A Review of Registered Randomized Controlled Trials for the Prevention of Obesity in Infancy
Abstract
:1. Introduction
2. Methods
2.1. Search Strategy
2.2. Data Extraction
2.3. Quality Assessment
2.4. Data Synthesis
3. Results
3.1. Intervention Characteristics
3.2. Intervention Components/Content
3.3. Target Populations
3.4. Theoretic Basis of Trials
3.5. Funding Sources
3.6. Cost Effectiveness Data
3.7. Biomarkers
3.8. Weight Related Outcomes
3.9. Secondary Outcomes
3.10. Risk of Bias Assessment
4. Discussion
5. Limitations
6. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Registration No | Trial Name/Acronym | Author, Year | Country | Study Design | Number Randomized | Intervention Commencement | Duration of Follow Up | |
---|---|---|---|---|---|---|---|---|
1. | ACTRN12607000168459 | Healthy Beginnings | Wen, 2012 [22] Wen, 2015 [34] | Australia | RCT | N = 667 | Antenatally | Birth until 5 years |
2. | ISRCTN81847050 | InFANT | Campbell, 2013 [23] Hesketh, 2020 [35] | Australia | Cluster RCT | N = 542 | Mean 3.8 months | 4 months until 5 years |
3. | ACTRN12608000056392 | NOURISH | Daniels, 2013 [24] Daniels, 2015 [36] | Australia | RCT | N = 698 | Child age 4 months | 4 months until 5 years |
4. | NCT00756626 | FYCS | Bonuck, 2013 [25] | USA | RCT | N = 300 | 12 months of age | 12 months until 24 months |
5. | NCT00892983 | POI.nz | Taylor, 2016 [26] Taylor, 2018 [37] | New Zealand | 2 × 2 factorial RCT | N = 802 | Antenatally | Birth until 5 years |
6. | NTR1831 | BeeBOFT | van Grieken, 2017 [27] | Netherlands | Cluster RCT | N = 2102 | 1 month of age | 1 month to 36 months |
7. | NCT01040897 | GREENLIGHT | Sanders, 2014 [38] | USA | RCT | N = 865 | Child age 2 months | 5 months to 2 years |
8. | NCT03370445 | Health Literacy and Numeracy | Cruzatt, 2017 [39] | USA | RCT | N = 450 * | Child age 2 months | 2 months to 5 years |
9. | NCT01167270 | INSIGHT | Savage, 2016 [28] Adams, 2018 [40] Paul, 2018 [41] | USA | RCT | N = 279 | Child age 1–2 weeks | 1–2 weeks to 3 years |
10. | NCT01198847 | Early STOPP | Sobko, 2011 [42] | Sweden | RCT | N = 200 | Child age 1 year | 1 year to 6 years |
11. | ACTRN12611000386932 | INFANT Extend | Campbell, 2016 [43] | Australia | Cluster RCT | N = 540 | Child age 3 months | 3 months to 36 months |
12. | NCT01541761 | Starting Early Obesity Prevention Program | Messito, 2017 [44] | USA | RCT | N = 533 | Antenatally | Birth to 3 years |
13. | NCT01649115 | HLPP | Reddy, 2012 [45] | USA | RCT | N = 150 | Antenatally | Birth to 5 years |
14. | ACTRN12612001133820 | Baby-led introduction to solids (BLISS) | Taylor, 2017 [29] | New Zealand | RCT | N = 206 | Antenatally | Birth to 24 months |
15. | NCT01905072 | Preventing Childhood Obesity through Early Guidance | Reifsnider, 2013 [46] Reifsnider, 2018 [47] | USA | RCT | N = 140 | Antenatally | 1 week to 3 years |
16. | ISRCTN16991919 | PRIMROSE | Doring, 2016 [30] | Sweden | Cluster RCT | N = 1369 | Child age 9–10 months | 9–10 months to 4 years |
17. | PMC4442409 | Early Obesity Prevention | Schroeder, 2015 [31] | USA | Cluster RCT | N = 232 | Paediatric visit at 1 month of age | 1 months to 5 years |
18. | ACTRN12616001470482 | CHAT | Wen, 2017 [48] | Australia | RCT (3 arm) | N = 1056 | Antenatally | Birth to 1 year |
