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Obesity Intervention for Low-Income African American Preschoolers

NCT ID: NCT02456623

Last Updated: 2019-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

Intervention

Intervention Type BEHAVIORAL

Home-based session targeting the parent

Attention Control

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.

Group Type ACTIVE_COMPARATOR

Attention Control

Intervention Type BEHAVIORAL

Attention condition with newsletters and support phone calls

Interventions

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Intervention

Home-based session targeting the parent

Intervention Type BEHAVIORAL

Attention Control

Attention condition with newsletters and support phone calls

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eastern Michigan University

OTHER

Sponsor Role lead

Responsible Party

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Heather Janisse

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heather C Janisse, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Eastern Michigan University

Locations

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Eastern Michigan University

Ypsilanti, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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1R03DK097444-01

Identifier Type: NIH

Identifier Source: org_study_id

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