NCT03195790

Brief Summary

Pediatric obesity interventions for low-income populations are increasingly delivered in children's homes, which may make treatment more accessible to families and enhance the potency of the intervention in several ways. This randomized trial will directly test whether delivering family-based behavioral interventions for pediatric overweight/obesity in the home setting improves weight loss outcomes in low-income children relative to medical center-based treatment. The trial will also quantify the cost-effectiveness of home visitation, and explore the mechanisms accounting for observed treatment effects

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
269

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 8, 2017

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2022

Completed
Last Updated

November 4, 2024

Status Verified

October 1, 2024

Enrollment Period

5.1 years

First QC Date

June 20, 2017

Last Update Submit

October 31, 2024

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (1)

  • Child adiposity

    Change from baseline in child body mass index z-score (zBMI)

    12 months

Secondary Outcomes (2)

  • Clinically significant weight loss

    12 months

  • Cost-effectiveness

    12 months

Other Outcomes (5)

  • Intervention dosage

    12 months

  • Treatment recommendations

    12 months

  • Change in the home food environment

    12 months

  • +2 more other outcomes

Study Arms (2)

Medical center treatment arm

ACTIVE COMPARATOR

Family-based pediatric obesity treatment delivered at an urban medical center.

Behavioral: Family-based pediatric obesity treatment

Home treatment arm

EXPERIMENTAL

Family-based pediatric obesity treatment delivered in the family's home.

Behavioral: Family-based pediatric obesity treatment

Interventions

Family-based pediatric obesity treatmentBEHAVIORAL

Families with at least one overweight/obese child between ages 6 and 11 years will receive 12-months of family-based pediatric obesity treatment that emphasizes healthy changes to the home environment and family routines. The intervention targets dietary intake, physical activity, and consistent sleep.

Home treatment armMedical center treatment arm

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Family includes at least one child who is 6 to 12 years old, and is overweight or obese (has a body mass index at or above the 85th percentile for age and sex)
  • Child's household has an income-to-poverty ratio ≤ 2.0

You may not qualify if:

  • Child or caregiver(s) are not fluent in English
  • Unwilling to attend and complete either home-based or clinic-based treatment, or to complete any aspect of the study assessment battery
  • Medical contraindication or barrier to weight loss treatment
  • Caregiver has a major medical or psychiatric condition likely to interfere with treatment
  • Plans to relocate outside the Chicago area in the next 12 months, or living in temporary or group housing with other families
  • Resides more than 15 miles from the Illinois Medical District (study site)
  • Conditions in or around the home that jeopardize staff/interventionist safety

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

  • Appelhans BM, French SA, Bradley LE, Lui K, Janssen I, Richardson D. CHECK: A randomized trial evaluating the efficacy and cost-effectiveness of home visitation in pediatric weight loss treatment. Contemp Clin Trials. 2020 Jan;88:105891. doi: 10.1016/j.cct.2019.105891. Epub 2019 Nov 15.

    PMID: 31740429DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Outcomes assessors, PI, and some co-investigators will be blinded to group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2017

First Posted

June 22, 2017

Study Start

August 8, 2017

Primary Completion

September 19, 2022

Study Completion

September 19, 2022

Last Updated

November 4, 2024

Record last verified: 2024-10

Locations

US(1)