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Preventing Childhood Obesity Through Early Guidance

Primary Purpose

Childhood Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Education Home Visits

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Obesity, Breastfeeding, Educational Intervention

Eligibility Criteria

1 Day - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

St. Austin Center - Arizona State University Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Education Home Visits

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Weight for Length Body Mass Index

The children in the study will be compared at age three (intervention and control group) for differences in weight, height, and Body Mass index.

Secondary Outcome Measures

Full Information

NCT ID

NCT01905072

First Posted

July 16, 2013

Last Updated

January 15, 2020

Sponsor

Arizona State University

1. Study Identification

Unique Protocol Identification Number

NCT01905072

Brief Title

Preventing Childhood Obesity Through Early Guidance

Official Title

Preventing Childhood Obesity Through Early Feeding and Parenting Guidance

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

June 30, 2017 (Actual)

Study Completion Date

June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Arizona State University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Childhood Obesity

Keywords

Obesity, Breastfeeding, Educational Intervention

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

177 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Education Home Visits

Arm Type

Experimental

Arm Description

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Education Home Visits

Intervention Description

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.

Primary Outcome Measure Information:

Title

Weight for Length Body Mass Index

Description

The children in the study will be compared at age three (intervention and control group) for differences in weight, height, and Body Mass index.

Time Frame

BMI will be assessed at three years of age for the study participants

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elizabeth A Reifsnider, PhD RN FAAN

Organizational Affiliation

Arizona State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Austin Center - Arizona State University Group

City

Houston

State/Province

Texas

ZIP/Postal Code

77023

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

24063435

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.

Results Reference

derived

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Preventing Childhood Obesity Through Early Guidance

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