A Mobile Intervention to Reduce Pain and Improve Health (MORPH)

NCT03377634 | Completed Results DMC

• 2 other identifiers: IRB000463641R21AG058249-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pain contributes to declining health and function in older adults; effects that are intensified by obesity and sedentary (sitting) behavior. The purpose of this study is to develop and test a novel, patient-centered intervention to reduce pain and improve physical function in older, obese adults. The study will utilize a combination of telephone based coaching and smartphone tools to deliver this novel intervention to decrease both body weight and sitting behavior. The long-term goals of this project are to test the efficacy of the intervention and to develop it as a tool for clinicians to provide outside-of-clinic patient-centered support for overweight/obese older adults with chronic pain.

Conditions

Chronic Pain; Obesity; Sedentary Lifestyle

Keywords

Older Adults; Physical Activity; MORPH; Telecoaching; mHealth; Weight Loss; Sedentary Behavior; Pain; Design; RCT; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (3)

• Change in PROMIS Pain Intensity Scale

  The Pain Intensity Scale tasks participants with rating how much they hurt on a scale of 1 (had no pain) to 5 (very severe). Final scores are given as T-scores, with higher scores representing worse intensity. PROMIS scores are a t-score representing relationships with an estimated population average collected on a general US sample of adults as well as clinical samples. On this t distribution, 50 represents the population average with a standard deviation of 10. Thus, a score of 55 represents a score that is a half-standard deviation about the US national average, and a 40 represents a score that is 1 standard deviation below the national average. Scores were computed using the HealthMeasures.org scoring service as recommended for PROMIS measures.

  Baseline to 12 weeks

• Change in PROMIS Pain Interference Scale

  The Pain Interference Scale captures the impact of pain on valued areas of an individual's life (e.g., how much did pain interfere with your day to day activities) on a scale of 1 (not at all) to 5 (very much). Final scores are given as T-scores, with higher scores representing worse interference. PROMIS scores are a t-score representing relationships with an estimated population average collected on a general US sample of adults as well as clinical samples. On this t distribution, 50 represents the population average with a standard deviation of 10. Thus, a score of 55 represents a score that is a half-standard deviation about the US national average, and a 40 represents a score that is 1 standard deviation below the national average. Scores were computed using the HealthMeasures.org scoring service as recommended for PROMIS measures.

  Baseline to 12 weeks

• Change in Short Physical Performance Battery

  This test of lower-extremity function consists of 4-m walk at usual pace, a timed repeated chair stand, and 3 increasingly difficult standing balance tests. Each measure is assigned a categorical score ranging from 0 (inability to complete the test) to 4 (best performance) resulting in a final score of 0-12. Higher scores denotes better outcomes.

  Baseline to 12 weeks

Secondary Outcomes (6)

• Change in Weight

  Baseline to 12 weeks

• Activity Minutes

  Baseline and Week 12

• Sitting Time

  Week 12

• Sit to Stand Transitions

  Baseline and Week 13

• Participant Retention

  Baseline to 12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Participants receive the MORPH intervention.

Behavioral: MORPH

Control

NO INTERVENTION

The wait list control participants receive usual care and are offered intervention materials on completion of the study.

Interventions

MORPH BEHAVIORAL

Participants will engage in 12 weekly group coaching sessions discussion behavioral approaches to pain management, weight loss, and daily physical activity. The first three sessions (i.e., weeks 1 - 3) will occur in-person, and the remaining 9 will take place via telephone. All intervention participants will receive access to an activity monitor, smart scale, and smartphone app that aims to provide support for daily physical activity and weight loss.

Intervention

Eligibility Criteria

• Age: 65 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Own smartphone
• Pain in 2 of 5 areas (i.e., back, neck, shoulders, hips, knees) on most days during the previous 3 months
• No contraindication for participation in exercise with approval for participation by their physician
• Obese (BMI=30-45 kg/m2)
• Weight-stable (i.e., no weight loss or gain \> 5% in the past 6 months)
• Low-active (i.e., engaging in less than 2 days/week of structured physical activity for at least 20 minutes).
• Approved for participation by LMC Pain Center Director and Dr. Brooks
• Willingness to provide consent; Agree to all study procedures and assessments; Able to provide own transportation to study visits
• Access to home Wi-Fi and smartphone device

You may not qualify if:

• Dependent on cane or walker
• \>1 fall (injurious or non-injurious) in past year
• Vision insufficient to read a smartphone screen, unable to read
• Participation in regular resistance training and/or \> 20 mins/d of aerobic exercise in past 6 months
• No contraindication to exercise
• Unable to walk without assistive devices
• Cognitive impairment as indicated by a Montreal Cognitive Assessment score \< 22
• Uncontrolled hypertension (\>160/90 mmHg);
• Current or recent past (within 1 year) severe symptomatic heart disease, uncontrolled angina, stroke, chronic respiratory disease requiring oxygen, neurological or hematological disease; cancer requiring treatment in past yr, except non-melanoma skin cancers
• Regular use of: growth hormones, oral steroids, or prescription osteoporosis medications
• Current participation in other research study targeting pain, physical activity, or weight loss

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Wake Forest Baptist Medical Center Pain Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (2)

• Fanning J, Brooks AK, Ip E, Nicklas BJ, Rejeski WJ, Nesbit B, Ford S. A Mobile Health Behavior Intervention to Reduce Pain and Improve Health in Older Adults With Obesity and Chronic Pain: The MORPH Pilot Trial. Front Digit Health. 2020 Dec;2:598456. doi: 10.3389/fdgth.2020.598456. Epub 2020 Dec 18.

  PMID: 33817686 DERIVED

• Fanning J, Brooks AK, Ip E, Nicklas BJ, Rejeski WJ. A Mobile Health Intervention to Reduce Pain and Improve Health (MORPH) in Older Adults With Obesity: Protocol for the MORPH Trial. JMIR Res Protoc. 2018 May 14;7(5):e128. doi: 10.2196/resprot.9712.

  PMID: 29759957 DERIVED

MeSH Terms

Conditions

Chronic Pain; Obesity; Sedentary Behavior; Motor Activity; Weight Loss; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Behavior; Body Weight Changes

Results Point of Contact

• Title: Amber Brooks, MD
• Organization: Wake Forest University School of Medicine

akbrooks@wakehealth.edu

336-716-4498

Study Officials

• Amber K Brooks, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 19, 2017
• Study Start: August 7, 2018
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: January 22, 2021
• Results First Posted: January 22, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)