Effectiveness of an Intervention Programme for Childhood Obesity: FAMILIACT

NCT04196556 | Active Not Recruiting

• 1 other identifier: CCI 25/17
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Childhood Obesity

Keywords

Childhood obesity; Primary Health Care; Nursing intervention; Family educational intervention

Outcome Measures

Primary Outcomes (4)

• 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.

  4, 6 and 12 months from the start of the intervention using the tables of Hernández 1988

• Weight of the child

  Weight in kilograms

  Baseline (at the start of the intervention) and at 4, 6 and 12 months of treatment.

• Height of the child

  height in meters

  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)

  Baseline (at the start of the intervention) and at 4, 6 and 12 months of treatment.

Secondary Outcomes (8)

• KIDMED test. Quality of the diet

  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 )

  Baseline (at the start of the intervention) and at 12 months of treatment

• Family Function. APGAR FAMILIAR

  Baseline (at the start of the intervention) and at 12 months of treatment.

• Physical activity of the caregiver (BPAAT)

  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)

  Baseline (at the start of the intervention) and at 12 months of treatment

Other Outcomes (13)

• Other Variables of the boy or girl

  Baseline (at the start of the intervention)

• Level of studies and other sociocultural and economic variables and of the main caregiver

  Baseline (at the start of the intervention)

• Number of sessions attended by the caregiver (in case of intervention group).

  12 months

Study Arms (2)

Active Families

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Active Families BEHAVIORAL

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

Active Families

Madrid's Primary Healthcare Standardized Service portfolio OTHER

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.

Active Families; Control group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: between 7 and 12 years old.
• Obesity: defined by a BMI equal to or greater than P97 for age and sex in the curves and growth charts of the semilongitudinal study by Hernández (1988). Definition recommended by the Clinical Practice Guide of the Ministry of Health. To have primary caregiver.
• Be able to follow the demands of the trial (child and primary caregiver participants).
• Have no intention of moving in the following 12 months. Give informed consent to participate in the study.

You may not qualify if:

• Intention of moving in the following 12 months.
• Do not sign informed consent.
• Sensory, psychiatric or occupational limitations of caregivers that do not allow follow-up sessions.

Sponsors & Collaborators

• Gerencia de Atención Primaria, Madrid: lead

Study Sites (1)

Gerencia Asistencial de Atención Primaria de Madrid

Madrid, Spain

Location

Related Publications (18)

• Hollands GJ, Carter P, Anwer S, King SE, Jebb SA, Ogilvie D, Shemilt I, Higgins JPT, Marteau TM. Altering the availability or proximity of food, alcohol, and tobacco products to change their selection and consumption. Cochrane Database Syst Rev. 2019 Sep 4;9(9):CD012573. doi: 10.1002/14651858.CD012573.pub3.

  PMID: 31482606 BACKGROUND

• Brown T, Moore TH, Hooper L, Gao Y, Zayegh A, Ijaz S, Elwenspoek M, Foxen SC, Magee L, O'Malley C, Waters E, Summerbell CD. Interventions for preventing obesity in children. Cochrane Database Syst Rev. 2019 Jul 23;7(7):CD001871. doi: 10.1002/14651858.CD001871.pub4.

  PMID: 31332776 BACKGROUND

• Muthuri SK, Onywera VO, Tremblay MS, Broyles ST, Chaput JP, Fogelholm M, Hu G, Kuriyan R, Kurpad A, Lambert EV, Maher C, Maia J, Matsudo V, Olds T, Sarmiento OL, Standage M, Tudor-Locke C, Zhao P, Church TS, Katzmarzyk PT; ISCOLE Research Group. Relationships between Parental Education and Overweight with Childhood Overweight and Physical Activity in 9-11 Year Old Children: Results from a 12-Country Study. PLoS One. 2016 Aug 24;11(8):e0147746. doi: 10.1371/journal.pone.0147746. eCollection 2016.

  PMID: 27557132 BACKGROUND

• Bammann K, Peplies J, Pigeot I, Ahrens W. [IDEFICS: a multicenter European project on diet- and lifestyle-related disorders in children]. Med Klin (Munich). 2007 Mar 15;102(3):230-5. doi: 10.1007/s00063-007-1027-2. German.

  PMID: 17345019 BACKGROUND

• McKey S, Heinen M, Mehegan J, Somerville R, Khalil H, Segurado R, Murrin C, Kelleher CC; Lifeways Cross-Generation Cohort Study Steering Group. Predictors of adults' body mass index and the association with index child's infant birth weight, in the Lifeways Cross-Generation Cohort Study of a thousand families in the Republic of Ireland. J Dev Orig Health Dis. 2017 Dec;8(6):649-657. doi: 10.1017/S2040174417000435. Epub 2017 Jun 22.

