Family Connections Weight Management
|ClinicalTrials.gov Identifier: NCT00433901|
Recruitment Status : Completed
First Posted : February 12, 2007
Last Update Posted : July 20, 2010
|Condition or disease||Intervention/treatment||Phase|
|Childhood Obesity||Behavioral: Targeted parental instruction for positive lifestyle change with follow-up calls.||Not Applicable|
Hide 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.
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.
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
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.
- 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
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Managing Weight in Overweight and At-Risk Children|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
- Child BMI
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00433901
|Principal Investigator:||Paul A. Estabrooks, PhD||Kaiser-Permanente of Colorado Clinical Research Unit|