FITLINE: Pediatric Practice-based Obesity Intervention to Support Families

Pediatric Practice-based Obesity Intervention to Support Families:FITLINE

The goal of this study is to investigate whether eight weekly telephone coaching sessions or materials on lifestyle interventions can be beneficial for overweight and obese 8-12 year olds.

Study Overview

• Status: Completed
• Conditions: Obesity, Childhood
• Intervention / Treatment: Behavioral: Coaching; Behavioral: Materials

Detailed Description

The proposed five-year cluster randomized controlled pediatric practice-based trial will compare the effectiveness of two practice-based interventions on improving diet and physical activity and reducing BMI among overweight and obese 8-12 year olds seen in pediatric practice: (1) Fitline-Coaching, consisting of a pediatric practice-based component plus Fitline counseling and workbook, or (2) Fitline-Workbook, consisting of the same practice-based component, but only the family workbook materials mailed over 8 weeks, with no referral to Fitline coaching. Sixteen pediatric primary care practices will be randomized to either the Fitline-Coaching (N=8) or the Fitline-Materials (N=8) condition. Five hundred and twelve parents and their children ages 8-12 with a body mass index (BMI) of > 85th percentile (overweight or obese) will be recruited from the practices to achieve N=400 at 12 month follow-up.

• Study Type: Interventional
• Enrollment (Actual): 501
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts, Worcester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. child BMI >= 85th percentile for age/sex,
2. participating parent and child English speaking,
3. parent has access to a telephone and is available to participate in telephone counseling sessions, and
4. referred by the child's primary care provider.

Exclusion Criteria:

1. planning to move out of the area during the period of study participation,
2. medical condition that precludes adherence to AAP dietary and physical activity recommendations,
3. genetic or endocrine causes of obesity,
4. prescribed medications associated with weight gain,
5. child on psychiatric medications, and/or
6. morbidly obese (> 300 pounds). -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Coaching; A parent support component consisting of eight weekly telephone counseling calls by centrally located nutritionists to provide parents coaching tailored to their family's unique needs to help them set goals and make targeted lifestyle changes recommended by the American Academy of Pediatrics (AAP) for Stage 1, Prevention Plus, accompanied by a parent booklet	Behavioral: Coaching; The eight weekly 30-minute Fitline calls provide personalized behavioral counseling and coaching to guide parents in improving their child's weight-related behaviors through targeted lifestyle changes recommended by the AAP for Stage 1, Prevention Plus. Calls are scheduled at a time convenient for the parent, including nights and weekends, with one nutritionist assigned to a family for consistency.
Active Comparator: Materials; Parents will receive the same educational materials provided in the Fitline family workbook mailed over 8 weeks to control for weekly contact and educational curriculum, but no Fitline counseling.	Behavioral: Materials; The workbook contains tips and practical strategies for implementing the AAP-recommended behavior changes discussed in the counseling sessions to support families in making lifestyle changes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reducing BMI in overweight and obese children.	BMI will be calculated from weight (kg)/height squared (in meters) and BMI z-score for age/sex will be determined using CDC growth charts for the child. It is hypothesized that the Fitline-Coaching group compared to the Fitline-Workbook group will have greater reductions in BMI z-scores at 12-month follow-up	Baseline and 12-months post-baseline
Reducing BMI in overweight and obese children.	BMI will be calculated from weight (kg)/height squared (in meters) and BMI z-score for age/sex will be determined using CDC growth charts for the child. It is hypothesized that the Fitline-Coaching group compared to the Fitline-Workbook group will have greater reductions in BMI z-scores at 6-month follow-up	Baseline and 6-months post-baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improving the child's diet	It is hypothesized that the Fitline-Coaching group compared to the Fitline-Workbook group will have greater improvements in diet at 6-month follow-up. This will be measured by 24 hour dietary recalls conducted 3 times at each time point.	Baseline and 6-months post-baseline
Improving the child's diet	It is hypothesized that the Fitline-Coaching group compared to the Fitline-Workbook group will have greater improvements in diet at 12-month follow-up. This will be measured by 24 hour dietary diet recalls conducted three times at each time point.	Baseline and 12-months post-baseline
Improving the child's physical activity	It is hypothesized that the Fitline-Coaching group compared to the Fitline-Workbook group will have greater improvements in their level of physical activity at 6-month follow-up. This will be measured by the Physical Activity Questionnaire (PAQ-C).	Baseline and 6-months post-baseline
Improving the child's physical activity	It is hypothesized that the Fitline-Coaching group compared to the Fitline-Workbook group will have greater improvements in their level of physical activity at 12-month follow-up. This will be measured by the Physical Activity Questionnaire (PAQ-C).	Baseline and 12-months post-baseline
Effect of the Fitline-Coaching on BMI through a composite measure of Social Cognitive Theory constructs	It is hypothesized that the effect of the Fitline-Coaching on child BMI will be predicted by changes in Social Cognitive Theory constructs. Parents will complete a survey assessing: (1) anticipated benefits of the behavior change (outcome expectations) (23-item questionnaire); (2) perceived support and barriers to addressing their child's behavior changes (15-item questionnaire); (3) self efficacy in helping their child improve their diet and physical activity (12-item) questionnaire; (4) behavioral capability (12-item questionnaire); and (5) knowledge (7-item questionnaire). Children will complete a survey assessing (1) anticipated benefits of the behavior change (outcome expectations) (23-item questionnaire); (2) perceived support and barriers (67-item questionnaire); (3) self efficacy (16-item questionnaire); (4) behavioral capability (12-item questionnaire); and (5) knowledge (7 item questionnaire).	Baseline and 6-months post-baseline
Effect of the Fitline-Coaching on BMI through a composite measure of Social Cognitive Theory constructs	The effect of the Fitline-Coaching on child BMI will be predicted by changes in Social Cognitive Theory constructs. Parents will complete a survey assessing: (1) the anticipated benefits of the behavior change (outcome expectations) using a 23-item questionnaire; (2) parent's perceived support and barriers to addressing their child's behavior changes using a 15 item questionnaire; (3) parent's self efficacy in helping their child improve their diet and physical activity using a 12 item questionnaire; (4) behavioral capability using a 12 item questionnaire; and (5) knowledge utilizing a 7 item questionnaire. Children will complete a survey assessing (1) the anticipated benefits of the behavior change (outcome expectations) using a 23-item questionnaire; (2) their perceived support and barriers a 67-item questionnaire; (3) child's self efficacy using a 16-item questionnaire; (4) behavioral capability using a 12-item questionnaire; and (5) knowledge utilizing a 7-item questionnaire.	Baseline and 12-months post-baseline
Cost Effectiveness	Costs and health outcomes will be compared across conditions. Costs will include those of: (1) provider training and intervention, (2) office set-up and support, (3) intervention materials, and (4) Fitline coaching. The outcome will be change in BMI z-score.	Baseline and 12-months post-baseline
Cost Effectiveness	Costs and health outcomes will be compared across conditions. Costs will include those of: (1) provider training and intervention, (2) office set-up and support, (3) intervention materials, and (4) Fitline coaching. The outcome will be change in quality of life as measured by the quality adjusted Pediatric Quality of Life Inventory (PedsQL 4.0) scores.	Baseline and 12-months post-baseline

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester

Publications and helpful links

General Publications

• Pbert L, Trivedi M, Druker S, Bram J, Olendzki B, Crawford S, Frisard C, Andersen V, Waring ME, Clements K, Schneider K, Geller AC. Supporting families of children with overweight and obesity to live healthy lifestyles: Design and rationale for the Fitline cluster randomized controlled pediatric practice-based trial. Contemp Clin Trials. 2021 May;104:106348. doi: 10.1016/j.cct.2021.106348. Epub 2021 Mar 8.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2017
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 28, 2022

Study Registration Dates

• First Submitted: April 16, 2017
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (Actual): May 8, 2017

Study Record Updates

• Last Update Posted (Actual): January 31, 2022
• Last Update Submitted That Met QC Criteria: January 28, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: obesity
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: R01HL130505 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No