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Mobile Intervention for Pain and Obesity (MORPH-II Trial)

N/A

Waitlist Available

Led By Jason Fanning, PhD

Research Sponsored by Wake Forest University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 24

Awards & highlights

No Placebo-Only Group

Summary

This trial is a study to see if a mobile intervention can help reduce pain and improve health in obese adults with chronic pain. The intervention will be delivered over 12 weeks and will include a focus on dietary weight loss plus movement across the day. The investigators hope that the intervention will help participants achieve a greater number of steps through conventional walking exercise, allowing for less pain intensity, and better physical function.

Who is the study for?

This trial is for older adults aged 55-85 with obesity (BMI of 30-45), chronic pain in multiple areas, and a sedentary lifestyle. They must have stable weight, data coverage at home, agree to the study's procedures, and own a smartphone.

What is being tested?

MORPH II tests a fully remote intervention aimed at reducing pain and promoting movement throughout the day using high-contact coaching via tablet computers. It compares this approach against standard control over 12 weeks to see if it improves pain, physical function, activity levels, and reduces sitting time.

What are the potential side effects?

Since MORPH II involves non-pharmacological interventions focusing on diet changes and increased movement facilitated by technology and coaching rather than medication or surgery, no direct side effects are expected from the intervention itself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 24 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Pain Intensity

Pain Interference

Sedentary time

Secondary study objectives

Steps

Other study objectives

Physical Function

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

Active Control

Group I: MORPHExperimental Treatment1 Intervention

Participants engage in 12 weeks of group and 1-on-1 coaching meant to promote physical activity throughout the day and caloric restriction. Participants engage with a custom smartphone application, use a smart scale and physical activity monitor, and meet using video conference software. At the end of 12 weeks, participants are provided with tools to continue meeting virtually on their own if desired, and will be followed for an additional 12-week maintenance phase.

Group II: ControlActive Control1 Intervention

This condition receives the wearable activity monitor and simply asked to use it and continue in their daily lives for 24 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MORPH

2018

N/A

~40

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