- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02456623
Obesity Intervention for Low-Income African American Preschoolers
December 11, 2019 updated by: Heather Janisse, Eastern Michigan University
Parent Focused 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Ypsilanti, Michigan, United States, 48197
- Eastern Michigan University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Home-based session targeting the parent
|
|
Active Comparator: 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.
|
Attention condition with newsletters and support phone calls
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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 fruit and vegetable intake between baseline and 5-month follow-up will be collected using the Block Food Frequency Questionnaire for children.
|
5-months
|
|
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.
|
5-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
5-months
|
|
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.
|
5-months
|
|
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.
|
5-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Heather C Janisse, Ph.D., Eastern Michigan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2013
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
September 1, 2017
Study Registration Dates
First Submitted
January 8, 2015
First Submitted That Met QC Criteria
May 27, 2015
First Posted (Estimate)
May 28, 2015
Study Record Updates
Last Update Posted (Actual)
December 12, 2019
Last Update Submitted That Met QC Criteria
December 11, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R03DK097444-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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