Clinical trial NCT06520072: Mobile Apps for Preschool Parents (MAPP) Study
Official title: Mobile Apps for Preschool Parents (MAPP) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Childhood
Nutrition, Healthy
Physical Inactivity
Sleep, Inadequate
Keywords: Mobile Application
Preschool children
Parents
Parenting
Reading
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: United States Department of Agriculture (USDA)
First posted: 2024-07-25
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. The ORGANIZATION SAMPLE has a 2-arm parallel cluster-randomized control trial design, with an attention control design. The clusters are the partner community-based organizations where participants are recruited/enrolled by study staff. The cluster is the level of randomization (not individuals).
2. The INDIVIDUAL SAMPLE has a 2-arm parallel randomized control trial design, with an attention control design. The individual parent/guardian as the level of randomization (no clusters). After completing the Baseline Survey (Parts 1 and 2), each individual parent/guardian will be randomized to the Intervention Arm or Control Arm.

Both: Parents/guardians will be asked to use the assigned app for 8-weeks. Next, they will complete the Follow Up Survey, then they have the option to download the other app, if interested. For both arms, usage of the CHEW app will be tracked for up to 20 weeks after the date of study enrollment.
Primary purpose: PREVENTION

Brief summary: The purpose of Mobile Apps for Preschool Parents (MAPP) Study is to test the effectiveness of two mobile applications for parents of preschool aged children: 1) an app focused on child and family nutrition and wellness, and 2) an app focused on parents reading to their children.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Healthy Kids childhood obesity risk score
timeFrame: 2 months
Secondary outcomes:
measure: Child intake of sugar-sweetened beverages (Healthy Kids items)
timeFrame: 2 months
measure: Child intake of fruits and vegetables (Healthy Kids items)
timeFrame: 2 months
measure: Child intake of energy dense food/beverages (Healthy Kids items)
timeFrame: 2 months
measure: Child intake of dairy/calcium (Healthy Kids items)
timeFrame: 2 months
measure: Child physical activity and sedentary behavior (Healthy Kids items)
timeFrame: 2 months
measure: Sleep: Child bedtime (Healthy Kids item)
timeFrame: 2 months
measure: Family meals: Eating meals with child (Healthy Kids item)
timeFrame: 2 months
measure: Child dietary intake (Healthy Kids items)
timeFrame: 2 months
measure: Diet quality: Variety of child vegetable intake (My Veggies questionnaire)
timeFrame: 2 months
measure: My Child at Mealtime questionnaire
timeFrame: 2 months
measure: Home Inventory Describing Eating and Activity (Home-IDEA2, food section)
timeFrame: 2 months
measure: Frequency of reading to child
timeFrame: 2 months
measure: Length of time reading to child
timeFrame: 2 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Pamela C Hull, PhD
role: PRINCIPAL_INVESTIGATOR
References: