Preventing Childhood Obesity Through Early Guidance

NCT01905072 | Completed DMC

• 2 other identifiers: 1R01DK096488-01A1GRANT11114271
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity

Keywords

Obesity; Breastfeeding; Educational Intervention

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (2)

Education Home Visits

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.

Other: Education Home Visits

Control Group

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.

Interventions

Education Home Visits OTHER

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.

Education Home Visits

Eligibility Criteria

• Age: 1 Day - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

St. Austin Center - Arizona State University Group

Houston, Texas, 77023, United States

Location

Related Publications (1)

• 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.

  PMID: 24063435 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Obesity; Breast Feeding

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Study Officials

• Elizabeth A Reifsnider, PhD RN FAAN

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean of Research

Study Record Dates

• First Submitted: July 16, 2013
• First Posted: July 23, 2013
• Study Start: October 1, 2012
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)