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
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
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
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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Family Connections Weight Management
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