The Effect of Three Different Dietary Messages on Dietary Intake and Health in Families

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Tennessee
ClinicalTrials.gov Identifier:
NCT01510678
First received: January 5, 2012
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Obesity
Behavioral: Increase Fruits and Vegetables
Behavioral: Decrease Snack Foods
Behavioral: Increase Fruits and Vegetables and Decrease Snack Foods
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Three Different Dietary Messages on Dietary Intake and Health in Families

Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • Change in Dietary intake [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Changes in F&Vs, SFs, energy density, overall energy, and percent energy from fat intake, will be assessed by a three-day food record (two weekdays, one weekend day).


Secondary Outcome Measures:
  • Change in Anthropometrics [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    child and parent height, weight, BMI, and z-BMI

  • Change in Parent Feeding Styles [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Includes 7 topics: perceived responsibility, perceived parent weight, perceived child weight, concern about child weight, restriction, pressure to eat, and monitoring.

  • Change in Parenting Styles [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Assesses practices associated with different parenting styles

  • Change in Eating Pathology [ Time Frame: baseline and 6 months ] [ Designated as safety issue: Yes ]
    Kids eating disorder survey and eating in the absence of hunger survey

  • Change in Physical Activity [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Previous day physical activity recall- looks at 2 weekdays and 1 weekend day. For parents and children to complete

  • Change in Obesogenic Home Food Availability [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    self-report on foods that are available in the home.


Estimated Enrollment: 45
Study Start Date: January 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Decrease Condition
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.
Behavioral: 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: Increase + Decrease Condition
Families will be encouraged to increase fruits and vegetables and decrease snack foods.
Behavioral: Increase Fruits and Vegetables and Decrease Snack Foods
Will combine the goals of the increase and decrease conditions.
Experimental: Increase Condition
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.
Behavioral: 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01510678

Locations
United States, Tennessee
Healthy Eating and Activity Laboratory, University of Tennessee
Knoxville, Tennessee, United States, 37996
The University of Tennessee
Knoxville, Tennessee, United States, 37996-1920
Sponsors and Collaborators
University of Tennessee
Investigators
Principal Investigator: Hollie Raynor, PhD, RD University of Tennessee
  More Information

Publications:
Fulkerson JA, Nelson MC, Lytle LA, Moe S, Heiztler C, Pasch KE. The vaildation of a home food inventory. International Journal of Behavioral Nutrition and Physical Activity. 2008;5:55.

Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT01510678     History of Changes
Other Study ID Numbers: 8721-B
Study First Received: January 5, 2012
Last Updated: July 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Tennessee:
Diet Quality

ClinicalTrials.gov processed this record on October 22, 2014