Healthy Mom Zone: A Gestational Weight Gain Management Intervention
Condition: Overweight and Obesity; Physical Activity; Weight Change, Body; Eating Behavior
MeSH terms: Overweight; Body Weight; Weight Gain; Body Weight Changes; Gestational Weight Gain
Study type: Interventional

Summary: 
      The purpose is to establish feasibility of delivering an individually-tailored, behavioral
      intervention to manage gestational weight gain [GWG] that adapts to the unique needs and
      challenges of overweight/obese pregnant women [OW/OBPW] and will utilize control systems
      engineering to optimize this intervention; in other words, make this intervention manage GWG
      in OW/OBPW as effectively and efficiently as possible.
    

Detailed description: 
      The research proposed here will establish the dosage of components needed to impact GWG and
      develop an efficient (optimized) intervention to effectively manage GWG in OW/OBPW before a
      randomized controlled trial (RCT) can be implemented. The aims of the proposed research are:
      to establish feasibility of delivering an individually-tailored behavioral intervention for
      managing GWG in OW/OBPW. Two studies will be conducted to establish feasibility. Study 1 will
      examine viability of delivering dosages/sequencing of components (education, goal-setting,
      self-monitoring, HE/PA), GWG/HE/PA self-monitoring using e-health technology mechanisms, and
      data collection by delivering varied dosages to OW/OBPW over a brief, 4-week period followed
      by focus groups to evaluate user acceptability. The investigators will then make necessary
      revisions to the intervention. Study 2 will pilot test intervention delivery with decision
      rules for when/how to adapt dosages for an individual and randomization/retention/data
      collection procedures with treatment and control groups in a new cohort of OW/OBPW. Also, the
      investigators aim to use feasibility data collected from Aim 1 and control systems
      engineering to build a model that characterizes the effects of energy balance and
      planned/self-regulatory behaviors on GWG over time and use this model to develop an optimized
      intervention. The investigators will identify a dynamical model from feasibility data
      collected in Aim 1 that considers how changes in GWG responds to changes in energy intake,
      PA, and planned/self-regulatory behaviors. Model predictive control (a decision-making method
      from control systems engineering) will inform how the dosage adaptations are decided. The
      investigators will then identify a customized intervention plan for each woman based on her
      levels of energy intake, PA, planned/self-regulatory behaviors and the extent to which she is
      meeting GWG goals over pregnancy. This will lead to final program modifications and result in
      an individually-tailored, optimized intervention. The investigators will test the efficacy of
      this optimized intervention for managing GWG in OW/OBPW in a future RCT. This innovative
      research will develop an individually-tailored, optimized intervention that effectively and
      efficiently manages GWG in OW/OBPW and that will eventually be available to all pregnant
      women (via e-health technology) to improve the health of mothers and infants and impact the
      etiology of obesity and cardiovascular disease at a critical time in the life cycle.
    

Intervention name(s): Intervention group; Control group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.; Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.
Other intervention name(s): Prenatal care as usual
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomly assigned to an intervention or control group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gestational weight gain; pregnancy weight regulation; individually tailored intervention