ObesityPhase 2SQ!IINCT01004094
Squire's Quest! II: Implementation Intentions and Children's Fruit, Juice, and Vegetable (FJV) Consumption
A Phase 2 study testing simple goal setting, goal setting plus action intentions and goal setting plus coping intentions in people with Obesity and Cancer, run by Baylor College of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- What is being tested?
- simple goal setting, goal setting plus action intentions and goal setting plus coping intentions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Mar 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Squire's Quest! II: Implementation Intentions and Children's FJV Consumption
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.
Read the detailed 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.
- Being tested
- simple goal setting, goal setting plus action intentions, goal setting plus coping intentions, goal setting plus action intentions plus coping intentions
- Keywords
- children, video games, internet, parents, fruit, vegetable, implementation intention, goal setting, fruit and vegetable consumption, obesity prevention, cancer prevention
- Medical subject headings
- Obesity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simple goal settingBehavioural
Also called goal setting
This group will set goals only
goal setting plus action intentionsBehavioural
Also called implementation intentions, action plans
This group will set goals and form action intentions (plans)
goal setting plus coping intentionsBehavioural
Also called implementation intentions, problem solving
This group will set goals and form coping intentions (plans)
goal setting plus action intentions plus coping intentionsBehavioural
Also called implementation intentions, action plans, problem solving
This group will set goals and form action intentions and coping intentions
| Study group | Role | What they receive |
|---|---|---|
| simple goal setting | Experimental | This group will only set a goal. Receives: Behavioral: simple goal setting |
| goal setting plus action intentions | Experimental | This group will set goals and form action intentions (plans) to facilitate goal attainment. Receives: Behavioral: goal setting plus action intentions |
| goal setting plus coping intentions | Experimental | This group will set goals and form coping intentions (plans) to facilitate goal attainment. Receives: Behavioral: goal setting plus coping intentions |
| goal setting plus action intentions plus coping intentions | Experimental | This group will set goals, form action intentions (plans), and form coping intentions (plans) to facilitate goal attainment. Receives: Behavioral: goal setting plus action intentions plus coping intentions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fruit and vegetable consumption
Measured: baseline, immediate post, 3 months later
Secondary outcomes (1)
Goal attainment
Measured: during intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), United States Department of Agriculture (USDA)
- Responsible party
- Principal investigator, Deborah Thompson, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004094
- Sponsor's protocol ID
- Thompson_Squires_Quest_II
- Other IDs
- 5R01HD050595
- Acronym
- SQ!II
- Status last verified
- Jan 2016
- First submitted
- 28 Oct 2009
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
DeSmet A, Liu Y, De Bourdeaudhuij I, Baranowski T, Thompson D. The effectiveness of asking behaviors among 9-11 year-old children in increasing home availability and children's intake of fruit and vegetables: results from the Squire's Quest II self-regulation game intervention. Int J Behav Nutr Phys Act. 2017 Apr 21;14(1):51. doi: 10.1186/s12966-017-0506-y.
PubMed 28431547Thompson D, Ferry RJ Jr, Cullen KW, Liu Y. Improvement in Fruit and Vegetable Consumption Associated with More Favorable Energy Density and Nutrient and Food Group Intake, but not Kilocalories. J Acad Nutr Diet. 2016 Sep;116(9):1443-1449. doi: 10.1016/j.jand.2016.05.002. Epub 2016 Jun 15.
PubMed 27316780Thompson D, Bhatt R, Vazquez I, Cullen KW, Baranowski J, Baranowski T, Liu Y. Creating action plans in a serious video game increases and maintains child fruit-vegetable intake: a randomized controlled trial. Int J Behav Nutr Phys Act. 2015 Mar 18;12:39. doi: 10.1186/s12966-015-0199-z.
