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
BackgroundThe 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,...
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| Format: | Article |
| Language: | English |
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JMIR Publications
2020-11-01
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| Series: | JMIR Research Protocols |
| Online Access: | http://www.researchprotocols.org/2020/11/e24968/ |
| _version_ | 1818566161553424384 |
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| author | Adebowale, Taiwo O Taylor, Barry J Gray, Andrew R Galland, Barbara C Heath, Anne-Louise M Fortune, Sarah Meredith-Jones, Kim A Sullivan, Trudy McIntosh, Deborah Brosnan, Bradley Taylor, Rachael W |
| author_facet | Adebowale, Taiwo O Taylor, Barry J Gray, Andrew R Galland, Barbara C Heath, Anne-Louise M Fortune, Sarah Meredith-Jones, Kim A Sullivan, Trudy McIntosh, Deborah Brosnan, Bradley Taylor, Rachael W |
| author_sort | Adebowale, Taiwo O |
| collection | DOAJ |
| description | BackgroundThe 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.
ObjectiveThe 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.
MethodsWe 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).
ResultsThis 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.
ConclusionsLong-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 RegistrationClinicalTrials.gov NCT00892983; https://tinyurl.com/y3xepvxf
International Registered Report Identifier (IRRID)DERR1-10.2196/24968 |
| first_indexed | 2024-12-14T01:50:13Z |
| format | Article |
| id | doaj.art-758c3d8e589e47818f6091b66317b750 |
| institution | Directory Open Access Journal |
| issn | 1929-0748 |
| language | English |
| last_indexed | 2024-12-14T01:50:13Z |
| publishDate | 2020-11-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj.art-758c3d8e589e47818f6091b66317b7502022-12-21T23:21:24ZengJMIR PublicationsJMIR Research Protocols1929-07482020-11-01911e2496810.2196/24968Long-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 YearsAdebowale, Taiwo OTaylor, Barry JGray, Andrew RGalland, Barbara CHeath, Anne-Louise MFortune, SarahMeredith-Jones, Kim ASullivan, TrudyMcIntosh, DeborahBrosnan, BradleyTaylor, Rachael WBackgroundThe 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. ObjectiveThe 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. MethodsWe 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). ResultsThis 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. ConclusionsLong-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 RegistrationClinicalTrials.gov NCT00892983; https://tinyurl.com/y3xepvxf International Registered Report Identifier (IRRID)DERR1-10.2196/24968http://www.researchprotocols.org/2020/11/e24968/ |
| spellingShingle | Adebowale, Taiwo O Taylor, Barry J Gray, Andrew R Galland, Barbara C Heath, Anne-Louise M Fortune, Sarah Meredith-Jones, Kim A Sullivan, Trudy McIntosh, Deborah Brosnan, Bradley Taylor, Rachael W 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 JMIR Research Protocols |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | http://www.researchprotocols.org/2020/11/e24968/ |
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