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Family Program for Weight Gain Prevention

This study has been completed.
United States Department of Agriculture (USDA)
Information provided by (Responsible Party):
University of Colorado, Denver Identifier:
First received: October 1, 2009
Last updated: February 9, 2016
Last verified: February 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:

  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 Intervention
Overweight Obesity Behavioral: Family Program for the Prevention of Weight Gain Behavioral: Control Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Prevention
Official Title: Family Program for Weight Gain Prevention

Resource links provided by NLM:

Further study details as provided by University of Colorado, Denver:

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. [ Time Frame: 6 months ]

Enrollment: 418
Study Start Date: July 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: University of Colorado, Denver Identifier: NCT00989170     History of Changes
Other Study ID Numbers: 08-1206
Study First Received: October 1, 2009
Last Updated: February 9, 2016

Additional relevant MeSH terms:
Weight Gain
Body Weight
Signs and Symptoms
Body Weight Changes processed this record on June 23, 2017