- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01905072
Preventing Childhood Obesity Through Early Guidance
Preventing Childhood Obesity Through Early Feeding and Parenting Guidance
The goal of this study is to compare the effectiveness of structured CHW- provided home visits, using an intervention created through community-based participatory research, to standard care received through WIC office visits in preventing the development of overweight (weight/length >85th percentile) and obesity (weight/length >95th percentile) in infants during their first 2 years of life.
Hypothesis 1: Children in the intervention group will remain within their growth centiles in height/weight and weight for age, while children in the control group will increase in height/weight percentiles and weight percentiles more rapidly (> .67 SD) during the first year of life.
Hypothesis 2: Fewer children who receive the intervention will have BMI >95th percentile at ages 2 and 3 than the children in the control group.
Hypothesis 3: Children who receive the intervention will exclusively breastfeed for a longer period of time than will children in the control group.
Hypothesis 4: Children who receive the intervention will have a higher percentage of fruits and vegetables and a lower percentage of sweetened beverages, desserts, and candy in their diets at ages 1, 2, and 3, than will children in the control group.
Hypothesis 5: Parents in the intervention group will be more responsive to infant feeding cues (hunger, satiety)than parents in the control group.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77023
- St. Austin Center - Arizona State University Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
MATERNAL - Self-described as Mexican American, pre-pregnant BMI of 25 or greater, speaks English or Spanish, is between the ages of 18 and 40, lives in a home where she can receive home visitors, has no diagnosed chronic diseases that can affect the growth of a fetus (cardiac, respiratory, etc.), have a telephone contact, and is not intending to move from the area. Gestational diabetes will be noted but is not an exclusion criterion; however, Type 1 diabetics will be excluded. Exposure to tobacco smoke (either maternal or household smoking) will be noted as it is associated with infant obesity, but will not be an inclusion or exclusion criteria.
INFANT - We will enroll the full-term singleton infants of enrolled mothers. The infants will be enrolled if they are > 38 weeks gestation, have a birth weight > 2500 gm, and are without endocrine/chromosomal/genetic abnormality that could interfere with growth.
Exclusion Criteria:
MATERNAL - Not enrolled in WIC clinic or does not plan to continue with WIC clinic after delivery, high-risk pregnancy, hospitalized after discharge of infant, separated from infant, or experiencing significant postpartum complications. If these criteria develop in an enrolled mother, she will remain in the study per CONSORT guidelines, but her infant will not be followed for study outcomes. We have sufficient power with our sample size to allow for these events.
INFANT - Not discharged home with the mother or who are otherwise separated from their mothers or who has a severe illness that can affect growth. CONSORT guidelines will apply in these cases as well as in maternal cases.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Education Home Visits
The intervention group will receive the full intervention delivered by community health workers (CHWs) through home visits.
CHWs will deliver the intervention in the subjects' homes.
Home visits will be arranged at subjects' convenience and occur on a planned schedule.
The intervention content will be based on the Institute of Medicine recommendations.
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Intervention will include educational home visits on:
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No Intervention: Control Group
The control group will receive only measurement visits, with no intervention or interaction during the home visits.
They will receive only support from their WIC clinic.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight for Length Body Mass Index
Time Frame: BMI will be assessed at three years of age for the study participants
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The children in the study will be compared at age three (intervention and control group) for differences in weight, height, and Body Mass index.
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BMI will be assessed at three years of age for the study participants
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elizabeth A Reifsnider, PhD RN FAAN, Arizona State University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01DK096488-01A1 (U.S. NIH Grant/Contract)
- GRANT11114271 (Other Identifier: Arizona State University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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