Clinical trial NCT01973153: The Added Value of Telephone Follow Up and Home Visits in Helping Children to Grow Up Healthy
Official title: The Added Value of Telephone Follow Up and Home Visits in Helping Children to Grow Up Healthy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity prevention
Weight management
Motivational Interviewing
Lead sponsor: Connecticut Children's Medical Center
Sponsor class: OTHER
Collaborators: name: Community Health Network
First posted: 2013-10-31
Enrollment: 81
Sex: ALL
Minimum age (years): 2
Maximum age (years): 50
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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)

Primary outcomes:
measure: Change in BMI Percentile
timeFrame: baseline and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
Study officials:
References:
citation: 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.