My Baby My Move A Community Wellness Intervention
Condition: Gestational Weight Gain
MeSH terms: Weight Gain; Gestational Weight Gain
Study type: Interventional

Summary: 
      My Baby, My Move+ (2019-2021) is a peer-led wellness intervention which aims to reduce
      excessive gestational weight gain (EGWG) by targeting prenatal physical activity, mood, and
      sleep quality. Up to 50% of pregnant women in the U.S. gain weight in excess of the Institute
      of Medicine guidelines. EGWG leads to poor maternal and child outcomes. It also sets the
      stage for long-term overweight/obesity for both mother and child. The MBMM+ intervention is
      an example of a theoretically-based prenatal physical activity intervention that targets
      these outcomes.

      Up to 100 pregnant women (50 intervention arm, 50 control arm) will be recruited from the
      University of Colorado Clinics. Women in the intervention arm will participate in the 12-week
      MBMM+ intervention. Leiferman and her team propose to develop and test the feasibility and
      sustainability of the MBMM+ intervention to instill good healthy habits (e.g., prenatal
      physical activity, good sleep hygiene, stress management) during and beyond pregnancy.
      Findings from this study will be used to inform a future, large randomized trial.
    

Detailed description: 
      Intervention Group:

      The MBMM+ intervention is designed to promote the engagement in physical activity and takes
      into account barriers among pregnant women cited in our formative work such as lack of
      knowledge and skills, body changes and discomfort, feeling limited, and lack of social
      support. Uniquely, the MBMM+ program also targets sleep hygiene and mood to further support
      regular physical activity engagement. Over the years of working with pregnant women, we have
      observed that once women notice how their regular physical activity helps their mood and
      sleep patterns they are often more likely to continue engaging in regular physical activity.
      During the first four weeks of the MBMM+ program, participants will receive electronic
      informational handouts covering topics on weight management (content will be based in part on
      Co-I Downs' Healthy Mom Zone intervention such as informing on benefits and guidelines of
      healthy GWG, tips on healthy eating, energy balance, and sleep quality) as well as the
      benefits and safety concerns related to prenatal physical activity. Starting week 5 of the
      12-week intervention, participants will attend two in-person, group physical activity
      sessions per week with each session lasting approximately 60 minutes and will be held at a
      local community center located close to the recruitment clinics. Sessions will be held on
      weekday evenings and weekend mornings as these times were preferred by pregnant women. Given
      that pregnant women often express a lack of knowledge about safe physical activities during
      pregnancy, preventing them from engaging in physical activity, each session will include both
      didactic and experiential components to increase knowledge and skill building. Sessions will
      begin with a didactic component covering overcoming barriers to physical activity, goal
      setting, self-monitoring, problem solving, topics related to mood (stress management,
      family/work balance, wellness wheel), sleep hygiene (setting routines, avoiding stimulants,
      environmental supports), and additional physical activity topics (e.g., managing physical
      activity in postpartum, overcoming relapses). Participants will be given educational
      materials in print and electronic form based on their preferences. The experiential component
      (i.e., physical activity) will be 30 minutes in duration and involve primarily walking, at a
      moderate intensity, based on national recommendations coupled with yoga. Our formative work
      suggests that mothers prefer walking and find it more enjoyable in the form of groups. We
      have chosen to also include yoga to provide options for ways to be active that also
      positively impact sleep and mood and pregnant women report desiring prenatal yoga. All
      walking sessions will be facilitated by the peer leaders. The yoga sessions will be taught by
      an experienced prenatal yoga instructor residing in Denver, CO.

      Each session will have 3-4 peer leaders to help facilitate and model the physical activity
      component (i.e., will accompany women during their walking and yoga sessions to provide
      support and ensure safety (e.g., correct postures during yoga, monitoring exercise intensity
      and symptoms during walking sessions). Our MBMM formative work and expertise in
      community-based physical activity interventions suggests participants prefer peer group
      leaders because they foster a sense of community and social support within the group setting.
      Peer leaders will be compensated for their time working with the MBMM+ program and will be
      peer mothers from the community who are recent mothers (< two years postpartum) who
      successfully engaged in regular physical activity during a previous pregnancy. Peer leaders
      will be identified by our research team, recreation center directors, and health care
      provider partners. At the end of every session, participants will check in with an assigned
      peer leader to discuss in small groups their weekly logs. Peer leaders will note the
      discussions that occurred amongst the participants in their group, describe barriers that
      were identified, problem-solving strategies that were suggested and used, and future
      goals/recommended action steps. This group work will help participants to learn ways to fit
      physical activity into their lifestyle and overcome barriers by receiving feedback from their
      peer leader and other group members. It will also ensure that the intervention is conducted
      and received in the way intended as the peer leaders and program manager/PI will review these
      small group progress notes each week and monitor intervention delivery.

      Peer leader training and fidelity: Weekly, the research team (PI/program manager) will have
      phone calls and/or in-person meetings with the group peer leaders to debrief and address any
      issues that may arise. The program manager and/or PI will be on-site for all sessions to
      ensure quality control of intervention delivery and data collection efforts by peer leaders.
      The PI will conduct a training session before the onset of the intervention with the peer
      group leaders to cover topics including how to engage in safe and effective physical activity
      during pregnancy, an overview of behavioral change theory and the behavioral skills that the
      intervention is targeting, ways to garner social support and leadership skills. The PI has
      been extensively trained by the Cooper Institute in Prenatal-Postnatal Physical Activity. The
      yoga instructor will have been extensively trained in prenatal yoga.

      Control Group:

      Women randomized to the control group will complete a similarly structured 12-week program;
      electronic materials related to various prenatal topics including preparation for birth,
      birthing options, and responsive parenting will be distributed twice a week for the first
      4-weeks of the program. Starting week 5 of the 12-week intervention, participants will attend
      two in-person, group sessions per week with each session lasting approximately 60 minutes and
      will be held at a local community center located close to the recruitment clinics. Sessions
      will be held on weekday evenings and weekend mornings as these times were preferred by
      pregnant women.
    

Intervention name(s): My Baby My Move +; Control
Intervention type(s): Other; Other
Intervention description(s): This is a community-based, peer-led 12-week wellness intervention to decrease excessive gestational weight gain.; This is a 12-week basic prenatal education class.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial (control and intervention)
Masking: None (Open Label)
Primary purpose: Prevention