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Preventing Childhood Obesity Through Early Guidance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01905072
Recruitment Status : Completed
First Posted : July 23, 2013
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Elizabeth Reifsnider, Arizona State University

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.


Condition or disease Intervention/treatment Phase
Childhood Obesity Other: Education Home Visits Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 177 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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:

  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.

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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   up to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

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


Locations
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United States, Texas
St. Austin Center - Arizona State University Group
Houston, Texas, United States, 77023
Sponsors and Collaborators
Arizona State University
Investigators
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Principal Investigator: Elizabeth A Reifsnider, PhD RN FAAN Arizona State University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Elizabeth Reifsnider, Associate Dean of Research, Arizona State University
ClinicalTrials.gov Identifier: NCT01905072    
Other Study ID Numbers: 1R01DK096488-01A1 ( U.S. NIH Grant/Contract )
GRANT11114271 ( Other Identifier: Arizona State University )
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will make our data available through our website. All data will be de-identified and will not be able to be altered but can be downloaded (with permission from PI) for secondary analysis.
Keywords provided by Elizabeth Reifsnider, Arizona State University:
Obesity
Breastfeeding
Educational Intervention
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms