NCT03065049

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 27, 2017

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

October 4, 2022

Status Verified

October 1, 2022

Enrollment Period

5.9 years

First QC Date

February 16, 2017

Last Update Submit

October 3, 2022

Conditions

Opioid-use Disorder

Keywords

Physical ActivityPeer-facilitationMethadone Maintenance Therapy

Outcome Measures

Primary Outcomes (1)

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

    Measured by accelerometry

    12 month

Secondary Outcomes (3)

  • Acceptability of the Intervention assessed with the Client Satisfaction Questionnaire

    12 weeks

  • level of depressive symptoms

    12 month

  • level of anxiety symptoms

    12 month

Study Arms (3)

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.

Behavioral: Peer-Facilitated CounselingBehavioral: Fitbit activity tracker

Fitbit Only

ACTIVE COMPARATOR

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

Behavioral: Fitbit activity tracker

Usual Care

NO INTERVENTION

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

Interventions

Peer-Facilitated CounselingBEHAVIORAL

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.

Peer-PA+Fitbit
Fitbit activity trackerBEHAVIORAL

Participants will be given a Fitbit activity tracker to monitor physical activity.

Fitbit OnlyPeer-PA+Fitbit

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanley Street Treatment and Resources (SSTAR) Lifeline

Fall River, Massachusetts, 02724, United States

Location

MeSH Terms

Conditions

Opioid-Related DisordersMotor Activity

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Study Officials

  • Ana M Abrantes, Ph.D.

    Butler Hospital

    PRINCIPAL INVESTIGATOR

  • Michael Stein, M.D.

    Boston University

    PRINCIPAL INVESTIGATOR

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

February 16, 2017

First Posted

February 27, 2017

Study Start

September 30, 2016

Primary Completion

August 30, 2022

Study Completion

August 31, 2022

Last Updated

October 4, 2022

Record last verified: 2022-10

Locations

US(1)