Clinical trial NCT03590301: Third Ward Wellness Study for Families
Official title: Third Ward Wellness Study for Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Obesity
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2018-07-18
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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.

Detailed 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).

Eligibility criteria: 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).

Primary outcomes:
measure: Comprehensive General Parenting Questionnaire
timeFrame: Baseline and immediate post intervention
Secondary outcomes:
measure: Structure Feeding Practices (Savage et al., 2017)
timeFrame: baseline and immediate post intervention
measure: Home environment
timeFrame: baseline and immediate post intervention
measure: Toddler fruit and vegetable intake
timeFrame: Baseline and immediate post intervention
measure: Toddler dietary intake
timeFrame: baseline and immediate post intervention
measure: Child sedentary, moderate to vigorous, and sleep activity
timeFrame: Baseline and immediate post intervention
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston
state: Texas
Study officials:
affiliation: University of Houston
name: Tracey Ledoux
role: PRINCIPAL_INVESTIGATOR
References: