The STAK tool: evaluation of a new device to treat arthrofibrosis and poor range of movement following total knee arthroplasty and major knee surgery

Aims This study aims to evaluate a new home medical stretching device called the Self Treatment Assisted Knee (STAK) tool to treat knee arthrofibrosis. Methods 35 patients post-major knee surgery with arthrofibrosis and mean range of movement (ROM) of 68° were recruited. Both the STAK intervention and control group received standard physiotherapy for eight weeks, with the intervention group additionally using the STAK at home. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Oxford Knee Scores (OKS) were collected at all timepoints. An acceptability and home exercise questionnaire capturing adherence was recorded after each of the interventions. Results Compared to the control group, the STAK intervention group made significant gains in mean ROM (30° versus 8°, p < 0.0005), WOMAC (19 points versus 3, p < 0.0005), and OKS (8 points versus 3, p < 0.0005). The improvements in the STAK group were maintained at long-term follow-up. No patients suffered any complications relating to the STAK, and 96% of patients found the STAK tool ‘perfectly acceptable’. Conclusion The STAK tool is effective in increasing ROM and reducing pain and stiffness. Patients find it acceptable and adherence to treatment was high. This study indicates that the STAK tool would be of benefit in clinical practice and may offer a new, cost-effective treatment for arthrofibrosis. Cite this article: Bone Joint Open 2020;1-8:465–473.

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Perceptions of caregivers on immunization in Ntungamo district, Uganda

International Journal of Community Medicine and Public Health ◽

10.18203/2394-6040.ijcmph20214559 ◽

2021 ◽

Vol 8 (12) ◽

pp. 5729

Author(s):

Byamukama Topher ◽

Keraka M. Margaret ◽

Gitonga Eliphas

Keyword(s):

Risk Factor ◽

Intervention Group ◽

Cost Effective ◽

Systematic Sampling ◽

Control Group ◽

Post Intervention ◽

Mortality And Morbidity ◽

Significant Difference ◽

Quasi Experimental ◽

And Control

Background: Immunization is one of the most cost-effective public health interventions to reduce child mortality and morbidity associated with infectious diseases. The objective of this study was to determine the perceptions of caregivers on immunization in Ntungamo district.Methods: Quasi-experimental study was used with health centres assigned to intervention and control groups. Purposive sampling was used to select the two counties where the study was done. Proportional sampling was done to get study samples from each health facility, while systematic sampling was done to get study participants. A total of 787 children from twelve health facilities provided the study sample. A post intervention evaluation was conducted to determine the effect of these interventions. Association of variables was tested using Mann Whitney U-test and Chi-square.Results: On benefits, most caregivers in the intervention group (85.3%) and in the control group (54.3%) regarded immunization as very highly and moderately beneficial to their children respectively. On risks, most caregivers in the intervention group (85.5%) and control group (43.1%) regarded the risk factor associated with immunization as very low and moderate respectively. From hypothesis testing, there was a significant difference on the perceived benefits and risks of immunization between the intervention and control group.Conclusions: Most caregivers in the intervention and control group regarded immunization as very highly beneficial and moderately to their children respectively. Most of the caregivers in the intervention and control group regarded the risk factor associated with immunization as very low and moderate respectively.

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Pengaruh latihan range of motion (ROM) ankle terhadap pencegahan terjadinya neuropati dan angiopati pada klien diabetes melitus

HOLISTIK JURNAL KESEHATAN ◽

10.33024/hjk.v13i3.1941 ◽

2019 ◽

Vol 13 (3) ◽

pp. 263-269

Author(s):

Djunizar Djamaludin ◽

Setiawati Setiawati ◽

Rika Yulendasari

Keyword(s):

Range Of Motion ◽

Intervention Group ◽

Exercise Program ◽

Home Exercise ◽

Control Group ◽

P Value ◽

Purposive Sampling ◽

Foot Injury ◽

Post Test ◽

And Control

The effect of range motion (ROM) ankle exercise on prevention of neuropathy and angiopathy in patient with diabetes mellitusBackground: Based on data from Basic Health Research (2013) conducted by the Indonesian Ministry of Health in a way to obtain the proportion of DM at the age of 15 years and over, confirmed / checked whether or not they suffer from DM or not.It was found that Lampung Province was ranked as the 8th largest DM person from 33 provinces throughout Indonesia, with DM patients with 38,923 lives and 5,560 people. One complication that needs attention is diabetes foot injury and it can cause amputation. The most common cause of diabetes foot injury is peripheral neuropathy which includes damage to sensory, autonomic and motor nerves.Purpose: The purpose of this study was to determine the effect of Range of Motion (ROM) ankle exercise on prevention of neuropathy and angiopathy on diabetes patients.Methods: A quasi experimental pre and post- test with control group study design was employed. The purposive sampling with 26 participants (13 respondents intervention group and 13 respondents control group) were recruited. The interventions groups performed ROM ankle exercise in their own respective training programs for 4 weeks, whereas no training was done in the control group. Both groups intervention and control, before and after the exercise program were measured with monofilament test for neuropathy and Venous Doppler for angiopathy. The data analysis was using t-test.Results: In the intervention group there were a significant improvements after ROM ankle exercise on prevention of neuropathy with p Value 0.000 and for angiopathy with p Value 0.000. There were significant different between intervention group and control group for neuropathy (p: .004) and angiopathy (p: .031).Conclusion: To prevent neuropathy and angiopathy on diabetes patients a home exercise program with Range of Motion (ROM) ankle could be implementedKeywords: Range of Motion; Neuropathy; Angiopathy; Diabetes MellitusPendahuluan: Berdasarkan Riskesdas tahun 2013 oleh Kemenkes RI dengan melakukan wawan cara untuk mendapatkan proporsi DM pada usia 15 tahun keatas yaitu proporsi penduduk yang terdiagnosis menderita DM dan penduduk yang belum pernah didiagnosis menderita DM. Provinsi Lampung menduduki peringkat ke – 8 penyandang DM terbesar dari 33 Provinsi diseluruh Indonesia, 38.923 jiwa dan 5.560 jiwa . Salah satu komplikasi yang harus mendapat perhatian yaitu luka kaki diabetes karena dapat mengakibarkan amputasi. Penyebab terbanyak dari luka kaki diabetes yaitu neuropati perifer yang meliputi kerusakan syaraf sensorik, otonom dan motorik.Tujuan: Diketahui pengaruh Range Of Motion (ROM) Ankle terhadap pencegahan terjadinya Neuropati dan Angiopati pada pasien Diabetes Melitus.Metode: Penelitian ini mengunakan desain quasi eksperimen pre post test dengan kelompok control dan intervensi..Sampel diambil dengan menggunakan tehnik Purposive Sampling dengan jumlah sampel yaitu 26 responden. Instrument penelitian ini menggunakan 10 gr semmens weinstein monofilament untuk mendeteksi Neuropati dan Venous Doppler Ultrasound untuk mendeteksi angiopati. Hasil: Menunjukkan adanya pengaruh latihan Range of Motion (ROM) Ankle terhadap pencegahan neuropati dengan p Value 0.000 dan angiopati dengan p Value 0.000. Terdapat perbedaan bermakna antara kelompok intervensi dan control untuk neuropati (p: .004) dan angiopati (p: .031).Simpulan: Untuk mencegah terjadinya neuropati dan angiopati pada penderita DM untuk dapat melakukan latihan Range of Motion (ROM) Ankle dirumah

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Efficacy of a written prayer technique on the anxiety of mothers of children with cancer

Palliative & Supportive Care ◽

10.1017/s1478951518000743 ◽

2018 ◽

Vol 17 (1) ◽

pp. 54-59

Author(s):

Maryam Ahmadi ◽

Khdije Zaree ◽

Anoushirvan Kazemnejad Leily ◽

Akram Sadat Sadat Hoseini

Keyword(s):

Group Intervention ◽

Intervention Group ◽

Cost Effective ◽

Practical Method ◽

Control Group ◽

Children With Cancer ◽

Demographic Questionnaire ◽

Significant Difference ◽

Convenience Sampling ◽

And Control

AbstractObjectiveTo investigate the effect of a written prayer technique on the anxiety of mothers of children with cancer.MethodThis clinical trial recruited 90 mothers of children with cancer admitted to the Medical Centre of Tehran. Using a convenience sampling method, we randomly assigned the participants to two groups: control (n = 45) and intervention (n = 45). Data were collected through the Spielberger's anxiety scale and a demographic questionnaire. Maternal anxiety was measured before the intervention, immediately after the three-day intervention, and five weeks after the intervention. We used a writing technique in the intervention and control groups for 20 minutes over three consecutive days. In the intervention group, participants wrote down their sincere desires and wishes that they demanded from God without any worry or stress. The control group spent 20 minutes writing their normal daily schedules; for example, feeding their children or changing their children's clothes. During the three consecutive days of intervention, we asked both groups not to worry about grammar or spelling errors. Finally, the data were analyzed using descriptive and analytical statistical methods.ResultA statistically significant difference was observed between the two groups (intervention and control mean, 34.9 ± 9.9 and 47.9 ± 16.2, respectively) relative to anxiety after the intervention (p < 0.001). After five weeks, the intervention group continued to exhibit significantly reduced anxiety compared with the control group (intervention and control mean, 34.7 ± 9.6 and 48.5 ± 16.4; p < 0.001).Significance of resultsThe written prayer technique appears to be an effective, efficient, cost-effective, and practical method for reducing anxiety in mothers of children with cancer.

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Manual therapy of infants with postural and movement asymmetries and positional preference

Manuelle Medizin ◽

10.1007/s00337-020-00760-9 ◽

2021 ◽

Author(s):

Robby Sacher ◽

Martin Knüdeler ◽

Marc Wuttke ◽

Nadine Wüstkamp ◽

Steffen Derlien ◽

...

Keyword(s):

Intervention Group ◽

Exercise Programme ◽

Manual Medicine ◽

Home Exercise ◽

Control Group ◽

Double Blind ◽

Positional Preference ◽

Home Exercise Programme ◽

The Difference ◽

And Control

Abstract Background There are different therapeutic approaches to persistent positional preference (kinematic imbalance due to suboccipital strain, KISS) in infants. There are no evidence-based or controlled studies investigating the effect of manual medicine treatment in children aged 3–6 months, particularly in combination with a home exercise programme. The presented monocentric study on one-time manual medicine treatment of infants aged 14–24 exhibiting these symptoms aims to close this gap. Methods This study comprises a controlled double-blind trial and per-protocol-analysis. Primary outcome was the 4-item symmetry score (4–17 points). The second measurement was performed after 4–6 weeks. Results A total of 62 infants were treated and evaluated (mean age 17 weeks). The intervention and control groups started with a symmetry score of 12.9 ± 2.1 and 12.5 ± 1.7 points, respectively. In the intervention group the score improved by 4.9 ± 2.4 to 8.0 ± 2.7 points, in the control group it improved by 2.9 ± 2.9 to 9.6 ± 3.0 points. The difference between the groups was statistically significant (p = 0.03). Both groups had significantly better values over time (p < 0.001). No adverse events or side effects were observed. Conclusion Manual medicine treatment of infants with postural and movement asymmetries as well as positional preference in combination with a home exercise programme is superior to a home exercise programme alone. Both treatment concepts achieved significant improvements. However, the manual medicine treatment played an important role in reducing the symmetry score value for the affected children, such they were no longer in need of treatment.

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Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

Journal of Nursing Education and Practice ◽

10.5430/jnep.v10n2p70 ◽

2019 ◽

Vol 10 (2) ◽

pp. 70

Author(s):

Samah Nasser Abd El-Aziz El-Shora ◽

Amina Mohamed Rashad El-Nemer

Keyword(s):

Randomized Controlled Trial ◽

Cesarean Section ◽

Controlled Trial ◽

Intervention Group ◽

Cost Effective ◽

Control Group ◽

Induced Hypotension ◽

Randomized Controlled ◽

Significant Difference ◽

Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

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OP0198-HPR A STRUCTURED MODEL FOR OA CARE IN PRIMARY HEALTHCARE IS A COST-EFFECTIVE ALTERNATIVE COMPARED TO USUAL CARE FOR PEOPLE WITH HIP AND KNEE OA

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.950 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 119-120

Author(s):

N. Østerås ◽

E. Aas ◽

T. Moseng ◽

L. Van Bodegom-Vos ◽

K. Dziedzic ◽

...

Keyword(s):

Usual Care ◽

Primary Healthcare ◽

Intervention Group ◽

Cost Effective ◽

Cost Utility ◽

Control Group ◽

Structured Model ◽

Knee Oa ◽

Cost Effective Alternative ◽

The Cost

Background:To improve quality of care for patients with hip and knee osteoarthritis (OA), a structured model for integrated OA care was developed based on international treatment recommendations. A previous analysis of a cluster RCT (cRCT) showed that compared to usual care, the intervention group reported higher quality of care and greater satisfaction with care. Also, more patients were treated according to international guidelines and fulfilled recommendations for physical activity at the 6-month follow-up.Objectives:To assess the cost-utility of a structured model for hip or knee OA care.Methods:A cRCT with stepped-wedge cohort design was conducted in 6 Norwegian municipalities (clusters) in 2015-17. The OA care model was implemented in one cluster at the time by switching from “usual care” to the structured model. The implementation of the model was facilitated by interactive workshops for general practitioners (GPs) and physiotherapists (PTs) with an update on OA treatment recommendations. The GPs explained the OA diagnosis and treatment alternatives, provided pharmacological treatment when appropriate, and suggested referral to physiotherapy. The PT-led patient OA education programme was group-based and lasted 3 hours followed by an 8–12-week individually tailored resistance exercise programme with twice weekly 1-hour supervised group sessions (5–10 patients per PT). An optional 10-hours Healthy Eating Program was available. Participants were ≥45 years with symptomatic hip or knee OA.Costs were measured from the healthcare perspective and collected from several sources. Patients self-reported visits in primary healthcare at 3, 6, 9 and 12 months. Secondary healthcare visits and joint surgery data were extracted from the Norwegian Patient Register. The health outcome, quality-adjusted life-year (QALY), was estimated based on the EQ-5D-5L scores at baseline, 3, 6, 9 and 12 months. The result of the cost-utility analysis was reported using the incremental cost-effectiveness ratio (ICER), defined as the incremental costs relative to incremental QALYs (QALYs gained). Based on Norwegian guidelines, the threshold is €27500. Sensitivity analyses were performed using bootstrapping to assess the robustness of reported results and presented in a cost-effectiveness plane (Figure 1).Results:The 393 patients’ mean age was 63 years (SD 9.6) and 74% were women. 109 patients were recruited during control periods (control group), and 284 patients were recruited during interventions periods (intervention group). Only the intervention group had a significant increase in EQ-5D-5L utility scores from baseline to 12 months follow-up (mean change 0.03; 95% CI 0.01, 0.05) with QALYs gained: 0.02 (95% CI -0.08, 0.12). The structured OA model cost approx. €301 p.p. with an additional €50 for the Healthy Eating Program. Total 12 months healthcare cost p.p. was €1281 in the intervention and €3147 in the control group, resulting in an incremental cost of -€1866 (95% CI -3147, -584) p.p. Costs related to surgical procedures had the largest impact on total healthcare costs in both groups. During the 12-months follow-up period, 5% (n=14) in the intervention compared to 12% (n=13) in the control group underwent joint surgery; resulting in a mean surgical procedure cost of €553 p.p. in the intervention as compared to €1624 p.p. in the control group. The ICER was -€93300, indicating that the OA care model resulted in QALYs gained and cost-savings. At a threshold of €27500, it is 99% likely that the OA care model is a cost-effective alternative.Conclusion:The results of the cost-utility analysis show that implementing a structured model for OA care in primary healthcare based on international guidelines is highly likely a cost-effective alternative compared to usual care for people with hip and knee OA. More studies are needed to confirm this finding, but this study results indicate that implementing structured OA care models in primary healthcare may be beneficial for the individual as well as for the society.Disclosure of Interests:None declared

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Effect of aromatherapy massage with orange essential oil on postoperative pain after cesarean section: a randomized controlled trial

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2020-0138 ◽

2021 ◽

Vol 0 (0) ◽

Author(s):

Seyedmohammad Mirhosseini ◽

Ali Abbasi ◽

Nastaran Norouzi ◽

Fatemeh Mobaraki ◽

Mohammad Hasan Basirinezhad ◽

...

