What side effects are associated with this type of intervention?

Common side effects of behavioral modification and support interventions for physical disabilities, such as those involving personalized exercise programs and telehealth support, include muscle soreness, fatigue, and minor injuries from physical activity. Some individuals may also experience frustration or decreased motivation. Overall, these treatments are generally well-tolerated with a low risk of serious adverse effects.

What prior FDA approvals exist?

The FDA has approved various treatments for physical disabilities, often focusing on medications, devices, and therapeutic interventions. While specific FDA approvals for behavioral modification and support interventions like Individual Home Visit Intervention (IH) and Group Remote Intervention via Video Conferencing (GR) are not detailed, these approaches are increasingly recognized in clinical practice. Behavioral interventions, including telehealth and home-based programs, are supported by evidence for improving physical and cognitive functions in patients with disabilities. These interventions aim to enhance adherence to exercise, dietary changes, and overall lifestyle modifications, contributing to better management of physical disabilities.

What other types of research exist?

Promising novel alternatives include: 1) Digital Cognitive Behavioral Therapy for Insomnia (CBT-I), which has shown efficacy in improving sleep-related quality of life and insomnia symptoms, potentially benefiting overall health and well-being. 2) Telehealth-based caregiver coaching and functional communication training (FCT), which have been effective in reducing problem behaviors and improving caregiver implementation integrity. 3) Telehealth-delivered physical activity programs, such as those used for Rett syndrome, which have demonstrated positive functional changes and high parental satisfaction. These alternatives leverage technology to provide accessible, effective support and behavioral modification for patients with physical disabilities.

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Behavioural Intervention

Weight Loss Interventions for Physical Disabilities

N/A

Waitlist Available

Led By Joseph Donnelly, EdD

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Unable to participate in light-to-moderate intensity PA, e.g., seated aerobics, resistance exercise, or physically unable to use the iPad.

Unwilling to be randomized.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6, 12, and 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two weight loss programs for overweight or obese adults with mobility-related disabilities. One program involves home visits, and the other uses video conferencing for group sessions. Both programs provide dietary advice, physical activity recommendations, and self-monitoring tools to help participants lose weight.

Who is the study for?

Adults over 18 with a BMI above 25 and mobility-related disabilities requiring wheelchair use or similar assistance, who have stable weight and internet at home. Excluded are those on special diets, recent structured weight loss programs, significant health risks, cognitive impairments, or psychiatric conditions.

What is being tested?

The study compares two weight loss interventions for adults with physical disabilities: individual home visits versus group sessions via video conferencing. It measures success by weight loss over six months and maintenance up to eighteen months.

What are the potential side effects?

Since the trial involves dieting and exercise modifications rather than medication, side effects may include typical dieting experiences such as hunger or fatigue and exercise-related issues like muscle soreness.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot do light exercises or use an iPad.

Select...

I am not open to being randomly assigned to a treatment group.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6, 12, and 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6, 12, and 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6, 12, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Weight Change in kg From Baseline to 6-months

Secondary study objectives

Blood Pressure

Change in Quality of Life

Cost of Intervention

+2 more

Other study objectives

Barriers to Exercise

Behavioral Session Attendance

Compliance With Physical Activity Recommendations

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Individual In-PersonExperimental Treatment2 Interventions

Group II: Group RemoteExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Individual In-Person

2020

N/A

~130

enhanced Stop Light Diet

2020

N/A

~130

Group Remote

2020

N/A

~130

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Behavioral modification and support interventions, such as Individual Home Visit (IH) and Group Remote Intervention via Video Conferencing (GR), primarily work by promoting lifestyle changes that enhance physical activity and dietary habits. These interventions often include personalized coaching, goal setting, and regular monitoring to encourage adherence to healthy behaviors. For patients with physical disabilities, these mechanisms are crucial as they help in managing weight, improving mobility, and reducing cardiovascular risk factors, thereby enhancing overall quality of life and functional independence.

Interventions to Improve Movement and Functional Outcomes in Adult Stroke Rehabilitation: Review and Evidence Summary.Mechanism-specific rehabilitation management of complex regional pain syndrome: Proposed recommendations from evidence synthesis.Effect of affordable technology on physical activity levels and mobility outcomes in rehabilitation: a protocol for the Activity and MObility UsiNg Technology (AMOUNT) rehabilitation trial.