HomeStyles-2: Shaping HOME Environments and LifeSTYLES to Prevent Childhood Obesity in SNAP-Education
Condition: Healthy Lifestyle; Home Environment Related Disease; Child Behavior; Cognitive Change; Child Obesity; Parenting; Parents; Parent-Child Relations
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      Childhood obesity prevention efforts are needed in the United States, especially for families
      with low income. Educating parents and caregivers on simple lifestyle and affordable home
      environment changes is an effective strategy to improve health outcomes for the entire
      family. Therefore, the purpose of this study is to determine whether HomeStyles-2, a
      nutrition education and childhood obesity prevention program for families with children in
      middle childhood (ages 6 to 11 years), motivates parents to shape their home environments and
      weight-related lifestyle practices to be more supportive of optimal health and weight status
      of their children aged 6-11 years more so than those in the control condition. The study will
      include the experimental group and an attention control group who will engage in a nutrition
      education program, Eat Healthy Be Active, that is equal in nonspecific treatment effects but
      does not overlap on topics covered in HomeStyles-2. This study will be implemented in
      Florida's Supplemental Nutrition Assistance Program-Education (SNAP-Ed) program, which
      provides nutrition education and obesity prevention supports for individuals with low income
      who are receiving or eligible for SNAP benefits. Nutrition Educators will be randomized to
      the experimental or attention control condition, and will lead participants through virtual,
      group-based nutrition education series. The following data will be collected:
      sociodemographic characteristics of the participant and child; child and parent health
      status; parent weight-related cognitions; weight-related behaviors of the participant and
      child; and weight-related characteristics of the home environment. Enrollment for this study
      will begin late-2021.
    

Detailed description: 
      The aim of the HomeStyles-2 for SNAP-Ed families RCT is to determine whether HomeStyles-2
      enables and motivates SNAP-Ed parents and child caregivers (e.g., guardians) to shape their
      home environments and weight-related lifestyle practices to be more supportive of optimal
      health and weight status of their children aged 6-11 years than those in the control
      condition. The study will be a two-arm, cluster randomized trial and will follow the CONSORT
      guidelines extension for cluster trials. Individual counties or groups of small counties
      operate as a single division with one individual who supervises the SNAP-Ed Nutrition
      Educators assigned to that division. Every participating division will function as a cluster
      in the study. Half of the Nutrition Educators in each cluster that choose to participate in
      the study will be randomized and trained to only deliver the experimental treatment and the
      other half the control intervention. Eligible participants will be recruited by Nutrition
      Educators through existing SNAP-Ed community partnerships.

      Once identified, eligible individuals will be screened for eligibility, consented, and
      complete the baseline survey with a trained research assistant over the phone. Participants
      who complete the baseline survey and meet survey plausibility checks will be enrolled in the
      study. Their assignment to experimental or attention control condition is dependent upon the
      Nutrition Educator's random assignment to teach experimental or attention control curriculum.
      Recruitment materials and the bona fide treatment to be delivered to the attention control
      group are designed to blind participant assignment to study condition.

      Participants will complete a six-week virtual nutrition education program, with each weekly
      session lasting approximately 30 minutes. Nutrition Educators will conduct the sessions over
      video conferencing software (e.g., Zoom). Participants will receive intervention materials by
      mail before the first class of the series and will have electronic access to the materials
      through a free learning management system. After the six-week virtual nutrition education
      program, participants will be invited to take the post survey over the telephone with a
      trained research assistant. Approximately 4 to 10 weeks after participants complete the post
      survey, they will be invited to take the follow-up survey to assess longer-term intervention
      effects.

      Participant progress through the RCT will be monitored by tracking attendance at each
      educational session. Trained research assistants and SNAP-Ed staff will be available to
      answer questions throughout the study. Participants will receive modest stipends that
      increase in value after they complete each survey.

      The HomeStyles-2 experimental group intervention materials (i.e., "Healthy" HomeStyles-2)
      were designed to be congruent with White House and IOM recommendations for home-centered
      obesity prevention interventions and critical elements for effective interventions (e.g.,
      interventions are positive, culturally sensitive, supportive of parent-child interaction and
      child development; develop realistic, effective plans that empower families). HomeStyles-2
      for middle childhood intervention materials provide intensive, interactive, fun,
      non-judgmental opportunities for parents to shape their home environments and lifestyle
      practices to protect child health. They also promote positive strategies and changes that
      adults can control in their environments to reduce risk of excessive weight gain in their
      middle childhood youth. Key factors contributing to childhood obesity that can be suitably
      addressed in the home environment with middle childhood kids identified for inclusion in the
      intervention materials were selected using systematic literature reviews and input from
      experts in childhood obesity prevention. The topics that emerged and will be covered in the
      SNAP-Ed arm of the study include inadequate intake of fruits and vegetables, infrequent
      family meals, excessive consumption of sugar-sweetened beverages, large portion sizes, and
      irregular breakfast consumption. An additional factor was children's limited food preparation
      skills.

      The attention control group will receive a different but bona fide, credible treatment at the
      same time as the experimental group. The control condition will provide information distinct
      from the "active" ingredient in the experimental intervention, while still aligning with the
      description of the study recruitment materials (i.e., to build happier, healthier families)
      and adhering to the regulations governing educational content of SNAP-Ed programming. The
      control condition materials are from the SNAP-Ed Eat Healthy, Be Active program and were
      adapted to match the experimental intervention in number of sessions, length of sessions,
      4-page informational guide, goal-setting activity, and incentive items.

      To adapt the experimental and control programs for virtual delivery, a Microsoft PowerPoint
      presentation and script was created for each of the educational sessions. The scripts include
      suggested questions and opportunities for Nutrition Educators to use to actively engage
      participants in the session, such as by speaking, typing questions and comments in the chat
      box, or using emojis to register reactions.

      The study survey, "Home Obesogenicity Measure of EnvironmentS"-Families with School-age Kids
      (HOMES-FSAK), will be used to collect baseline, post, and follow-up data in the HomeStyles-2
      RCT. The Social Cognitive Theory along with the key concepts addressed in the HomeStyles-2
      guides provided the framework for identification of cognitions, behaviors, and aspects of the
      home environment to be assessed. The survey will collect sociodemographic characteristics of
      the participant and child; child and participant health status; parent weight-related
      cognitions; weight-related behaviors of the parent and child; and weight-related
      characteristics of the home environment.
    

Intervention name(s): Healthy HomeStyles; Eat Healthy Be Active
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Comparison of 2 educational interventions; Comparison of 2 educational interventions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: experimental group and attention control group
Masking: None (Open Label)
Primary purpose: Prevention