Raising Well at Home

Obesity Clinical Trial

Official title:

Raising Well at Home

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04224623
• Other study ID #: 201510154
• Status: Completed
• Phase: N/A
• Start date: July 17, 2016
• Est. completion date: August 17, 2019

Study information

• Verified date: January 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This pilot study employed a pretest-posttest design to assess the feasibility and efficacy of the Raising Well at Home pilot intervention delivered by peer coaches on weight (caregiver/child), behaviors (eating, walking), and the home environment. The Raising Well at Home intervention was delivered via home visits with additional support via text or phone over 6 months, beginning after completion of the baseline assessment. This study was implemented in partnership with the parent Raising Well programs located in three states: Florida, Louisiana, and Missouri. The caregiver and the child's height and weight were measured by trained staff in the home with the same scale and stadiometer at the pre- and post-intervention time points. Measures were completed on a paper survey with the same caregiver pre and post intervention delivery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: August 17, 2019
• Est. primary completion date: August 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Unable to speak English or Spanish

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Raising Well at Home
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.

Locations

Country	Name	City	State
United States	Debra Haire-Joshu	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Envolve, Inc., a wholly owned subsidiary of Centene Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight	Mother and child weight assessed by trained staff	6 months