Overview

This trial is active, not recruiting.

Condition overweight and obesity
Treatments intervention, attention control
Sponsor Eastern Michigan University
Start date September 2013
End date December 2016
Trial size 51 participants
Trial identifier NCT02456623, 1R03DK097444-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Behavioral intervention that targets the parent of a preschool age child who is overweight. The intervention is 8 sessions in length. Each session is expected to last 1-1.5 hours and will be carried out in the participant's home over 4 months. The sessions will target the nutrition and physical activity knowledge of parents and their motivation for changing parenting related to these factors. Intervention content for the parent will be based on Motivational Interviewing principles.
intervention
Home-based session targeting the parent
(Active Comparator)
The attention control condition includes 1 initial Motivational Interviewing (MI) session conducted in the home. The content of the MI session will be the same as for the intervention participants. Following this session, parents will receive bi-monthly newsletters that will include content similar to what intervention participants receive. AC participants will receive a total of 7 newsletters; 2 on nutrition, 2 on physical activity, 2 on parenting behavior and 1 on community resources. AC participants will also receive a monthly 20-min phone call designed to review newsletter content and answer parent questions.
attention control
Attention condition with newsletters and support phone calls

Primary Outcomes

Measure
Change in Child Body Mass Index (BMI)
time frame: 5-months
Change in child fruit, vegetable, and sugary beverage intake using the Block Food Frequency Questionnaire for children
time frame: 5-months
Change in child physical activity level assessed using accelerometers
time frame: 5-months

Secondary Outcomes

Measure
Change in parent nutrition/physical activity knowledge, assessed via a self-report survey
time frame: 5-months
Change in parent motivation for health behavior change, assessed using the "readiness ruler"
time frame: 5-months
Change in parenting Behavior, assessed using the Caregiver Feeding Style Questionnaire and the Parenting Young Children Scale
time frame: 5-months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Parent Focused Obesity Intervention for Low-Income African American Preschoolers
Principal investigator Heather C Janisse, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Eastern Michigan University.