NCT03590301

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

August 8, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2019

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2019

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

10 months

First QC Date

July 6, 2018

Last Update Submit

April 6, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Structure Feeding Practices (Savage et al., 2017)

    baseline and immediate post intervention

  • Home environment

    baseline and immediate post intervention

  • Toddler fruit and vegetable intake

    Baseline and immediate post intervention

  • Toddler dietary intake

    baseline and immediate post intervention

  • Child sedentary, moderate to vigorous, and sleep activity

    Baseline and immediate post intervention

Study Arms (2)

FUNPALs Playgroup

EXPERIMENTAL

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

Healthy Toddlers Parent Group

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: experimental group
FUNPALs Playgroup

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.

Also known as: control group
Healthy Toddlers Parent Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Houston

Houston, Texas, 77204, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Tracey Ledoux

    University of Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not know whether they are in the control or experimental group.
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 6, 2018

First Posted

July 18, 2018

Study Start

August 8, 2018

Primary Completion

May 29, 2019

Study Completion

June 10, 2019

Last Updated

April 7, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations