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

This study has been completed.
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT00200265
First received: September 12, 2005
Last updated: April 19, 2012
Last verified: December 2007
  Purpose

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.


Condition Intervention
Obesity
Behavioral: diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Changing Eating Behaviors in Young Children: Should Healthy Foods be Increased or Unhealthy Foods Decreased?

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • z-BMI in children [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Eating and activity behaviors [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 101
Study Start Date: July 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Behavioral: diet
Behavioral: diet
diet
Experimental: 2
Behavioral: diet
Behavioral: diet
diet
Placebo Comparator: 3
Behavioral: diet
Behavioral: diet
diet

  Eligibility

Ages Eligible for Study:   4 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

    -

  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: NCT00200265

Locations
United States, Rhode Island
The Weight Control and Diabetes Research Center
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
The Miriam Hospital
American Diabetes Association
Investigators
Principal Investigator: Hollie A Raynor, PhD The Miriam Hospital
  More Information

No publications provided by The Miriam Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT00200265     History of Changes
Other Study ID Numbers: 7-05-HFC-27
Study First Received: September 12, 2005
Last Updated: April 19, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 30, 2014