Family Connections Weight Management
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      The prevalence of overweight children has increased significantly over the past 3 decades and
      3 out of every 4 overweight children become obese adults. Additionally, overweight children
      are now at risk for developing type-2 diabetes while still in their youth. To address the
      issue of childhood weight management, Golan and colleagues provided a model for intervention
      development that targets parents as an exclusive agent of change when attempting to treat
      weight issues for children under 12 years of age. The Kaiser Permanente Colorado (KPCO)
      Weight Management Program (WMP) developed Family Connections, a condensed two-session
      program, based on the Golan model, for parents of children between the ages of 8-12 with a
      Body Mass Index (BMI) greater than the 85 percentile for age and gender. There is a need to
      determine if the content of Golan's model can be translated into a practical intervention to
      be used in usual pediatric weight management practice. The Family Connections study uses
      three arms to determine the effectiveness of healthy eating and active living messages.
    

Detailed description: 
      We used a 3 condition randomized controlled trial design to allow us to make comparisons
      across current standard care, Family Connections, and Family Connections plus telephone
      follow-up support.

      Duration:

      The study is conducted in a two year and four month period; beginning in November, 2004 and
      ending in February, 2007.

      Description of intervention:

      Workbook Control. A workbook was created from the content of the two part Family Connections
      classes, the current standard of care. The workbook has themes which promote increased PA and
      fruit & vegetable (FV) consumption in concert with decreased soda consumption (SC), and
      television viewing/recreational computer time (TV). Specific intervention themes included
      parental cognitive and behavior change, home environment change, and parental modeling of
      healthy behaviors.

      Family Connections-current standard of care. The Family Connections classes are a two part
      intervention targeted toward the primary caretakers of the overweight child. The classes were
      held one week apart at a local Kaiser Permanente health clinic. Parents were also given a
      copy of the workbook to use in class and at home.

      Family Connections plus Automated Telephone Follow-up. Parents assigned to this intervention
      arm will complete the Family Connections program and subsequently receive 10 follow-up
      sessions delivered via Interactive Voice Response (IVR) technology. The calls will be
      completed with high frequency initially and then scaled back over time. To sustain changes
      that are made as a result of the Family Connections program, telephone follow-up calls
      commenced 1 week after the second class. Calls occurred on a weekly basis for 1 month. During
      the 3rd and 4th month calls occurred biweekly. Finally a monthly call was provided during the
      5th and 6th months of the study. The calls will include content targeted towards, increasing
      parental behavioral health, parenting and role modeling skills as well as providing
      strategies for home environmental changes to promote healthy eating and PA. In addition, a
      goal setting and assessment tool was provided; at the beginning of each call the primary
      parent would hear the goal they selected the week prior and rate their achievement. Based on
      the rating, the primary parent was given the option to hear tips related to the topic of
      their prior week's selected goal area.

      Specific aims:

      PRIMARY AIM 1: To determine the effectiveness (6 & 12 months after the intervention
      initiation) of Family Connections when compared to a standard care control group in reducing
      child BMI percentile rankings. Other key outcomes will be physical activity (PA) and healthy
      eating behaviors (i.e., ↑ fruits & vegetables; ↓Soda/sugar drinks).

      PRIMARY AIM 2: To determine the effectiveness (6 & 12 months after the initiation of
      intervention) of adding automated telephone follow-ups using a 3 group randomized controlled
      trial design. The maintenance intervention will reinforce and extend the messages of Family
      Connections related to strategies to address the home environment, parenting skills to
      promote healthy eating and activity, and parental modeling of appropriate eating and PA.
      Changes in BMI percentile ranking will be used as the primary outcome. Other key outcomes
      will be PA and eating behaviors (i.e., compares Family Connections alone to Family
      Connections plus automated telephone follow-up)

      SECONDARY AIM 1: Compare the effectiveness of each intervention condition to positively
      change parental BMI, PA, and eating behaviors. Second, by omitting the overweight child from
      the intervention process significant reductions in the child's reporting of eating disorder
      symptoms were found when compared to intervention models that included the child as a primary
      agent of personal change.

      SECONDARY AIM 2: Determine the effectiveness of Family Connections (with and without
      follow-up) to decrease child eating disorder symptoms when compared to standard care

      Study Measures:

      Measures were collected from the child and parent at the baseline study visit; at the 6 month
      study visit; and at the 12 month study visit.

      Child:

        -  height and weight

        -  accelerometer (measure of physical activity)

        -  self efficacy questions

        -  subjective measures of screen time and physical activity

        -  Kids Eating Disorders Survey (KEDS)

        -  Pediatric Quality of Life survey (PEDSQL)

        -  Block dietary recall survey

      Parent:

        -  Height and weight

        -  Fat and Fibre survey

        -  Demographic information

        -  Self efficacy questions

        -  Health literacy questions

        -  Rapid Assessment of Physical Activity (RAPA)

        -  Home Environment survey

        -  Family health history

        -  Quality of life questions

      During the 6 month assessment, parents (regardless of study arm assigned) were given a short
      survey to complete regarding their level of interest and satisfaction of IVR. At the 12 month
      assessment, parents completed a satisfaction survey regarding their experience with the study
      process.
    

Intervention name(s): Targeted parental instruction for positive lifestyle change with follow-up calls.
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: obesity in children; childhood disorders; overweight children; physical activity; home environment