Clinical trial NCT01905072: Preventing Childhood Obesity Through Early Guidance
Official title: Preventing Childhood Obesity Through Early Feeding and Parenting Guidance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Obesity
Breastfeeding
Educational Intervention
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 177
Sex: ALL
Minimum age (years): 1
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Along with birth weight and parental body size, infant feeding is recognized as one of the most influential biological and environmental factors that affect weight gain during infancy. Parental feeding practices have a strong impact on children's food availability, eating behaviors, and weight. The Institute of Medicine's(IOM) recent report (2011) on early childhood obesity prevention policies recommends five approaches to preventing obesity: assess, monitor, and track growth from birth to age 5; increase physical activity and decrease sedentary behavior in young children; support breastfeeding and be responsive to children's feeding cues; limit screen time; and promote age-appropriate sleep for young children. Based on the previous work by this research team, and in collaboration with a major urban health department, we propose to test an intervention that incorporates all the IOM's recommendations to prevent the development of obesity in at-risk infants. The intervention will be guided by health professionals and delivered through home visits by community health workers (CHWs), supervised by public health nurses (PHN), to Mexican American women and children who are clients of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Program in Houston, TX. The intervention will occur for 2 years with 1 year of follow-up, for a total of 3 years of measures.

Eligibility criteria: 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.

Primary outcomes:
measure: Weight for Length Body Mass Index
timeFrame: BMI will be assessed at three years of age for the study participants
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: St. Austin Center - Arizona State University Group
state: Texas
Study officials:
affiliation: Arizona State University
name: Elizabeth A Reifsnider, PhD RN FAAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reifsnider E, McCormick DP, Cullen KW, Szalacha L, Moramarco MW, Diaz A, Reyna L. A randomized controlled trial to prevent childhood obesity through early childhood feeding and parenting guidance: rationale and design of study. BMC Public Health. 2013 Sep 24;13:880. doi: 10.1186/1471-2458-13-880.