NCT02958280

Brief Summary

The purpose of the study twofold: first, a smartphone-based physical activity application (app), which will be called Fit\&Sober, will be developed and tailored specifically for patients with alcohol use disorders (AUDs); then, the feasibility, acceptability, and short-term increases in physical activity with the use of the Fit\&Sober app will be examined over the course of a 12-week intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

5.7 years

First QC Date

September 27, 2016

Last Update Submit

August 10, 2022

Conditions

Alcohol Dependence

Keywords

ExerciseSmartphone

Outcome Measures

Primary Outcomes (1)

  • Minutes of moderate-to-vigorous physical activity per week

    Measured by accelerometry

    12-months

Secondary Outcomes (3)

  • Satisfaction with App

    12 Weeks

  • App Usage

    12 weeks

  • Alcohol Abstinence

    12-months

Study Arms (2)

Brief Advice Plus the Fit&Sober App

EXPERIMENTAL

Phase 1 (app development \& Open Pilot) will consist of: 1) development of the Fit\&Sober prototype; 2) series of usability studies with patients with AUDs; and 3) An open pilot of a 12-week trial (n=20) to test the feasibility and acceptability of the Fit\&Sober app with patients with AUDs in early recovery. Phase 2: RCT of the Fit\&Sober app with 160 patients with AUD

Behavioral: Fit&Sober AppBehavioral: Brief Advice

Brief Advice for Physical Activity

ACTIVE COMPARATOR

Phase 2: Participants randomized to the BA only condition will meet for a 30-minute discussion with a research staff member. In this session, participants will receive information about the public health guidelines for physical activity, the benefits of physical activity for physical and mental health, as well as sobriety, strategies for getting started as well as instruction on gradually increasing physical activity

Behavioral: Brief Advice

Interventions

Fit&Sober AppBEHAVIORAL

Fit\&Sober is a smartphone-based physical activity app that includes multilevel strategies for increasing physical activity for patients with AUDs in early recovery.

Brief Advice Plus the Fit&Sober App
Brief AdviceBEHAVIORAL

Participants randomized to the BA only condition will meet for a 30-minute discussion with a research staff member. In this session, participants will receive information about the public health guidelines for physical activity, the benefits of physical activity for physical and mental health, as well as sobriety, strategies for getting started as well as instruction on gradually increasing physical activity

Brief Advice Plus the Fit&Sober AppBrief Advice for Physical Activity

Eligibility Criteria

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

You may qualify if:

  • between 18 and 65 years of age,
  • meet DSM-5 criteria for alcohol use disorder as assessed by the SCID-P,
  • are sedentary, (i.e., less than 60 minutes of moderate-intensity exercise per week for the past 6 months), and
  • are currently engaged in alcohol treatment.

You may not qualify if:

  • current DSM-5 diagnosis moderate/severe substance use disorder or anorexia or bulimia nervosa
  • a history of psychotic disorder or current psychotic symptoms
  • current suicidality or homicidality,
  • current mania
  • marked organic impairment according to either the medical record or 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 study 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)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

  • Abrantes AM, Meshesha LZ, E Blevins C, Battle CL, Lindsay C, Marsh E, Feltus S, Buman M, Agu E, Stein M. A Smartphone Physical Activity App for Patients in Alcohol Treatment: Single-Arm Feasibility Trial. JMIR Form Res. 2022 Oct 19;6(10):e35926. doi: 10.2196/35926.

    PMID: 36260381DERIVED

MeSH Terms

Conditions

AlcoholismMotor Activity

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

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

September 27, 2016

First Posted

November 8, 2016

Study Start

November 1, 2016

Primary Completion

July 30, 2022

Study Completion

July 30, 2022

Last Updated

August 11, 2022

Record last verified: 2022-08

Locations

US(1)