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Keys to Healthy Family Child Care Homes

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ClinicalTrials.gov Identifier: NCT01814215
Recruitment Status : Completed
First Posted : March 19, 2013
Last Update Posted : June 8, 2016
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Duke University
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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).

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Keys to Healthy Family Child Care Homes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 805 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: The Business of Childcare Homes & Child Health: Innovations for Nurturing Growth
Study Start Date : April 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healthy Lifestyles Group
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
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.
Other Name: Healthy Lifestyles Education and Coaching

Placebo Comparator: Healthy Business Group
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
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.
Other Name: Healthy Lifestyles Education and Coaching




Primary Outcome Measures :
  1. Change in Child Physical Activity [ Time Frame: 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. ]
    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.

  2. Change in Child Dietary Intake [ Time Frame: 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. ]
    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.


Secondary Outcome Measures :
  1. Change in Child Body Mass Index [ Time Frame: 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. ]
    Child Body Mass Index will be calculated with child height measurements using a Shorr stadiometer and child weight measurement using a Seca scale.

  2. Change in Provider Physical Activity [ Time Frame: 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. ]
    Child Care Provider Physical Activity (Moderate to vigorous physical activity (MVPA)) will be assessed by Actigraph GT3X Accelerometer, as well as self-reported physical activity. Note: Adult physical activity and dietary intake are linked in their relationship to adult obesity prevention.

  3. Change in Provider Dietary Intake [ Time Frame: 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. ]
    Child Care Provider Dietary Intake will be assessed using the 3-month Block Brief 2000 Food Frequency Questionnaire (FFQ). Dietary intake data will be used to calculate a Healthy Eating Index (HEI) score. Note: Adult physical activity and dietary intake are linked in their relationship to adult obesity prevention.

  4. Change in Provider Body Mass Index [ Time Frame: 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. ]
    Child Care Provider Body Mass Index will be calculated with adult height measurements using a Shorr stadiometer and adult weight measurement using a Seca scale.

  5. Change in Provider Motivation for Providing Children with Physical Activity and Healthy Eating Opportunities [ Time Frame: 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. ]
    Child Care Provider Motivation will be assessed using the Intrinsic Motivation Inventory (IMI) modified to assess motivation for providing children with physical activity opportunities and healthy foods.

  6. Change in Provider Self-Efficacy for Physical Activity and Healthy Eating [ Time Frame: 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. ]
    Child Care Provider Self-Efficacy will be assessed using a questionaire looking at self-efficacy for provider's own physical activity and healthy eating.

  7. Change in Provider Social Support [ Time Frame: 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. ]
    Child Care Provider Social Support will be assessed using a questionnaire to measure social support for provider's own physical activity and healthy eating.

  8. Change in Physical Activity- and Nutrition-Related Environmental Characteristics of Family Child Care Home [ Time Frame: 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. ]
    Family Child Care Home Physical Activity- and Nutrition-Related Environmental Characteristics will be assessed using the Environmental and Policy Assessment Observation (EPAO; Ward, 2008) modified for the FCCH. In addition, a newly developed survey to assess provider-parent communication around children's physical activity and nutrition will also be used.

  9. Change in Child Waist Circumference [ Time Frame: 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. ]
    Child Waist Circumference will be assessed with measuring tape.


Other Outcome Measures:
  1. Change in Provider Sleep Index Score [ Time Frame: 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. ]
    Child Care Provider Sleep Index Score (comprised of sleep disturbance, sleep adequacy, daytime somnolence, snoring, awaken short of breath or with headache, and sleep duration) will be assessed using the Medical Outcomes Study Sleep Scale (Hays & Stewart, 1992).

  2. Change in Provider Perceived Stress [ Time Frame: 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. ]
    Child Care Provider Perceived Stress will be assessed using the Perceived Stress Scale (Cohen, 1983).

  3. Provider Physical Activity Readiness [ Time Frame: Baseline only will be collected over a 2-month period prior to initiating a 9 month intervention. ]
    Child Care Provider Physical Activity Readiness will be assessed using the Physical Activity Readiness Questionnaire Plus (PAR-Q+).

  4. Change in Business Practices of the FCCH [ Time Frame: 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. ]
    Family Child Care Home Business Practices will be assessed using the Business Administration Scale (BAS; Talan & Bloom, 2009) modified for self-administration and intervention objectives.



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Ages Eligible for Study:   18 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

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): NCT01814215


Locations
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United States, North Carolina
Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Duke University
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI)
Duke University
Investigators
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Principal Investigator: Dianne S Ward, EdD University of North Carolina, Chapel Hill
Principal Investigator: Truls Ostbye, MD, PhD Duke University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01814215    
Other Study ID Numbers: 11-2129
1R01HL108390-01A1 ( U.S. NIH Grant/Contract )
39422 ( Other Identifier: Duke University )
First Posted: March 19, 2013    Key Record Dates
Last Update Posted: June 8, 2016
Last Verified: June 2016
Keywords provided by University of North Carolina, Chapel Hill:
Obesity
Prevention and Control
Diet
Motor Activity
Intervention Studies
Child, Preschool
Child Care
Food Habits
Feeding Behavior
Child Behavior
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight