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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02215421
Other study ID # H-33915
Secondary ID R44HD075521
Status Withdrawn
Phase N/A
First received August 8, 2014
Last updated October 12, 2016
Start date June 2015
Est. completion date February 2016

Study information

Verified date October 2016
Source Archimage, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

A 20 episode video game called Mommio simulates parent-child feeding interactions for parents of 3-5 year old children within a storyline addressing a problem commonly reported by parents (getting their 3-5 yo to taste a vegetable, which is often a first step toward eating the vegetable), thereby training parents in effective food parenting practices. This research evaluates whether the 20 episodes targeting barriers identified by parents across five levels of difficulty influences vegetable parenting practices and children's dietary intake. We had to discontinue the study since changes in commercial availability of game development software required reprogramming and available funding did not allow for completion of game programming. Thus, no game evaluation was possible.


Description:

Video games for parents that simulate interactions with a child using a narrative, offering feedback on performance and goal setting for changing practices in the real world, and addressing vegetable (V) feeding problems commonly reported by parents, may elicit desirable cognitive, affective, and behavioral outcomes.

The rationale for training parents of preschool children in effective V parenting practices is that: 1) parents have an important influence on young children's dietary intake; 2) child dietary intake tracks into the adult years; and 3) high V consumption protects against several chronic diseases later in life. Since parents of young children commonly complain about not getting their child to eat V, there should be broad interest in playing Mommio.

A pre-post randomized clinical trial with 110 parents of 3-5 year olds who report having difficulty getting their child to eat vegetables will be employed. The primary outcome will be parent report of children's dietary intake; the secondary outcome will be use of V parenting practices.

We had to discontinue the study since changes in commercial availability of game development software required reprogramming and available funding did not allow for completion of game programming. Thus, no game evaluation was possible.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- being a parent of a child 3-5 years old

- willing to complete all measures

- having an iPhone.

Exclusion Criteria:

- the parent not speaking English (since the games are in English alone, due to budget constraints);

- having a 3-5 year old child with a medical condition that influences diet; or

- a parent with an illness that impairs the ability to complete questionnaires

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:
Mommio
The objective is to build parent's skills in encouraging their child to eat vegetables. The player is asked to read a novella, "Totally Frobisher" (providing backstory to the game), and play a game called Mommio (a "casual" video game for parents of 3 to 5 year old children). The player calls Kiddio, the child character, to dinner, and offers a vegetable (V) (selected from among several). Kiddio refuses. The player is offered a selection of V parenting statements (from the scientific literature on food parenting) or manipulation of the environment (e.g. turning off the kitchen TV) to control the situation and encourage the child to eat the V. As problems arise (e.g. a permissive father saying he doesn't like vegetables), the player must select ways to cope. Players set a goal to do with their child at home what they learned in the game. Game episodes include food store shopping, eating in the car, at grandma's, and at a fast food store.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Archimage, Inc. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Baranowski T, O'Connor T, Hughes S, Beltran A, Baranowski J, Nicklas T, Sleddens E, Thompson D, Lu AS, Buday R. Smart phone video game simulation of parent-child interactions: Learning skills for effective vegetable parenting. In: Arnab S, Dunwell I, Debattista K (Eds). Serious Games for Healthcare: Applications and Implications. Hershey, PA: IGI Global, 2012, 248-265.

Beltran A, O'Connor T, Hughes S, Baranowski J, Nicklas TA, Thompson D, Baranowski T. Alpha Test of a Videogame to Increase Children's Vegetable Consumption. Games Health J. 2012 Jun;1(3):219-222. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Qualitative Interviews The intensive interviews will be conducted using a standardized script and commonly accepted procedures (e.g., 8-10 open ended questions, with follow up questions, prompts, and areas to probe). The questions will assess whether they attempted changes in their vegetable parenting practices with their 3-5 year old child, problems they encountered, what parents liked and disliked about the game, and how it could be made better. The parents' interviews will be about 30 minutes and audio tape recorded. Audio tapes will be transcribed verbatim and checked for accuracy prior to analysis. Following generally accepted qualitative data coding and analysis procedures, NVIVO, a qualitative software analysis program, will be utilized to facilitate data coding, retrieval, and analysis. One month at post only No
Primary Change in Parent Reported Child Vegetable FFQ To assess the preschool child's usual vegetable (V) intake, the participating parent will complete the V items from a 36 item FV screener which was demonstrated to have acceptable correlations with serum lycopene, lutein, cryptoxanthin, alphacarotene, and beta-carotene with a validity coefficient (r=0.35 with total carotenoids) comparable to the sum of three 24-hour dietary recalls. Parents have been shown to reliably and validly report preschool child diet intake. The response scales will be worded to reflect child's intake in the previous week. Item responses will be summed to estimate number of V servings consumed in the previous week. This questionnaire has been validated for parent report on children, and was sensitive to change. One month from pre to post No
Secondary Change in Vegetable Parenting Practices Questionnaire Fruit and Vegetable Parenting Practices Questionnaire (FVPPQ), a parent-report questionnaire, includes 33 items associated with the effectiveness of parenting practices to get children to eat FV. Items will be scored on a three-point scale to indicate frequency of use of V parenting practices (1 - "frequently", 2 - "sometime", 3 - "rarely-never"). Internal consistency has been demonstrated. Helping HAND induced changes in these parenting practices. One month from pre to post No
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