An interventional study of Active Families and Madrid's Primary Healthcare Standardized Service portfolio in Childhood Obesity, sponsored by Gerencia de Atención Primaria, Madrid. Active, not recruiting at 1 site in Spain. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Gerencia de Atención Primaria, Madrid · Not applicable, Interventional, and Treatment
Among 40 studies in Pediatric Obesity with a site in Spain — 8 open to participants now, 16 under way, none of them phase 3. Pediatric Obesity · Spain.
Among the 40 studies in Pediatric Obesity with a site in Spain, this one is the 12th largest by planned enrollment of the 34 interventional ones that give a count, is one of 8 that started in 2022, is one of 33 with no phase, reaches primary completion later than 4 of the 15 other live ones, and was the 11th registered.
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
Browse Pediatric Obesity studies →8 of the 40 studies in Pediatric Obesity with a site in Spain are open now. Recruiting first, the newest first:
Helena Vall Roqué · Sites in Spain
Adhera Health, Inc. · Sites in Spain
Instituto de Salud Carlos III · Sites in Spain
Maimónides Biomedical Research Institute of Córdoba · Sites in Spain
Luis A. Moreno Aznar · Sites in Spain
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 124 Pediatric Obesity studies recruiting now, 19 (15%) set no upper age limit and 103 (83%) stop at 75 or younger; 114 take children under 18; 69 take healthy volunteers.
This study: 7 Years to 12 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
40 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 8 started in 2022.
This study's planned enrollment of 253 is above the median of 100 across 870 interventional studies indexed under Pediatric Obesity.
Median enrollment 170 across the 34 interventional studies, 774 across the 6 observational. Of the 21 that completed or were terminated, 1 (5%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 40 have an industry lead sponsor. The 10 most frequent:
Gerencia de Atención Primaria, Madrid is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
Gerencia de Atención Primaria, Madrid has 1 study filed under Pediatric Obesity — fewer than ten, so there is no comparison to draw.
1 of the studies in Pediatric Obesity with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07103343University of Castilla-La ManchaMOVI-OLE! [Open Learning Environments] | 2027-08-31 |
Among the 40 studies in Pediatric Obesity with a site in Spain, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Objectives. To assess the effectiveness of a programmed family/group intervention to reduce weight in the treatment of obesity in children 7 to 12 years old in front of usual treatment. Design. Cluster randomized controlled trial, multicenter. Location. Primary health care centers. Participants. Obese children 7 to 12 years old of primary health care centers. Body mass index (BMI) > P 97. Patients give Informed consent. Sampling. Randomized cluster assigned. Assignation unit: primary care center. Analysis unit. Patient (Children and childminder). Size: 280 patients (140 by group). Principal measurements Variables.BMI z score (BMI-SDS) after the 6 month intervention and after 12 -month follow-up. Secondary Measurements Variables. quality of Mediterranean diet, Brief questionnaire of physical activity in children. Brief Physical Activity Assessment Tool (BPAAT) for adults (Parents) , apgar-family questionnaire. sociocultural level., educational level, Gender. Age. BMI parents, family antecedent. Analysis: Primary effectiveness. Initial comparability of groups according to the outcome and confusion variables. Mean differences in z score of BMI with 95% confidence intervals, between groups and generation of a multivariate and multilevel model. Analysis by intention to treat.
This clinical trial aims to evaluate the effectiveness of a family intervention to reduce obesity in children. Overweight and obesity, as defined by the World Organization of Health (WHO) as abnormal or excessive fat accumulation that can be harmful to health, they are considered by this body as one of the most important public health problems of the century XXI, which is the fifth leading death risk factor in the world.
OI has been associated with high co-morbidity in adulthood. The percentile increase in body mass index (BMI) in OI increases the incidence of cases of hypertension , dyslipidemia, left ventricular hypertrophy, atherosclerosis, metabolic syndrome, type 2 diabetes, sleep disorders, as well as psychological effects, such as stigmatization, discrimination, depression and emotional trauma. Obesity in childhood also substantially increases the risk of being an obese adult. In addition, childhood obesity is an independent risk factor for obesity in adulthood. Criteria favorable to therapeutic intervention in cases of obesity are based on the demonstration that with a moderate weight loss (5-10%) can achieve a marked improvement in the associated comorbidity and quality of life even in severe obesity. The prevalence of multiple risk factors increases as the BMI percentile increases, and severe obesity is associated with an increased risk of comorbidity and resistance to sustained weight loss.
