Goals for Reaching Optimum Wellness (GROWell)
Condition: Pregnant Women
Study type: Interventional

Summary: 
      This is a pilot study to assess the feasibility, acceptability and preliminary efficacy of
      the GROWell diet intervention. The objective of this study is to determine whether the
      GROWell intervention can help transition women from consuming a Western diet to consuming a
      prudent diet (characterized by consumption of primarily fruits, vegetables, healthy fats,
      lean proteins, and whole grains) during pregnancy. Efficacy will be measured as change in
      dietary components, using a Food Frequency Questionnaire (FFQ) at baseline and at a follow up
      visit at 37 weeks gestation.

      The GROWell intervention is a mobile health technology that uses interactive text messaging
      and dietician coaching calls, and may be effective in transitioning pregnant women from a
      Western to a prudent diet during an approximately 6 month intervention period. GROWell
      results will be measured against an Attention Support Control (ASC) arm, where participants
      will receive messaging that is pregnancy rather than diet focused, and a Usual Care (USC)
      arm, where participants will not receive text messages or study coaching.

      Results from this study will be used to support a grant submission for a larger study, aiming
      to investigate the GROWell intervention and prudent diet consumption as preventatives against
      postpartum depression.
    

Detailed description: 
      The GROWell intervention is a mobile health technology, including diet tracking, skills
      training and tailored feedback based on digital and human support strategies. Its structure
      is based on the iOTA (interactive obesity treatment approach), designed for dietary change,
      obesity, and chronic disease management, with message content modified for healthy diet
      change during pregnancy.

      GROWell incorporates 4 elements: phone coaching, goal setting, self-monitoring of behavior
      and skills training. These interactions take place on a study subject's cell phone, through
      text messaging, and phone calls with a dietician coach. At the initiation of the
      intervention, the subject takes a short survey, after which the intervention algorithm
      assigns up to 4 tailored behavior change goals from the GROWell library. Examples of goals
      would be to eliminate fast food from the diet, or to limit red meat. Goals are tailored to
      the subject's needs as indicated by the initial survey, so if for example the subject doesn't
      eat fast food, that goal is not assigned. The algorithm prioritizes behaviors in highest need
      of change, and those for which participant has high self-efficacy and readiness based on the
      survey responses. Subjects self-monitor adherence weekly via text, responding to prompts from
      the system regarding their level of success with a given goal. Via text they receive
      immediate tailored feedback regarding their current adherence and long-term progress.

      Feedback includes showing progress trends, reinforcing success, and offering motivational
      strategies to support behavior change based on the self-monitoring data. To support the next
      week's efforts, the algorithm tailors feedback, selecting content from a skills training
      library and sending materials to assist behavior change efforts. Skills training materials
      include online handouts, featuring content that discusses the adoption of healthy dietary
      changes in pregnancy. A set of skills training materials exists for each goal in the library.
      When a subject is assigned a goal, they receive a link to the training materials for that
      goal over the phone.

      The human support component of the intervention relies in part on the GROWell platform's
      interface, which allows diet coaches to view participant data. This information is then used
      to inform feedback during coaching calls. These 15-minute conversations will be guided by
      principles of motivational interviewing (MI). In each session, the dietician coach and the
      subject will discuss self-monitoring data and reinforce its importance, discuss barrier
      reduction strategies and skills training content, and engaging community resources. The
      GROWell study will implement a series of dietician coaching calls starting weekly for the
      first month and decreasing in frequency to biweekly during the study period, totaling
      approximately 12 calls depending on delivery date.

      The ASC control arm of the study involves more limited intervention. There will be one
      coaching call at baseline, regarding prenatal diet. Weekly text or IVR messages will focus on
      pregnancy, labor, delivery, and early infancy education.

      The USC will receive no intervention. They will simply complete baseline and follow-up
      questionnaires.

      Participants on all arms may opt to have blood drawn at the baseline visit and the follow up
      visit for an optional biomarker study.
    

Intervention name(s): GROWell
Intervention type(s): Other
Intervention description(s): The GROWell intervention is a mobile health technology, including diet tracking, skills training and tailored feedback based on digital and human support strategies. Its message content is geared toward healthy diet change during pregnancy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other