NCT01510678

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 16, 2012

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 3, 2025

Status Verified

April 1, 2025

Enrollment Period

7 years

First QC Date

January 5, 2012

Last Update Submit

April 1, 2025

Conditions

Keywords

Diet Quality

Outcome Measures

Primary Outcomes (1)

  • Change in Dietary intake

    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 Outcomes (6)

  • Change in Anthropometrics

    baseline and 6 months

  • Change in Parent Feeding Styles

    baseline and 6 months

  • Change in Parenting Styles

    baseline and 6 months

  • Change in Eating Pathology

    baseline and 6 months

  • Change in Physical Activity

    baseline and 6 months

  • +1 more secondary outcomes

Study Arms (3)

Decrease Condition

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.

Behavioral: Decrease Snack Foods

Increase + Decrease Condition

EXPERIMENTAL

Families will be encouraged to increase fruits and vegetables and decrease snack foods.

Behavioral: Increase Fruits and Vegetables and Decrease Snack Foods

Increase Condition

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.

Behavioral: Increase Fruits and Vegetables

Interventions

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.

Increase Condition

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.

Decrease Condition

Will combine the goals of the increase and decrease conditions.

Increase + Decrease Condition

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The University of Tennessee

Knoxville, Tennessee, 37996-1920, United States

Location

Healthy Eating and Activity Laboratory, University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

Related Publications (36)

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MeSH Terms

Conditions

Obesity

Interventions

Vegetables

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Hollie Raynor, PhD, RD

    University of Tennessee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 5, 2012

First Posted

January 16, 2012

Study Start

January 1, 2012

Primary Completion

December 31, 2018

Study Completion

December 31, 2025

Last Updated

April 3, 2025

Record last verified: 2025-04

Locations