FITLINE: Pediatric Practice-based Obesity Intervention to Support Families

Obesity, Childhood Clinical Trial

Official title:

Pediatric Practice-based Obesity Intervention to Support Families:FITLINE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03143660
• Other study ID #: R01HL130505
• Status: Completed
• Phase: N/A
• Start date: October 11, 2017
• Est. completion date: January 28, 2022

Study information

• Verified date: January 2022
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: January 28, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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). -

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Massachusetts, Worcester	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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