Family Program for Weight Gain Prevention
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|ClinicalTrials.gov Identifier: NCT00989170|
Recruitment Status : Completed
First Posted : October 2, 2009
Last Update Posted : February 10, 2016
The long-term goal of this project is to develop, evaluate, and disseminate to Extension Service families across the state of Colorado, an engaging, interactive, and evidence-based Family Program in order to prevent weight gain in adults and excess weight gain in children. Excess weight gain in children is defined as an increase in body weight beyond the increase in weight associated with normal growth and development. The program will focus on small, easily adopted, sustainable, lifestyle changes.
Project Objectives include:
- Enhancing a Family Program by including food and physical activity environmental assessments, an online social network, and a pre-programmed health-based text messaging system, and by gaining feedback from extension families through a series of 6 focus groups.
- Conducting a randomized trial to evaluate the impact of the enhanced Family Program on the prevention of weight gain in families with overweight children. The investigators hypothesize that excess weight gain will be prevented in subjects in the intervention group, while those in the control group will gain excess weight.
- Disseminating the Family Program through USDA Cooperative Extension Services in Colorado and evaluate the usefulness/effectiveness of the program for USDA Extension agents and participating families. The investigators will conduct 4 additional focus groups at the end of this objective to gain feedback on its usefulness in a "real-life" setting. This objective is different from objective 2 in that the investigators are evaluating the program in a real-life setting, using qualitative and self-reported data, rather than conducting a clinical trial.
By conducting focus groups with Extension families during both objectives #1 and 3, the Family Program will help to improve knowledge regarding behavioral and environmental factors influencing obesity. After enhancing the Family Program (Objective #1), the investigators will test its effectiveness in a randomized study of 200 families (Objective #2). Finally, after having developed and tested this effective intervention strategy, the investigators will disseminate it through Extension Agents throughout the state to evaluate its usefulness in a "real-life" setting (Objective #3).
|Condition or disease||Intervention/treatment||Phase|
|Overweight Obesity||Behavioral: Family Program for the Prevention of Weight Gain Behavioral: Control Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||418 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Family Program for Weight Gain Prevention|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Experimental: Family Program for the Prevention of Weight Gain
Use of an enhanced Family Program on the prevention of weight gain in families with overweight children.
Behavioral: Family Program for the Prevention of Weight Gain
The Family Workbook is a step-by-step instruction guide for families to use throughout the 6-month period, detailing healthy lifestyle. All handouts, instructions, activities, and a timeline of the program are laid out for families in this workbook.
|Active Comparator: No enhanced Family Program||
Behavioral: Control Group
This group will not be provided the workbook and it is hypothesized those in the control group will gain excess weight.
- The primary outcome of the randomized study is the proportion of overweight children who gain BMIp during the 6-month study period. [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00989170
|United States, Colorado|
|Center for Human Nutrition|
|Denver, Colorado, United States, 80220|
|Principal Investigator:||James Hill, PhD||University of Colorado, Denver|