19. | NCT03077425 | CHALO | Karasz, 2018 [49] | USA | RCT | N = 360 | Home visits at 6 months of age | 6 months to 18 months |
20. | NCT03131284 | Prevention of Obesity in Toddlers (PROBIT) Trial | Morandi, 2019 [32] | Italy | RCT | N = 529 | First 2 weeks of life | Newborn to 2 years of age |
21. | NL6727 (NTR6938) | Samen Happie! | Karssen, 2017 [50] | Netherlands | RCT | N = 300 * | 7–11 months | 7–11 months until 4 years |
22. | NCT03334266 | Family Spirit Nurture, Prenatal–18 Months | Ingalls, 2019 [51] | USA | RCT | N = 338 * | Antenatally | Birth to 24 months |
23. | NCT03348176 | Baby’s First Bites | Van der Veek, 2019 [52] | Netherlands | RCT factorial | N = 240 | Child age 4 months | 4 months until 36 months |
24. | NCT03399617 | SPOON: Guatemala | Gonzalez-Acero, 2018 [53] | Guatemala | RCT | N = 1500 * | 0–6 months | 0–6 months until 24 months |
25. | NCT03438721 | Strong Futures | Beck, 2018 [54] | USA | RCT | N = 240 * | Child age 2 weeks | 2 weeks until 24 months |
26. | NCT03444415 | PROGESPI | Perez-Lopez, 2018 [55] | Spain | Cluster RCT | N = 414 * | Antenatally | Birth to 24 months age |
27. | ChiCTR1800017773 | SCHeLTI | Wu, 2018 [56] | China | Cluster RCT | N = 4000 * | 6 weeks | 6 weeks until 5 years |
28. | NCT03752762 | SPOON: Mexico | Martinez, 2018 [33] | Mexico | RCT | N = 1200 * | 0–6 months | 0–6 months until 24 months |
29. | NCT04042467 | Greenlight plus study | Rothman, 2019 [57] | USA | RCT | N = 900 | First newborn clinic visit | Newborn to 24 months |
Intervention Delivery | N | % of Total | |
---|---|---|---|
Materials | |||
Educational handout | 15 | 52 | |
Educational handout (image-based) | 4 | 14 | |
Educational video | 2 | 7 | |
Low literacy educational tool kit | 3 | 10 | |
Educational website/app | 5 | 17 | |
Educational material mailed out | 5 | 17 | |
Feeding supplement | 2 | 7 | |
Procedures | |||
Nutrition and parenting support groups | 7 | 24 | |
Phone call consultation | 6 | 21 | |
Home visits | 12 | 41 | |
Educational text messages | 4 | 14 | |
Agents | |||
Nurse (via home visits) | 5 | 17 | |
Nurse (via clinic visits) | 5 | 17 | |
Registered dietitian | 5 | 17 | |
Lactation consultants | 3 | 10 | |
Trained research assistants | 4 | 13 | |
Community health worker | 1 | 3 | |
Community health worker (via home visits) | 4 | 13 | |
Nutrition expert | 2 | 7 | |
Paediatric residents/paediatrician | 4 | 13 | |
Psychologist | 1 | 3 | |
General practitioners | 1 | 3 | |
Midwives | 1 | 3 | |
Physiotherapist | 1 | 3 | |
Trained sleep specialists | 1 | 3 | |
Multidisciplinary team | 2 | 7 |
Advice/Key Message/Component | N | % |
---|---|---|
Breastfeeding/bottle feeding advice | 16 | 55 |
Introduction of solids | 10 | 34 |
Limit junk foods (e.g., sweets) | 6 | 21 |
Repeat food exposure | 3 | 10 |
Healthy dietary behaviours in children | 24 | 83 |
Food serving size | 5 | 17 |
Parenting/hunger satiety cues | 13 | 45 |
Parent modelling | 13 | 45 |
Fussy eating | 5 | 17 |
Soothe/sleep | 3 | 10 |
Sleep promotion | 10 | 34 |
Play/activity | 20 | 69 |
Tummy time | 3 | 10 |
TV/screen time | 9 | 31 |
Oral hygiene practices | 1 | 3 |
Growth chart education | 1 | 3 |
Health information technology access education | 1 | 3 |
Health-communication curriculum | 2 | 7 |
Study, Author, Year | Sample Size | Primary Outcome | Reported Outcome at End of Follow Up | Effect Size | |||
