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Completed

NCT Number: NCT00200265

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.

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Key information

Conditions

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

Age range

4 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.
  • Tanner stage 1 (prepubertal) sexual maturation status.
  • Self-report at least one of the following problematic behaviors:
  • Consume < 2 servings per day of whole fruit (not juice) or < 3 servings per day of vegetables.
  • Consume > 1 serving of sweetened drink per day.
  • Consume < 2 servings of low-fat milk per day.
  • Consume > 4 times per week of sweet or salty snack foods.
  • A parent willing to attend treatment meetings.
  • Parent and child speak English.

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Exclusion criteria

  • Report a family member participating in another weight loss program.
  • Report that the child or parent planning to attend the treatment meetings has a major psychiatric disease or organic brain syndrome.
  • Report that the child or parent planning to attend the treatment meetings has dietary or physical activity restrictions.
  • Intend to move outside of the metropolitan area within the time frame of the investigation.

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Treatment and study plan

Diet

Behavioral

diet

Primary outcomes

  1. z-BMI in children

    Time frame: 12 months

Secondary outcomes

  1. Eating and activity behaviors

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

  • American Diabetes Association

Registry information

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Sep 20, 2005
Registry last updated
Apr 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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