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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: diet

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 9 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

   -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Behavioral: diet	Behavioral: diet; diet
Experimental: 2; Behavioral: diet	Behavioral: diet; diet
Placebo Comparator: 3; Behavioral: diet	Behavioral: diet; diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
z-BMI in children	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Eating and activity behaviors	12 months

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Collaborators: American Diabetes Association
• Investigators: Principal Investigator: Hollie A Raynor, PhD, The Miriam Hospital

Publications and helpful links

General Publications

• Hart CN, Raynor HA, Osterholt KM, Jelalian E, Wing RR. Eating and activity habits of overweight children on weekdays and weekends. Int J Pediatr Obes. 2011 Oct;6(5-6):467-72. doi: 10.3109/17477166.2011.590204. Epub 2011 Jul 20.
• Raynor HA, Osterholt KM, Hart CN, Jelalian E, Vivier P, Wing RR. Evaluation of active and passive recruitment methods used in randomized controlled trials targeting pediatric obesity. Int J Pediatr Obes. 2009;4(4):224-32. doi: 10.3109/17477160802596189.

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Estimate): April 20, 2012
• Last Update Submitted That Met QC Criteria: April 19, 2012
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Other Study ID Numbers: 7-05-HFC-27