Preventing Childhood Obesity Through Early Guidance
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|ClinicalTrials.gov Identifier: NCT01905072|
Recruitment Status : Completed
First Posted : July 23, 2013
Last Update Posted : January 18, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Childhood Obesity||Other: Education Home Visits||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||177 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Preventing Childhood Obesity Through Early Feeding and Parenting Guidance|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||June 30, 2017|
|Actual Study Completion Date :||June 30, 2017|
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.
Other: Education Home Visits
Intervention will include educational home visits on:
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.
- Weight for Length Body Mass Index [ Time Frame: BMI will be assessed at three years of age for the study participants ]The children in the study will be compared at age three (intervention and control group) for differences in weight, height, and Body Mass index.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905072
|United States, Texas|
|St. Austin Center - Arizona State University Group|
|Houston, Texas, United States, 77023|
|Principal Investigator:||Elizabeth A Reifsnider, PhD RN FAAN||Arizona State University|