- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06520072
Mobile Apps for Preschool Parents (MAPP) Study (MAPP)
Study Overview
Status
Intervention / Treatment
Detailed Description
The Mobile Apps for Preschool Parents (MAPP) Study addresses an important gap in the scientific literature, which is the need to evaluate the use of parent-targeted, guided goal-setting for childhood obesity risk reduction via a mobile application, specifically for parents of preschool-aged children for early intervention.
Obesity is a leading cause of multiple chronic diseases, including 13 types of cancer, heart disease, stroke, and type II diabetes. Major behavioral determinants of obesity are also independent risk factors for these chronic diseases, including unhealthy diet, lack of physical activity, and poor sleep quality. Childhood obesity increases risk for adult obesity and early onset of conditions such as high blood pressure, high cholesterol, asthma, sleep apnea, and joint problems. Childhood obesity disproportionately affects children of lower socioeconomic status, racial/ethnic minority groups, and rural areas, thus exacerbating and contributing to health disparities among obesity-related health conditions. Children in low-income families that qualify for income-based public assistance programs represent a population that is at high risk for obesity. These programs include the Women, Infants and Children (WIC) Supplemental Nutrition Program; Head Start (preschool child care centers); the Supplemental Nutrition Assistance Program (SNAP); Temporary Assistance for Needy Families (TANF); and Medicaid.
With the Attention Control Arm, the MAPP Study will also contribute valuable information about the effectiveness of using a mobile application with parent-targeted, guided goal-setting for reading to preschool-aged children. Previous studies have shown that adults reading to children is beneficial for child learning and development.
All parents/guardians (both samples and both arms) will be asked to use the respective apps for an 8-week intervention period. The primary outcome will be measured in the Baseline Survey and a Follow Up Survey after completing the 8-week intervention period. After completion of the Follow Up Survey, parents/guardians will be given the option to download and use the other app, if they are interested (i.e., information about the CHEW app for the Control Arm, and information about the Control app for the Intervention Arm). For both the Intervention Arm and those who choose to download the CHEW app in the Control Arm, usage of the CHEW app (i.e., app analytics) will be tracked for up to 20 weeks after the date of study enrollment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kentucky
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Lexington, Kentucky, United States, 40536
- University Of Kentucky
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Parent/Guardian (age 18+ years) of a 2-5 year old
- Living in United States
- Receives services at partner community organization (Organization Sample only)
Exclusion Criteria:
- Does not own iOS/Apple or Android mobile device (phone or tablet)
- Does not have internet access for the mobile device (data plan on device or in-home WiFi)
- Not able to successfully load and access the Intervention Arm or Attention Control Arm mobile app on the mobile device at the time of enrollment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention Arm: Nutrition and wellness app
The parents/guardians in this study arm will use the Children Eating Well (CHEW) mobile app focused on child and family nutrition and wellness for the first 8 weeks of the study.
This app is designed to help parents/guardians of preschool-aged children to improve nutrition, physical activity, sleep, feeding children at mealtimes, and related wellness topics.
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The target users of the CHEW app are parents/guardians of preschool aged children. The purpose of the CHEW app is to provide parents/guardians with easy, practical ways to improve nutrition and wellness among their preschool-aged children. The app provides guided goal setting and tracking tools. Parents/guardians set goals related to their preschool-aged children focused on nutrition, physical activity, sleep behaviors and parenting styles. The parents/guardians can also to set goals for themselves for behaviors related to nutrition, physical activity, sleep, and stress. The app does not have features that target children as users. The CHEW app was developed by the study team and can be downloaded for mobile devices (phones or tablets) at no cost in the Apple App Store (iOS/Apple) and the Google Play Store (Android). After downloading the CHEW app, enrolled participants must enter the Access Code provided by the study team in order to unlock the app and use it. |
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Active Comparator: Attention Control Arm: Reading app
The parents/guardians this study arm will use the Beanstack mobile app (or the Bookroo app, as an alternative) focused on parents reading to their children for the first 8 weeks of the study.
This app may help parents/guardians to read more to their preschool children (and other children), which is good for child learning and development.
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Beanstack is free commercially-available mobile app that provides goal setting and tracking tools similar to the CHEW app, but focused on a different topic, specifically encouraging parents/guardians to read to their preschool children more frequently. In the case that a parent/guardian is not able to successfully download Beanstack to their mobile device, as a backup alternative they will be asked to use a similar free commercially-available mobile application called Bookroo. Beanstack is available to the public for mobile devices (phones or tablets) at no cost in the Apple App Store (iOS/Apple) and the Google Play Store (Android). Bookroo is a web-based application that users access via the mobile device's web browser and looks and functions like a regular mobile application. It should work on any mobile device with a browser and data/wifi access,
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Healthy Kids childhood obesity risk score
Time Frame: 2 months
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Using the 19-item Healthy Kids scale, each item is coded from 1 to 5, with 1 being the least healthful and 5 being the most healthful.
To calculate the childhood obesity risk score, all 19 items are summed together, ranging from 19 to 95, with higher values reflecting a more healthful, or positive, outcome.
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2 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Child intake of sugar-sweetened beverages (Healthy Kids items)
Time Frame: 2 months
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Child intake of sugar-sweetened beverages (Healthy Kids items)
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2 months
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Child intake of fruits and vegetables (Healthy Kids items)
Time Frame: 2 months
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Child intake of fruits and vegetables (Healthy Kids items)
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2 months
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Child intake of energy dense food/beverages (Healthy Kids items)
Time Frame: 2 months
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Child intake of energy dense food/beverages (Healthy Kids items)
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2 months
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Child intake of dairy/calcium (Healthy Kids items)
Time Frame: 2 months
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Child intake of dairy/calcium (Healthy Kids items)
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2 months
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Child physical activity and sedentary behavior (Healthy Kids items)
Time Frame: 2 months
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Child physical activity and sedentary behavior (Healthy Kids items)
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2 months
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Sleep: Child bedtime (Healthy Kids item)
Time Frame: 2 months
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Child bedtime (Healthy Kids item)
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2 months
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Family meals: Eating meals with child (Healthy Kids item)
Time Frame: 2 months
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Eating meals with child (Healthy Kids item)
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2 months
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Child dietary intake (Healthy Kids items)
Time Frame: 2 months
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Child dietary intake (Healthy Kids items)
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2 months
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Diet quality: Variety of child vegetable intake (My Veggies questionnaire)
Time Frame: 2 months
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Variety of child vegetable intake (My Veggies questionnaire)
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2 months
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My Child at Mealtime questionnaire
Time Frame: 2 months
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My Child at Mealtime questionnaire measures food-related parenting styles.
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2 months
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Home Inventory Describing Eating and Activity (Home-IDEA2, food section)
Time Frame: 2 months
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Home Inventory Describing Eating and Activity (Home-IDEA2, food section) measures home food environment.
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2 months
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Frequency of reading to child
Time Frame: 2 months
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Frequency of reading to child
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2 months
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Length of time reading to child
Time Frame: 2 months
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Length of time reading to child
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2 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Pamela C Hull, PhD, University Of Kentucky
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Nutrition Disorders
- Overnutrition
- Body Weight
- Sleep Wake Disorders
- Overweight
- Dyssomnias
- Obesity
- Pathological Conditions, Signs and Symptoms
- Behavior
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Pediatric Obesity
- Sleep Deprivation
- Sedentary Behavior
- Diet, Food, and Nutrition
- Physiological Phenomena
- Nutritional Physiological Phenomena
- Digestive System Physiological Phenomena
- Digestive System and Oral Physiological Phenomena
- Eating
- Mastication
Other Study ID Numbers
- 93603
- 2017-68001-34846 (Other Grant/Funding Number: USDA NIFA)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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