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

NCT01973153 | Completed

• 1 other identifier: CHNCT-012
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity prevention; Weight management; Motivational Interviewing

Outcome Measures

Primary Outcomes (1)

• Change in BMI Percentile

  BMI Percentile calculated using the 2000 revised CDC/NCH growth charts for the United States

  baseline and 12 months

Study Arms (3)

Brief Motivational Counseling (BMC)

ACTIVE COMPARATOR

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 (BMC)

Brief Motivational Counseling Plus Phone Calls (BMC+Phone)

ACTIVE COMPARATOR

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 (BMC); Behavioral: Brief Motivational Counseling Plus Phone Calls (BMC + Phone)

Brief Motivational Counseling Plus Home Visits (BMC+Home)

ACTIVE COMPARATOR

BMC as described above that is supplemented by monthly home visits with community health workers designed to identify and overcome barriers to goal progress.

Behavioral: Brief Motivational Counseling (BMC); Behavioral: Brief Motivational Counseling Plus Home Visits (BMC + Home)

Interventions

Brief Motivational Counseling (BMC) BEHAVIORAL

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.

Brief Motivational Counseling (BMC); Brief Motivational Counseling Plus Home Visits (BMC+Home); Brief Motivational Counseling Plus Phone Calls (BMC+Phone)

Brief Motivational Counseling Plus Phone Calls (BMC + Phone) BEHAVIORAL

BMC as described above that is supplemented by monthly telephone contacts with community health workers designed to identify and overcome barriers to goal progress.

Brief Motivational Counseling Plus Phone Calls (BMC+Phone)

Brief Motivational Counseling Plus Home Visits (BMC + Home) BEHAVIORAL

BMC as described above that is supplemented by monthly home visits with community health workers designed to identify and overcome barriers to goal progress.

Brief Motivational Counseling Plus Home Visits (BMC+Home)

Eligibility Criteria

• Age: 2 Years - 50 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead
• Community Health Network: collaborator

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Related Publications (1)

• 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.

  PMID: 24456698 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Bone Density; House Calls; Home Care Services

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Professional Practice; Organization and Administration; Health Services Administration; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Nursing Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: October 31, 2013
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 10, 2023

Record last verified: 2023-06

Locations

US (1)