Gestational Weight and Incentive Research Study
Gestational Weight and Incentive Research Study
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.
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.
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