Extension Family Lifestyle Intervention Project (E-FLIP for Kids)
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The Extension Family Lifestyle Intervention Project (E-FLIP for Kids) trial will evaluate the
      impact of a community based intervention delivered to families in rural settings utilizing
      the existing Cooperative Extension Service network on child dietary intake and weight.
      Specifically, the E-FLIP for Kids study will determine if behavioral treatments for child
      obesity lead to greater improvement in child weight compared to educational only
      treatment.Participants will include 240 parent-child dyads from ten rural counties in north
      central Florida. Study outcomes will be measure prior to treatment, at the end of treatment
      (month 12) and at one year follow-up (month 24). All treatment meetings will be held at
      Cooperative Extension Service offices within each participating county.
    

Detailed description: 
      The study sample will include 240 overweight and obese children, ages 8 to 12 years, and
      their parent(s) from rural counties in North Central Florida. Participants will be randomized
      to one of three conditions: family-based (FB) healthy lifestyle intervention, parent-only
      (PO) healthy lifestyle intervention, and health education control (HEC) condition. Each of
      the treatment conditions will involve 23 group meetings delivered on the same schedule.

      Recruitment will include direct solicitation methods combined with culturally-tailored
      efforts targeting the recruitment of minority participants. Direct solicitation methods will
      entail direct mailings to households and to health-care providers, a press release, and
      presentations/brochure distribution by Extension agents and research team members at
      churches, social organizations, community events, and through local businesses. Brochures
      will also be distributed through local schools. Recruitment information will contain a
      toll-free phone number to our research office. Potential participants will be encouraged to
      call our office to learn more about the study and complete an initial phone screen. The phone
      calls will be received by trained staff that will describe the study and perform a brief
      phone screen in order to determine initial eligibility. Those families who meet initial
      eligibility and express interest will be scheduled for an in-person screening visit to
      determine their final eligibility for the program.

      Participants (child and parent) will complete assessment measures at an initial screening
      visit, pre-start baseline assessment, post-treatment assessment (12 months after the baseline
      assessment), and a follow-up assessment (24 months after the baseline assessment).

      At the initial in-person screening visit interested participants (child and parent/legal
      guardian) will complete informed consent procedures and then measures of height and weight,
      medical history questionnaires, and a general family information form. Parents will complete
      questionnaires regarding family functioning, parent psychological functioning, parent
      mobility, child behavior, reasons for seeking treatment, and family cost of program
      participation. Children will complete questionnaires regarding reasons for joining the
      program and social interactions. In addition, the child will be assessed for resting heart
      rate and blood pressure.

      The pre-start/baseline assessment visit will occur approximately one to two weeks prior to
      the beginning of the intervention. At this assessment children and parents will be measured
      for height and weight, and the child's waist circumference will also be assessed. Families
      will complete a packet of self-report study questionnaires. Children will be assessed for
      blood pressure and heart rate. Children's body fat percentage will be assessed by an
      electrical impedence scale. Child will be asked to wear an armband accelerometer for seven
      days following the assessment. Children will also be asked to complete one finger prick (with
      collection of approximately 2-3 drops of blood) to assess blood lipids and HbA1C using a
      point-of-care device. A 20 meter shuttle physical fitness assessment will also be completed
      by children to assess their level of physical fitness. The finger prick, blood pressure,
      physical fitness, and heart rate assessment protocol will be completed by study medical
      personnel trained in these procedures. Children, with help from their parents, will complete
      measures of the child's dietary intake and physical activity habits, eating behaviors,
      qualify of life, body image, and pubertal development. Parents will complete measures about
      their own dietary intake and physical activity habits, the family feeding environment,
      perceive family support and social problem solving abilities. At the end of this baseline
      assessment visit, participants will be notified as to which of the three treatment conditions
      they were randomized.

      The same assessment protocol administered at the baseline visit will be administered at the
      post-treatment assessment, and follow-up assessment. Measures of post-treatment satisfaction
      will also be administered to the child and parent at these two follow-up assessments.

