Gestational Weight and Incentive Research Study
Bloom
Effect of Incentives for Self-weighing, Weight Management Goals and Physical Activity Goals on Gaining Weight Healthily During Pregnancy
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2019
CompletedFirst Posted
Study publicly available on registry
February 7, 2019
CompletedStudy Start
First participant enrolled
February 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 9, 2020
CompletedResults Posted
Study results publicly available
August 8, 2023
CompletedAugust 8, 2023
March 1, 2020
1.1 years
January 3, 2019
March 28, 2022
October 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Recruitment Yields Observed From Enrollment Survey
The number of participants initially recruited for the study will be closely monitored.
Up to 36 weeks
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 Outcomes (2)
Gestational Weight Gain Observed From Weight Recorded at Baseline and up to 36 Weeks
Up to 36 weeks
Number of Participants With Gestational Weight Gain Within IOM Recommendation
Up to 36 weeks pregnancy
Study Arms (8)
Lottery + Monthly Weight
EXPERIMENTALParticipants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings ($0, $2, $15 or not eligible for lottery due to lack of weighing). Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, participants will be specifically notified that they would have received $14 had they had gained within the recommended range for the month, drawing on research showing that loss aversion can be motivating.
Lottery + Overall Weight + Exercise
EXPERIMENTALParticipants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings if any. Participants will be given the IOM GWG recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.
Lottery + Overall Weight
EXPERIMENTALParticipants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings ($0, $2, $15 or not eligible for lottery due to lack of weighing). Participants will be given the Institute of Medicine gestational weight gain recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit.
Lottery + Monthly Weight + Exercise
EXPERIMENTALParticipants will be eligible for a daily lottery if they have weighed themselves in the previous day on the e-scale. For each day of the study, participants will be informed of the study's randomly-generated winning lottery number and their winnings if any. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, they will be notified that they would have received $14 had they had gained within the recommendation for the month. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.
Loss + Monthly Weight
EXPERIMENTALParticipants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, participants will be specifically notified that they would have received $14 had they had gained within the recommended range for the month, drawing on research showing that loss aversion can be motivating.
Loss + Overall Weight + Exercise
EXPERIMENTALParticipants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will be given the IOM GWG recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.
Loss + Overall Weight
EXPERIMENTALParticipants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will be given the Institute of Medicine gestational weight gain recommendation based on their body mass index at randomization, adjusted for data collection at 36 weeks. If they achieve the goal at 36 weeks, they will receive $112 after the data collection visit.
Loss + Monthly Weight + Exercise
EXPERIMENTALParticipants randomized to an arm that contains the self-weighing (certain loss) component will have a balance of $3.50 at the beginning of each week of the study and each day that they do not weigh, $0.50 will be subtracted from this account. Participants will receive $14 per month if they have gained within the recommended monthly range for their BMI category. Otherwise, they will be notified that they would have received $14 had they had gained within the recommendation for the month. Participants will be asked to engage in 150 minutes of exercise each week based on the guideline from the ACOG. They will receive $3.50 if they meet their activity goal for the week. Otherwise, they will be notified that they would have received $3.50 had they meet their activity goal.
Interventions
Lottery for daily self-weighing. Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.
Lottery for daily self-weighing. Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study. Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.
Lottery for daily self-weighing. Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.
Certain loss for not engaging in daily self-weighing. Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.
Certain loss for not engaging in daily self-weighing. Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study. Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.
Lottery for daily self-weighing. Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis. Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.
Certain loss for not engaging in daily self-weighing. Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.
Certain loss for not engaging in daily self-weighing. Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis. Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Greater than 12 week gestation up on recruitment (based on the health care provider's assessment)
- Underweight (BMI \< 18.5) at baseline
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Tennessee Health Science Center
Memphis, Tennessee, 38105, United States
Related Publications (28)
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.
PMID: 25751216BACKGROUNDCheng 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.
PMID: 18978100BACKGROUNDTovar 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.
PMID: 18597166BACKGROUNDVohr 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.
PMID: 18297569BACKGROUNDVambergue 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.
PMID: 18028442BACKGROUNDBellamy 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.
PMID: 19465232BACKGROUNDBottalico 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.
PMID: 17531899BACKGROUNDPaul-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.
PMID: 17956546BACKGROUNDBurns 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.
PMID: 22907712BACKGROUNDPhelan 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.
PMID: 22040207BACKGROUNDOlson 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.
PMID: 28573669BACKGROUNDHarrison 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.
PMID: 23784892BACKGROUNDHarrison 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.
PMID: 24738837BACKGROUNDMcDonald 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.
PMID: 25846125BACKGROUNDLeahey 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.
PMID: 25384463BACKGROUNDVolpp 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.
PMID: 21812669BACKGROUNDLoewenstein 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.
PMID: 18042920BACKGROUNDVolpp 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.
PMID: 19066383BACKGROUNDGardner 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.
PMID: 21521451BACKGROUNDOken 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.
PMID: 17403405BACKGROUNDMartin 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.
PMID: 24974591BACKGROUNDFinkelstein 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.
PMID: 17848854BACKGROUNDLeon 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.
PMID: 21035130BACKGROUNDYancy 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.
PMID: 29795365BACKGROUNDShaw 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.
PMID: 27646508BACKGROUNDPatel 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.
PMID: 26733703BACKGROUNDPatel 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.
PMID: 26881417BACKGROUNDKrukowski R, Johnson B, Kim H, Sen S, Homsi R. A Pragmatic Intervention Using Financial Incentives for Pregnancy Weight Management: Feasibility Randomized Controlled Trial. JMIR Form Res. 2021 Dec 24;5(12):e30578. doi: 10.2196/30578.
PMID: 34951594DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Rebecca Krukowski
- Organization
- University of Virginia, School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca A Krukowski, PhD
University of Tennessee
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2019
First Posted
February 7, 2019
Study Start
February 26, 2019
Primary Completion
April 9, 2020
Study Completion
April 9, 2020
Last Updated
August 8, 2023
Results First Posted
August 8, 2023
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share
IPD are protected by the Institutional Review Board (IRB) at the University of Tennessee Health Science Center (UTHSC). No individual without the IRB of UTHSC will have access to IDP.