Family Program for Weight Gain Prevention

NCT00989170 | Completed

• 1 other identifier: 08-1206
• Study Type: interventional
• Target: 418
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• The primary outcome of the randomized study is the proportion of overweight children who gain BMIp during the 6-month study period.

  6 months

Study Arms (2)

Family Program for the Prevention of Weight Gain

EXPERIMENTAL

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

No enhanced Family Program

ACTIVE COMPARATOR

Behavioral: Control Group

Interventions

Family Program for the Prevention of Weight Gain 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.

Family Program for the Prevention of Weight Gain

Control Group BEHAVIORAL

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

No enhanced Family Program

Eligibility Criteria

• Age: 3 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Families with at least one overweight child (8-12 years of age, BMI for age between the 84.6th and 95.4th percentile)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

Center for Human Nutrition

Denver, Colorado, 80220, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• James Hill, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2009
• First Posted: October 2, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 10, 2016

Record last verified: 2016-02

Locations

US (1)