Clinical trial NCT03834194: Gestational Weight and Incentive Research Study
Official title: Effect of Incentives for Self-weighing, Weight Management Goals and Physical Activity Goals on Gaining Weight Healthily During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Weight Gain
Keywords: excessive weight gain
pregnancy
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2019-02-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Gestational weight gain (GWG) is a serious public health concern, and 37% of normal weight, 64% of overweight, and 49-64% of obese women exceed the Institute of Medicine's GWG guidelines. \[Deputy 2015\] Excessive GWG increases the risk for illnesses, such as gestational diabetes mellitus (GDM) \[Cheng 2008, Tovar 2009\] which has a long-term impact on the health of both the mother (i.e., increased likelihood of developing metabolic syndrome, \[Vohr 2008\] type 2 diabetes, \[Vambergue 2007, Bellamy 2009\] and GDM in subsequent pregnancies \[Bottalico 2007\] and child \[Vohr 2008\].

For weight loss, research has found that modest financial incentives are a promising pragmatic strategy for an intervention. Yet, most previous weight management research that has utilized incentives has targeted weight outcomes rather than the behaviors necessary to achieve them. \[Paul-Ebhohimhen 2008, Burns 2012\] For self-weighing, research has found that daily self-weighing is an important component that supplements behavioral interventions' effort in monitoring and managing gestational weight. \[Phelan 2011, Olson 2017, Harrison 2013, Harrison 2014\] For physical activity, research has found that physical activity may successfully manage GWG, and a greater adherence to the exercise program is linked to interventions that resulted in weight management success. \[McDonald 2016\] Thus, a strategy to increase adherence, like financial incentives, may be beneficial.

Consistent with recent research, \[Leahey 2015\] the investigators will incentivize daily self-weighing and participation in physical activity (i.e., the behaviors) in addition to GWG within the guidelines (i.e., the outcome). Behaviors that negatively impact health often involve immediate benefits and delayed costs (i.e., "eating for two" provides immediate gratification but may lead to excessive GWG), and many interventions involve immediate costs (i.e., the inconvenience and time of an intervention) with delayed and often uncertain benefits of better health years later. \[Volpp 2011\] Researchers also hypothesize that an approach that offers frequent chances to win small lotteries based on meeting short-term goals will be more effective than a straight pay-for-performance approach (of equal expected value) because people are emotionally attracted to the possibility of winning a lottery. \[Loewenstein 2007, Volpp 2008\] Therefore, the current study proposes to examine the impact of frequent chances to win small, proximal incentives for meeting short-term goals of self-weighing and physical activity and larger incentives for meeting overall GWG goals by the end of the 36-week gestational period.

To our knowledge, the study is the first to use financial incentives to reduce the likelihood of excessive GWG. This project will support evaluation of the feasibility of this promising approach to decreasing excessive GWG. The incentive strategy is based in theory and focuses on behaviors that has a strong link with gestational weight management (i.e., self-weighing and physical activity) and on an outcome (i.e., achievement of GWG goals), thereby moving the field forward in identifying promising approaches to incorporating financial incentives into gestational weight management. The study design is also pragmatic and has a strong potential for scalability and sustainability within the health care setting.

Pregnant participants (N=40) in their first trimester at an obstetric clinic in Memphis, TN will be randomized in a factorial experiment. Three intervention components will be randomized using a 2 x 2 x 2 factorial design: 1) daily incentives for self-weighing on an electronic scale that will transmit data to the study team (lottery/certain loss), 2) incentives for adhering to the Institute of Medicine's gestational weight gain guidelines based on BMI category (monthly/overall), and 3) incentives for reaching physical activity goals to manage gestational weight gain (yes/no).

