NCT04224623

Brief Summary

The purpose of this pilot study was to test the feasibility and efficacy of a balanced lifestyle intervention for caregivers and their children with obesity, conducted in partnership with Envolve, Inc., a family of comprehensive health solutions and wholly owned subsidiary of Centene Corporation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
195

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable obesity

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

Study Start

First participant enrolled

July 17, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

3.1 years

First QC Date

January 8, 2020

Last Update Submit

January 8, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Weight

    Mother and child weight assessed by trained staff

    6 months

Interventions

The Raising Well at Home intervention was delivered via 3 core home visits designed to be delivered every 4-6 weeks, with additional support via text or phone over 6 months. The home visits were designed to engage the whole family, build skills, and promote changes in the home environment to support lifestyle behavior change. These essential behaviors focused on reducing sugary beverage intake, promoting appropriate portion sizes, improving fruit and vegetable intake, increasing walking and reducing screen time/sedentary activity.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Caregivers had to be at least 18 years old, live in one of the states offering the Raising Well program, and be the primary caregiver to at least one child 2-17 years old served by an Envolve Medicaid Health Plan with International Classification of Diseases, Ninth Revision (ICD-9) coding for overweight or obesity. Caregivers had to be able to give informed consent. If more than one child within a household was eligible to participate, all children were invited to participate.

You may not qualify if:

  • Unable to speak English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Debra Haire-Joshu

St Louis, Missouri, 63130, United States

Location

Related Publications (1)

  • Haire-Joshu D, Schwarz C, Jacob R, Kristen P, Johnston S, Quinn K, Tabak R. Raising Well at Home: a pre-post feasibility study of a lifestyle intervention for caregivers and their child with obesity. Pilot Feasibility Stud. 2020 Oct 6;6:149. doi: 10.1186/s40814-020-00692-0. eCollection 2020.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2020

First Posted

January 13, 2020

Study Start

July 17, 2016

Primary Completion

August 17, 2019

Study Completion

August 17, 2019

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations