Third Ward Wellness Study for Families

NCT ID: NCT03590301

Last Updated: 2020-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-08
• Study Completion Date: 2019-06-10

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).

Conditions

Child Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

FUNPALs Playgroup

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.

Group Type: EXPERIMENTAL

FUNPALs Playgroup

Intervention Type: BEHAVIORAL

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 Toddlers Parent Group

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.

Group Type: ACTIVE_COMPARATOR

Healthy Toddler Parent Group

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

experimental group; control group

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Houston

OTHER

Sponsor Role: lead

Responsible Party

Tracey Ledoux

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tracey Ledoux

Role: PRINCIPAL_INVESTIGATOR

University of Houston

Locations

University of Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

STUDY00001076

Identifier Type: -

Identifier Source: org_study_id