NCT04042493

Brief Summary

The overall aim of this study is to disseminate the evidence-based Connect for Health program, specifically targeting pediatric primary care practices that deliver care to low-income children in the US who have a disproportionately high prevalence of childhood obesity and evaluate the effectiveness of the program implementation and dissemination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19,304

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

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

July 31, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

November 19, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

2.4 years

First QC Date

July 31, 2019

Last Update Submit

March 21, 2023

Conditions

Overweight and ObesitySevere Obesity

Keywords

OverweightObesityPediatricImplementationDissemination

Outcome Measures

Primary Outcomes (1)

  • Change in child Body Mass Index

    Age- and sex-specific Body Mass Index z-score

    One year

Study Arms (1)

Connect for Health Program

EXPERIMENTAL
Behavioral: Connect for Health

Interventions

Connect for HealthBEHAVIORAL

The program includes (1) electronic health record (EHR)-based clinical decision support tools to guide pediatric providers in child weight management; (2) clinician and medical staff training in obesity management best practices, (3) family educational materials focused on evidence-based behavioral targets; and (4) social- and community-informed text messages for parents to support behavior change.

Connect for Health Program

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All children receiving primary care at the participating health centers across the three health systems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Greenville Health System / Prisma Health

Greenville, South Carolina, 29605, United States

Location

Related Publications (3)

  • Simione M, Aschbrenner K, Farrar-Muir H, Luo M, Granadeno J, Caballero-Gonzalez A, Price SN, Torres C, Boudreau AA, Fiechtner L, Hambidge SJ, Sease K, Taveras EM. Adapting Connect for Health pediatric weight management program for telehealth in response to the COVID-19 pandemic. Implement Sci Commun. 2023 Nov 16;4(1):139. doi: 10.1186/s43058-023-00523-2.

    PMID: 37974245DERIVED

  • Simione M, Farrar-Muir H, Mini FN, Perkins ME, Luo M, Frost H, Orav EJ, Metlay J, Zai AH, Kistin CJ, Sease K, Hambidge SJ, Taveras EM; Connect for Health Collaborative. Implementation of the Connect for Health pediatric weight management program: study protocol and baseline characteristics. J Comp Eff Res. 2021 Aug;10(11):881-892. doi: 10.2217/cer-2021-0076. Epub 2021 May 24.

    PMID: 34024120DERIVED

  • Simione M, Frost HM, Cournoyer R, Mini FN, Cassidy J, Craddock C, Moreland J, Wallace J, Metlay J, Kistin CJ, Sease K, Hambidge SJ, Taveras EM. Engaging stakeholders in the adaptation of the Connect for Health pediatric weight management program for national implementation. Implement Sci Commun. 2020 Jun 17;1:55. doi: 10.1186/s43058-020-00047-z. eCollection 2020.

    PMID: 32885211DERIVED

MeSH Terms

Conditions

OverweightObesityObesity, Morbid

Interventions

Health

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

  • Elsie Taveras, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: The Connect for Health program is a package of practice-level care enhancements to systematically improve the quality of clinical care provided for childhood obesity and offer support directly to parents to improve the children's growth trajectories.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of General Academic Pediatrics

Study Record Dates

First Submitted

July 31, 2019

First Posted

August 2, 2019

Study Start

November 19, 2019

Primary Completion

April 30, 2022

Study Completion

July 31, 2022

Last Updated

March 22, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)