Third Ward Wellness Study for Families

Child Obesity Clinical Trial

Official title:

Third Ward Wellness Study for Families

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03590301
• Other study ID #: STUDY00001076
• Status: Completed
• Phase: N/A
• Start date: August 8, 2018
• Est. completion date: June 10, 2019

Study information

• Verified date: April 2020
• Source: University of Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 10, 2019
• Est. primary completion date: May 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Child Obesity
• Pediatric Obesity

Intervention

Behavioral:
• FUNPALs Playgroup
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.
• Healthy Toddler Parent Group
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.

Locations

Country	Name	City	State
United States	University of Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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