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Family Connections Weight Management

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Targeted parental instruction for positive lifestyle change with follow-up calls.
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring obesity in children, childhood disorders, overweight children, physical activity, home environment

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All boys and girls within the KPCO HMO system of the greater Denver area who are between the ages of 8 and 12 at the time of the initial assessment with a BMI of 85% or above.

Exclusion Criteria:

  • Parents for whom English is not their language of communication
  • Families who intend to move within the first three months of intervention
  • Families who do not have access to a telephone
  • Did not agree to be randomized.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Child BMI

    Secondary Outcome Measures

    Parent BMI
    Objective measure of physical activity using child accelorometer
    Kids Eating Disorder Survey (KEDS)
    Peds QOL survey
    SE (self efficacy)
    Self resport of physical activity
    Self report of sedintary activity
    Children's block food frequency survey
    Parent's home environment survey
    Parent self efficacy
    Parent demographics
    Parent QOL
    Parent Rapid assessment of phycial activity (parent)
    Parent Fat and Fiber survey
    Parent Health Literacy
    Child/family medical history
    Economic survey type of medical weight management services

    Full Information

    First Posted
    February 8, 2007
    Last Updated
    July 16, 2010
    Sponsor
    Kaiser Permanente
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00433901
    Brief Title
    Family Connections Weight Management
    Official Title
    Managing Weight in Overweight and At-Risk Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2004 (undefined)
    Primary Completion Date
    March 2009 (Actual)
    Study Completion Date
    March 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Kaiser Permanente

    4. Oversight

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Childhood Obesity
    Keywords
    obesity in children, childhood disorders, overweight children, physical activity, home environment

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    220 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    Targeted parental instruction for positive lifestyle change with follow-up calls.
    Primary Outcome Measure Information:
    Title
    Child BMI
    Secondary Outcome Measure Information:
    Title
    Parent BMI
    Title
    Objective measure of physical activity using child accelorometer
    Title
    Kids Eating Disorder Survey (KEDS)
    Title
    Peds QOL survey
    Title
    SE (self efficacy)
    Title
    Self resport of physical activity
    Title
    Self report of sedintary activity
    Title
    Children's block food frequency survey
    Title
    Parent's home environment survey
    Title
    Parent self efficacy
    Title
    Parent demographics
    Title
    Parent QOL
    Title
    Parent Rapid assessment of phycial activity (parent)
    Title
    Parent Fat and Fiber survey
    Title
    Parent Health Literacy
    Title
    Child/family medical history
    Title
    Economic survey type of medical weight management services

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All boys and girls within the KPCO HMO system of the greater Denver area who are between the ages of 8 and 12 at the time of the initial assessment with a BMI of 85% or above. Exclusion Criteria: Parents for whom English is not their language of communication Families who intend to move within the first three months of intervention Families who do not have access to a telephone Did not agree to be randomized.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paul A. Estabrooks, PhD
    Organizational Affiliation
    Kaiser-Permanente of Colorado Clinical Research Unit
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19095163
    Citation
    Estabrooks PA, Shoup JA, Gattshall M, Dandamudi P, Shetterly S, Xu S. Automated telephone counseling for parents of overweight children: a randomized controlled trial. Am J Prev Med. 2009 Jan;36(1):35-42. doi: 10.1016/j.amepre.2008.09.024.
    Results Reference
    derived

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