Family Program for Weight Gain Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00989170
Recruitment Status : Completed
First Posted : October 2, 2009
Last Update Posted : February 10, 2016
United States Department of Agriculture (USDA)
Information provided by (Responsible Party):
University of Colorado, Denver

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:

  1. 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.
  2. 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.
  3. 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00989170

United States, Colorado
Center for Human Nutrition
Denver, Colorado, United States, 80220
Sponsors and Collaborators
University of Colorado, Denver
United States Department of Agriculture (USDA)
Principal Investigator: James Hill, PhD University of Colorado, Denver

Responsible Party: University of Colorado, Denver Identifier: NCT00989170     History of Changes
Other Study ID Numbers: 08-1206
First Posted: October 2, 2009    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Weight Gain
Body Weight
Signs and Symptoms
Body Weight Changes