Can an Action-based Help-sheet Help People to Move More and Sit Less.

NCT04280250 | Unknown

• 1 other identifier: NHS00164
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

Implementation intentions support people to turn intentions into action, and "Volitional Help-Sheets" are a tool which helps people to form implementation intentions. The study will recruit participants from secondary and tertiary mental health services. The participants will be randomised to one of two groups. Participants in Group 1, the control group, will receive the Volitional Help-Sheet (psychoeducational self-help sheet) but not form implementation intentions. Participants in Group 2, the experimental condition, will use the Volitional Help-Sheet to form implementation intentions. Participants will then complete an acceptability and feasibility measure. At follow up, participants will repeat baseline measures. The feasibility and acceptability of using a Volitional Help-Sheet to form implementation intentions to help people using secondary and tertiary care mental health services to reduce sedentary behaviour will be evaluated.

Conditions

Sedentary Behavior

Keywords

Implementation Intention; If-Then plan; Tertiary mental health services; Secondary mental health services

Outcome Measures

Primary Outcomes (3)

• Acceptability of Intervention Measure (AIM). (Weiner et al, 2017)

  Self reported acceptability measure

  Change from Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)

• Feasibility of Intervention Measure (FIM). (Weiner et al, 2017)

  Self reported feasibility measure

  Change from Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)

• Intervention Appropriateness Measure (IAM). (Weiner et al, 2017)

  Self reported appropriateness measure

  Change from Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)

Secondary Outcomes (5)

• International Physical Activity Questionnaire short form (Booth, 2000)

  Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)

• Sedentary Behaviour Questionnaire (Gardener et al, 2011)

  Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)

• CORE-OM (Evans et al, 2000)

  Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)

• Office for National Statistics' Measure of Subjective Wellbeing (Dolan, Layard, and Metcalfe, 2011).

  Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)

• COM-B measures (Keyworth, Epton, Goldthorpe, Calam, and Armitage, 2019)

  Time point 1 (baseline) and Time point 2 (follow up, 4 weeks after baseline)

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Active control arm: Volitional help-sheet with instruction: We want you to plan to increase your level of physical activity. Research shows that if people can identify situations in which they are likely to be tempted not to be physically active and ways to overcome temptation they are much more likely to be successful in their intention to increase their level of physical activity. On the left hand side of the page are a series of common situations in which people feel tempted not to be physically active; please tick all those that apply to you personally. On the right hand side of the page are a series of possible solutions; please tick all those that apply to you personally. Tick as many or as few situations and solutions as you like.

Other: Control condition

Group 2

EXPERIMENTAL

Experimental arm: Volitional help-sheet with instruction: We want you to plan to increase your level of physical activity. Research shows that if people link being tempted not to be physically active with a way to overcome that temptation, they are much more likely to be successful in their intention to increase their level of physical activity. On the left hand side of the page below is the temptation not to be physically active; on the right hand side of the page are a series of possible solutions. Please draw lines linking being tempted not to be physically active (left hand side) to solutions (right hand side) that you think might work for you personally. Please make as many situation-solution links as you like.

Other: Volitional Help-Sheet

Interventions

Volitional Help-Sheet OTHER

Self-help sheet in order to form implementation intentions

Group 2

Control condition OTHER

Psychoeducational self-help sheet

Group 1

Eligibility Criteria

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

You may qualify if:

• + years old
• Motivated to decrease sedentary behaviour (demonstrated by choosing to make contact with the researcher to indicate an interest in participation in the study
• Has capacity to consent to study
• Currently receiving support from any secondary or tertiary care mental health service
• English language ability sufficient to be able to meet the requirements of the study
• Participants will not be recruited on the basis of an assumption that they are sedentary, and participants must demonstrate a desire to increase their sedentary behaviour as indicated by choosing to make contact with the researcher to indicate an interest in participation in the study.

You may not qualify if:

• Cannot give informed consent
• English language not sufficient to be able to meet the requirements of the study

Sponsors & Collaborators

• University of Manchester: lead

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Stephanie Roebuck

  University of Manchester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Roebuck

CONTACT

01613060400; stephanie.roebuck@postgrad.manchester.ac.uk

Chris Armitage

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee Clinical Psychologist

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 21, 2020
• Study Start: March 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: June 1, 2021
• Last Updated: February 21, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share