Addressing Place and People Micro Environments in Weight Loss Disparities
Condition: Obese
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to A) capture obesogenic cues that occur in daily life, and B)
      to deliver cue alerts. Investigators hypothesized that A) black women experience more cues,
      B) racial disparities in obesity are reduced in models that adjust for cues, and C) the
      priming arm will achieve a weight loss of 2kg or more. Investigators will explore whether
      racial disparities in weight loss differ between the groups receiving usual care or those
      receiving cues.
    

Detailed description: 
      Aim 1: After participants have been consented over the phone or in clinic, the Research
      Assistants (RA) will schedule a baseline assessment. Baseline interviewer administered survey
      questions, assessments, and equipment set-up will be completed in participants' homes to
      allow a physical environment assessment of the home. Assessments and surveys will be carried
      out using Research Electronic Data Capture (REDCap; see Resources). The in-home baseline
      assessment piloted for the proposed study takes 1 to 1.5 hours. Global Positioning System
      (GPS) locating, accelerometry, bite monitoring, and EMA surveys will operate through the
      mHealth app over the immediate 2-4 week period. For GPS locating, the mHealth app uses
      software that identifies and sends the longitude and latitude at the time of EMA response to
      a secure IU server. Software then determines the address of the location and whether it is
      the participant's home, work, restaurant, retail store, etc. For messaging, the mHealth app
      uses "Push Notification" to deliver EMA requests to the device (i.e., smartphone). This
      bypasses the phone carrier's Short Message Service (SMS) gateway, which is not always
      reliable or secure. The mHealth app makes sure the messages are delivered and secure.
      Participants receive a notification and open the application to answer the EMA questions. The
      database is located in a secure network within Indiana University servers. None of the data
      are stored inside the smartphone at rest. The actual questions are very brief with radio
      button responses.

      At the end of the 2-4 week window, RAs will return to the home to collect the accelerometer
      and bite counter which takes about 1 hour. The accelerometer and bite counter are to be
      marked by the RA with the study participants ID and data are retrieved. At this time,
      participants who responded to 75% or more of the messages over the 2-4 week period, will be
      randomized to Usual Care (UC) or Priming Arm for Aim 2 and given instruction on the next
      steps of study participation. Randomization will be carried out within each race group to
      ensure a balance in the number of subjects between the two treatment arms. The Investigator
      will computer-generate randomization lists in field envelopes to be provided to the RAs for
      treatment assignment.

      Aim 2: The second aim of the study will last 6 months. Both UC and Priming arms will have
      full access to Healthy-Me coaches and classes as well as receive training and access to the
      mHealth app. When study participation is excluded, all apps and associated data will be
      removed from the smartphone. At no time will Patient Health Information (PHI) be stored on
      the smartphone. Smartphones will only be identified by study ID number and the developer will
      only have access to the participants' study ID number and smartphone data collected by the
      mHealth app. Subjects in UC and Priming will undergo similar assessments and procedures;
      however, the Priming arm participants will, in addition receive 6-8 message alerts per day.
      The application and notifications that will be used in the Priming arm will be built from
      each participants own library to be delivered at times and in locations that their Aim 1 data
      indicate they often experience an eating or sedentary cue. In short, this intervention
      counters an obesogenic cue with a "healthy" prime in real-time and location.

      Finally, following 6 months of UC or Priming, blinded RAs will return to participants home to
      complete 6-month follow-up assessment and collect all study related equipment. The final
      assessment and surveys will take about 1-1.5 hours and all data captured will also be carried
      out in REDCap.
    

Intervention name(s): Usual Care; Priming
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Usual care is not considered an intervention. This arm of the study involves a lifestyle coaching intervention delivered in primary care sites to the subjects.; The intervention is a just in time eating or physical activity reminder. Each individual participant reports physical activity goals as well as times that they most often eat. This information is used to select for that individual the best time to send an eating or physical activity reminder. The reminders come to the participant's smartphone or a study provided smartphone. Participants will receive reminder 2 to 4 times per day depending on their goals and behavior pattern.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The participants are randomized to one of two treatment arms, usual care or intervention.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Middle aged women; 35-64yrs; BMI= >30