Keyword(s):

Side Effects ◽

Essential Oil ◽

Cesarean Section ◽

Statistical Tests ◽

Intervention Group ◽

Nursing Intervention ◽

Anxiety Score ◽

Control Group ◽

And Control ◽

Orange Essential Oil

Abstract Objectives Many women in recent years have been willing to undergo puncture surgery for childbirth, which, like other surgeries, has physical and psychological side effects such as incision, infertility, chronic pain, and anxiety. Therefore, it is important to reduce and improve these side effects. The aim of this study was to determine the effect of foot massage with orange essential oil on pain and anxiety in women undergoing cesarean section. Methods This randomized clinical trial study was conducted in 2019 on 80 women referred to Bahar Shahroud Hospital after cesarean section surgery. The samples were divided into two groups by intervention (foot massage with orange essential oil) and control (foot massage without orange essential oil). The Spielberger scale was used to determine anxiety scores after cesarean section. In the intervention group, the feet were massaged with orange essential oil, and in the control group, the orange essential oil massage was performed without oil. Anxiety before, immediately after, and 60 min after the intervention was measured and evaluated in both groups. Data analysis was performed using descriptive and inferential statistics. Significant levels were considered for all statistical tests (p<0.05). Results The anxiety score before the intervention in the two groups of intervention and control was 57.12 ± 3.12 and 57.07 ± 3.54, respectively, which were not significantly different, but immediately after the intervention, the anxiety scores in both groups decreased significantly so that there was a further decrease in the intervention group (52.10 ± 4.75 and 56.02 ± 3.77), 1 h after the intervention, the anxiety score in the intervention group decreased compared to the previous stage and increased in the control group (50.40 ± 3.74 and 56.85 ± 4.27). Conclusions Foot massage with orange essential oil can probably be effective as a proper nursing intervention in reducing anxiety after cesarean section surgery.

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The effect of practicing yoga during pregnancy on labor stages length, anxiety and pain: a randomized controlled trial

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2019-0291 ◽

2020 ◽

Vol 0 (0) ◽

Author(s):

Ellahe Mohyadin ◽

Zohreh Ghorashi ◽

Zahra Molamomanaei

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Total Duration ◽

Measurement Data ◽

Labor Pain ◽

Control Group ◽

Chi Square ◽

Nulliparous Women ◽

Two Stages ◽

And Control

AbstractBackgroundAnxiety and fear of labor pain has led to elevated cesarean section rate in some countries. This study was conducted to investigate the effect of yoga in pregnancy on anxiety, labor pain and length of labor stages.MethodsThis clinical trial study was performed on 84 nulliparous women who were at least 18 years old and were randomly divided into two groups of yoga and control groups. Pregnancy Yoga Program consisting of 6 60-min training sessions was started every 2 weeks from week 26 of pregnancy and continued until 37 weeks of gestation. Anxiety severity at maternal admission to labor was measured by the Spielbergers State-Trait Anxiety Inventory, and labor pain was measured by Visual Analogue Scale (VAS) at dilatation (4–5 cm) and 2 h after the first measurement. Data were analyzed using Chi-Square and t-test.ResultsIntervention group reported less pain at dilatation (4–5 cm) (p=0.001) and 2 h after the first measurement (p=0.001) than the control group. Stat anxiety was also lower in intervention group than the control group (p=0.003) at the entrance to labor room. Subjects in the control group required more induction compared to intervention group (p=0.003). Women in intervention group experienced shorter duration of the first phase of the labor than the control group (p=0.002). Also, the total duration of two stages of labor was shorter in intervention group than the control group (p=0.003).ConclusionsPracticing yoga during pregnancy may reduce women’s anxiety during labor; shorten labor stages, and lower labor pain.