  PMID: 28637529 BACKGROUND

• Setayeshgar S, Ekwaru JP, Maximova K, Majumdar SR, Storey KE, McGavock J, Veugelers PJ. Dietary intake and prospective changes in cardiometabolic risk factors in children and youth. Appl Physiol Nutr Metab. 2017 Jan;42(1):39-45. doi: 10.1139/apnm-2016-0215. Epub 2016 Dec 13.

  PMID: 27959641 BACKGROUND

• Ogden CL, Flegal KM, Carroll MD, Johnson CL. Prevalence and trends in overweight among US children and adolescents, 1999-2000. JAMA. 2002 Oct 9;288(14):1728-32. doi: 10.1001/jama.288.14.1728.

  PMID: 12365956 BACKGROUND

• Sharifi M, Franz C, Horan CM, Giles CM, Long MW, Ward ZJ, Resch SC, Marshall R, Gortmaker SL, Taveras EM. Cost-Effectiveness of a Clinical Childhood Obesity Intervention. Pediatrics. 2017 Nov;140(5):e20162998. doi: 10.1542/peds.2016-2998.

  PMID: 29089403 BACKGROUND

• Singh AS, Mulder C, Twisk JW, van Mechelen W, Chinapaw MJ. Tracking of childhood overweight into adulthood: a systematic review of the literature. Obes Rev. 2008 Sep;9(5):474-88. doi: 10.1111/j.1467-789X.2008.00475.x. Epub 2008 Mar 5.

  PMID: 18331423 BACKGROUND

• Wilfley DE, Saelens BE, Stein RI, Best JR, Kolko RP, Schechtman KB, Wallendorf M, Welch RR, Perri MG, Epstein LH. Dose, Content, and Mediators of Family-Based Treatment for Childhood Obesity: A Multisite Randomized Clinical Trial. JAMA Pediatr. 2017 Dec 1;171(12):1151-1159. doi: 10.1001/jamapediatrics.2017.2960.

  PMID: 29084318 BACKGROUND

• Freedman DS, Mei Z, Srinivasan SR, Berenson GS, Dietz WH. Cardiovascular risk factors and excess adiposity among overweight children and adolescents: the Bogalusa Heart Study. J Pediatr. 2007 Jan;150(1):12-17.e2. doi: 10.1016/j.jpeds.2006.08.042.

  PMID: 17188605 BACKGROUND

• Metcalf PA, Scragg RK, Stewart AW, Scott AJ. Design effects associated with dietary nutrient intakes from a clustered design of 1 to 14-year-old children. Eur J Clin Nutr. 2007 Sep;61(9):1064-71. doi: 10.1038/sj.ejcn.1602618. Epub 2007 Jan 31.

  PMID: 17268420 BACKGROUND

• Robson SM, Bolling C, McCullough MB, Stough CO, Stark LJ. A Preschool Obesity Treatment Clinical Trial: Reasons Primary Care Providers Declined Referrals. J Pediatr. 2016 Oct;177:262-266.e1. doi: 10.1016/j.jpeds.2016.06.027. Epub 2016 Jul 22.

  PMID: 27453375 BACKGROUND

• Baker S, Barlow S, Cochran W, Fuchs G, Klish W, Krebs N, Strauss R, Tershakovec A, Udall J. Overweight children and adolescents: a clinical report of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. J Pediatr Gastroenterol Nutr. 2005 May;40(5):533-43. doi: 10.1097/01.mpg.0000161147.16590.12.

  PMID: 15861011 BACKGROUND

• Golan M, Kaufman V, Shahar DR. Childhood obesity treatment: targeting parents exclusively v. parents and children. Br J Nutr. 2006 May;95(5):1008-15. doi: 10.1079/bjn20061757.

  PMID: 16611394 BACKGROUND

• Epstein LH, Roemmich JN, Stein RI, Paluch RA, Kilanowski CK. The challenge of identifying behavioral alternatives to food: clinic and field studies. Ann Behav Med. 2005 Dec;30(3):201-9. doi: 10.1207/s15324796abm3003_4.

  PMID: 16336071 BACKGROUND

• Rodearmel SJ, Wyatt HR, Stroebele N, Smith SM, Ogden LG, Hill JO. Small changes in dietary sugar and physical activity as an approach to preventing excessive weight gain: the America on the Move family study. Pediatrics. 2007 Oct;120(4):e869-79. doi: 10.1542/peds.2006-2927.

  PMID: 17908743 BACKGROUND

• McGarvey E, Keller A, Forrester M, Williams E, Seward D, Suttle DE. Feasibility and benefits of a parent-focused preschool child obesity intervention. Am J Public Health. 2004 Sep;94(9):1490-5. doi: 10.2105/ajph.94.9.1490.

  PMID: 15333300 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Intervention can't be masked. Statistician conducting the analysis will not know to which study arm a given patient has been assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse. Clinical research

Model Details: A multicenter Cluster Randomized Clinical Trial

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 12, 2019
• Study Start: December 10, 2022
• Primary Completion: December 14, 2024
• Study Completion: December 14, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)