Family Program for Weight Gain Prevention

NCT ID: NCT00989170

Last Updated: 2016-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 418 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2012-12-31

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).

Conditions

Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Family Program for the Prevention of Weight Gain

Intervention Type: BEHAVIORAL

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.

No enhanced Family Program

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: BEHAVIORAL

This group will not be provided the workbook and it is hypothesized those in the control group will gain excess weight.

Interventions

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.

Intervention Type: BEHAVIORAL

Control Group

This group will not be provided the workbook and it is hypothesized those in the control group will gain excess weight.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Agriculture (USDA)

FED

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Hill, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Center for Human Nutrition

Denver, Colorado, United States

Countries

United States

Other Identifiers

08-1206

Identifier Type: -

Identifier Source: org_study_id