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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.

ABSTRACT: 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.

SUBMITTER: Adebowale TO

PROVIDER: S-EPMC7735907 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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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.

Adebowale Taiwo O TO Taylor Barry J BJ Gray Andrew R AR Galland Barbara C BC Heath Anne-Louise M AM Fortune Sarah S Meredith-Jones Kim A KA Sullivan Trudy T McIntosh Deborah D Brosnan Bradley B Taylor Rachael W RW

JMIR research protocols 20201130 11

<h4>Background</h4>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 ...[more]

PMID: 33252344

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Project description:BACKGROUND:The Prevention of Overweight in Infancy (POI) study was a four-arm randomised controlled trial (RCT) in 802 families which assessed whether additional education and support on sleep (Sleep group); food, physical activity and breastfeeding (FAB group); or both (Combination group), reduced excessive weight gain from birth to 2 years of age, compared to usual care (Control group). The study had high uptake at recruitment (58 %) and retention at 2 years (86 %). Although the FAB intervention produced no significant effect on BMI or weight status at 2 years, the odds of obesity were halved in those who received the sleep intervention, despite no apparent effect on sleep duration. We speculate that enhanced self-regulatory behaviours may exist in the Sleep group. Self-regulation was not measured in our initial intervention, but extensive measures have been included in this follow-up study. Thus, the overall aim of the POI follow-up is to determine the extent to which augmented parental support and education on infant sleep, feeding, diet, and physical activity in the first 2 years of life reduces BMI at 3.5 and 5 years of age, and to determine the role of self-regulation in any such relationship. METHODS/DESIGN:We will contact all 802 families and seek renewed consent to participate in the follow-up study. The families have received no POI intervention since the RCT finished at 2 years of age. Follow-up data collection will occur when the children are aged 3.5 and 5 years (i.e. up to 3 years post-intervention). Outcomes of interest include child anthropometry, body composition (DXA scan), diet (validated food frequency questionnaire), physical activity (accelerometry), sleep (questionnaire and accelerometry), and self-regulation (questionnaires and neuropsychological assessment). DISCUSSION:Our follow-up study has been designed primarily to enable us to determine whether the intriguing benefit of the sleep intervention suggested at 2 years of age remains as children approach school age. However, cohort analyses will also investigate how BMI, self-regulation, and sleep consolidation develop during the early years. This information will be valuable to researchers and policy makers progressing the field of early childhood obesity prevention. TRIAL REGISTRATION:ClinicalTrials.gov number NCT00892983 .

Project description:Rapid weight gain in infancy increases the risk of developing obesity early in life and contributes significantly to racial and ethnic disparities in childhood obesity. While maternal perceived stress is associated with childhood obesity, little is known about the impact it has on infant weight gain. Therefore, this study explores the impact of maternal perceived stress on change in weight-for-length (WFL) z-scores and the risk of rapid weight gain in infancy. We conducted a secondary data analysis of the longitudinal Nurture birth cohort (n = 666). Most mothers in the cohort were non-Hispanic/Latinx Black (71.6%). About one-half of mothers had a body mass index (BMI) greater than 25 prior to pregnancy, were unemployed, and had a low income. Most infants in the cohort were born full-term and were of normal weight. Data were collected at 3-, 6-, 9-, and 12-months postpartum. At each assessment, mothers completed the Cohen's Perceived Stress Scale (PSS), and research assistants weighed and measured each infant. Tertiles were used to compare mothers with high and low perceived stress. A mixed model analysis of repeated measures assessed the associations between baseline perceived stress and the change in infant WFL z-scores over time. Log-binomial models assessed the association between baseline perceived stress and rapid weight gain, defined as a change in WFL z-score > 0.67 standard deviations from three to twelve months. Just under one-half of the infants (47%) experienced rapid weight gain between three and twelve months of age. Birthweight for gestational age (RR = 1.18, 95% CI = 1.08-1.29, p-value = 0.004), gestational age at birth (RR = 1.07, 95% CI = 1.01-1.14, p-value = 0.031), and weeks breastfed (0.99, 95% CI 0.99-1.00, p-value 0.044) were associated with risk of rapid weight gain in unadjusted analyses. WFL z-scores increased significantly over time, with no effect of perceived stress on change in WFL z-score or risk of rapid weight gain. Rapid weight gain in infancy was prevalent in this sample of predominately Black infants in the Southeastern US. We did not find evidence to support the hypothesis that maternal perceived stress influenced the risk of rapid weight gain. More work is needed to identify and assess the risk factors for rapid weight gain in infancy and to understand the role that maternal stress plays in the risk of childhood obesity so that prevention efforts can be targeted.

