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

This study is currently recruiting participants.
Verified July 2013 by University of Tennessee
Sponsor:
Information provided by (Responsible Party):
University of Tennessee
ClinicalTrials.gov Identifier:
NCT01510678
First received: January 5, 2012
Last updated: July 24, 2013
Last verified: July 2013
  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

Resource links provided by NLM:


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 2013
Estimated Primary Completion Date: July 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01510678

Locations
United States, Tennessee
The University of Tennessee Not yet recruiting
Knoxville, Tennessee, United States, 37996-1920
Contact: Hollie Raynor, Ph.D.    865-974-6259    hraynor@utk.edu   
Contact: Lauren Gellar, Ph.D.    865-974-6254    lgellar@utk.edu   
Principal Investigator: Hollie Raynor, Ph.D.         
Principal Investigator: Lauren Gellar, Ph.D.         
Healthy Eating and Activity Laboratory, University of Tennessee Recruiting
Knoxville, Tennessee, United States, 37996
Contact: Hollie Raynor, PhD, RD    865-974-0752      
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, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Tennessee:
Diet Quality

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014