomes are measured at the individual participant level.
| Arm | Type | Receives |
|---|---|---|
| Intervention group (Bambú program) | Experimental | Behavioral: Bambú programThis arm will include all primary care centers assigned to the intervention group. All participants (parents) within these centers will receive the Bambú intervention. They will participate in a 9-session group-based face-to-face intervention. Sessions will last 2 hours. The first 5 sessions will be delivered weekly and the following 4 sessions will be delivered monthly. They will be delivered at primary care centers in Catalonia, Andalusia, the Balearic Islands and Castile and León. They will be led by two professionals, either healthcare professionals working at the primary care center (who will be previously trained) or by members of the research team. The following main topics will be covered in the program: (1) nutrition; (2) physical activity and interactive play; (3) emotion regulation; (4) positive parenting; (5) child sleep; and (6) community support networks. Approximately 38 groups will be conducted, and each of them will include around 7 families. |
| Control group | No intervention | –The control group will not receive the intervention. Families who are assigned to the control group will receive their usual care. No restrictions will be placed on families or primary care centers regarding access to other training and support services during the course of the study, but this information will be monitored as a potential confounder. Primary care centers who are assigned to the intervention group will be asked not to share the intervention contents with other centers who are in the control group before the end of the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Mothers and/or fathers aged 18 years or older.
- Primary caregivers of a healthy child aged 6 months to 3 years, born at term (≥37 weeks of gestation).
- At least one parent with overweight or obesity (as defined by BMI criteria).
- Families in a situation of vulnerability, defined as meeting ≥1 of the following criteria: (1) Low educational level of at least one parent (≤ lower secondary education or equivalent); (2) Precarious employment situation during the past year, (3) Perceived financial difficulties during the past year; (4) Insecure or unstable housing conditions; (5) Single-parent family or prolonged absence of one of the primary caregivers; (6) Recent immigration (≤10 years) without a stable support network or with language barriers.
Key exclusion criteria (5 listed)
- Parents of a child aged 6 months to 3 years with low birth weight (<2500 g)
- Parents of a child aged 6 months to 3 years from a multiple birth (e.g., twins, triplets)
- Parents/caregivers of a child aged 6 months to 3 years with congenital conditions, chronic diseases, or severe disabilities that may affect feeding, growth, or participation in the study
- Parents or caregivers with severe physical or mental health conditions that would limit their ability to participate in the intervention or assessments
- Families planning to move out of the study area during the study period
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 |
|---|---|---|
| Bambú programThe Bambú program is a face-to-face 9-session group-based intervention for parents of children aged 6 months - 3.11 years, where at least one parent has overweight or obesity. Sessions last 2 hours. The first five sessions are delivered weekly and the other four sessions are delivered monthly. Sessions are led by two trained co-leaders (training includes two online sessions and access to a virtual platform with all intervention materials). The program covers six main topics: (1) nutrition: feeding practices and dietary recommendations; (2) physical activity and interactive play; (3) emotion regulation skills and techniques; (4) positive parenting; (5) child sleep; and (6) community support networks. The intervention is structured and includes video visualization and interactive activities. The program has been previously co-designed with families and healthcare professionals aiming to target it to the needs and preferences of vulnerable families with overweight or obesity. | Behavioural | Intervention group (Bambú program) |
Primary outcome
Changes from baseline to post-intervention and each follow-up in Body Mass Index (BMI) z-score
Time frame: Measured to the intervention and control group at baseline (prior to program initiation) and after the intervention (at 6, 12 and 18 months after baseline)
The BMI z-scored will be measured using the WHO Child Growth Standards. "At risk for overweight," "overweight," and "childhood obesity" for children under five are defined as BMI z-scores >1 and ≤2, >2 and ≤3, or >3 standard deviations above the median established by WHO growth standards, respectively.
