Family Program for Weight Gain Prevention
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Program for the Prevention of Weight Gain
Control Group
Sponsored by
About this trial
This is an interventional prevention trial for Overweight
Eligibility Criteria
Inclusion Criteria:
- Families with at least one overweight child (8-12 years of age, BMI for age between the 84.6th and 95.4th percentile)
Exclusion Criteria:
- Individuals with physical or medical limitations that prevent them from engaging in physical activity. We will screen potential subjects and exclude subjects with an underlying disease that would inhibit activity using the Physical Activity Readiness Questionnaire (PAR-Q)
- Individuals using medication that influences body weight and appetite such as ADHD medication (e.g. Ritalin) and medication for depression.
- Pregnant and lactating women because their patterns of physical activity and eating may be different from their usual baseline. In the event a woman becomes pregnant during the study her data will not be included in the final analyses.
- Adults or children who are weight unstable due to weight loss surgery, weight loss medication, or dietary behavior.
- Families who do not have access to the internet at home or are not willing or able to use public access computers e.g., libraries and schools.
Sites / Locations
- Center for Human Nutrition
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Family Program for the Prevention of Weight Gain
No enhanced Family Program
Arm Description
Use of an enhanced Family Program on the prevention of weight gain in families with overweight children.
Outcomes
Primary Outcome Measures
The primary outcome of the randomized study is the proportion of overweight children who gain BMIp during the 6-month study period.
Secondary Outcome Measures
Full Information
NCT ID
NCT00989170
First Posted
October 1, 2009
Last Updated
February 9, 2016
Sponsor
University of Colorado, Denver
Collaborators
United States Department of Agriculture (USDA)
1. Study Identification
Unique Protocol Identification Number
NCT00989170
Brief Title
Family Program for Weight Gain Prevention
Official Title
Family Program for Weight Gain Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
United States Department of Agriculture (USDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
418 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Family Program for the Prevention of Weight Gain
Arm Type
Experimental
Arm Description
Use of an enhanced Family Program on the prevention of weight gain in families with overweight children.
Arm Title
No enhanced Family Program
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Family Program for the Prevention of Weight Gain
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Group
Intervention Description
This group will not be provided the workbook and it is hypothesized those in the control group will gain excess weight.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Families with at least one overweight child (8-12 years of age, BMI for age between the 84.6th and 95.4th percentile)
Exclusion Criteria:
Individuals with physical or medical limitations that prevent them from engaging in physical activity. We will screen potential subjects and exclude subjects with an underlying disease that would inhibit activity using the Physical Activity Readiness Questionnaire (PAR-Q)
Individuals using medication that influences body weight and appetite such as ADHD medication (e.g. Ritalin) and medication for depression.
Pregnant and lactating women because their patterns of physical activity and eating may be different from their usual baseline. In the event a woman becomes pregnant during the study her data will not be included in the final analyses.
Adults or children who are weight unstable due to weight loss surgery, weight loss medication, or dietary behavior.
Families who do not have access to the internet at home or are not willing or able to use public access computers e.g., libraries and schools.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Hill, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Human Nutrition
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Family Program for Weight Gain Prevention
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