Our Year of Healthy Living (Formative Research & Intervention)

NCT02330354 | Completed DMC

• 2 other identifiers: 13-2379R01HL120969
• Study Type: interventional
• Target: 2,293
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of a 7-month social marketing program - Healthy Me, Healthy We (previously called Our Year of Healthy Living) - in improving preschool children's (3-4 years) diet and physical activity behavior. Healthy Me, Healthy We will use social marketing approaches in the child care center to promote the use of healthy diet and physical activity behaviors by children, as well as their teachers and parents. The program will use visual cues, educational materials, activities, and a song to deliver targeted healthy behavior messages that connect the teacher, child, and parents. Centers will implement the Our Year of Healthy Living program in their classrooms over the course of a school year (October-April). Prior to initiation and after completion of the program, researchers will collect information about diet, physical activity, child body mass index (BMI), and center and home environment information from participants. From the beginning of the program to the end, children enrolled in the program will have 1) a greater increase in physical activity and decrease in sedentary time, 2) improved diet, and 3) smaller increase in body mass index compared to children in centers that do not complete the program. Additionally, from the beginning of the program to the end, homes and centers that participate in the program will have greater improvements in scores on the home and center environment assessments compared to centers and homes that do not participate.

Conditions

Obesity

Keywords

preschool; behavior change; social marketing; child care providers; nutrition; child care centers; physical activity

Outcome Measures

Primary Outcomes (2)

• Change in child physical activity

  Physical activity of 3-4 year old children will be assessed via accelerometry using ActiGraph monitors worn over the right hip for 7 days. Age-appropriate cut-points will be applied to calculate minutes of non-sedentary activity.

  Measures collected 3-10 weeks prior to start of intervention and 1-8 weeks post intervention

• Change in child diet quality

  Dietary intakes of 3-4 year old children will be assessed via direct observation of foods eaten at child care and parent report of foods eaten outside of child care. These dietary intake data will be used to calculate Healthy Eating Index scores as an indication of diet quality.

  Measures collected 3-10 weeks prior to start of intervention and 1-8 weeks post intervention

Secondary Outcomes (2)

• Change in child weight

  Measures collected 3-10 weeks prior to start of intervention and 1-8 weeks post intervention

• Change in nutrition and physical activity environments in homes and child care centers

  Measures collected 3-10 weeks prior to start of intervention and 1-8 weeks post intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Centers in this group will participate in the Healthy Me, Healthy We program.

Behavioral: Healthy Me, Healthy We

Control Group

OTHER

Centers in this group will participate in the Healthy Me, Healthy We program after follow-up measures are collected.

Behavioral: Healthy Me, Healthy We

Interventions

Healthy Me, Healthy We BEHAVIORAL

The intervention - Healthy Me, Healthy We - is a 7-month social marketing campaign designed to improve preschool children's (3-4 years) diet and physical activity behaviors.

Control Group; Intervention group

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Child Care Centers:
• Have 7-12 parent-child dyads willing to take part
• Have a Three, Four, or Five Star Rating OR GS110-106
• Serve lunch
• Have 3-4 year old classroom teachers that speak/write in English
• Providers
• Teachers must teach in the 3-4 year old classrooms.
• Center directors and teachers must be able to read and speak English.
• Parent-Child Dyad:
• Primary caregivers must have at least one 3-4 year old child enrolled in the participating center.
• Only one parent/primary caregiver will be eligible to participate.
• Can be male or female.
• Primary caregivers must be able to read and speak English.
• Special needs children must not have a chronic health issue that severely impacts their diet or physical activity.

You may not qualify if:

• Child Care Centers:
• Serve special needs children exclusively
• Serve only non-English speaking families

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Dianne S Ward, EdD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: January 1, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2018
• Last Updated: August 28, 2018

Record last verified: 2018-08

Locations

US (1)