10 secondary outcomes
Changes from baseline to post-intervention and each follow-up in child dietary intake
Time frame: Administered to the intervention and control group at baseline (prior to program initiation) and after the intervention (at 6, 12 and 18 months after baseline)
Changes from baseline to post-intervention and each follow-up in the Feeding Practices and Structure Questionnaire (FPSQ)
Time frame: Administered to the intervention and control group at baseline (prior to program initiation) and after the intervention (at 6, 12 and 18 months after baseline)
Changes from baseline to post-intervention and each follow-up in the Movement Behavior Questionnaire (MBQ)
Time frame: Administered to the intervention and control group at baseline (prior to program initiation) and after the intervention (at 6, 12 and 18 months after baseline)
Changes from baseline to post-intervention and each follow-up in Brief Physical Activity Assessment Tool (BPAAT)
Time frame: Administered to the intervention and control group at baseline (prior to program initiation) and after the intervention (at 6, 12 and 18 months after baseline)
Changes from baseline to post-intervention and each follow-up in the Dutch Eating Behavior Questionnaire (DEBQ)
Time frame: Administered to the intervention and control group at baseline (prior to program initiation) and after the intervention (at 6, 12 and 18 months after baseline)
Changes from baseline to post-intervention and each follow-up in infant sleep
Time frame: Administered to the intervention and control group at baseline (prior to program initiation) and after the intervention (at 6, 12 and 18 months after baseline)
Percentage of parents engaging with and finishing the program
Time frame: Through intervention completion (9 sessions, approximately 6 months)
Parents' acceptability and satisfaction with the program (evaluated with a Final Participant Satisfaction Questionnaire)
Time frame: Administered to the intervention group at intervention completion (approximately 6 months after baseline)
Group leaders' fidelity with the program (evaluated with the Leader Checklist)
Time frame: Through intervention completion (9 sessions, approximately 6 months)
Parents' and group leaders' overall experiences with the program (evaluated with individual interviews and focus groups)
Time frame: Through intervention completion (approximately 6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Background: PubMed 37314275Epstein LH, Wilfley DE, Kilanowski C, Quattrin T, Cook SR, Eneli IU, Geller N, Lew D, Wallendorf M, Dore P, Paluch RA, Schechtman KB. Family-Based Behavioral Treatment for Childhood Obesity Implemented in Pediatric Primary Care: A Randomized Clinical Trial. JAMA. 2023 Jun 13;329(22):1947-1956. doi: 10.1001/jama.2023.8061.
- Background: PubMed 39221382Guerra Toro HI, Jaramillo AP, Caceres VM. Family-Based Interventions for Pediatric Obesity: A Comprehensive Systematic Review and Meta-Analysis of Their Effectiveness. Cureus. 2024 Aug 1;16(8):e65919. doi: 10.7759/cureus.65919. eCollection 2024 Aug.
- Background: PubMed 21135337Ciampa PJ, Kumar D, Barkin SL, Sanders LM, Yin HS, Perrin EM, Rothman RL. Interventions aimed at decreasing obesity in children younger than 2 years: a systematic review. Arch Pediatr Adolesc Med. 2010 Dec;164(12):1098-104. doi: 10.1001/archpediatrics.2010.232.
- Background: PubMed 26916260Blake-Lamb TL, Locks LM, Perkins ME, Woo Baidal JA, Cheng ER, Taveras EM. Interventions for Childhood Obesity in the First 1,000 Days A Systematic Review. Am J Prev Med. 2016 Jun;50(6):780-789. doi: 10.1016/j.amepre.2015.11.010. Epub 2016 Feb 22.
- Website of the projectLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Obesity & Overweight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Nuria Hidalgo contact
Carola Orrego, PhD principal investigator
Avedis Donabedian Research Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bambú program in people with Obesity & Overweight and Vulnerable Families, run by Helena Vall Roqué at 4 sites 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helena Vall Roqué, PhD (+34932076608, hvall@fadq.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline to post-intervention and each follow-up in Body Mass Index (BMI) z-score (time frame: Measured to the intervention and control group at baseline (prior to program initiation) and after the intervention (at 6, 12 and 18 months after baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07529704, which also lists 4 linked publications.
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 5 Aug 2026.