scholarly journals Long-Term Follow-Up of a Randomized Controlled Trial to Reduce Excessive Weight Gain in Infancy: Protocol for the Prevention of Overweight in Infancy (POI) Follow-Up Study at 11 Years (Preprint)

2020 ◽  
Author(s):  
Taiwo O Adebowale ◽  
Barry J Taylor ◽  
Andrew R Gray ◽  
Barbara C Galland ◽  
Anne-Louise M Heath ◽  
...  
Keyword(s):  
Mental Health ◽  
Physical Activity ◽  
Controlled Trial ◽  
Electronic Media ◽  
Health And Wellbeing ◽  
Validated Questionnaires ◽  
Follow Up Study ◽  
Randomized Controlled

BACKGROUND The Prevention of Overweight in Infancy (POI) randomized controlled trial assessed the effect of a more conventional food, physical activity, and breastfeeding intervention, with a more novel sleep intervention on weight outcomes at 2 years of age. The trial had 58% uptake at recruitment, and retention was 86% at age 2 years, 77% at age 3.5 years, and 69% at age 5 years. Children who received the brief sleep intervention in infancy had just half the risk of obesity at 2 years of age compared to those who did not receive the sleep intervention. Importantly, this substantially reduced risk was still apparent at our follow-up at 5 years of age. OBJECTIVE The primary aim of this follow-up at age 11 years is to determine whether differences in BMI z-score and obesity risk remain apparent now that it is at least 9 years since cessation of the sleep intervention. Several secondary outcomes of interest will also be examined including 24-hour movement patterns, mental health and wellbeing, and use of electronic media, particularly prior to sleep. METHODS We will seek renewed consent from all 734 of the original 802 POI families who expressed interest in further involvement. Children and parent(s) will attend 2 clinics and 1 home appointment to obtain measures of anthropometry and body composition (dual-energy x-ray absorptiometry scan), 24-hour movement patterns (sleep, sedentary time, and physical activity measured using an AX3 accelerometer), mental health and wellbeing (validated questionnaires), family functioning (validated questionnaires), use of electronic media (wearable and stationary cameras, questionnaires), and diet and eating behaviors (24-hour recall, questionnaires). RESULTS This follow-up study has full ethical approval from the University of Otago Human Ethics Committee (H19/109) and was funded in May 2019 by the Health Research Council of New Zealand (grant 19/346). Data collection commenced in June 2020, and first results are expected to be submitted for publication in 2022. CONCLUSIONS Long-term outcomes of early obesity intervention are rare. Despite the growing body of evidence linking insufficient sleep with an increased risk of obesity in children, interventions targeting improvements in sleep have been insufficiently explored. Our initial follow-up at 5 years of age suggested that an early sleep intervention may have long-term benefits for effective weight management in children. Further analysis in our now preteen population will provide much-needed evidence regarding the long-term effectiveness of sleep interventions in infancy as an obesity prevention approach. CLINICALTRIAL ClinicalTrials.gov NCT00892983; https://tinyurl.com/y3xepvxf INTERNATIONAL REGISTERED REPORT DERR1-10.2196/24968

scholarly journals Long-Term Follow-Up of a Randomized Controlled Trial to Reduce Excessive Weight Gain in Infancy: Protocol for the Prevention of Overweight in Infancy (POI) Follow-Up Study at 11 Years

10.2196/24968 ◽  
2020 ◽  
Vol 9 (11) ◽  
pp. e24968
Author(s):  
Taiwo O Adebowale ◽  
Barry J Taylor ◽  
Andrew R Gray ◽  
Barbara C Galland ◽  
Anne-Louise M Heath ◽  
...  
Keyword(s):  
Mental Health ◽  
Physical Activity ◽  
Controlled Trial ◽  
Electronic Media ◽  
Health And Wellbeing ◽  
Validated Questionnaires ◽  
Follow Up Study ◽  
Randomized Controlled

Background The Prevention of Overweight in Infancy (POI) randomized controlled trial assessed the effect of a more conventional food, physical activity, and breastfeeding intervention, with a more novel sleep intervention on weight outcomes at 2 years of age. The trial had 58% uptake at recruitment, and retention was 86% at age 2 years, 77% at age 3.5 years, and 69% at age 5 years. Children who received the brief sleep intervention in infancy had just half the risk of obesity at 2 years of age compared to those who did not receive the sleep intervention. Importantly, this substantially reduced risk was still apparent at our follow-up at 5 years of age. Objective The primary aim of this follow-up at age 11 years is to determine whether differences in BMI z-score and obesity risk remain apparent now that it is at least 9 years since cessation of the sleep intervention. Several secondary outcomes of interest will also be examined including 24-hour movement patterns, mental health and wellbeing, and use of electronic media, particularly prior to sleep. Methods We will seek renewed consent from all 734 of the original 802 POI families who expressed interest in further involvement. Children and parent(s) will attend 2 clinics and 1 home appointment to obtain measures of anthropometry and body composition (dual-energy x-ray absorptiometry scan), 24-hour movement patterns (sleep, sedentary time, and physical activity measured using an AX3 accelerometer), mental health and wellbeing (validated questionnaires), family functioning (validated questionnaires), use of electronic media (wearable and stationary cameras, questionnaires), and diet and eating behaviors (24-hour recall, questionnaires). Results This follow-up study has full ethical approval from the University of Otago Human Ethics Committee (H19/109) and was funded in May 2019 by the Health Research Council of New Zealand (grant 19/346). Data collection commenced in June 2020, and first results are expected to be submitted for publication in 2022. Conclusions Long-term outcomes of early obesity intervention are rare. Despite the growing body of evidence linking insufficient sleep with an increased risk of obesity in children, interventions targeting improvements in sleep have been insufficiently explored. Our initial follow-up at 5 years of age suggested that an early sleep intervention may have long-term benefits for effective weight management in children. Further analysis in our now preteen population will provide much-needed evidence regarding the long-term effectiveness of sleep interventions in infancy as an obesity prevention approach. Trial Registration ClinicalTrials.gov NCT00892983; https://tinyurl.com/y3xepvxf International Registered Report Identifier (IRRID) DERR1-10.2196/24968

scholarly journals Immunoglobulins in Neonates with Rhesus Hemolytic Disease of the Fetus and Newborn: Long-Term Outcome in a Randomized Trial

