Keys to Healthy Family Child Care Homes

NCT01814215 | Completed DMC

• 3 other identifiers: 11-21291R01HL108390-01A139422
• Study Type: interventional
• Target: 805
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this project is to evaluate the efficacy of a 9-month Family Child Care Home (FCCH)-based intervention, Keys to Healthy Family Child Care Homes, to increase the physical activity and improve the diet quality of children (1.5 to 4.9 years).

Conditions

Obesity

Keywords

Obesity; Prevention and Control; Diet; Motor Activity; Intervention Studies; Child, Preschool; Child Care; Food Habits; Feeding Behavior; Child Behavior

Outcome Measures

Primary Outcomes (2)

• Change in Child Physical Activity

  Child Physical Activity (Moderate to vigorous physical activity (MVPA)), will be assessed using Actigraph GT3X Accelerometers. Note: Child physical activity and dietary intake are linked in their relationship to child obesity prevention.

  Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.

• Change in Child Dietary Intake

  Child Dietary Intake will be assessed using the Dietary Observation for Child Care (DOCC). Note: Child physical activity and dietary intake are linked in their relationship to child obesity prevention.

  Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.

Secondary Outcomes (9)

• Change in Child Body Mass Index

  Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.

• Change in Provider Physical Activity

  Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.

• Change in Provider Dietary Intake

  Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.

• Change in Provider Body Mass Index

  Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.

• Change in Provider Motivation for Providing Children with Physical Activity and Healthy Eating Opportunities

  Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.

Other Outcomes (4)

• Change in Provider Sleep Index Score

  Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.

• Change in Provider Perceived Stress

  Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.

• Provider Physical Activity Readiness

  Baseline only will be collected over a 2-month period prior to initiating a 9 month intervention.

Study Arms (2)

Healthy Lifestyles Group

EXPERIMENTAL

The Experimental Arm will receive the Keys to Healthy Family Child Care Homes intervention to be delivered over 9 months in 3 modules (3 months/module). The intervention group will be asked to participate in 3 workshops on 3 content areas. Participants will be asked to meet with a coach 3 times in-person, as well 3-9 times by phone/email, over the course of the 9-months. Three content areas are designed to help providers:(1) modify their own weight-related behaviors so they can role model healthy behaviors for children in their care (Healthy You module), (2) create environments that support children's physical activity and healthy dietary intakes (Healthy Home module), and (3) adopt sound business practices that will help them sustain the changes introduced (Healthy Business module).

Behavioral: Keys to Healthy Family Child Care Homes

Healthy Business Group

PLACEBO COMPARATOR

The Control Arm will receive the Healthy Business Education and Coaching program to be delivered over 9 months in 3 modules (3 months/module). The control group will be asked to participate in 3 workshops and a similar number of coaching contacts about their business practices. The focus on business topics is relevant, but not directly related to physical activity or nutrition.

Behavioral: Keys to Healthy Family Child Care Homes

Interventions

Keys to Healthy Family Child Care Homes BEHAVIORAL

The Keys to Healthy Family Child Care Homes intervention will be delivered to providers via a health behavior coach using a consistent structure and sequence of coaching contacts, including an introductory self-assessment, hands-on workshops, on-site home visits with goal setting and action planning, follow-up coaching phone calls using Motivational Interviewing-inspired techniques, and supportive print toolkit materials.

Also known as: Healthy Lifestyles Education and Coaching

Healthy Business Group; Healthy Lifestyles Group

Eligibility Criteria

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

You may qualify if:

• FCCH must have at least 2 children between the ages of 1.5 and 4 years currently enrolled. \* At least 2 children/families must agree to take part for the FCCH to remain eligible. (Note: Children ages 0-17 months may take part in height and weight measurements only)
• FCCH must have been in business for at least 2 years.
• FCCH must have a working telephone number.
• Provider must be able to read and speak English.

You may not qualify if:

• FCCHs cannot serve exclusively special needs children.
• FCCHs cannot close down during the summer months.

Sponsors & Collaborators

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

Study Sites (2)

Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Related Publications (2)

• Ward DS, Vaughn AE, Burney RV, Hales D, Benjamin-Neelon SE, Tovar A, Ostbye T. Keys to healthy family child care homes: Results from a cluster randomized trial. Prev Med. 2020 Mar;132:105974. doi: 10.1016/j.ypmed.2019.105974. Epub 2019 Dec 30.

  PMID: 31899253 DERIVED

• Vaughn AE, Mazzucca S, Burney R, Ostbye T, Benjamin Neelon SE, Tovar A, Ward DS. Assessment of nutrition and physical activity environments in family child care homes: modification and psychometric testing of the Environment and Policy Assessment and Observation. BMC Public Health. 2017 Aug 29;17(1):680. doi: 10.1186/s12889-017-4686-9.

  PMID: 28851348 DERIVED

MeSH Terms

Conditions

Obesity; Motor Activity; Feeding Behavior; Child Behavior

Condition Hierarchy (Ancestors)

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

Study Officials

• Dianne S Ward, EdD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Truls Ostbye, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 15, 2013
• First Posted: March 19, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 8, 2016

Record last verified: 2016-06

Locations

US (2)