Clinical trial NCT03143660: FITLINE: Pediatric Practice-based Obesity Intervention to Support Families
Official title: Pediatric Practice-based Obesity Intervention to Support Families:FITLINE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Keywords: obesity
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 501
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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). -

Primary outcomes:
measure: Reducing BMI in overweight and obese children.
timeFrame: Baseline and 12-months post-baseline
measure: Reducing BMI in overweight and obese children.
timeFrame: Baseline and 6-months post-baseline
Secondary outcomes:
measure: Improving the child's diet
timeFrame: Baseline and 6-months post-baseline
measure: Improving the child's diet
timeFrame: Baseline and 12-months post-baseline
measure: Improving the child's physical activity
timeFrame: Baseline and 6-months post-baseline
measure: Improving the child's physical activity
timeFrame: Baseline and 12-months post-baseline
measure: Effect of the Fitline-Coaching on BMI through a composite measure of Social Cognitive Theory constructs
timeFrame: Baseline and 6-months post-baseline
measure: Effect of the Fitline-Coaching on BMI through a composite measure of Social Cognitive Theory constructs
timeFrame: Baseline and 12-months post-baseline
measure: Cost Effectiveness
timeFrame: Baseline and 12-months post-baseline
measure: Cost Effectiveness
timeFrame: Baseline and 12-months post-baseline
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts, Worcester
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Lori Pbert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.