Dataset Information

Effectiveness of home based early intervention on children's BMI at age 2: randomised controlled trial.

ABSTRACT:

Objective

To assess the effectiveness of a home based early intervention on children's body mass index (BMI) at age 2.

Design

Randomised controlled trial.

Setting

The Healthy Beginnings Trial was conducted in socially and economically disadvantaged areas of Sydney, Australia, during 2007-10.

Participants

667 first time mothers and their infants.

Intervention

Eight home visits from specially trained community nurses delivering a staged home based intervention, one in the antenatal period, and seven at 1, 3, 5, 9, 12, 18 and 24 months after birth. Timing of the visits was designed to coincide with early childhood developmental milestones.

Main outcome measures

The primary outcome was children's BMI (the healthy BMI ranges for children aged 2 are 14.12-18.41 for boys and 13.90-18.02 for girls). Secondary outcomes included infant feeding practices and TV viewing time when children were aged 2, according to a modified research protocol. The data collectors and data entry staff were blinded to treatment allocation, but the participating mothers were not blinded.

Results

497 mothers and their children (75%) completed the trial. An intention to treat analysis in all 667 participants recruited, and multiple imputation of BMI for the 170 lost to follow-up and the 14 missing, showed that mean BMI was significantly lower in the intervention group (16.53) than in the control group (16.82), with a difference of 0.29 (95% confidence interval -0.55 to -0.02; P=0.04).

Conclusions

The home based early intervention delivered by trained community nurses was effective in reducing mean BMI for children at age 2.

Trial registration

Australian Clinical Trial Registry No 12607000168459.

SUBMITTER: Wen LM

PROVIDER: S-EPMC3383864 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:ObjectivesAs parents of young children are often unaware their child is overweight, screening provides the opportunity to inform parents and provide the impetus for behaviour change. We aimed to determine if parents could recall and understand the information they received about their overweight child after weight screening.DesignRandomised controlled trial of different methods of feedback.SettingParticipants were recruited through primary and secondary care but appointments took place at a University research clinic.Participants and intervention1093 children aged 4-8?years were screened. Only overweight children (n=271, 24.7%) are included in this study. Parents of overweight children were randomised to receive feedback regarding their child's weight using best practice care (BPC) or motivational interviewing (MI) at face-to-face interviews typically lasting 20-40?min. 244 (90%) parents participated in a follow-up interview 2?weeks later to assess recall and understanding of information from the feedback session.Primary and secondary outcome measuresInterviews were audio-taped and transcribed verbatim before coding for amount and accuracy of recall. Scores were calculated for total recall and sub-categories of interest.ResultsOverall, 39% of the information was recalled (mean score 6.3 from possible score of 16). Parents given feedback via BPC recalled more than those in the MI group (difference in total score 0.48; 95% CI 0.05 to 0.92). Although 94% of parents were able to correctly recall their child's weight status, fewer than 10 parents could accurately describe what the measurements meant. Maternal education (0.81; 0.25 to 1.37) and parental ratings of how useful they found the information (0.19; 0.04 to 0.35) were significant predictors of recall score in multivariate analyses.ConclusionsWhile parents remember that their child's body mass index is higher than recommended, they are unable to remember much of the information and advice provided about the result.Trial registration numberAustralian New Zealand Clinical Trials Registry ACTRN12609000749202.

Project description:BackgroundYoung children with developmental disabilities and delays spend significant amounts of time at home, show decreased participation in home-based activities, and receive home-based early intervention services to improve participation in activities. Yet, knowledge about the relationship between EI service use and children's home participation in activities remains poorly understood but needed for program improvement. The purpose of this study was to understand the relationships between EI service use and children's home participation.MethodsIn a cross-sectional design, data were gathered from caregivers (N = 139) who enrolled in a pilot trial of the Young Children's Participation in Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO), as implemented within 1 month of their child's next EI progress evaluation. A series of path analytic models were used to estimate EI service intensity as a predictor of parent-reported young children's home participation 1) frequency, 2) level of involvement, and 3) desired change, adjusting for family and child social and functional characteristics. Models included caregiver perceptions of home environmental support to test its indirect (i.e., mediation) effects on the relationship between EI service intensity and each of the three home participation dimensions.ResultsAll three models fit the data well (comparative fit index = 1.00). EI service intensity was not a significant predictor of participation frequency. However, EI service intensity had a significant direct effect on a child's participation according to level of involvement and desired change, explaining between 13.3-33.5% of the variance in home participation. Caregiver perceptions of environmental support had a small yet significant indirect effect on the relationship between EI service intensity and level of involvement and desired change; these models explained between 18.5-38.1% of the variance in home participation.ConclusionsEI service intensity has important links with involvement in and desired change for home-based activities. Caregiver perceptions of environmental support appears to be a factor in the relationship between EI service intensity and home participation. Results warrant longitudinal replication with a control group, which would be possible with the implementation of the YC-PEM e-PRO in a routine EI clinical workflow.Trial retrospectively registeredNCT03904797 .

Project description:BackgroundIt is unknown if and how children's movement behaviour accumulation patterns change as a result of physical activity and/or sedentary behaviour interventions. It is important to establish the effectiveness of interventions targeting changes in such accumulation patterns. This study aimed to investigate the effect of the Transform-Us! school- and home-based intervention program on children's movement behaviour accumulation patterns, focusing on sporadic accumulation versus time in bouts.MethodsBaseline and post-intervention (18 months) accelerometer data from the Transform-Us! 2 × 2 factorial design cluster randomised controlled trial was used (Melbourne, 2010-2012; analytical sample n = 267; aged 8-9 years). Linear mixed models were fitted to examine effects of three different interventions (targeting increases in physical activity [PA-I], reductions in sedentary time [SB-I], or both [PA + SB-I]) compared to a usual practice (control) group on post-intervention movement behaviour accumulation compositions with eight components, including sporadic time and bouts of sedentary time, and light-, moderate- and vigorous-intensity physical activity.ResultsIntervention effects on distribution of time in the post-intervention waking movement behaviour accumulation composition (adjusted for baseline composition) were small and not significant. However, visual inspection of the change in compositions over time revealed that only groups with a sedentary behaviour intervention component (SB-I and PA + SB-I) reduced time in sedentary bouts, compared to the overall sample compositional mean. In addition, the SB-I group was the only group with an increase in vigorous-intensity physical activity. The combined intervention group (PA + SB-I) was characterized by the largest proportional increase in MPA bouts. The usual practice group was characterized by the largest proportional increases in both sporadic and bouts of sedentary time.ConclusionsThis study showed some early evidence to suggest that the "break up your sitting" message may result in greater impact than the "move more" message. Future research, including larger sample sizes, should investigate if this type of messaging is indeed more effective in changing movement behaviours and ultimately child health.Trial registrationInternational Standard Randomized Controlled Trial Number ISRCTN83725066 ; Australian New Zealand Clinical Trials Registry Number ACTRN12609000715279 .

Project description:BACKGROUND:Road traffic accidents (RTAs) are the leading health threat to children in Europe, resulting in 355,000 injuries annually. Because children can suffer significant and long-term mental health problems following RTAs, there is considerable interest in the development of early psychological interventions. To date, the research in this field is scarce, and currently no evidence-based recommendations can be made. METHODS:To evaluate the effectiveness of a single-session early psychological intervention, 99 children age 7-16 were randomly assigned to an intervention or control group. The manualised intervention was provided to the child and at least one parent around 10 days after the child's involvement in an RTA. It included reconstruction of the accident using drawings and accident-related toys, and psychoeducation. All of the children were interviewed at 10 days, 2 months and 6 months after the accident. Parents filled in questionnaires. Standardised instruments were used to assess acute stress disorder (ASD), posttraumatic stress disorder (PTSD), depressive symptoms and behavioural problems. RESULTS:The children of the two study groups showed no significant differences concerning posttraumatic symptoms and other outcome variables at 2 or at 6 months. Interestingly, analyses showed a significant intervention x age-group effect, indicating that for preadolescent children the intervention was effective in decreasing depressive symptoms and behavioural problems. CONCLUSIONS:This study is the first to show a beneficial effect of a single-session early psychological intervention after RTA in preadolescent children. Therefore, an age-specific approach in an early stage after RTAs may be a promising way for further research. Younger children can benefit from the intervention evaluated here. However, these results have to be interpreted with caution, because of small subgroup sizes. Future studies are needed to examine specific approaches for children and adolescents. Also, the intervention evaluated here needs to be studied in other groups of traumatised children. TRIAL REGISTRATION: CLINICAL TRIAL REGISTRY:ClinicalTrials.gov: NCT00296842.

Project description:To improve adherence to physical activity (PA), behavioural support in the form of behavioural change counselling may be necessary. However, limited evidence of the effectiveness of home-based PA combined with counselling in breast cancer patients exists. The aim of this current randomised controlled trial with a parallel group design was to evaluate the effectiveness of a home-based PA intervention on PA levels, anthropometric measures, health-related quality of life (HRQoL), and blood biomarkers in breast cancer survivors.Eighty post-adjuvant therapy invasive breast cancer patients (age = 53.6 ± 9.4 years; height = 161.2 ± 6.8 cm; mass = 68.7 ± 10.5 kg) were randomly allocated to a 6-month home-based PA intervention or usual care. The intervention group received face-to-face and telephone PA counselling aimed at encouraging the achievement of current recommended PA guidelines. All patients were evaluated for our primary outcome, PA (International PA Questionnaire) and secondary outcomes, mass, BMI, body fat %, HRQoL (Functional assessment of Cancer Therapy-Breast), insulin resistance, triglycerides (TG) and total (TC), high-density lipoprotein (HDL-C) and low-density lipoprotein (LDL-C) cholesterol were assessed at baseline and at 6-months.On the basis of linear mixed-model analyses adjusted for baseline values performed on 40 patients in each group, total, leisure and vigorous PA significantly increased from baseline to post-intervention in the intervention compared to usual care (between-group differences, 578.5 MET-min?wk(-1), p =?.024, 382.2 MET-min?wk(-1), p =?.010, and 264.1 MET-min?wk(-1), p =?.007, respectively). Both body mass and BMI decreased significantly in the intervention compared to usual care (between-group differences, -1.6 kg, p =?.040, and -.6 kg/m(2), p =?.020, respectively). Of the HRQoL variables, FACT-Breast, Trial Outcome Index, functional wellbeing, and breast cancer subscale improved significantly in the PA group compared to the usual care group (between-group differences, 5.1, p =?.024; 5.6, p =?.001; 1.9 p =?.025; and 2.8, p =?.007, respectively). Finally, TC and LDL-C was significantly reduced in the PA group compared to the usual care group (between-group differences, -.38 mmol?L(-1), p =?.001; and -.3 mmol?L(-1), p =?.023, respectively).We found that home-based PA resulted in significant albeit small to moderate improvements in self-reported PA, mass, BMI, breast cancer specific HRQoL, and TC and LDL-C compared with usual care. CLINICALTRIALS.NCT02408107 (March 25, 2015).

Project description:ObjectivesTo evaluate the impact of a multicomponent intervention (Stand More AT (SMArT) Work) designed to reduce sitting time on short (three months), medium (six months), and longer term (12 months) changes in occupational, daily, and prolonged sitting, standing, and physical activity, and physical, psychological, and work related health.DesignCluster two arm randomised controlled trial.SettingNational Health Service trust, England.Participants37 office clusters (146 participants) of desk based workers: 19 clusters (77 participants) were randomised to the intervention and 18 (69 participants) to control.InterventionsThe intervention group received a height adjustable workstation, a brief seminar with supporting leaflet, workstation instructions with sitting and standing targets, feedback on sitting and physical activity at three time points, posters, action planning and goal setting booklet, self monitoring and prompt tool, and coaching sessions (month 1 and every three months thereafter). The control group continued with usual practice.Main outcome measuresThe primary outcome was occupational sitting time (thigh worn accelerometer). Secondary outcomes were objectively measured daily sitting, prolonged sitting (?30 minutes), and standing time, physical activity, musculoskeletal problems, self reported work related health (job performance, job satisfaction, work engagement, occupational fatigue, sickness presenteeism, and sickness absenteeism), cognitive function, and self reported psychological measures (mood and affective states, quality of life) assessed at 3, 6, and 12 months. Data were analysed using generalised estimating equation models, accounting for clustering.ResultsA significant difference between groups (in favour of the intervention group) was found in occupational sitting time at 12 months (-83.28 min/workday, 95% confidence interval -116.57 to -49.98, P=0.001). Differences between groups (in favour of the intervention group compared with control) were observed for occupational sitting time at three months (-50.62 min/workday, -78.71 to -22.54, P<0.001) and six months (-64.40 min/workday, -97.31 to -31.50, P<0.001) and daily sitting time at six months (-59.32 min/day, -88.40 to -30.25, P<0.001) and 12 months (-82.39 min/day, -114.54 to -50.26, P=0.001). Group differences (in favour of the intervention group compared with control) were found for prolonged sitting time, standing time, job performance, work engagement, occupational fatigue, sickness presenteeism, daily anxiety, and quality of life. No differences were seen for sickness absenteeism.ConclusionsSMArT Work successfully reduced sitting time over the short, medium, and longer term, and positive changes were observed in work related and psychological health.Trial registrationCurrent Controlled Trials ISRCTN10967042.

Project description:BackgroundInterventions are needed to reduce poor perinatal health. We trained community health workers (CHWs) as home visitors to address maternal/infant risks.MethodsIn a cluster randomised controlled trial in Cape Town townships, neighbourhoods were randomised within matched pairs to 1) the control, healthcare at clinics (n?=?12 neighbourhoods; n?=?594 women), or 2) a home visiting intervention by CBW trained in cognitive-behavioural strategies to address health risks (by the Philani Maternal, Child Health and Nutrition Programme), in addition to clinic care (n?=?12 neighbourhoods; n?=?644 women). Participants were assessed during pregnancy (2% refusal) and 92% were reassessed at two weeks post-birth, 88% at six months and 84% at 18 months later. We analysed 32 measures of maternal/infant well-being over the 18 month follow-up period using longitudinal random effects regressions. A binomial test for correlated outcomes evaluated overall effectiveness over time. The 18 month post-birth assessment outcomes also were examined alone and as a function of the number of home visits received.ResultsBenefits were found on 7 of 32 measures of outcomes, resulting in significant overall benefits for the intervention compared to the control when using the binomial test (p?=?0.008); nevertheless, no effects were observed when only the 18 month outcomes were analyzed. Benefits on individual outcomes were related to the number of home visits received. Among women living with HIV, intervention mothers were more likely to implement the PMTCT regimens, use condoms during all sexual episodes (OR?=?1.25; p?=?0.014), have infants with healthy weight-for-age measurements (OR?=?1.42; p?=?0.045), height-for-age measurements (OR?=?1.13, p<0.001), breastfeed exclusively for six months (OR?=?3.59; p<0.001), and breastfeed longer (OR?=?3.08; p<0.001). Number of visits was positively associated with infant birth weight ?2500 grams (OR?=?1.07; p?=?0.012), healthy head-circumference-for-age measurements at 6 months (OR?=?1.09, p?=?0.017), and improved cognitive development at 18 months (OR?=?1.02, p?=?0.048).ConclusionsHome visits to neighbourhood mothers by CHWs may be a feasible strategy for enhancing maternal/child outcomes. However, visits likely must extend over several years for persistent benefits.Trial registrationClinicalTrials.gov NCT00996528.

Project description:OBJECTIVES:Delivery of interventions via smartphone is a relatively new initiative in public health, and limited evidence exists regarding optimal strategies for recruitment. We describe the effectiveness of approaches used to recruit participants to a smartphone-enabled nutrition intervention trial. METHODS:Internet and social media advertising, mainstream media advertising and research team networks were used to recruit New Zealand adults to a fully automated smartphone-delivered nutrition labelling trial (no face-to-face visits were required). Recruitment of M?ori and Pacific participants was a key focus and ethically relevant recruitment materials and approaches were used where possible. The effectiveness of recruitment strategies was evaluated using Google Analytics, monitoring of study website registrations and randomisations, and self-reported participant data. The cost of the various strategies and associations with participant demographics were assessed. RESULTS:Over a period of 13 months, there were 2448 registrations on the study website, and 1357 eligible individuals were randomised into the study (55%). Facebook campaigns were the most successful recruitment strategy overall (43% of all randomised participants) and for all ethnic groups (M?ori 44%, Pacific 44% and other 43%). Significant associations were observed between recruitment strategy and age (p<0.001), household size (p<0.001), ethnicity (p<0.001), gender (p=0.005) and interest in healthy eating (p=0.022). Facebook campaigns resulted in the highest absolute numbers of study registrations and randomisations (966 and 584, respectively). Network strategies and Facebook campaigns cost least per randomised participant (NZ$4 and NZ$5, respectively), whereas radio advertising costs most (NZ$179 per participant). CONCLUSION:Internet and social media advertising were the most effective and least costly approaches to recruiting participants to a smartphone-delivered trial. These approaches also reached diverse ethnic groups. However, more culturally appropriate recruitment strategies are likely to be necessary in studies where large numbers of participants from specific ethnic groups are sought. TRIAL REGISTRATION:ACTRN12614000644662; Post-results.