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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01510678
First Posted: January 16, 2012
Last Update Posted: July 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hollie Raynor, University of Tennessee
  Purpose
Examine the effect of three different dietary messages on dietary intake and the health of parents and their children.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (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 Hollie Raynor, University of Tennessee:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • Change in Anthropometrics [ Time Frame: baseline and 6 months ]
    child and parent height, weight, BMI, and z-BMI

  • 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.

  • Change in Parenting Styles [ Time Frame: baseline and 6 months ]
    Assesses practices associated with different parenting styles

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

  • 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

  • Change in Obesogenic Home Food Availability [ Time Frame: baseline and 6 months ]
    self-report on foods that are available in the home.


Estimated Enrollment: 45
Actual Study Start Date: January 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01510678


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

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Raynor HA, Osterholt KM, Hart CN, Jelalian E, Vivier P, Wing RR. Efficacy of U.S. paediatric obesity primary care guidelines: two randomized trials. Pediatr Obes. 2012 Feb;7(1):28-38. doi: 10.1111/j.2047-6310.2011.00005.x. Epub 2011 Dec 13.
Epstein LH, Gordy CC, Raynor HA, Beddome M, Kilanowski CK, Paluch R. Increasing fruit and vegetable intake and decreasing fat and sugar intake in families at risk for childhood obesity. Obes Res. 2001 Mar;9(3):171-8.

Responsible Party: Hollie Raynor, Professor, University of Tennessee
ClinicalTrials.gov Identifier: NCT01510678     History of Changes
Other Study ID Numbers: 8721-B
First Submitted: January 5, 2012
First Posted: January 16, 2012
Last Update Posted: July 19, 2017
Last Verified: July 2017

Keywords provided by Hollie Raynor, University of Tennessee:
Diet Quality


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