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

April 1, 2025 updated by: Hollie Raynor, The University of Tennessee, Knoxville
Examine the effect of three different dietary messages on dietary intake and the health of parents and their children.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Knoxville, Tennessee, United States, 37996
        • Healthy Eating and Activity Laboratory, University of Tennessee
      • Knoxville, Tennessee, United States, 37996-1920
        • The University of Tennessee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Dietary intake
Time Frame: baseline and 6 months
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).
baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Anthropometrics
Time Frame: baseline and 6 months
child and parent height, weight, BMI, and z-BMI
baseline and 6 months
Change in Parent Feeding Styles
Time Frame: baseline and 6 months
Includes 7 topics: perceived responsibility, perceived parent weight, perceived child weight, concern about child weight, restriction, pressure to eat, and monitoring.
baseline and 6 months
Change in Parenting Styles
Time Frame: baseline and 6 months
Assesses practices associated with different parenting styles
baseline and 6 months
Change in Eating Pathology
Time Frame: baseline and 6 months
Kids eating disorder survey and eating in the absence of hunger survey
baseline and 6 months
Change in Physical Activity
Time Frame: baseline and 6 months
Previous day physical activity recall- looks at 2 weekdays and 1 weekend day. For parents and children to complete
baseline and 6 months
Change in Obesogenic Home Food Availability
Time Frame: baseline and 6 months
self-report on foods that are available in the home.
baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Tennessee, Knoxville

Investigators

  • Principal Investigator: Hollie Raynor, PhD, RD, University of Tennessee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

December 31, 2018

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 5, 2012

First Submitted That Met QC Criteria

January 11, 2012

First Posted (Estimated)

January 16, 2012

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 8721-B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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