Gestational Weight Gain Clinical Trial
— BloomOfficial title:
Effect of Incentives for Self-weighing, Weight Management Goals and Physical Activity Goals on Gaining Weight Healthily During Pregnancy
Verified date | March 2020 |
Source | University of Tennessee |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Bloom is a research study that examines whether incentives for daily self-weighing, weekly physical activity, monthly weight management or overall (from enrollment up to 36 weeks pregnancy) weight management could help pregnant mothers manage a health weight gain during pregnancy.
Status | Completed |
Enrollment | 40 |
Est. completion date | April 9, 2020 |
Est. primary completion date | April 9, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - no greater than 12 weeks gestation upon recruitment (based on the date of their last menstrual period) - have regular access to Wi-Fi or Bluetooth Exclusion criteria: - Greater than 12 week gestation up on recruitment (based on the health care provider's assessment) - Underweight (BMI < 18.5) at baseline |
Country | Name | City | State |
---|---|---|---|
United States | University of Tennessee Health Science Center | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
University of Tennessee |
United States,
Bellamy L, Casas JP, Hingorani AD, Williams D. Type 2 diabetes mellitus after gestational diabetes: a systematic review and meta-analysis. Lancet. 2009 May 23;373(9677):1773-9. doi: 10.1016/S0140-6736(09)60731-5. — View Citation
Bottalico JN. Recurrent gestational diabetes: risk factors, diagnosis, management, and implications. Semin Perinatol. 2007 Jun;31(3):176-84. doi: 10.1053/j.semperi.2007.03.006. — View Citation
Burns RJ, Donovan AS, Ackermann RT, Finch EA, Rothman AJ, Jeffery RW. A theoretically grounded systematic review of material incentives for weight loss: implications for interventions. Ann Behav Med. 2012 Dec;44(3):375-88. doi: 10.1007/s12160-012-9403-4. — View Citation
Cheng YW, Chung JH, Kurbisch-Block I, Inturrisi M, Shafer S, Caughey AB. Gestational weight gain and gestational diabetes mellitus: perinatal outcomes. Obstet Gynecol. 2008 Nov;112(5):1015-22. doi: 10.1097/AOG.0b013e31818b5dd9. — View Citation
Deputy NP, Sharma AJ, Kim SY, Hinkle SN. Prevalence and characteristics associated with gestational weight gain adequacy. Obstet Gynecol. 2015 Apr;125(4):773-781. doi: 10.1097/AOG.0000000000000739. — View Citation
Finkelstein EA, Linnan LA, Tate DF, Birken BE. A pilot study testing the effect of different levels of financial incentives on weight loss among overweight employees. J Occup Environ Med. 2007 Sep;49(9):981-9. doi: 10.1097/JOM.0b013e31813c6dcb. — View Citation
Gardner B, Wardle J, Poston L, Croker H. Changing diet and physical activity to reduce gestational weight gain: a meta-analysis. Obes Rev. 2011 Jul;12(7):e602-20. doi: 10.1111/j.1467-789X.2011.00884.x. Epub 2011 Apr 27. — View Citation
Harrison CL, Lombard CB, Strauss BJ, Teede HJ. Optimizing healthy gestational weight gain in women at high risk of gestational diabetes: a randomized controlled trial. Obesity (Silver Spring). 2013 May;21(5):904-9. doi: 10.1002/oby.20163. Erratum In: Obesity (Silver Spring). 2016 Jan;24(1):268. — View Citation
Harrison CL, Teede HJ, Lombard CB. How effective is self-weighing in the setting of a lifestyle intervention to reduce gestational weight gain and postpartum weight retention? Aust N Z J Obstet Gynaecol. 2014 Aug;54(4):382-5. doi: 10.1111/ajo.12207. Epub 2014 Apr 16. — View Citation
Leahey TM, Subak LL, Fava J, Schembri M, Thomas G, Xu X, Krupel K, Kent K, Boguszewski K, Kumar R, Weinberg B, Wing R. Benefits of adding small financial incentives or optional group meetings to a web-based statewide obesity initiative. Obesity (Silver Spring). 2015 Jan;23(1):70-6. doi: 10.1002/oby.20937. Epub 2014 Nov 11. — View Citation
Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011 May;45(5):626-9. doi: 10.1016/j.jpsychires.2010.10.008. Epub 2010 Oct 28. — View Citation
Loewenstein G, Brennan T, Volpp KG. Asymmetric paternalism to improve health behaviors. JAMA. 2007 Nov 28;298(20):2415-7. doi: 10.1001/jama.298.20.2415. No abstract available. — View Citation
Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Mathews TJ. Births: final data for 2011. Natl Vital Stat Rep. 2013 Jun 28;62(1):1-69, 72. — View Citation
McDonald SM, Liu J, Wilcox S, Lau EY, Archer E. Does dose matter in reducing gestational weight gain in exercise interventions? A systematic review of literature. J Sci Med Sport. 2016 Apr;19(4):323-35. doi: 10.1016/j.jsams.2015.03.004. Epub 2015 Mar 26. — View Citation
Oken E, Taveras EM, Kleinman KP, Rich-Edwards JW, Gillman MW. Gestational weight gain and child adiposity at age 3 years. Am J Obstet Gynecol. 2007 Apr;196(4):322.e1-8. doi: 10.1016/j.ajog.2006.11.027. — View Citation
Olson CM, Strawderman MS, Graham ML. Association between consistent weight gain tracking and gestational weight gain: Secondary analysis of a randomized trial. Obesity (Silver Spring). 2017 Jul;25(7):1217-1227. doi: 10.1002/oby.21873. Epub 2017 Jun 2. — View Citation
Patel MS, Asch DA, Rosin R, Small DS, Bellamy SL, Heuer J, Sproat S, Hyson C, Haff N, Lee SM, Wesby L, Hoffer K, Shuttleworth D, Taylor DH, Hilbert V, Zhu J, Yang L, Wang X, Volpp KG. Framing Financial Incentives to Increase Physical Activity Among Overweight and Obese Adults: A Randomized, Controlled Trial. Ann Intern Med. 2016 Mar 15;164(6):385-94. doi: 10.7326/M15-1635. Epub 2016 Feb 16. — View Citation
Patel MS, Asch DA, Troxel AB, Fletcher M, Osman-Koss R, Brady J, Wesby L, Hilbert V, Zhu J, Wang W, Volpp KG. Premium-Based Financial Incentives Did Not Promote Workplace Weight Loss In A 2013-15 Study. Health Aff (Millwood). 2016 Jan;35(1):71-9. doi: 10.1377/hlthaff.2015.0945. — View Citation
Paul-Ebhohimhen V, Avenell A. Systematic review of the use of financial incentives in treatments for obesity and overweight. Obes Rev. 2008 Jul;9(4):355-67. doi: 10.1111/j.1467-789X.2007.00409.x. Epub 2007 Oct 23. — View Citation
Phelan S, Jankovitz K, Hagobian T, Abrams B. Reducing excessive gestational weight gain: lessons from the weight control literature and avenues for future research. Womens Health (Lond). 2011 Nov;7(6):641-61. doi: 10.2217/whe.11.70. — View Citation
Shaw PA, Yancy WS Jr, Wesby L, Ulrich V, Troxel AB, Huffman D, Foster GD, Volpp K. The design and conduct of Keep It Off: An online randomized trial of financial incentives for weight-loss maintenance. Clin Trials. 2017 Feb;14(1):29-36. doi: 10.1177/1740774516669679. Epub 2016 Sep 23. — View Citation
Tovar A, Must A, Bermudez OI, Hyatt RR, Chasan-Taber L. The impact of gestational weight gain and diet on abnormal glucose tolerance during pregnancy in Hispanic women. Matern Child Health J. 2009 Jul;13(4):520-30. doi: 10.1007/s10995-008-0381-x. Epub 2008 Jul 3. Erratum In: Matern Child Health J. 2009 Jul;13(4):434. — View Citation
Vambergue A, Dognin C, Boulogne A, Rejou MC, Biausque S, Fontaine P. Increasing incidence of abnormal glucose tolerance in women with prior abnormal glucose tolerance during pregnancy: DIAGEST 2 study. Diabet Med. 2008 Jan;25(1):58-64. doi: 10.1111/j.1464-5491.2007.02306.x. Epub 2007 Nov 19. — View Citation
