Preventing Childhood Obesity Through Early Guidance

NCT01905072 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2020-01-18

No results posted yet for this study

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.

Conditions

  • Childhood Obesity

Interventions

OTHER

Education Home Visits

Intervention will include educational home visits on: 1. Growth monitoring and feedback 2. 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. 3. Parenting: recognizing hunger and satiety cues; handling colic/crying; engaging baby in play. 4. 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. 5. Sleep: at least 10-12 hours sleep per day needed; how to promote sleeping environment for baby.

Sponsors & Collaborators

  • Arizona State University

    lead OTHER

Principal Investigators

  • Elizabeth A Reifsnider, PhD RN FAAN · Arizona State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01905072 on ClinicalTrials.gov