Family Program for Weight Gain Prevention

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
USDA Beltsville Human Nutrition Research Center
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00989170
First received: October 1, 2009
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: July 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   3 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  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 ClinicalTrials.gov identifier: NCT00989170

Locations
United States, Colorado
Center for Human Nutrition
Denver, Colorado, United States, 80220
Sponsors and Collaborators
University of Colorado, Denver
USDA Beltsville Human Nutrition Research Center
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00989170     History of Changes
Other Study ID Numbers: 08-1206
Study First Received: October 1, 2009
Last Updated: November 20, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014