2015 ◽  
Vol 39 (3) ◽  
pp. 209-213 ◽  
Author(s):  
Jeanine M.M. van Klink ◽  
Suzanne J. van Veen ◽  
Vivianne E.H.J. Smits-Wintjens ◽  
Irene T.M. Lindenburg ◽  
Monique Rijken ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Placebo Group ◽  
Controlled Trial ◽  
Neurodevelopmental Outcome ◽  
Hemolytic Disease ◽  
Follow Up Study ◽  
Randomized Controlled ◽  
Neurodevelopmental Impairment

Objective: Prophylactic intravenous immunoglobulin (IVIg) does neither reduce the need for exchange transfusion nor the rates of other adverse neonatal outcomes in neonates with rhesus hemolytic disease of the fetus and newborn (rhesus HDFN) according to our randomized controlled trial analysis. Our objective was to assess the long-term neurodevelopmental outcome in the children included in the trial and treated with either IVIg or placebo. Methods: All families of the children included in the trial were asked to participate in this follow-up study. The long-term neurodevelopmental outcome in children at least 2 years of age was assessed using standardized tests. The primary outcome was the incidence of neurodevelopmental impairment defined as at least one of the following: cerebral palsy, severe cognitive and/or motor developmental delay (with a test score of less than -2 SD), bilateral deafness or blindness. Results: Sixty-six of the 80 children (82.5%) who had been recruited to the initial randomized controlled trial participated in the follow-up study. The children were assessed at a median age of 4 years (range 2-7). The median cognitive score was 96 (range 68-118) in the IVIg group and 97 (range 66-118) in the placebo group (p = 0.79). There was no difference in the rate of neurodevelopmental impairment between the IVIg and the placebo group [3% (1/34) vs. 3% (1/32); p = 1.00]. Conclusions: The long-term neurodevelopmental outcome in children treated with IVIg was not different from that in children treated with placebo. Standardized long-term follow-up studies with large enough case series and sufficient power are needed to replicate these findings.

scholarly journals An Intervention With Dance and Yoga for Girls With Functional Abdominal Pain Disorders (Just in TIME): Protocol for a Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Anna Philipson ◽  
Stefan Särnblad ◽  
Lars Ekstav ◽  
Mats Eriksson ◽  
Ulrika L Fagerberg ◽  
...  
Keyword(s):  
Physical Activity ◽  
Abdominal Pain ◽  
Controlled Trial ◽  
Cost Effective ◽  
Just In Time ◽  
Negative Consequences ◽  
Functional Abdominal Pain ◽  
Randomized Controlled

BACKGROUND Functional abdominal pain disorders (FAPDs) affect many children worldwide, predominantly girls, and cause considerable long-term negative consequences for individuals and society. Evidence-based and cost-effective treatments are therefore strongly needed. Physical activity has shown promising effects in the practical management of FAPDs. Dance and yoga are both popular activities that have been shown to provide significant psychological and pain-related benefits with minimal risk. The activities complement each other, in that dance involves dynamic, rhythmic physical activity, while yoga enhances relaxation and focus. OBJECTIVE This study aims to evaluate the effects of a dance and yoga intervention among girls aged 9 to 13 years with FAPDs. METHODS The study is a prospective randomized controlled trial among girls aged 9 to 13 years with functional abdominal pain, irritable bowel syndrome, or both. The target sample size was 150 girls randomized into 2 arms: an intervention arm that receives dance and yoga sessions twice weekly for 8 months and a control arm that receives standard care. Outcomes will be measured at baseline and after 4, 8, 12, and 24 months, and long-term follow-up will be conducted 5 years from baseline. Questionnaires, interviews, and biomarker measures, such as cortisol in saliva and fecal microbiota, will be used. The primary outcome is the proportion of girls in each group with reduced pain, as measured by the faces pain scale-revised in a pain diary, immediately after the intervention. Secondary outcomes are gastrointestinal symptoms, general health, mental health, stress, and physical activity. The study also includes qualitative evaluations and health economic analyses. This study was approved by the Regional Ethical Review Board in Uppsala (No. 2016/082 1-2). RESULTS Data collection began in October 2016. The intervention has been performed in 3 periods from 2016 through 2019. The final 5-year follow-up is anticipated to be completed by fall 2023. CONCLUSIONS Cost-effective and easily accessible interventions are warranted to reduce the negative consequences arising from FAPDs in young girls. Physical activity is an effective strategy, but intervention studies are needed to better understand what types of activities facilitate regular participation in this target group. The Just in TIME (Try, Identify, Move, and Enjoy) study will provide insights regarding the effectiveness of dance and yoga and is anticipated to contribute to the challenging work of reducing the burden of FAPDs for young girls. CLINICALTRIAL ClinicalTrials.gov (NCT02920268); https://clinicaltrials.gov/ct2/show/NCT02920268 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19748

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