      Family-Based Group Intervention Condition: Each parent and child dyad will participate in 23
      group meetings. Children and parents will meet in simultaneous, but separate, parent and
      child groups at each meeting. The intervention will include weekly sessions for the first 8
      weeks and biweekly sessions for the next 8 weeks. Families will also participate in a
      maintenance intervention for the next eight months (months 5 to 12) that includes one session
      per month, with the exception of month 8, which will include 4 weekly sessions. For all child
      and parent participants, the primary treatment objectives will be to decrease caloric intake
      in a nutritionally sound manner and to increase moderate intensity exercise. Changes in
      dietary habits will be addressed via a modified version of the Stoplight System. The
      stoplight system is designed to teach children and parents to classify foods according to the
      colors of the stoplight. Green foods are "go foods", are foods high in nutrients and low in
      calories (i.e., fruits and vegetables). Yellow foods are "caution" foods. Yellow foods have
      lots of nutrition, but also significant calories and should be eaten in moderation. Red foods
      are "stop" foods. These foods are high in calories relative to nutrients. Red foods should be
      limited, but are not considered forbidden. Weekly goals will target gradual reductions in
      caloric intake through limiting consumption of high-fat/high-sugar foods "Red foods" and
      increasing consumption of fruits and vegetables. Children and adults will be encouraged to
      eat a well-balanced diet based on the food guide pyramid. Parents and children will also be
      given pedometers (step counters) and they will be asked to keep track of the number of steps
      they take each day. Each week parents and children will set goals to gradually increase the
      number of steps they take each day. Parent and their children will be asked to record what
      they eat and drink, as well as their physical activity (number of steps taken) on daily food
      logs.

      Parent Group Session. Each session will last 90 minutes and will include three segments. In
      the first segment will review parent and child progress in implementing the strategies
      recommended and goals set for changing their eating or exercise in the previous session.
      Parents will discuss with group leaders the successes, challenges, and barriers encountered
      as they attempted to make lifestyle changes over the past week, as well as discuss possible
      strategies for overcoming various challenges. The second segment will focus on the specific
      "topic of the day" or "session lesson". The third segment will involve bringing the children
      and parents back together at the end of each session to set specific goals for the next week.

      Child Group Session. Each session will last 90 minutes. During the first part of the session
      we will review the children's progress in achieving their dietary and physical activity goals
      over the previous week. After a private weigh-in, child participants will describe the
      progress they achieved in reaching their dietary and physical activity goals. Good progress
      will be highlighted by strong positive feedback. The second segment will include an exercise
      or game component to demonstrate strategies/activities to help children keep physically
      active including activities such as Frisbee, flashlight tag, watermelon relay, jump rope,
      kickball and dancing. Third, the children and group leaders will prepare and sample a variety
      of healthy snacks including fruits and vegetables with various healthy low fat dips, bagels
      with low fat cream cheese, low fat cheese quesadillas, fruit smoothies, and yogurt fruit
      parfaits. During the food sampling portion of each session, fun and educational activities
      will be used to teach children about nutrition (e.g., recognizing calorie and fat content of
      foods via "signals" of the Stoplight program), strategies to increase physical activity,
      behavioral management skills (self-monitoring and goal setting), and strategies to cope with
      psychosocial concerns (i.e., building self-esteem) and how to also support their parents.

      Parent-only Group Intervention Condition: Only the participating parent(s) will attend 23
      group meetings over the course of one year. The parent-only interventions will meet on the
      same schedule as the family-based intervention. The intervention will include weekly sessions
      for the first 8 weeks and biweekly sessions for the next 8 weeks. Families will also
      participate in a maintenance intervention for eight months (months 5 to 12) that includes one
      session per month, with the exception of month 8, which will include 4 weekly sessions.

      Each session will last 90 minutes and will include three segments, similar to the parent
      group previously described in the FB intervention. The sessions for parents in the
      parent-only program will be structured the same as the parents sessions for the family-based
      intervention (described above) and will also cover the same topics. As with the family-based
      intervention, the parent and their children assigned to the parent-only intervention will be
      asked to record what they eat and drink, as well as their physical activity, on a daily
      basis. As children will not be attending group sessions in this condition, an emphasis will
      be placed on helping parents effectively communicate the topics of each session to the target
      child at home, as well as teaching parents how to work with their children to set goals
      together and monitor their food intake and physical activity. Each week group
      interventionists will model the goal setting process with parents and suggest a general range
      of age-appropriate dietary and physical activity targets that might be appropriate for each
      child and parent.

      Health Education Condition: Both the child and parent will attend the treatment sessions in
      this program. This condition will include 23 group meetings on the same schedule as the
      previously described conditions. Each session will last 90 minutes. The Health Education
      condition will be tailored for children and families, and will include a series of meetings
      addressing key aspects of nutrition, physical activity, and health promotion. The health
      education curriculum will include topics such as national guidelines regarding proper
      nutrition, guidelines for physical activity, strategies to cope with stress, healthy sources
      and guidelines for intake of fiber, calcium, protein, grains & carbohydrates. Topics will
      also include use of vitamin & mineral supplements, dental and sleep hygiene, self-esteem,
      family communication, and assertiveness training in dealing with peer victimization. The
      families in the Health Education group will not receive training in behavioral
      self-regulation strategies, such as goal setting and self-monitoring. Children will
      participate in a group physical activity during each session such as frisbee, jump rope,
      stoplight tag. They will also sample healthy snacks such as pretzels or fruits and
      vegetables. There will be no discussion of implementing these activities and preparing
      healthy snacks in other settings. Children will not help prepare the snack items.
    

Intervention name(s): Behavioral Child Tx Contacts; Behavioral Parent-Tx Contacts; Dietary and Physical Activity Information
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): Each parent and child dyad will participate in group meetings. Children and parents will meet in simultaneous, but separate, groups at each meeting. The intervention will include 12 sessions over 16 weeks. Families will also participate in a maintenance intervention for the next eight months. The primary treatment objectives will be to decrease caloric intake in a nutritionally sound manner and to increase moderate intensity exercise. Changes in dietary habits will be addressed via a modified version of the Stoplight System. Children and adults will be encouraged to eat a well-balanced diet based on the food guide pyramid. Parents and children will also be given pedometers and they will be asked to keep track of the number of steps they take each day. Each week parents and children will set goals to gradually increase physical activity. Parent and their children will be asked to record what they eat and drink, as well as their physical activity on daily food logs.; Only the participating parent(s) will attend group meetings. The intervention will include weekly sessions for the first 8 weeks and biweekly sessions for the next 8 weeks. They will also participate in a maintenance intervention for eight months. Each session will last 90 minutes. The sessions for parents in the parent-only program will be structured the same as the parents sessions for the family-based intervention and will also cover the same topics. As with the family-based intervention, the parent and their children assigned to the parent-only intervention will be asked to record what they eat and drink, as well as their physical activity, on a daily basis. Each week group interventionists will model the goal setting process with parents and suggest a general range of age-appropriate dietary and physical activity targets that might be appropriate for each child and parent.; Both the child and parent will attend the treatment sessions in this program. The condition will include a series of meetings addressing key aspects of nutrition, physical activity, and health promotion such as national guidelines regarding proper nutrition, guidelines for physical activity, strategies to cope with stress, healthy sources and guidelines for intake of fiber, calcium, protein, grains & carbohydrates. Topics will also include use of vitamin & mineral supplements, dental and sleep hygiene, self-esteem, family communication, and assertiveness training in dealing with peer victimization. The families in the Health Education group will not receive training in behavioral self-regulation strategies, such as goal setting and self-monitoring. Children will participate in a group physical activity during each session such as frisbee, jump rope, stoplight tag. They will also sample healthy snacks such as pretzels or fruits and vegetables.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Children, Obesity, Intervention