Third Ward Wellness Study for Families

Study Overview
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Brief Summary
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The Third Ward Wellness Study aims to pilot test a wellness program for families with toddler age children. Participants will be recruited from the Third Ward neighborhood in Houston, TX and then randomly assigned to one of two wellness programs. The goal of both programs is to enable and inspire parents to help their toddler age children develop healthy habits that will stay with them through life. Participating families will complete an assessment batter before and after the program. Both programs will meet once per week for 10 weeks.

Detailed Description
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Dietary and activity habits begin to develop in early childhood. Parents have the most influence on children's health behaviors at this age. Many parents, particularly those from lower income and underserved areas may benefit from programs to inspire and enable them to raise their toddler age children with good health habits. The experimental group was developed to help parents instill healthy habits in their children through a healthy home environment. This study will pilot test the experimental group among parent-toddler dyads residing in Greater Third Ward neighborhoods, where > 80% of the residents are AA or Hispanic and 35%-54% have annual household incomes <$25,000. The aims are to ascertain 1) recruitment and retention barriers and facilitators, 2) treatment success barriers and facilitators, and 3) the estimated effect sizes of outcomes to inform a fully powered RCT. The exploratory hypotheses are that compared to those in the control group, parents in the experimental group will have greater increases in positive parenting skills (Comprehensive General Parenting Questionnaire), and toddlers will have greater increases in indicators of a healthy home environments, diets and activity habits (MVPA, sedentary activity, and sleep).

Official Title
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Third Ward Wellness Study for Families

Conditions
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Child Obesity

Intervention / Treatment
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* Behavioral: FUNPALs Playgroup
* Behavioral: Healthy Toddler Parent Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents need to be... The legal custodian of a toddler, At least 18 years, Able to make food decisions in the home, Have access to a phone at home, Be fluent in English Toddlers need to be... Between 12 and 36 months of age Be able to walk. Exclusion Criteria: Adults unable to consent for themselves and their child, Parents or toddlers who have mental or physical health conditions that would prevent them from fully engaging in activities of the program (e.g., reliance on feeding tube).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FUNPALs Playgroup<br>Based on Self-Determination Theory, the FUNPALs Playgroup will enable and inspire parents to encourage their children to improve their diet and activity behaviors through general authoritative parenting, structured feeding practices, and a healthy home environment. Parents and toddlers will participate in the FUNPALs Playgroup together where they will be led through a series of open but structured activities including free play, exercise, snack preparation, discussion, singing, and yoga stretches. | Behavioral: FUNPALs Playgroup<br>* Based on Self-Determination Theory, the FUNPALs Playgroup aims to enable and inspire parents to improve their toddlers dietary intake and physical activity habits through authoritative parenting, structured feeding practices, and a healthy home environment. Playgroups will include open but structured experiential learning activities, free play, and instruction/discussion.<br>* Other names: experimental group;|
| Active Comparator: Healthy Toddlers Parent Group<br>The goal of the Healthy Toddlers Parent Group is to deliver the same nutrition and activity messages to parents as those delivered in the FUNPALs Playgroup. In the Healthy Toddlers Parent Group, parents (without children) will meet in groups to receive information on nutrition and activity as it relates to their toddlers and they will engage in a discussion around how they do or can implement these behaviors. No experiential learning, children, play, or parenting instruction will be included in this control condition. | Behavioral: Healthy Toddler Parent Group<br>* The parent class will serve as our instruction only control group. Parents in this class will receive information about nutrition and activity recommendations regarding their toddler age children and will discuss it in a group with other parents. No experiential learning activities, information about parenting, or children will be involved in this class.<br>* Other names: control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comprehensive General Parenting Questionnaire | This 69-item measure of general parenting will assess changes in domains of positive parenting (i.e., authoritative parenting): nurturance, structure, and behavioral control. | Baseline and immediate post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Structure Feeding Practices (Savage et al., 2017) | This 22 item measure will assess limiting exposure to unhealthy foods and establishing mealtime routines | baseline and immediate post intervention | 
| Home environment | a phone interview will assess home availability of foods, physical activity resources, screen media devices, and sleep conditions as well as social norms and family policies regarding meals, active play, sleep, and screen media | baseline and immediate post intervention | 
| Toddler fruit and vegetable intake | Dermal reflectance spectrometry (Veggie Meter (R), Longevity Link Corp) will used to assess skin carotenoid levels of the toddlers. Skin carotenoid levels reflect dietary intake of carotenoids, which are pigments found in many fruit and vegetables | Baseline and immediate post intervention | 
| Toddler dietary intake | The Kids Bites Food Frequency Questionnaire (Aguilar et al., 2014) will assess consumption of snack foods, sugar, sweetened beverages and fruit and vegetables. Parents will complete this measure for their children. | baseline and immediate post intervention | 
| Child sedentary, moderate to vigorous, and sleep activity | Toddlers will wear the GT3X+ Actigraph (Pensacola, FL) for 8 consecutive days at baseline and immediate post. THe actigraph is a triaxial accelerometer that has been validated on toddler age children to measure activity levels. | Baseline and immediate post intervention |