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Clinical Trials/NCT03065049
NCT03065049CompletedNot Applicable

Peer-Facilitated Physical Activity Intervention Delivered During Methadone Maintenance

Butler Hospital1 site in 1 country81 target enrollmentStarted: September 30, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
81
Locations
1
Primary Endpoint
Minutes of moderate-to-vigorous physical activity (MVPA)/week

Study Overview

Brief Summary

The primary aim of this study is to develop a feasible, acceptable, and effective multilevel physical activity (PA) intervention that addresses both individual and interpersonal factors that can be easily scalable and delivered in the context of a methadone clinic. To do so, the investigators will train methadone maintenance treatment (MMT) patients who are already engaging in PA at public health recommended levels to deliver a group-based PA intervention to physically inactive MMT patients at a large community-based methadone clinic. Through the development of interpersonal relationships and social support, the investigators expect that MMT peers who have successfully navigated challenges associated with PA in this population (i.e. depression, smoking, triggers for drug use in environment) will help physically inactive MMT patients increase self-efficacy and motivation for initiating and sustaining PA.

Detailed Description

Opioid Use Disorders (OUDs) are a highly prevalent and costly public health concern in the United States, with over 2.59 million Americans qualifying for abuse or dependence of opioids in 2015. Methadone maintenance treatment (MMT), involving daily distribution of methadone at regulated clinics, is the most common treatment for opioid use disorder. While MMT has been effective in helping OUD patients improve their quality of life, the overwhelming majority of these patients continue to engage in unhealthy lifestyles (e.g., physical inactivity and cigarette smoking) that lead to significant physical and mental health morbidities. For example, patients in MMT have much higher rates of cardiovascular disease, diabetes, hypertension, obesity, depression, sleep difficulties, and cognitive impairments than age-matched controls, which lead to premature death. Given the mental health, physical health, and drug use related benefits of physical activity (PA), interventions targeting increases in PA in patients receiving MMT could have a significant impact on reducing their overall morbidity and mortality.

To date, few PA studies have been conducted with substance abusing populations - and, only one small pilot study with MMT patients. The goal of this project is to develop a feasible, acceptable and effective multilevel PA intervention that addresses both individual and interpersonal factors that can be easily scalable and delivered in the context of a health care setting (i.e., methadone clinics). To do so, the investigators are proposing to train MMT patients who are already engaging in PA at public health recommended levels to deliver a group-based PA intervention to physically inactive MMT patients at SSTAR Lifeline, a large community-based methadone clinic in Fall River, Massachusetts. Peer-facilitated interventions for self-management skills are common in the care of patients with chronic medical conditions. Peers may play a particularly important role in increasing physical activity in MMT, as this population faces unique and significant barriers to PA (e.g., depression, smoking, minimal social supports). Through the development of interpersonal relationships, the investigators expect that MMT peers who have successfully navigated these challenges will help physically inactive MMT patients increase self-efficacy and motivation for initiating and sustaining PA.

The aims of the study include:

  1. PHASE 1 (Peer-PA Manual Development):
  • To develop a theoretically-informed peer-facilitated PA plus Fitbit (Peer-PA+Fitbit) intervention specific to SSTAR Lifeline, in order to help patients in MMT increase levels of physical activity.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •receiving MMT at SSTAR and planning to remain in treatment for the next 6 months
  • •low active (i.e., less than 90 minutes of MIPA per week for the past 6 months)
  • •has access to a computer connected to the internet or a smartphone compatible with the Fitbit application

Exclusion Criteria

  • •a history of psychotic disorder or current psychotic symptoms
  • •current suicidality or homicidality
  • •marked organic impairment according to responses to the diagnostic assessments
  • •physical or medical problems that would not allow safe participation in a program of moderate intensity physical activity (i.e., not medically cleared by methadone clinic physician)
  • •current pregnancy or intent to become pregnant during the next 12 weeks

Arms & Interventions

Peer-PA+Fitbit

Experimental

Participants will engage in a 12-week physical activity intervention guided by a peer-facilitator at the methadone clinic they receive treatment. Participants will attend weekly groups, engage in a guided walking group, and utilize the Fitbit to self-monitor physical activity.

Intervention: Peer-Facilitated Counseling (Behavioral)

Peer-PA+Fitbit

Experimental

Participants will engage in a 12-week physical activity intervention guided by a peer-facilitator at the methadone clinic they receive treatment. Participants will attend weekly groups, engage in a guided walking group, and utilize the Fitbit to self-monitor physical activity.

Intervention: Fitbit activity tracker (Behavioral)

Fitbit Only

Active Comparator

Participants will be given a Fitbit activity tracker along with brief advice for increasing physical activity.

Intervention: Fitbit activity tracker (Behavioral)

Usual Care

No Intervention

Participants do not receive any intervention but participate in the assessments only.

Outcomes

Primary Outcomes

Minutes of moderate-to-vigorous physical activity (MVPA)/week

Time Frame: 12 month

Measured by accelerometry

Secondary Outcomes

  • Acceptability of the Intervention assessed with the Client Satisfaction Questionnaire(12 weeks)
  • level of depressive symptoms(12 month)
  • level of anxiety symptoms(12 month)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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