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The Effect of Reflexology on Lactation in Women Who Had Cesarean Section: A Randomized Controlled Pilot Study

Complementary Medicine Research ◽

10.1159/000513924 ◽

2021 ◽

pp. 1-8

Author(s):

Sevde Aksu ◽

Pelin Palas Karaca

Keyword(s):

Pilot Study ◽

Cesarean Section ◽

Intervention Group ◽

Control Group ◽

Breast Pain ◽

Randomized Controlled ◽

Significant Difference ◽

The Right ◽

Documentation Tool ◽

And Control

Aim: The research was conducted as a randomized controlled pilot study to evaluate the effects of reflexology on lactation in mothers who delivered by cesarean section (CS). Methods: A single-blind randomized controlled experimental study was conducted with a total of 60 postpartum women in the reflexology application (n = 30) and control groups (n = 30). After the CS, the mothers in the control group were given approximately 3-h routine nursing care after recovering from the effects of anesthesia; the introductory information form was applied, and the Breastfeeding Charting System and Documentation Tool (LATCH) and visual analog scale (VAS) for the signs of the onset of lactation were implemented on the first and second days. Reflexology was applied to the women in the intervention group after an average of 3 h following the mother’s condition had become stable and she had recovered from the effects of anesthesia. Reflexology was applied a total of 20 min – 10 min for the right foot, 10 min for the left foot – twice a day with 8-h intervals on the first and second days after CS. After the last reflexology application, the LATCH and VAS for the signs of the onset of lactation were applied. Results: Of the women, 70% breastfed their babies within 60 min after delivery; 46.7% of the mothers received breastfeeding training and 81.7% needed support for breastfeeding after the CS. The LATCH breastfeeding scores of the women in the intervention group on both days were significantly higher compared to those of the women in the control group (p < 0.001). On the first day after the CS, apart from breast pain, there was no significant difference between the two groups in terms of breast heat and breast tension (p > 0.05). On the second day after the CS, apart from breast tension, there was no significant difference between the groups in terms of breast heat and breast pain (p < 0.05). In the study, women in the intervention group were found to have higher scores in terms of all three symptoms compared to the control group (p < 0.05). Conclusions: In the study, it was determined that LATCH scores and signs of the onset of breastfeeding increased in the mothers who received reflexology after CS.

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School-based obesity interventions in the metropolitan area of Rio De Janeiro, Brazil: pooled analysis from five randomised studies

British Journal Of Nutrition ◽

10.1017/s0007114521000076 ◽

2021 ◽

pp. 1-7

Author(s):

Renata da R. M. Rodrigues ◽

Bruna K. Hassan ◽

Michele R. Sgambato ◽

Bárbara da S. N. Souza ◽

Diana B. Cunha ◽

...

Keyword(s):

Eating Habits ◽

Intervention Group ◽

Pooled Analysis ◽

Control Group ◽

Intention To Treat ◽

School Year ◽

School Based ◽

Obesity Interventions ◽

The One ◽

And Control

Abstract School-based studies, despite the large number of studies conducted, have reported inconclusive results on obesity prevention. The sample size is a major constraint in such studies by requiring large samples. This pooled analysis overcomes this problem by analysing 5926 students (mean age 11·5 years) from five randomised school-based interventions. These studies focused on encouraging students to change their drinking and eating habits, and physical activities over the one school year, with monthly 1-h sessions in the classroom; culinary class aimed at developing cooking skills to increase healthy eating and attempts to family engagement. Pooled intention-to-treat analysis using linear mixed models accounted for school clusters. Control and intervention groups were balanced at baseline. The overall result was a non-significant change in BMI after one school year of positive changes in behaviours associated with obesity. Estimated mean BMI changed from 19·02 to 19·22 kg/m2 in the control group and from 19·08 to 19·32 kg/m2 in the intervention group (P value of change over time = 0·09). Subgroup analyses among those overweight or with obesity at baseline also did not show differences between intervention and control groups. The percentage of fat measured by bioimpedance indicated a small reduction in the control compared with intervention (P = 0·05). This large pooled analysis showed no effect on obesity measures, although promising results were observed about modifying behaviours associated with obesity.

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