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

NCT ID: NCT01973153

Last Updated: 2023-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Brief Motivational Counseling (BMC)

Intervention Type: 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 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.

Group Type: ACTIVE_COMPARATOR

Brief Motivational Counseling (BMC)

Intervention Type: 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 Plus Phone Calls (BMC + Phone)

Intervention Type: 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 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.

Group Type: ACTIVE_COMPARATOR

Brief Motivational Counseling (BMC)

Intervention Type: 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 Plus Home Visits (BMC + Home)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 50 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Community Health Network

OTHER

Sponsor Role: collaborator

Connecticut Children's Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Christine M Trapp, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24456698 (View on PubMed)

Other Identifiers

CHNCT-012

Identifier Type: -

Identifier Source: org_study_id