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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01004094
Other study ID # Thompson_Squires_Quest_II
Secondary ID 5R01HD050595
Status Completed
Phase Phase 2
First received October 28, 2009
Last updated January 18, 2016
Start date October 2009
Est. completion date March 2011

Study information

Verified date January 2016
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The primary purpose of this research is to test the effects of goal setting on fruit and vegetable goal attainment and consumption in a 10 episode video game. Factors associated with maintenance of behavior change will also be examined. Secondary purposes are to explore the impact of the intervention on psychosocial factors and the home environment. 400 parent-child pairs will be recruited for this research (800 participants total). Children will play the video game and participate in data collection activities. Parents will receive newsletters, have access to a healthy foods web site, and participate in data collection activities. A small subset will be randomly selected to participate in interviews about the intervention and its effect on the home food environment.


Description:

Obesity is increasing among youth and is associated with increased risk of certain cancers and other chronic diseases. Fruit, juice, and vegetable (FJV) intake is associated with decreased risk of many types of cancer and obesity, but is well below the recommended minimum of five servings a day. Innovative methods are needed to promote increased consumption among youth.

Goal setting enhances goal attainment and, therefore, facilitates behavior change. Little research has been conducted, however, on the most effective goal setting methods to use with youth. Among adults, the formation of implementation intentions (a detailed plan of when, where, and how goals will be achieved) has been shown to enhance goal attainment and/or behavior change, including dietary change. Research is needed to determine if extending the goal setting process to include implementation intentions is an effective method for enhancing goal attainment, and therefore, increasing FJV intake among youth.

Squire's Quest! is a proven-effective 10-session, 5 week interactive multi media program that enabled children to increase FJV consumption by 1.0 servings a day. Total consumption was still well below five servings a day, however. Additionally, goal attainment was related to FJV consumption among certain sub-groups of youth. Therefore, additional work in this area is warranted. The research outlined in this proposal will expand the goal setting component of this successful intervention to include the formation of implementation intentions. Hypotheses related to the impact of implementation intentions on goal attainment and FJV consumption will then be tested. Issues related to maintenance of youth dietary behavior change will also be explored.

This project is relevant to public health because enhancing our understanding of how to more effectively help young children set and achieve FJV goals should result in increased FJV consumption, which should decrease risk of both obesity and certain cancers in a vulnerable segment of the population.


Recruitment information / eligibility

Status Completed
Enrollment 800
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 8 Years to 12 Years
Eligibility Inclusion Criteria:

- child: 4th or 5th grade children who speak, write, and understand English; have access to a computer with high speed internet; provide written parental consent and child assent; and have a parent who speaks and understands English or Spanish who is willing to participate in the study

- Parents: parent or legal guardian of a child participating in the study

Exclusion Criteria:

- child: not meeting inclusion criteria; having physical, mental, or medical limitations that inhibit ability to fully participate in the study (answer questions online and over the phone, play the video game, eat fruit and vegetables); and/or not having a parent/legal guardian willing to participate in data collection activities.

- Parents. Exclusion criteria are limited to not meeting the inclusion criteria.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
simple goal setting
This group will set goals only
goal setting plus action intentions
This group will set goals and form action intentions (plans)
goal setting plus coping intentions
This group will set goals and form coping intentions (plans)
goal setting plus action intentions plus coping intentions
This group will set goals and form action intentions and coping intentions

Locations

Country Name City State
United States Baylor College of Medicine Houston Texas

Sponsors (3)

Lead Sponsor Collaborator
Baylor College of Medicine Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), United States Department of Agriculture (USDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fruit and vegetable consumption baseline, immediate post, 3 months later No
Secondary Goal attainment during intervention No
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