The discussion about the relevance and form of the approach to childhood obesity is an open and current issue. A 2007 Cochrane review established that there may be a benefit to behavioral treatment where parents are given responsibility for behavioral change and this is done as a family. To start the intervention, professionals with specific training in physical activity and nutrition applied in childhood, behavioral intervention techniques and promotion of healthy habits in working with families are required.
Another more recent review focused on evaluating the effectiveness of different interventions to treat childhood obesity concludes that although there is not much quality data to recommend a treatment program superior to another, the combined lifestyle and behavior interventions in Comparison with standard care or self-help can lead to a significant reduction in overweight in children and adolescents.
Another aspect to take into account is the relevance of the early intervention of obesity during childhood-adolescence, since it is at this stage that the eating habits and practice of physical exercise are consolidated, in addition to where they conform the personality characteristics of the individual.
The family intervention is proposed as one of the areas most likely to be successful in treating childhood obesity. There are several clinical trials that evaluate different interventions aimed primarily at families and show that they have beneficial effects in the promotion of healthy behaviors related to food and exercise in boys and girls, in addition to highlighting the importance of a combined dietary, behavioral and physical activity component.
The few studies carried out in the specific field of community nursing have small sample sizes and have not shown that the intervention in nursing consultation has been effective as far as weight loss is concerned. Another study comparing the effect of medical counseling and group therapy in childhood obesity concluded that cognitive behavioral therapy is more effective than medical advice and that none of the two treatment improved results compared to the untreated group. There are several limitations that could justify this result, among others the possible insufficient family involvement that is considered of vital importance.
4.2. OPERATIONAL HYPOTHESIS: The "Active Families" family intervention program decreases an average of 0.5 standard deviations plus the BMI of children with childhood obesity than the usual practice at the end of the intervention and at 6 and 12 months after the start of the intervention.
Secondary Objectives:
Design : Controlled clinical trial with randomized allocation by conglomerates, open, multicenter, 12 months follow-up, in primary care consultations. Location or scope: Health Centers of the Community of Madrid. Duration: 12 months years. Study population : Children diagnosed with obesity attended in primary care consultations of 7 to 12 years of both sexes.
Sample size: It has been estimated for a difference of 0.5 standard deviations ( clinically relevant result ), and a power of 80%. Specifying a total of 170 children, 85 in each group. Correcting for a design effect of 1,369, considering an ICC of 0,041 (28) and an average cluster size of 10 boys or girls, 233 boys or girls are required. Estimating losses of 20%, the final size is 280 children, 140 in each group. Sampling : Randomized allocation by conglomerates (nurses). Randomization unit: Primary Health Care Centers. The Health Centers will be assigned to the intervention or to the control group through a random sequence generated by computer. Analysis Unit: Diads child / caregiver. They will be included by consecutive sampling. During the consultation, that child susceptible to being included in the study will be informed and offered participation. If you agree to participate, you will be asked to complete and sign the informed consent and verify that you meet all the inclusion criteria and none of the exclusion criteria. Randomization of health centers will be carried out once the eligible dyads have been selected for the study, so that the recruitment by professionals is not influenced by the branch of the study to which they have been assigned.
Data Collection :
The information will be collected through clinical interview and physical examination and the data will be recorded in an electronic data collection notebook specially designed for this study. The variables will be collected during 4 visits: at the beginning of the study, at the end of the intervention, at 6 and 12 months.
Losses in participation: Losses and abandonment of follow-up during the study. The cause will be collected (voluntary abandonment, displacement, comorbidity, death and cause). If a patient does not attend a session, at least two telephone contact attempts will be made.
Control group . The activities included in the Service for Childhood Obesity Patients of the Portfolio of Standardized Primary Care Services of the Community of Madrid will be carried out , which establishes a monthly follow-up in the first 6 months and bimonthly from 6 to 12. This consultation will be attended by at least the child and the primary caregiver, the child's educating agent, and will receive supporting documentation for Exercise and strengthen your role.
* Experimental group : Regular intervention plus intervention active families. This intervention, based on the methodology of meaningful learning , it will have two components: group education aimed at parents (caregivers) and education aimed at children in the reviews in consultation. The group intervention will consist of 6 sessions, which with a biweekly / monthly frequency, will be taught as determined in the program monitoring annex, in the 3 months after the initial assessment.
In order to normalize and protocolize the activities in both groups (intervention and control) a training session will be held prior to the start of the field work
Analysis Strategy :
It will be done according to the intention to treat principle.
This same analysis will be applied to analyze the impact of the intervention on the rest of the quantitative dependent variables contemplated in the secondary objectives of the study.
Technical Group.
