Healia Clinical Trials Information Database

Changing Eating Behaviors in Young Children: Should Healthy Foods be Increased or Unhealthy Foods Decreased?

Recommendations for treatment of childhood obesity in a primary care setting have been developed. These recommendations include beginning treatment with young children, focusing treatment on the parent so the parent can assist the child in making changes, and changing 2 or 3 very specific eating or activity behaviors (i.e., eat less snacks, rather than eat less calories). The effectiveness of these recommendations has never been evaluated. This project’s goal is to develop, implement, and evaluate a 6-month childhood obesity intervention meeting these recommendations. Another goal of the project is to compare two different approaches, focusing on either decreasing intake of two unhealthy foods or increasing intake of two healthy foods, for changing eating behaviors during treatment. Two hundred ten children, between the ages of 4 to 9 years, who are at risk for overweight or overweight, based upon weight and height standards, will be randomized to one of three treatments: 1) a Newsletter treatment (provided with information on healthy eating only); 2) a Parent Program that decreases intake of sweet/salty snack foods (< 3 servings/week) and sweetened drinks (< 3 servings/week); or 3) a Parent Program that increases intake of fruits and vegetables (5 servings/day) and low-fat dairy products (2 servings/day). Children’s height and weight will be measured at 0, 3, 6, 9, and 12 months. This project will determine if the recommendations for treatment are effective, and if focusing on decreasing intake of unhealthy foods or increasing intake of healthy foods produces a better long-term weight loss outcome.

Status: Active, not recruiting (N/A). Started on July 1st, 2005. Ended on July 1st, 2009.

Enrollment: 210 subjects

Study Type: Interventional

Study Design:

  • Treatment
  • Randomized
  • Open Label
  • Active Control
  • Parallel Assignment

Conditions:

Interventions:

  • Behavioral: diet

Eligibility

Inclusion Criteria:

  1. Age between 4 and 9 years. We propose to use this age group since parents are in control of the eating and exercise choices of such children, and thus a program that focuses on parenting behaviors (i.e., positive reinforcement, stimulus control, parental modeling) should be developmentally appropriate. This age group also meets the Expert Committee’s goal of intervening early5; moreover children aged 4 to 8 years have similar nutritional needs.

  2. Body mass index (BMI) > 85th percentile BMI. Based upon the Expert Committee recommendations,5 children > 2 years of age who are identified as being at risk for overweight (85th to 94th percentile BMI) or overweight (> 95th percentile BMI) should focus on weight maintenance as height continues to increase. These recommendations are aimed at reducing z-BMI.

  3. Tanner stage 1 (prepubertal) sexual maturation status.

  4. Self-report at least one of the following problematic behaviors:

    1. Consume < 2 servings per day of whole fruit (not juice) or < 3 servings per day of vegetables.

    2. Consume > 1 serving of sweetened drink per day.

    3. Consume < 2 servings of low-fat milk per day.

    4. Consume > 4 times per week of sweet or salty snack foods.

  5. A parent willing to attend treatment meetings.

  6. Parent and child speak English.

    -

Exclusion Criteria:

  1. Report a family member participating in another weight loss program.

  2. Report that the child or parent planning to attend the treatment meetings has a major psychiatric disease or organic brain syndrome.

  3. Report that the child or parent planning to attend the treatment meetings has dietary or physical activity restrictions.

  4. Intend to move outside of the metropolitan area within the time frame of the investigation.

    -

Gender

Both

Mininum Age

4 Years

Maximum Age

9 Years

Healthy Volunteers

Accepts Healthy Volunteers


Resources

Source: The Miriam Hospital

Authority: United States: Food and Drug Administration

Locations

  • The Weight Control and Diabetes Research Center
    Providence
    Rhode Island
    02903
    United States

Officials

  • Hollie A Raynor, PhD (Principal Investigator, The Miriam Hospital)

Sponsors

  • The Miriam Hospital (Lead Sponsor)

  • American Diabetes Association (Collaborator)

References

None.

Links

None.


Date Verified
December 1st, 2007
First Received
December 26th, 2007
Last Changed
December 26th, 2007

Information obtained from ClinicalTrials.gov on July 15, 2008. Link to the current ClinicalTrials.gov record.


All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.

The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.


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