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Completed

NCT Number: NCT03590301

Third Ward Wellness Study for Families

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.

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Key information

Conditions

Child Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Houston

Houston, Texas, 77204, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

FUNPALs Playgroup

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.

Other names: experimental group

Healthy Toddler Parent Group

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.

Other names: control group

Primary outcomes

  1. Comprehensive General Parenting Questionnaire

    Time frame: Baseline and immediate post intervention

    This 69-item measure of general parenting will assess changes in domains of positive parenting (i.e., authoritative parenting): nurturance, structure, and behavioral control.

Secondary outcomes

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

    Time frame: baseline and immediate post intervention

    This 22 item measure will assess limiting exposure to unhealthy foods and establishing mealtime routines

  2. Home environment

    Time frame: baseline and immediate post intervention

    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

  3. Toddler fruit and vegetable intake

    Time frame: Baseline and immediate post intervention

    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

  4. Toddler dietary intake

    Time frame: baseline and immediate post intervention

    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.

  5. Child sedentary, moderate to vigorous, and sleep activity

    Time frame: Baseline and immediate post intervention

    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.

Sponsors and collaborators

Lead sponsor

University of Houston

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 18, 2018
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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