Pediatric Practice-based Obesity Intervention to Support Families: FITLINE

Pediatric Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02085434
• Other study ID #: H00000948
• Status: Completed
• Phase: Phase 1
• First received: February 20, 2014
• Last updated: November 20, 2014
• Start date: February 2013

Study information

• Verified date: November 2014
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The American Academy of Pediatrics (AAP) recommends a staged approach for pediatric practices to manage the growing problem of pediatric overweight and obesity, starting with Stage 1, Prevention Plus, which encourages families to improve basic lifestyle choices related to eating and activity in order to improve BMI status. This study will test the effectiveness of an innovative FITLINE telephone counseling program for overweight and obese 8-12 year olds seen in pediatric practices where nutritionists coach parents in improving their child's diet and physical activity, to reduce BMI. If found to be effective, the FITLINE program will provide a model for widespread implementation of Stage 1, Prevention Plus of the AAP expert committee recommendations through pediatric practices nationwide.

Description:

The American Academy of Pediatrics (AAP) recommends a staged approach to the management of pediatric overweight and obesity, starting with Stage 1, Prevention Plus, which encourages families to improve lifestyle choices related to eating and activity in order to improve BMI status. Most pediatric practices, however, have difficulty implementing these guidelines due to limited time and access to weight loss experts to whom they can refer their patients and families, and burden to families in accessing in-person weight loss services. In response, The investigators team developed the FITLINE pediatric practice-based referral program that provides practices an easily accessible resource to help families make AAP-recommended Stage 1 lifestyle changes. The program includes two components. The first, a pediatric practice-based component, consists of systems to identify overweight and obese children ages 8-12, a brief pediatric provider-delivered intervention, referral to the FITLINE counseling program, and feedback from the FITLINE nutritionist. The second, a parent support component, consists of six weekly FITLINE counseling telephone calls delivered by centrally located nutritionists who provide tailored, personalized coaching, along with a parent booklet to guide parents in setting goals and working with their child to make Stage 1 lifestyle changes. Providers receive a summary from the nutritionist of the progress made by families so they may support maintenance of an improved lifestyle, or refer for additional intervention. A nonrandomized intervention study with contemporaneous control was used. Parents and their children ages 8-12 with BMI ≥85th percentile (N=40) were recruited from two pediatric practices. Practices implemented systems to identify overweight/obese children, prompt brief provider intervention, and refer parents to 6-weekly FITLINE telephone counseling sessions with a nutritionist who guided parents in setting goals and helping their child make American Academy of Pediatrics (AAP)-recommended lifestyle changes. Child BMI and parent survey of child diet and physical activity were completed at baseline and 3 months. Medical record data from 44 children matched for age and BMI was collected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• child ages 8-12

• child BMI > 85th percentile for age/sex

• access to a telephone and parent available to participate in telephone counseling sessions,

• referred by the child's primary care provider (i.e., family deemed by the provider as able to participate in the study and interventions). If more than one child in a family is eligible, the oldest child will be invited to participate.

Exclusion Criteria:

• planning to move out of the area during the period of study participation

• medical condition that precludes adherence to AAP dietary and physical activity recommendations

• prescribed medications associated with weight gain, or (4) morbidly obese (> 300 pounds).

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pediatric Obesity

Intervention

Behavioral:
• FITLINE practice-based referral program
The FITLINE practice-based referral program provides pediatric practices an easily accessible resource to help families make AAP-recommended Stage 1 lifestyle changes. The program includes a pediatric practice-based component (systems to identify overweight and obese children ages 8-12, a brief pediatric provider-delivered intervention, referral to the FITLINE counseling program, and feedback from the FITLINE nutritionist) and a parent support component(eight weekly FITLINE counseling telephone calls delivered by centrally located nutritionists). Providers receive a summary from the nutritionist of the progress made by families so they may support maintenance of an improved lifestyle, or refer for additional intervention.

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Harvard School of Public Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index (BMI)	The child's weight and height were measure in the clinic using standard methodology. BMI was calculated from weight (kg)/height squared (in meters) and BMI-z score for age/sex determined using Centers for Disease Control growth charts.	Baseline and 3 months post-baseline	No
Secondary	Diet	Parents completed a survey assessing: (1) parent's feeding style using an 11-item questionnaire to assess interactions of the parent with the child during the dinner meal; (2) parent's perceived support and barriers to addressing their child's behavior changes using the Caregiver Attitudes and Beliefs Survey, created by the authors; (3) a 12-item survey regarding number of days their child engaged in key dietary behaviors (e.g., eat breakfast in the morning, eat fast food or restaurant meal, eat dinner with the family, (4) number of days in past week their child ate 5 fruit or vegetables, and drank water, fruit juice, and punch/sweet tea/soda/sports drinks; and (5) type of milk the child drinks.	Baseline and 3-months post-baseline	No
Secondary	Physical activity behaviors	Parents completed a survey assessing: (1) parent's perceived support and barriers to addressing their child's behavior changes using the Caregiver Attitudes and Beliefs Survey, created by the authors; (2) a 12-item survey regarding number of days their child engaged in key physical activity behaviors (e.g., use computer or play video games, watch television, play sports).	Baseline and 3 months post-baseline	No