Project description:Excessive gestational weight gain (GWG) is associated with elevated weight retention in mothers and might be related to adiposity of their offspring. Little is known if lifestyle intervention during pregnancy has beneficial effects for mothers and children beyond gestation.A cluster-randomized controlled intervention trial was performed with 250 pregnant women in 8 gynaecological practices. Lifestyle intervention was carried out twice with individual counselling sessions on nutrition, physical activity and weight monitoring. Participants in the control group received routine prenatal care and an information leaflet. Follow-up data of women and their offspring were collected one year postpartum (pp) by phone call and/or via e-mail using a structured questionnaire. Maternal weight retention at 12 months pp and weight development of the children in their first year of life was compared between groups using linear regression. The association between energy and macronutrient intake during pregnancy with maternal weight retention and children weight development was also assessed.The intervention resulted in a trend towards lower mean weight retention 12 months pp (0.2 vs. 0.8 kg), but was not statistically significant (p = 0.321). Among women receiving lifestyle counselling, only 8% retained more than 5 kg weight while 17% in the control group retained >5 kg (OR: 0.40 (95% CI: 0.16, 0.97)). For the whole study cohort, an association between higher GWG and increased 12 month weight retention was found (0.4 kg weight retention per 1 kg increase in GWG, p < 0.001). Weight development of the infants did not differ between groups in the first months after birth. At the 10th-12th month weight measurement, infants born to mothers in the intervention group tended towards lower body weights. Both energy intake and macronutrient composition of the diet during pregnancy did not affect maternal weight retention and weight development of the infants.Lifestyle counselling during pregnancy to avoid GWG had a rather modest effect on maternal pp weight retention and weight development of the infants. However, larger intervention studies and longer follow-up are required to be able to draw definite conclusions.German Clinical Trials Register DRKS00003801.

Project description:BackgroundExcessive gestational weight gain is associated with adverse infant, childhood and maternal outcomes and research to develop interventions to address this issue is ongoing. The views of women on gestational weight gain and the resources they would consider helpful in addressing this are however largely unknown. This survey aimed to determine the views of newly pregnant women, living in areas of social disadvantage, on 1) their current body weight and potential gestational weight gain and 2) the resources or interventions they would consider helpful in preventing excessive gestational weight gain.MethodsA convenience sample of overweight and obese pregnant women living in Fife, UK, were invited to complete a short anonymised questionnaire at their 12 week booking visit.Results428 women, BMI>25 kg/m(2), completed the questionnaire. Fifty-four per cent of respondents were obese (231) and 62% were living in areas of mild to moderate deprivation. Over three-quarters of participants felt dissatisfied with their current weight (81%). The majority of women (60%) expressed some concern about potential weight gain. Thirty-nine percent were unconcerned about weight gain during their pregnancy, including 34 women (19%) who reported having retained weight gained in earlier pregnancies. Amongst those concerned about weight gain advice on physical activity (41%) and access to sports/leisure facilities were favoured resources (36%). Fewer women (12%) felt that group sessions on healthy eating or attending a clinic for individualised advice (14%) would be helpful. "Getting time off work" was the most frequently cited barrier (48%) to uptake of resources other than leaflets.ConclusionsThese data suggest a lack of awareness amongst overweight and obese women regarding excessive gestational weight gain. Monitoring of gestational weight gain, and approaches for its management, should be formally integrated into routine antenatal care. Barriers to the uptake of resources to address weight gain are numerous and must be considered in the design of future interventions and services.

Project description:BackgroundRapid infant weight gain (RIWG) is a very strong predictor of childhood overweight and obesity (COO). Socioeconomic position (SEP) is also related to the risk of COO and parents of different SEP may differ in their reaction to accelerated infant weight gain. Together this could lead to differences in how weight gain and COO risk relate across SEP. This study aimed to analyse possible interaction of SEP and RIWG on COO risk.MethodsA register-based longitudinal cohort study followed 19,894 healthy, term infants, born in Denmark between December 2011 and May 2015. Logistic regression models were used to estimate odds ratios (OR) of COO risk at 2 years (22-26 months) of age with 95% confidence intervals (95% CI) for categories of infancy weight gain based on changes in weight-for-age z-scores between 0 and 8-10 months of age (slow (<- 0.67), mean (- 0.67-0.67), rapid (> 0.67-1.34) and very rapid (> 1.34)). Possible multiplicative and additive interaction of SEP (based on household income and maternal education) on the relationship between infancy weight gain and COO were analysed.ResultsIn total, 19.1 and 15.1% experienced rapid or very rapid weight gain, respectively, and 1497 (7.5%) children were classified with COO at follow-up. These prevalences were higher in those with lower levels of SEP. Adjusted OR for COO were 3.09 (95% CI [2.66-3.59]) and 7.58 (95% CI [6.51-8.83]) for rapid and very rapid weight gain, respectively, when household income was included in the model. Results were similar in the model including maternal education. No signs of interactions were detected on a multiplicative scale. Weak signs of additive interaction were present, but these values did not reach significance.ConclusionBoth rapid and very rapid weight gain were associated with substantially higher risks of COO but these associations were not modified by SEP. This indicates that promotion of healthy weight gain should take place in all population groups irrespective of their SEP.

Project description:BackgroundExcessive weight gain during pregnancy and subsequent postpartum weight retention may contribute to the epidemic of obesity among women of childbearing age. Preventing excessive gestational weight gain (GWG) to optimize maternal, fetal and infant wellbeing is therefore of great importance. A number of dietary interventions in this area has been conducted with inconsistent results, which has made it difficult to identify effective strategies to prevent excessive weight gain during pregnancy among normal weight, overweight and obese women. The primary objective of this review was to evaluate the effect of dietary interventions for reducing GWG. The secondary objective was to examine the impact of these interventions on different child and maternal health outcomes.MethodThe PUBMED, the Cochrane Central Register of Controlled Trials (CENTRAL) and the LILACS databases were searched for relevant articles. All published randomized controlled trials (RCT) and quasi-randomized controlled trials (QCT), with concurrent controls, on dietary interventions during pregnancy were considered. Results were presented using relative risk (RR) for categorical data and weighted mean difference (WMD) for continuous data. Data were primarily analyzed with a fixed-effect model and a random-effects model was used in the presence of heterogeneity. No date and language restrictions were applied.ResultsIn total, 13 studies were included in this review and 10 trials contributed data on total GWG. Dietary intervention significantly reduced total GWG (n = 1434; WMD = -1.92 kg; 95% CI = -3.65/-0.19; p = 0.03), weight retention at six months postpartum (n = 443; WMD = -1.90 kg; 95% CI = -2.69/-1.12; p < 0.0001) and incidence of cesarean section (n = 609; RR = 0.75; 95% CI = 0.60/0.94; p = 0.013). However, dietary intervention had no significant effect on weight retention at six weeks postpartum, birth weight, preeclampsia, gestational diabetes and preterm birth.ConclusionDietary advice during pregnancy appears effective in decreasing total GWG and long-term postpartum weight retention, but so far there is limited evidence for further benefits on infant and maternal health.

Dataset Information

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.

Publications

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.

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