---|---|---|---|---|---|---|---|
Control Group | Intervention Group | ||||||
Healthy Beginnings, Wen, 2012 [22] |
N = 667 * N = 497 | BMI at 2 years | 16.82 | 16.53 | Mean difference −0.29 (95% CI, 0.02 to 0.55), p = 0.04 | ||
Wen, 2015 [34] | * N = 415 | BMI at 3.5 years | 16.8 | 16.74 | Mean difference −0.06 (95% CI, −0.41 to 0.28), p = 0.33 | ||
BMI z score at 3.5 years | 0.97 | 0.89 | Mean difference −0.08 (95% CI, −30 to 0.16), p = 0.44 | ||||
* N = 369 | BMI 5 years | 16.28 | 16.31 | Mean difference 0.3 (95% CI, −0.30 to 0.37), p = 0.06 | |||
BMI z score at 5 years | 0.63 | 0.65 | Mean difference 0.02 (95% CI, −0.19 to 0.22), p = 0.06 | ||||
INFANT, Campbell, 2013 [23] | N = 542 * N = 457 | BMI (z score) at age 20 months | 0.8 | 0.8 | Mean difference −0.01 (95% CI, −0.16 to 0.13), p = 0.86 | ||
INFANT, Hesketh, 2020 [35] | * N = 361 | BMI (z score) at age 3.6 years | - | - | Mean difference 0.05 (95% CI, −0.1 to 0.19) | ||
Waist circumference at 3.6 years | - | - | Mean difference −0.01 (95% CI, −0.12 to 0.19) | ||||
* N = 337 | BMI (z score) at age 5 years | - | - | Mean difference −0.02 (95% CI, −0.2 to 0.16) | |||
Waist circumference at 5 years | - | - | Mean difference 0.01 (95% CI, −0.17 to 0.20) | ||||
NOURISH, Daniels, 2013 [24] | N = 698 * N= 530 | BMI z score at age 2 years | 0.75 | 0.61 | Mean difference −0.14, p = 0.10 | ||
Daniels, 2015 [36] | * N= 424 | BMI z score at age 5 years | 0.41 | 0.34 | Mean difference 0.07, p = 0.06 | ||
Feeding Young Children Study, Bonuck, 2014 [25] | N = 300 * N = 135 | Reduction in weight for length >85th percentile | - | - | OR 1.01 (95% CI, 0.9 to 1.1), p = 0.8 | ||
POI.nz, Taylor, 2017 [26] | BMI at 2 years | 16.9 | FAB 17.1 | Sleep 16.8 | Both 16.8 | p = 0.086 (overall) | |
BMI z score at age 2 years | 0.77 | FAB 0.92 | Sleep 0.68 | Both 0.72 | p = 0.104 (overall) | ||
Waist circumference at 2 years | 46.7 | FAB 47.0 | Sleep 46.6 | Both 46.9 | p = 0.610 (overall) | ||
Prevalence of overweight and obesity at 2 years | 68 | FAB 73 | Sleep 61 | Both 70 | p = 0.770 (overall) | ||
Prevalence of obesity at 2 years | 33 | FAB 40 | Sleep 19 | Both 21 | p = 0.027 (overall) FAB vs. sleep group (odds ratio (OR) 0.46, 95% confidence interval (CI), 0.25–0.83), p = 0.011 FAB vs. combination group (OR 0.51, 95% CI, 0.28–0.90), p = 0.022 Sleep and combination vs. FAB and control (OR 0.54, 95% CI, 0.35–0.82), p = 0.004 | ||
POI.nz, Taylor, 2018 [37] |
N = 808 * N = 616 | BMI z score at age 3.5 years | 0.68 | FAB 0.81 | Sleep 0.54 | Both 0.56 | p = −0.004 (overall) FAB vs. Control difference 0.15 (95% CI, −0.04 to 0.34) Sleep vs. Control difference −0.16 (95% CI, −0.36 to 0.04) Both vs. Control difference −0.18 (95% CI, −0.37 to 0.02) |
* N = 557 | BMI z score at age 5 years | 0.39 | FAB 0.66 | Sleep 0.31 | Both 0.44 | p = 0.004 (overall) FAB vs. Control difference 0.25 (95% CI, 0.04 to 0.47) Sleep vs. Control difference −0.14 (95% CI, −0.36 to 0.09) Both vs. Control difference 0.06 (95% CI, −0.29 to 0.16) | |
BeeBOFT, van Grieken, 2017 [27] | N = 2102 * N = 1543 | BMI (mean) at 36 months | 15.66 | 15.78 | Mean difference 0.12, p = 0.12 | ||
Prevalence of overweight/obesity (%) at 36 months | 3.99% | 4.77% | 0.78% difference in prevalence, p = 0.51 | ||||
INSIGHT Savage, 2016 [28] | N = 291 * N = 250 | Weight-for-length percentile at 1 year of age | 64.4% | 57.5% | Mean difference 6.9%, 95% CI (52.6%−69.0%), p = 0.4 | ||
INSIGHT Paul, 2018 [41] | * N = 232 | BMI z-score at 3 years of age | 0.15 | −0.13 | Mean difference −0.28 (95% CI, −0.53 to 0.01), p = 0.04 | ||
Mean BMI percentiles | 54th | 47th | Difference 6.9 percentile points (95% CI, −14.5 to 0.6), p = 0.7 | ||||
BLISS, Taylor, 2017 [29] |
N = 206 * N= 178 | BMI z score age 12 months | 0.20 | 0.44 | Adjusted difference, 0.21, (95% CI, −0.7 to 0.48) | ||
* N = 166 | BMI z score age 24 months | 0.24 | 0.39 | Adjusted difference 0.16, (95% CI, −0.13 to 0.45) | |||
PRIMROSE, Doring, 2016 [30] | N = 1369 * N = 1148 | BMI at 4 years of age | 16.1 | 16.0 | Mean change −0.11 (95% CI, −0.31 to 0.08), p = 0.26 | ||
Waist circumference (cm) at 4 years of age | 53 | 52.5 | Mean change −0.48 (CI, −0.99 to 0.04), p= 0.07 | ||||
Prevalence of overweight and obesity at 4 years of age | 15.5% | 14.8% | RR 0.95 (95% CI, 0.69 to 1.32) p = 0.78 | ||||
Early Obesity Prevention, Schroeder, 2015 [31] | N = 292 * N = 278 | BMI at baseline | 15.03 | 15.29 | Mean difference 0.26 | ||
BMI Z score at baseline | −0.152 | −0.283 | Mean difference −0.435 | ||||
Weight at baseline | 4.56 | 4.91 | Mean difference 0.35, p < 0.006 | ||||
* N = 218 | BMI at 12 months | 17.29 | 17.23 | Mean difference −0.06 | |||
BMI Z score at 12 months | 0.539 | 0.492 | Mean difference −0.047 | ||||
Weight at 12 months | 9.81 | 9.85 | Mean difference 0.04, p > 0.05 | ||||
* N = 232 | BMI at 24 months | 16.20 | 16.34 | Mean difference 0.14 | |||
BMI Z score at 24 months | 0.218 | 0.339 | Mean difference 0.121 | ||||
Weight at 24 months | 12.61 | 12.76 | Mean difference 0.15, p > 0.05 | ||||
PROBIT, Morandi, 2019 [32] | N = 569 * N = 529 | Prevalence of overweight/obesity (%) at 2 years of age | 26.3% | 23.8% | 3% difference in prevalence, p = 0.49 |
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Mihrshahi, S.; Jawad, D.; Richards, L.; Hunter, K.E.; Ekambareshwar, M.; Seidler, A.L.; Baur, L.A. A Review of Registered Randomized Controlled Trials for the Prevention of Obesity in Infancy. Int. J. Environ. Res. Public Health 2021, 18, 2444. https://doi.org/10.3390/ijerph18052444
Mihrshahi S, Jawad D, Richards L, Hunter KE, Ekambareshwar M, Seidler AL, Baur LA. A Review of Registered Randomized Controlled Trials for the Prevention of Obesity in Infancy. International Journal of Environmental Research and Public Health. 2021; 18(5):2444. https://doi.org/10.3390/ijerph18052444
Chicago/Turabian StyleMihrshahi, Seema, Danielle Jawad, Louise Richards, Kylie E. Hunter, Mahalakshmi Ekambareshwar, Anna Lene Seidler, and Louise A. Baur. 2021. "A Review of Registered Randomized Controlled Trials for the Prevention of Obesity in Infancy" International Journal of Environmental Research and Public Health 18, no. 5: 2444. https://doi.org/10.3390/ijerph18052444
APA StyleMihrshahi, S., Jawad, D., Richards, L., Hunter, K. E., Ekambareshwar, M., Seidler, A. L., & Baur, L. A. (2021). A Review of Registered Randomized Controlled Trials for the Prevention of Obesity in Infancy. International Journal of Environmental Research and Public Health, 18(5), 2444. https://doi.org/10.3390/ijerph18052444