Assistance Group: This group will be formed by nurses and pediatricians of the participating centers. There will be two people responsible for implementing the program in each center that will facilitate contact with the coordinating group. Perform the tasks of the assistance group:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Usual care plus intervention active families. This intervention, based on the methodology of meaningful learning, will have two components: group education directed to parents (caregivers) and education directed to children in the reviews in consultation. The group intervention will consist of 6 sessions, with a biweekly / monthly frequency, will be taught as determined in the program monitoring annex, in the 3 months after the initial assessment. The content of the sessions is defined in attached annex. Regarding the proposed methodology, it has nuances and tools different from the traditional ones to achieve significant learning in the field of health. It is based on participatory methods and a more profound modification of knowledge, skills, emotions and attitudes than the brief advice that is used in family intervention in scheduled consultations.
Behavioral: Active Families · Other: Madrid's Primary Healthcare Standardized Service portfolio
Usual care: The activities included in the Service for Attention to Patients with Childhood Obesity will be carried out in the Madrid's Primary Healthcare Standardized Service portfolio, which establishes a monthly follow-up in the first 6 months and bimonthly of month 6 to 12. To this At least the child and the primary caregiver, the child's educational agent, will be consulted and will receive support documentation to exercise and reinforce their role.
Other: Madrid's Primary Healthcare Standardized Service portfolio
This intervention, based on the methodology of meaningful learning, will have two components: group education aimed at parents (caregivers) and and education directed to children in the reviews in consultation. Group education (caregivers) groups will consist of 6 sessions, which will be given every two weeks, as determined in the program's follow-up annex, in the 3 months after the initial assessment. The content of the sessions is defined in attached annex. Regarding the proposed methodology, it has nuances and tools different from the traditional ones to achieve significant learning in the field of health. It is based on participatory methods and a more profound modification of knowledge, skills, emotions and attitudes than the brief advice that is used in family intervention in scheduled consultations.
Also known as: Madrid's Primary Healthcare Standardized Service portfolio
An anamnesis or functional assessment on the following aspects: o Family history of obesity up to 2nd degree inbreeding. o Nutritional status - metabolic that includes at least no meals/day and daily consumption of liquids, fruits, vegetables, dairy, fats and sugars. o Activity - exercise that includes at least the type and intensity of exercise and time spent on sedentary activities (television, video games or the like). o Self-concept that includes at least the existence or not of behavioral problems and body image problems. o Role - relationships that include at least the performance of extracurricular activities. A care plan in relation to identified problems and/or situations reviewed on a biannual basis. They will be supplemented with the study-specific variables listed in the data collection notebook.
Change Score Z score of the BMI of the child
Change Score Z score of the BMI at the end of the intervention and at 4, 6 and 12 months from the start of the intervention using the tables of Hernández 1988 (annex 8). The Z score of the BMI is the variable of choice according to international proposals to explain the changes related to sex and age over time after an intervention in childhood obesity (12). Calculation of the score Z score of the BMI = (X-X') / DS. In which X = BMI of the child, X '= average BMI value for a specific age and sex according to the 1988 Hernández tables and SD = standard deviation of the mean BMI value according to the 1988 Hernández tables.
Time frame: 4, 6 and 12 months from the start of the intervention using the tables of Hernández 1988
Weight of the child
Weight in kilograms
Time frame: Baseline (at the start of the intervention) and at 4, 6 and 12 months of treatment.
Height of the child
height in meters
Time frame: Baseline (at the start of the intervention) and at 4, 6 and 12 months of treatment.
BMI of the child
weight and height will be combined to report BMI in kg/m\^2)
Time frame: Baseline (at the start of the intervention) and at 4, 6 and 12 months of treatment.
KIDMED test. Quality of the diet
KIDMED test consisting of 16 issues that are based on the principles of the Mediterranean Diet. The score that can be achieved after answering the questions of the test goes from O to 12 and allows to make a classification of the quality of the diet in three groups: \<_3 poor quality, 4-7 average quality and \>8 optimal quality.
