Preventing Childhood Obesity Through Early Guidance

Completed · Not applicable

Conditions studied: Childhood Obesity

In brief

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.

Key facts

Study ID

NCT01905072

Run by

Arizona State University

People needed

177

Starts

2012-10-01

Expected to finish

2017-06-30

Last updated by the study team

2020-01-18

Who can join

Age: 0 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• St. Austin Center - Arizona State University Group — Houston, Texas, United States

Full record on ClinicalTrials.gov

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