Examination of Whether an Exercise Programme Reduces Alcohol Consumption Among Alcohol-Dependent Adults

NCT03848000 | Completed DMC

• 1 other identifier: Active over Alcohol study
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

This study is composed of two phases. Phase 1 will determine baseline demographic characteristics of participants, currently drinking harmful amounts of alcohol, who would be interested in an alternative treatment option to reduce alcohol consumption. Once baseline data is collected, participants will then be informed that the intervention is an exercise programme and those interested will be offered participation in Phase 2: a two-arm randomised controlled study. If eligible, participants will be randomly assigned to either: 1) a 12 week combined exercise programme and NHS standard care group, or 2) 12 weeks of NHS (National Health Service) standard care only group. The aims are to study the feasibility of conducting a randomised controlled trial in this cohort and to determine the effectiveness of the exercise programme to reduce alcohol consumption, improve physical and mental health among people drinking harmful amounts of alcohol, compared to standard NHS care. Assessment visits, measuring alcohol consumption, mental health and physical health, will be conducted at baseline, and at Weeks 13, 24, 36 and 48 since commencement of the intervention period. Focus groups will take place during the 2nd and 12th week of the exercise programme where qualitative feedback on the exercise programme will be collected.

Conditions

Alcohol Abuse or Dependence; Alcohol Use Disorder

Keywords

Alcohol abuse; Exercise; Alcohol consumption; Depression; Anxiety

Outcome Measures

Primary Outcomes (4)

• Change in absolute total weekly alcohol consumption from baseline, at 13 weeks follow-up

  The change in absolute total weekly alcohol consumption will be assessed by changes in self-reported units of alcohol consumed per week (via a 7 day self-reported drinking diary)

  Baseline visit and Week 13 follow-up visit

• Change in absolute total weekly alcohol consumption from baseline, at 24 weeks follow-up

  The change in absolute total weekly alcohol consumption will be assessed by changes in self-reported units of alcohol consumed per week (via a 7 day self-reported drinking diary)

  Baseline visit and Week 24 follow-up visit

• Change in absolute total weekly alcohol consumption from baseline, at 36 weeks follow-up

  The change in absolute total weekly alcohol consumption will be assessed by changes in self-reported units of alcohol consumed per week (via a 7 day self-reported drinking diary)

  Baseline visit and Week 36 follow-up visit

• Change in absolute total weekly alcohol consumption from baseline, at 48 weeks follow-up

  The change in absolute total weekly alcohol consumption will be assessed by changes in self-reported units of alcohol consumed per week (via a 7 day self-reported drinking diary)

  Baseline visit and Week 48 follow-up visit

Secondary Outcomes (97)

• Change in number of drinking days per week from baseline, at 13 weeks follow-up

  Baseline visit and Week 13 follow-up visit

• Change in number of drinking days per week from baseline, at 24 weeks follow-up

  Baseline visit and Week 24 follow-up visit

• Change in number of drinking days per week from baseline, at 36 weeks follow-up

  Baseline visit and Week 36 follow-up visit

• Change in number of drinking days per week from baseline, at 48 weeks follow-up

  Baseline visit and Week 48 follow-up visit

• Change in number of heavy drinking days per week from baseline, at 13 weeks follow-up

  Baseline visit and Week 13 follow-up visit

Study Arms (2)

Exercise Programme and NHS Standard Care

EXPERIMENTAL

Exercise and NHS standard care.

Other: Exercise Programme; Behavioral: NHS Standard Care

NHS Standard Care only

ACTIVE COMPARATOR

Alcohol addiction counselling.

Behavioral: NHS Standard Care

Interventions

Exercise Programme OTHER

Two sessions per week for 12 consecutive weeks. 30 minute education talks covering topics regarding the physical and mental health benefits of exercise and behaviour change. The following 30-60 minute exercise sessions will utilise pad-boxing, football, body-weight training and circuit training.

Exercise Programme and NHS Standard Care

NHS Standard Care BEHAVIORAL

Weekly one-to-one cognitive-behavioral counselling alcohol addiction support session lasting 1 hour. Drug therapy will be offered if indicated in line with standard therapy.

Exercise Programme and NHS Standard Care; NHS Standard Care only

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 65 years old
• AUDIT score of ≥ 8
• In the opinion of the referring physician, is capable of performing moderate/high-intensity exercise
• Agrees to their GP being informed of their participation
• Able and willing to provide written informed consent and complete the study questionnaires

You may not qualify if:

• Absolute contraindications to exercise testing and training as defined by the American College of Sports Medicine.
• Have anorexia, bipolar disorder or severe (unstable) psychosis disorder which may preclude active participation.
• In the opinion of the referring physician, is physically incapable or likely to be incapable of undertaking an exercise programme.
• Pregnant or planning pregnancy within the first 3 months after randomisation.
• Currently participating in \>90 minutes/week of structured moderate-intensity exercise, such as jogging, cycling or swimming (not including walking).

Sponsors & Collaborators

• Queen Mary University of London: lead
• Barts & The London NHS Trust: collaborator
• University of Hertfordshire: collaborator

Study Sites (1)

Barts Health NHS Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Alcoholism; Motor Activity; Alcohol Drinking; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior; Drinking Behavior; Behavioral Symptoms

Study Officials

• Graham R Foster

  Queen Mary University of London

  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 14, 2019
• First Posted: February 20, 2019
• Study Start: December 6, 2018
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)