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The Added Value of Telephone Follow Up and Home Visits in Helping Children to Grow Up Healthy

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ClinicalTrials.gov Identifier: NCT01973153
Recruitment Status : Completed
First Posted : October 31, 2013
Last Update Posted : January 31, 2014
Sponsor:
Collaborator:
Community Health Network
Information provided by (Responsible Party):
Michelle Cloutier, MD, Connecticut Children's Medical Center

Tracking Information
First Submitted Date  ICMJE October 25, 2013
First Posted Date  ICMJE October 31, 2013
Last Update Posted Date January 31, 2014
Study Start Date  ICMJE January 2012
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2013)
Change in BMI Percentile [ Time Frame: baseline and 12 months ]
BMI Percentile calculated using the 2000 revised CDC/NCH growth charts for the United States
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01973153 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Added Value of Telephone Follow Up and Home Visits in Helping Children to Grow Up Healthy
Official Title  ICMJE The Added Value of Telephone Follow Up and Home Visits in Helping Children to Grow Up Healthy
Brief Summary Leading medical organizations have called on primary care pediatricians to take a central role in the prevention of childhood obesity. Weight counseling typically has not been incorporated into routine pediatric practice due to time and training constraints. Brief interventions with simple behavior change messages are needed to reach high-risk children, particularly Latino and Black children who are disproportionately affected by obesity and related comorbidities. Steps to Growing Up Healthy (Added Value) is a randomized controlled trial testing the efficacy of brief motivational counseling (BMC) delivered by primary care clinicians and the added value of supplementing BMC with monthly contact by community health workers (CHW) in the prevention/reversal of obesity in Latino and Black children ages 2-4 years old. Mother-child dyads (targeted n=150) are recruited for this 12-month randomized trial at an inner-city pediatric primary care clinic and randomized to: 1) BMC delivered by clinicians and nurses at well, sick, and WIC visits with the goal of reducing obesogenic behaviors (BMC); 2) BMC plus monthly phone calls by a CHW (BMC+Phone); or 3) BMC plus monthly home visits by a CHW (BMC+Home). During BMC, the medical team facilitates the selection of a specific goal (i.e., reduce sugar sweetened beverage consumption) that is meaningful to the mother and teaches the mother simple behavioral strategies. Monthly contacts with CHWs are designed to identify and overcome barriers to goal progress. Dyads are assessed at baseline and 12 months and the primary outcome is change in the child's BMI percentile. We hypothesize that BMC+Phone and BMC+Home will produce greater reductions in BMI percentiles than BMC alone and that BMC+Home will produce greater reductions in BMI percentiles than BMC+Phone.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Obesity
Intervention  ICMJE
  • Behavioral: Brief Motivational Counseling (BMC)
    3-5 minute BMC delivered by clinicians and nurses at well, sick, and WIC visits with the goal of reducing obesogenic behaviors. During BMC, the medical team facilitates the selection of a specific goal (i.e., reduce sugar sweetened beverage consumption) that is meaningful to the mother and teaches the mother simple behavioral strategies.
  • Behavioral: Brief Motivational Counseling Plus Phone Calls (BMC + Phone)
    BMC as described above that is supplemented by monthly telephone contacts with community health workers designed to identify and overcome barriers to goal progress.
  • Behavioral: Brief Motivational Counseling Plus Home Visits (BMC + Home)
    BMC as described above that is supplemented by monthly home visits with community health workers designed to identify and overcome barriers to goal progress.
Study Arms  ICMJE
  • Active Comparator: Brief Motivational Counseling (BMC)
    Intervention: Behavioral: Brief Motivational Counseling (BMC)
  • Active Comparator: Brief Motivational Counseling Plus Phone Calls (BMC+Phone)
    Interventions:
    • Behavioral: Brief Motivational Counseling (BMC)
    • Behavioral: Brief Motivational Counseling Plus Phone Calls (BMC + Phone)
  • Active Comparator: Brief Motivational Counseling Plus Home Visits (BMC+Home)
    Interventions:
    • Behavioral: Brief Motivational Counseling (BMC)
    • Behavioral: Brief Motivational Counseling Plus Home Visits (BMC + Home)
Publications * Gorin AA, Wiley J, Ohannessian CM, Hernandez D, Grant A, Cloutier MM. Steps to Growing Up Healthy: a pediatric primary care based obesity prevention program for young children. BMC Public Health. 2014 Jan 23;14:72. doi: 10.1186/1471-2458-14-72.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2013)
81
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Child is 2-4 years old
  • Latino or Black descent by maternal report
  • Receiving services through the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)

Exclusion Criteria:

  • Mother is younger than 18 years old
  • Dad does not live in the Greater Hartford area or if they have plans to move out of the area in the next 12 months
  • Child or mother has special needs (dietary, physical, and/or emotional) that would make the intervention inappropriate (e.g. failure to thrive, type 1 diabetes, cystic fibrosis)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 50 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01973153
Other Study ID Numbers  ICMJE CHNCT-012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michelle Cloutier, MD, Connecticut Children's Medical Center
Study Sponsor  ICMJE Connecticut Children's Medical Center
Collaborators  ICMJE Community Health Network
Investigators  ICMJE Not Provided
PRS Account Connecticut Children's Medical Center
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP