FITLINE: Pediatric Practice-based Obesity Intervention to Support Families

Not Applicable

Completed

• Conditions: Obesity, Childhood
• Interventions: Behavioral: Coaching; Behavioral: Materials

• Registration Number: NCT03143660
• Lead Sponsor: University of Massachusetts, Worcester

Brief 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.

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 Timeline

• Study First Submitted: 2017-04-16
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-08
• Study Start: 2017-10-11
• Status Verified: 2022-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-28
• Last Update Submitted: 2022-01-28
• Last Update Posted: 2022-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 501

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coaching	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
Materials	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.

Primary Outcome Measures

Name	Time	Method
Reducing BMI in overweight and obese children.	Baseline and 6-months post-baseline	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

Secondary Outcome Measures

Name	Time	Method
Improving the child's diet	Baseline and 12-months post-baseline	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.
Effect of the Fitline-Coaching on BMI through a composite measure of Social Cognitive Theory constructs	Baseline and 12-months post-baseline	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.
Improving the child's physical activity	Baseline and 12-months post-baseline	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).
Cost Effectiveness	Baseline and 12-months post-baseline	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.

Trial Locations

Locations (1)

University of Massachusetts, Worcester; 🇺🇸 Worcester, Massachusetts, United States