Vohr BR, Boney CM. Gestational diabetes: the forerunner for the development of maternal and childhood obesity and metabolic syndrome? J Matern Fetal Neonatal Med. 2008 Mar;21(3):149-57. doi: 10.1080/14767050801929430. — View Citation
Volpp KG, Asch DA, Galvin R, Loewenstein G. Redesigning employee health incentives--lessons from behavioral economics. N Engl J Med. 2011 Aug 4;365(5):388-90. doi: 10.1056/NEJMp1105966. No abstract available. — View Citation
Volpp KG, John LK, Troxel AB, Norton L, Fassbender J, Loewenstein G. Financial incentive-based approaches for weight loss: a randomized trial. JAMA. 2008 Dec 10;300(22):2631-7. doi: 10.1001/jama.2008.804. — View Citation
Yancy WS Jr, Shaw PA, Wesby L, Hilbert V, Yang L, Zhu J, Troxel A, Huffman D, Foster GD, Wojtanowski AC, Volpp KG. Financial incentive strategies for maintenance of weight loss: results from an internet-based randomized controlled trial. Nutr Diabetes. 2018 May 25;8(1):33. doi: 10.1038/s41387-018-0036-y. — View Citation
* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intervention Satisfaction Observed From Follow-up Survey | At 32 weeks gestation participants will be asked to offer insight into program acceptability in each condition, as well as satisfaction to the program in general by answering an internet-based survey, that was developed for this study (not a standardized scale). The investigators will examine participants' survey responses regarding participants' satisfaction of the program (items are scored on a scale from 1 to 5, with 5 being the most positive). | Up to 32 weeks | |
Primary | Recruitment Yields Observed From Enrollment Survey | The number of participants initially recruited for the study will be closely monitored. | Up to 36 weeks | |
Primary | Program Retention Observed From Enrollment and Followup Surveys | The number of participants stayed in the study within the time frame of the study will be closely monitored. | Up to 36 weeks | |
Secondary | Gestational Weight Gain Observed From Weight Recorded at Baseline and up to 36 Weeks | At all measurement visits, weight will be recorded in kilograms on a calibrated research-grade scale. Weight will be measured on a calibrated digital scale in duplicate, with the participant wearing light clothing and no shoes. While we will obtain the mother's weight at baseline, we will also obtain self-reported preconception weight (before the last menstrual period). We will calculate the participant's GWG goal based on self-reported preconception BMI. The difficulty of anticipating when a final weight should be obtained to capture the fullest extent of GWG was considered, and we elected to use an approach that afforded two possible weights that would be available for analytic purposes. The Week 36 weight will be the primary outcome except for mothers who deliver prior to 36 weeks, in which case we will use the Week 32 weight. | Up to 36 weeks | |
Secondary | Number of Participants With Gestational Weight Gain Within IOM Recommendation | We will evaluate whether participants' final gestational weight gain at Week 32 or Week 36 pregnancy would be under, within, or above IOM's recommendation. The Week 36 weight will be the primary outcome except for mothers who deliver prior to 36 weeks, in which case we will use the Week 32 weight. This is to determine the effect of the intervention on prevention of excess gestational weight gain. | Up to 36 weeks pregnancy |
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