FITLINE: Pediatric Practice-based Obesity Intervention to Support Families

NCT03143660 | Completed DMC

• 1 other identifier: R01HL130505
• Study Type: interventional
• Target: 501
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Childhood

Keywords

obesity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Improving the child's diet

  Baseline and 6-months post-baseline

• Improving the child's diet

  Baseline and 12-months post-baseline

• Improving the child's physical activity

  Baseline and 6-months post-baseline

• Improving the child's physical activity

  Baseline and 12-months post-baseline

• Effect of the Fitline-Coaching on BMI through a composite measure of Social Cognitive Theory constructs

  Baseline and 6-months post-baseline

Study Arms (2)

Coaching

ACTIVE COMPARATOR

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

Materials

ACTIVE COMPARATOR

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

Interventions

Coaching BEHAVIORAL

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.

Coaching

Materials BEHAVIORAL

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.

Materials

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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,
• genetic or endocrine causes of obesity,
• prescribed medications associated with weight gain,
• child on psychiatric medications, and/or
• morbidly obese (\> 300 pounds). -

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

University of Massachusetts, Worcester

Worcester, Massachusetts, 01655, United States

Location

Related Publications (1)

• 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.

  PMID: 33706002 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lori Pbert, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 16, 2017
• First Posted: May 8, 2017
• Study Start: October 11, 2017
• Primary Completion: January 1, 2022
• Study Completion: January 28, 2022
• Last Updated: January 31, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)