Potential participants will be identified by the clinics' health professionals (i.e., nurses, obstetricians) at their pregnancy confirmation visit or will be self-identified through recruitment materials posted in the obstetric clinic (e.g., exam rooms, lobby and bathrooms). They will encouraged to contact the study team if they wish to learn more about the study and potentially enroll in the study. Upon recruitment, individuals who are interested in learning more about the study will be directed to the Way to Health web portal. Upon reaching the portal, potential participants will be asked to create an account and will then be informed of the details of the study, including its objectives, duration, requirements, and financial payments. If participants are still interested in participating, the Way to Health portal will take them through an automated online informed consent. Potential participants who click a clearly delineated button stating that they agree to participate in the study will be considered to have consented to enroll. After consenting, participants will complete an online questionnaire to determine their eligibility. Eligible participants will first answer a few questions about the number of pregnancies they have prior to the current one, age, annual household income, marital status, employment status, household size, education level, race, and ethnicity. Then, they will be randomized to one of the study arms and led through an automated description of the details specific to that arm. Participants will be provided with details regarding how to contact the research team via email or phone at any time if they subsequently wish to withdraw from the study. This contact information will remain easily accessible via the participants' individual Way to Health web portal dashboards throughout the study.

Participants will be randomized to one of 8 conditions, with combinations of 3 different components of incentive for GWG management and physical activity. Participants will be asked to complete daily self-weighing using the scale provided by the study, as well as wear a physical activity tracker.

Participants randomized to an arm that contains the self-weighing (lottery) component will be asked to pick a number between 00 and 99 at randomization, and will be informed that there will be a daily lottery, for which they will be eligible if they have weighed themselves in the previous day on the Withings e-scale. Then, for each day of their pregnancy, participants will be informed of the study's randomly-generated winning lottery number. Participants will be notified about the results of the lottery.

Participants randomized to an arm that contains the self-weighing (certain loss) component will have a portion of their incentives deducted from a weekly total.

Participants randomized to an arm that contains the monthly GWG incentive component will receive incentives for each month that they have gained within the recommended monthly range for their BMI category for the full months they are enrolled.

Participants randomized to an arm that contains the overall GWG incentive component will receive incentives for weight gain within the recommended range according to the Institute of Medicine gestational weight gain recommendation (based on their body mass index at randomization, adjusted for data collection at 36 weeks).

Participants randomized to an arm that contains the physical activity component will receive a weekly incentive if they achieved a 150 minute physical activity goal for each week based on the guideline from the American College of Obstetricians and Gynecologists (ACOG) \[The American College of Obstetricians and Gynecologists 2015\].

Measures will be obtained by trained research staff who are blinded to treatment assignment and who will be located within the obstetric clinic.

Baseline measures will be obtained in the first trimester. In-person follow-up data collection visits will be scheduled at gestational week 32 and week 36 (for those still pregnant at 36 weeks). Incentives ($30 for each follow-up visit) will be used to obtain high retention at all follow-up data collection visits. In addition, the research staff will attempt to schedule the data collection visits before or after regular office visits, in order to facilitate retention.

Weekly study meetings, which include retention as a standing agenda item, are also a component of this systematic and comprehensive approach. However, as the investigators will be recruiting participants at \<12 weeks gestation (and miscarriage rates are highest in the first trimester), the investigators may lose up to 15% of participants due to miscarriage. \[The American College of Obstetricians and Gynecologists 2015\] Thus, the investigators project 20% attrition at the final data collection point (36 weeks gestation).

As this is a novel intervention, no related data exist to inform the effect size that might be expected, and as a pilot study, the trial is not powered to detect a significant difference between conditions.

Analyses of GWG (in kg) will be performed using mixed model longitudinal methods. Analyses of the proportion of women with excessive GWG will use logistic regression models to estimate the odds of an intervention participant's GWG falling below or above the guidelines, relative to staying within the recommendations. All of these analyses will inform effect size estimation for the full-scale trial.

Eligibility criteria: 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

Primary outcomes:
measure: Intervention Satisfaction Observed From Follow-up Survey
timeFrame: Up to 32 weeks
measure: Recruitment Yields Observed From Enrollment Survey
timeFrame: Up to 36 weeks
measure: Program Retention Observed From Enrollment and Followup Surveys
timeFrame: Up to 36 weeks
Secondary outcomes:
measure: Gestational Weight Gain Observed From Weight Recorded at Baseline and up to 36 Weeks
timeFrame: Up to 36 weeks
measure: Number of Participants With Gestational Weight Gain Within IOM Recommendation
timeFrame: Up to 36 weeks pregnancy
Other outcomes:
Locations:
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Rebecca A Krukowski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
citation: 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
citation: Krukowski 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.