Time frame: Baseline (at the start of the intervention) and at 12 months of treatment
Physical activity of the child (Gasol Foundation Questionnaire for assessment of physical activity and sedentary lifestyle adapted version )
Physical activity questionnaire adapted version . It measures physical activity, PAU QUESTIONARY, allows to classify as active/inactive ; sedentary/non-sedentary physical exercise and sedentary leisure. The questions of which allow researchers to know whether or not children meet the recommendation of the World Health Organization (WHO) to do a minimum of 60 minutes of physical activity per day. Complying with the recommendation determines that the child is ACTIVE. Failure to comply with the recommendation classifies the child as inactive. Two questions value if you accumulate 2 hours a day on a regular basis of sedentary leisure (screens). Regularly accumulating more than 2 hours classifies the child as sedentary, not reaching the two hours of daily sedentary leisure classifies the child as nonsedentary. The questionnaire classifies boys and girls according to the minutes of exercise accumulated per week
Time frame: Baseline (at the start of the intervention) and at 12 months of treatment
Family Function. APGAR FAMILIAR
Application to the main caregiver of the Apgar-family questionnaire that has demonstrated its validity and reliability in primary care. APGAR FAMILAR. There are five questions, each question is scored on a value from 0 to 2, eventually getting an index of 0 and 10. Interpretation: * Normal 7-10 point functionality * Moderate dysfunction of 4-6 points. * Severe dysfunction from 0 to 3 points.
Time frame: Baseline (at the start of the intervention) and at 12 months of treatment.
Physical activity of the caregiver (BPAAT)
Physical activity questionnaire adapted version . It measures physical activity, physical exercise.The Brief Physical Activity Assessment Tool (BPAAT) are valid and reliable assessment tools to identify "inactive" patients in primary. Brief Physical Activity Assessment Tool. It is a questionnaire administered by the healthcare professional. It consists of 2 questions that measure the frequency and duration of AF at vigorous and moderate intensity during a "typical" week. The scoring system identifies 'sufficiently active' patients (perform 3 sessions/week of 20 min at vigorous intensity or 5 sessions/week of 30 min at moderate intensity or 5 sessions of any combination of moderate or vigorous FA) or "insufficiently active" (do not meet healthy AF recommendations) care.
Time frame: Baseline (at the start of the intervention) and at 12 months of treatment.
blood pressure of the child (systolic blood pressure and diastolic blood pressure)
systolic blood pressure and diastolic blood pressure (mm Hg)
Time frame: Baseline (at the start of the intervention) and at 12 months of treatment
waist circumference of the child
waist circumference (cm)
Time frame: Baseline (at the start of the intervention) and at 12 months of treatment
Sex
Sex (Male/ Female)
Time frame: Baseline (at the start of the intervention)
Age
Age (date of birth)
Time frame: Baseline (at the start of the intervention)
Other Variables of the boy or girl
Antecedents of 1st degree obesity (yes / no).
Time frame: Baseline (at the start of the intervention)
Level of studies and other sociocultural and economic variables and of the main caregiver
Level of studies and other sociocultural and economic variables
Time frame: Baseline (at the start of the intervention)
Number of sessions attended by the caregiver (in case of intervention group).
Number of sessions attended by the caregiver (in case of intervention group).
Time frame: 12 months
Variables of the professional / Health Center: Years of experience in Primary Care
Years of experience in Primary Care.
Time frame: Baseline (at the start of the intervention)
Mother's weight
Weight in kilograms
Time frame: Baseline (at the start of the intervention) and at 4, 6 and 12 months of treatment
Father's weight
Weight in kilograms
Time frame: Baseline (at the start of the intervention) and at 4, 6 and 12 months of treatment
BMI of the Mother
weight and height will be combined to report BMI in kg/m\^2)
Time frame: Baseline (at the start of the intervention) and at 4, 6 and 12 months of treatment
BMI of the Father
weight and height will be combined to report BMI in kg/m\^2)
Time frame: Baseline (at the start of the intervention) and at 4, 6 and 12 months of treatment
Mother's Height
height in meters
Time frame: Baseline (at the start of the intervention) and at 4, 6 and 12 months of treatment
Father's Height
height in meters
Time frame: Baseline (at the start of the intervention) and at 4, 6 and 12 months of treatment
Sex (Male /female) of the main caregiver
Sex (Male /female),
Time frame: Baseline (at the start of the intervention)
Change stage of the main caregiver
precontemplation (no motivation to be active) contemplation (motivation to change in the next 6 months) preparation (It has planned changes in the next month) action (active adherence to behavior lasting less than 6 months) maintenance (adherence to an active lifestyle greater than 6 months) (It has planned changes in the next month) action maintenance
Time frame: Baseline (at the start of the intervention) and at 12 months of treatment
Variables of the professional / Health Center: Sex (Male/ Female)
Sex (Male/ Female)
Time frame: Baseline (at the start of the intervention)
Plan to share: No
Started Dec 2022 (actual). Primary completion is estimated for Dec 2024, 24 months after the start.
Of 539 non-industry interventional studies with no phase under Pediatric Obesity, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 24 months is close to that.
Counting every sponsor, half of 541 studies reached it within 25 months; a quarter within 11 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Gerencia de Atención Primaria, Madrid