Overview

This trial is active, not recruiting.

Condition obesity
Treatments increase fruits and vegetables, decrease snack foods, increase fruits and vegetables and decrease snack foods
Phase phase 2/phase 3
Sponsor University of Tennessee
Start date January 2012
End date July 2016
Trial size 45 participants
Trial identifier NCT01510678, 8721-B

Summary

Examine the effect of three different dietary messages on dietary intake and the health of parents and their children.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model factorial assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
In the Decrease Snack Foods condition participants will reduce intake of SFs (i.e., candy, cookies, cakes, ice cream, chips, nuts) to < 3 servings/week (for children aged 6 to 12 years, the solid fats and added sugar energy limit is 840 kcals/week and the DECREASE goal will help with meeting this limit). Children and parents will gradually work towards meeting these goals and self-monitor these behaviors.
decrease snack foods
This condition will reduce intake of SFs (i.e., candy, cookies, cakes, ice cream, chips, nuts) to < 3 servings/week (for children aged 6 to 12 years, the solid fats and added sugar energy limit is 840 kcals/week and the DECREASE goal will help with meeting this limit). Children and parents will gradually work towards meeting these goals and self-monitor these behaviors.
(Experimental)
Families will be encouraged to increase fruits and vegetables and decrease snack foods.
increase fruits and vegetables and decrease snack foods
Will combine the goals of the increase and decrease conditions.
(Experimental)
A parent and child will be encouraged to increase fruits and vegetables. Children will be encouraged to consume 1 cup/day and 1.5 cups/day of whole fruit, and 1.5 cups/day and 2 cups/day of vegetables for children aged 6 to 8 years and 9 to 12 years, respectively. Children will gradually work towards these goals. Parents will also work towards F&V goals, with 2 cups/day of whole fruit and 2.5 cups/day of vegetables.
increase fruits and vegetables
Children will be encouraged to consume 1 cup/day and 1.5 cups/day of whole fruit, and 1.5 cups/day and 2 cups/day of vegetables for children aged 6 to 8 years and 9 to 12 years, respectively. Children will gradually work towards these goals. Parents will also work towards F&V goals, with 2 cups/day of whole fruit and 2.5 cups/day of vegetables. Both parent and child will self-monitor these behaviors. As one barrier to consuming F&Vs is perceived cost of these foods, information regarding lower-cost options for F&Vs will be included in the manual.

Primary Outcomes

Measure
Change in Dietary intake
time frame: baseline and 6 months

Secondary Outcomes

Measure
Change in Anthropometrics
time frame: baseline and 6 months
Change in Parent Feeding Styles
time frame: baseline and 6 months
Change in Parenting Styles
time frame: baseline and 6 months
Change in Eating Pathology
time frame: baseline and 6 months
Change in Physical Activity
time frame: baseline and 6 months
Change in Obesogenic Home Food Availability
time frame: baseline and 6 months

Eligibility Criteria

Male or female participants from 6 years up to 12 years old.

Inclusion Criteria: - Children between ages 6-12 years - BMI percentile > 5th and < 85th percentile for age and sex - Have a parent aged > 21 years with a BMI > 25 - Have an overweight/obese parent willing to attend intervention meetings - Parent and child speak and read English - Not moving out of the metropolitan area during the course of the investigation Exclusion Criteria: - Reporting that the child and parent planning to participate have dietary restrictions related to fruit and vegetable intake - Physical activity restrictions - A parent reporting that she is pregnant, planning to become pregnant, or currently breastfeeding

Additional Information

Official title The Effect of Three Different Dietary Messages on Dietary Intake and Health in Families
Principal investigator Hollie Raynor, PhD, RD
Description The goal of this pilot study is to conduct a randomized controlled trial examining three dietary messages: increase fruits and vegetables [INCREASE], decrease energy-dense, non-nutrient dense snack foods [DECREASE], or increase fruits and vegetables plus decrease snack foods [INCREASE+DECREASE], within a 6-month, family-based obesity prevention intervention. Each condition will also focus on increasing family evening meals and physical activity. Primary hypotheses are: 1) INCREASE + DECREASE will consume a greater ratio of F&Vs:SFs than INCREASE and DECREASE at 6 months. 2)INCREASE + DECREASE will consume less energy than INCREASE and DECREASE at 6 months.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of Tennessee.