PubMed 25890060Thompson D, Bhatt R, Lazarus M, Cullen K, Baranowski J, Baranowski T. A Serious Video Game to Increase Fruit and Vegetable Consumption Among Elementary Aged Youth (Squire's Quest! II): Rationale, Design, and Methods. JMIR Res Protoc. 2012 Nov 21;1(2):e19. doi: 10.2196/resprot.2348.
PubMed 23612366
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Squire's Quest! II: Implementation Intentions and Children's FJV Consumption
- ClinicalTrials.gov ID
- NCT01004094
- Acronym / sponsor ID
- SQ!II / Thompson_Squires_Quest_II
- Keywords
- children, video games, internet, parents, fruit, vegetable, implementation intention, goal setting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), United States Department of Agriculture (USDA)
- Study start
- Oct 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 29 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| simple goal setting | Experimental | Behavioral: simple goal settingThis group will only set a goal. |
| goal setting plus action intentions | Experimental | Behavioral: goal setting plus action intentionsThis group will set goals and form action intentions (plans) to facilitate goal attainment. |
| goal setting plus coping intentions | Experimental | Behavioral: goal setting plus coping intentionsThis group will set goals and form coping intentions (plans) to facilitate goal attainment. |
| goal setting plus action intentions plus coping intentions | Experimental | Behavioral: goal setting plus action intentions plus coping intentionsThis group will set goals, form action intentions (plans), and form coping intentions (plans) to facilitate goal attainment. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| simple goal settingAlso: goal settingThis group will set goals only | Behavioural | simple goal setting |
| goal setting plus action intentionsAlso: implementation intentions, action plansThis group will set goals and form action intentions (plans) | Behavioural | goal setting plus action intentions |
| goal setting plus coping intentionsAlso: implementation intentions, problem solvingThis group will set goals and form coping intentions (plans) | Behavioural | goal setting plus coping intentions |
| goal setting plus action intentions plus coping intentionsAlso: implementation intentions, action plans, problem solvingThis group will set goals and form action intentions and coping intentions | Behavioural | goal setting plus action intentions plus coping intentions |
Primary outcome
Fruit and vegetable consumption
Time frame: baseline, immediate post, 3 months later
1 secondary outcome
Goal attainment
Time frame: during intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
- Derived from this study: PubMed 28431547DeSmet A, Liu Y, De Bourdeaudhuij I, Baranowski T, Thompson D. The effectiveness of asking behaviors among 9-11 year-old children in increasing home availability and children's intake of fruit and vegetables: results from the Squire's Quest II self-regulation game intervention. Int J Behav Nutr Phys Act. 2017 Apr 21;14(1):51. doi: 10.1186/s12966-017-0506-y.
- Derived from this study: PubMed 27316780Thompson D, Ferry RJ Jr, Cullen KW, Liu Y. Improvement in Fruit and Vegetable Consumption Associated with More Favorable Energy Density and Nutrient and Food Group Intake, but not Kilocalories. J Acad Nutr Diet. 2016 Sep;116(9):1443-1449. doi: 10.1016/j.jand.2016.05.002. Epub 2016 Jun 15.
- Derived from this study: PubMed 25890060Thompson D, Bhatt R, Vazquez I, Cullen KW, Baranowski J, Baranowski T, Liu Y. Creating action plans in a serious video game increases and maintains child fruit-vegetable intake: a randomized controlled trial. Int J Behav Nutr Phys Act. 2015 Mar 18;12:39. doi: 10.1186/s12966-015-0199-z.
- Derived from this study: PubMed 23612366Thompson D, Bhatt R, Lazarus M, Cullen K, Baranowski J, Baranowski T. A Serious Video Game to Increase Fruit and Vegetable Consumption Among Elementary Aged Youth (Squire's Quest! II): Rationale, Design, and Methods. JMIR Res Protoc. 2012 Nov 21;1(2):e19. doi: 10.2196/resprot.2348.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing simple goal setting, goal setting plus action intentions and goal setting plus coping intentions in people with Obesity and Cancer, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fruit and vegetable consumption (time frame: baseline, immediate post, 3 months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01004094, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016.