Obesity Intervention for Low-Income African American Preschoolers

Overweight and Obesity Clinical Trial

Official title:

Parent Focused Obesity Intervention for Low-Income African American Preschoolers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02456623
• Other study ID #: 1R03DK097444-01
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: September 2017

Study information

• Verified date: December 2019
• Source: Eastern Michigan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Intervention
Home-based session targeting the parent
• Attention Control
Attention condition with newsletters and support phone calls

Locations

Country	Name	City	State
United States	Eastern Michigan University	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Michigan University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Child Body Mass Index (BMI)	Change in child BMI will be assessed between baseline and 5-month follow-up.	5-months
Primary	Change in child fruit, vegetable, and sugary beverage intake using the Block Food Frequency Questionnaire for children	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.	5-months
Primary	Change in child physical activity level assessed using accelerometers	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.	5-months
Secondary	Change in parent nutrition/physical activity knowledge, assessed via a self-report survey	Change in parent knowledge between baseline and 5-month follow-up will be assessed via a self-report survey	5-months
Secondary	Change in parent motivation for health behavior change, assessed using the "readiness ruler"	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.	5-months
Secondary	Change in parenting Behavior, assessed using the Caregiver Feeding Style Questionnaire and the Parenting Young Children Scale	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.	5-months