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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

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Brief Motivational Counseling (BMC) Behavioral: Brief Motivational Counseling Plus Phone Calls (BMC + Phone) Behavioral: Brief Motivational Counseling Plus Home Visits (BMC + Home) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Added Value of Telephone Follow Up and Home Visits in Helping Children to Grow Up Healthy
Study Start Date : January 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Active Comparator: Brief Motivational Counseling (BMC) 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.

Active Comparator: Brief Motivational Counseling Plus Phone Calls (BMC+Phone) 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.

Active Comparator: Brief Motivational Counseling Plus Home Visits (BMC+Home) 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 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.




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   up to 50 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

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): NCT01973153


Locations
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United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Connecticut Children's Medical Center
Community Health Network

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michelle Cloutier, MD, Professor of Pediatrics and Medicine, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier: NCT01973153     History of Changes
Other Study ID Numbers: CHNCT-012
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: January 31, 2014
Last Verified: January 2014
Keywords provided by Michelle Cloutier, MD, Connecticut Children's Medical Center:
Obesity prevention
Weight management
Motivational Interviewing
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms