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Completed

NCT Number: NCT02456623

Obesity Intervention for Low-Income African American Preschoolers

The purpose of this study is to preliminarily validate a parent-focused obesity intervention program for parents of low-income, African American preschoolers who are currently overweight (> 85th BMI %tile). Half of the participants will receive an intervention that is eight sessions in length and carried out in the participant's home. The sessions will target the nutrition and physical activity knowledge of parents and their motivation for changing parenting related to family eating habits and activity level. The remaining participants will receive an attention comparison control condition (ACCC), which includes one home visit, 7 newsletters and 4 monthly support phone calls. It is hypothesized that children of parents receiving the intervention will have decreases in BMI %tile, consume more fruits/vegetables and fewer sugary beverages, and engage in more activity as compared to ACCC.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eastern Michigan University

Ypsilanti, Michigan, 48197, United States

About this study

This study will do a preliminarily validation of a parent-focused obesity intervention program for parents of low-income, African American preschoolers who are currently overweight (> 85th BMI %tile). Participants will be randomly assigned to an intervention or attention control condition. Those in the intervention will receive an intervention that is eight sessions in length and carried out in the participant's home. The sessions will target the nutrition and physical activity knowledge of parents and their motivation for changing parenting related to family eating habits and activity level. Sessions include psycho-education and skills building exercises. The attention comparison control condition (ACCC) participants will receive one home visit, 7 newsletters and 4 monthly support phone calls. The content of this condition also focuses on nutrition and activity knowledge, motivation and parenting. Outcomes for the intervention and ACC conditions will be assessed at baseline, post-intervention and at a 6-month and 1-year followed up. Child BMI %tile, consumption of fruits/vegetables and sugary beverages, and activity level will be analyzed to examine intervention effectiveness across time.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Parents of children enrolled in Head Start preschool in Detroit, MI will be included. Parents must be 18 years of age or older and their child must be of preschool age, between 3 and 5 years of age. Based on recruitment from Detroit Head Start, families will be low-income and of African American descent. Children will have a current body mass index percentile at or above the 85th percentile.

Exclusion criteria

Child BMI percentile below the 85th percentile.

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Treatment and study plan

Intervention

Behavioral

Home-based session targeting the parent

Attention Control

Behavioral

Attention condition with newsletters and support phone calls

Primary outcomes

  1. Change in Child Body Mass Index (BMI)

    Time frame: 5-months

    Change in child BMI will be assessed between baseline and 5-month follow-up.

  2. Change in child fruit, vegetable, and sugary beverage intake using the Block Food Frequency Questionnaire for children

    Time frame: 5-months

    Change in child fruit and vegetable intake between baseline and 5-month follow-up will be collected using the Block Food Frequency Questionnaire for children.

  3. Change in child physical activity level assessed using accelerometers

    Time frame: 5-months

    Change in child's activity level between baseline and 5-month follow-up will be assessed using accelerometers, which will be worn for four days time at each assessment point.

Secondary outcomes

  1. Change in parent nutrition/physical activity knowledge, assessed via a self-report survey

    Time frame: 5-months

    Change in parent knowledge between baseline and 5-month follow-up will be assessed via a self-report survey

  2. Change in parent motivation for health behavior change, assessed using the "readiness ruler"

    Time frame: 5-months

    Change in parent's motivation for health behavior change between baseline and 5-month follow-up will be assessed using the "readiness ruler", which is a self-report survey.

  3. Change in parenting Behavior, assessed using the Caregiver Feeding Style Questionnaire and the Parenting Young Children Scale

    Time frame: 5-months

    Change in parenting behavior between baseline and 5-month follow-up will be assessed using two self-report parent surveys, the Caregiver Feeding Style Questionnaire and the Parenting Young Children Scale.

Sponsors and collaborators

Lead sponsor

Eastern Michigan University

Other

Registry information

Official study title

Parent Focused Obesity Intervention for Low-Income African American Preschoolers

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
May 28, 2015
Registry last updated
Dec 12, 2019

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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