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Completed

NCT Number: NCT04224623

Raising Well at Home

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Debra Haire-Joshu

St Louis, Missouri, 63130, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Raising Well at Home

Behavioral

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.

Primary outcomes

  1. Change in Weight

    Time frame: 6 months

    Mother and child weight assessed by trained staff

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Envolve, Inc., a wholly owned subsidiary of Centene Corporation

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 13, 2020
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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