Overview

This trial is active, not recruiting.

Condition childhood obesity
Treatment education home visits
Sponsor Arizona State University
Start date October 2012
End date June 2017
Trial size 177 participants
Trial identifier NCT01905072, 1R01DK096488-01A1, GRANT11114271

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose prevention
Masking participant, outcomes assessor
Arm
(Experimental)
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.
education home visits
Intervention will include educational home visits on: Growth monitoring and feedback Feeding: support exclusive breastfeeding until 6 months; delay solid feeding until 6 months; appropriate amounts of food for age; stop bottle feeding at 12 months; have nothing but breast milk/formula/4 oz juice in bottle; limit juice amount to 4 oz day; introduce cup by 10-11 months; no sweetened beverages; limited amounts of sweets. Parenting: recognizing hunger and satiety cues; handling colic/crying; engaging baby in play. Activity: being active with the baby; no screen time for baby and limited to 1 hour for 1-3 year olds; promote active play while maintaining safety. Sleep: at least 10-12 hours sleep per day needed; how to promote sleeping environment for baby.
(No Intervention)
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.

Primary Outcomes

Measure
Weight for Length Body Mass Index
time frame: BMI will be assessed at three years of age for the study participants

Eligibility Criteria

All participants up to 40 years old.

Inclusion Criteria

    Exclusion Criteria

      Additional Information

      Official title Preventing Childhood Obesity Through Early Feeding and Parenting Guidance
      Principal investigator Elizabeth A Reifsnider, PhD RN FAAN
      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.
      Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
      Information provided to ClinicalTrials.gov by Arizona State University.