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DanceFit Prime: A Dance Based Physical Activity and Nutritional Intervention for Primary Care - A Feasibility Study (DanceFit)

Primary Purpose

Cardiac Diseases, Stroke, Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Facilitated group-based aerobic dance
Online, video prompted, individual aerobic dance
Facilitated group-based nutritional intervention
Self-paced online aerobic dance activity
Individual self-paced nutritional intervention
Sponsored by
North Essex Partnership NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiac Diseases focused on measuring Physical activity intervention, Aerobic dance, Nutritional intervention, Online participation, Primary Care settings, General Practice Physical Activity Questionnaire GPPAQ, Qrisk2, QDS Diabetes

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female patients identified as Inactive/Moderately Inactive on the GPPAQ and at high risk due the presence of one or more of the following additional risk factors:

    • 20% or higher 10 year risk of stroke or heart attack by using QRISK2 for stroke (Hippisley-Cox, Coupland, Vinogradova, et al, 2008).
    • 20% or higher 10-year risk of type 2 diabetes on the QDS measure (Hippisley-Cox, Coupland, Robson, et al, 2009).
    • Diagnosis of mild cognitive impairment from a memory clinic.
    • Diagnosed transient ischaemic cardiac or cerebral event (stable ischaemic heart disease, transient ischaemic attack).
  2. Aged 17 years or older.
  3. At low risk from serious adverse effects from increased physical activity as indicated by performance on the revised Physical Activity Readiness Questionnaire (PAR-Q)(Thomas, Reading & Shephard, 1992).
  4. Participants should have a suitable exercise space available at home for safe participation in the online component.
  5. Participants with access to the internet at home, and where it has been determined following a home visit by the research team that they can access the online material and safely participate.

Exclusion Criteria:

  1. Blood pressure above 160/100 mmHg.
  2. Body mass index over 40 kg/m2.
  3. Musculoskeletal or other medical problems preventing safe participation in regular moderate intensity exercise (65-77% of predicted maximum heart rate). This will include a resting tachycardia (heart rate above 100 bpm) and history of myocardial infarction, unstable angina or transient cerebral ischemia within the last month, severe osteoporosis, uncontrolled diabetes, febrile illness and destabilising arrythmias.
  4. Participants with modifiable exclusion criteria will be reconsidered after successful management. Patients will be referred for medical /cardiological review and management prior to commencing exercise if indicated by the PAR-Q and the intervention will be guided by the PARmed-X (Chisholm, Stewart & Crooks, 1987).
  5. Participants taking medications affecting heart rate will need to be on a stable dosing regimen for 3 months prior to commencing in order to control for potential spurious results on fitness measures caused by these treatments.
  6. Participants who do not have the necessary space, internet connection or computer equipment to allow them to participate safely using the online material.

Sites / Locations

  • Chigwell Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Phase 1

Phase 2

Arm Description

Facilitated group-based physical activity (aerobic dance), online physical activity (video based aerobic dance) and nutritional intervention (nutritional education, cooking skill training, access and use of NHS Change4Life Eat Well web resource).

Self-paced online physical activity (video based aerobic dance) intervention and use of NHS Change4Life Eat Well web resource.

Outcomes

Primary Outcome Measures

Recruitment and retention rates
Activity adherence rates

Secondary Outcome Measures

Level of physical activity participation
Assessed using the General Practice Physical Activity Questionnaire (GPPAQ)
10 year risk of cardiac or cerebral ischaemic event
Assessed using the QRISK2 for CVD / Stroke
10 year risk of developing diabetes mellitus
Assessed using the QDS Diabetes risk tool

Full Information

First Posted
June 3, 2014
Last Updated
October 13, 2015
Sponsor
North Essex Partnership NHS Foundation Trust
Collaborators
West Essex Clinical Commissioning Group, School for Social Entrepreneurs London and Lloyds TSB, University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT02159014
Brief Title
DanceFit Prime: A Dance Based Physical Activity and Nutritional Intervention for Primary Care - A Feasibility Study
Acronym
DanceFit
Official Title
DanceFit Prime: A Dance Based Physical Activity and Nutritional Intervention to Reduce the Risk of Heart Disease, Stroke, Diabetes, and Dementia in Inactive Adults, in Primary Care Settings - A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North Essex Partnership NHS Foundation Trust
Collaborators
West Essex Clinical Commissioning Group, School for Social Entrepreneurs London and Lloyds TSB, University College, London

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Regular physical activity improves physical and mental health and reduces the risk of heart disease, stroke, cancer, diabetes, obesity and premature death from any cause. Unfortunately the majority of adults are not active enough to reap these benefits. People who are inactive and at high risk of stroke, heart disease, diabetes and dementia, and who may benefit from increased activity can be identified in primary care by combining standard risk tools. These high risk patients can be offered physical activity programmes that are designed to increase longterm adherence. Aerobic dance is an activity that combines physical, social and cognitive stimulation and allows easily adjusted intensity levels to meet individual needs. Engagement in an activity program also provides opportunities to offer advice on healthy nutrition and associated meal preparation skills. Information technology can be used to increase activity participation. Video materials can be produced to guide activity participation at home, thereby increasing overall activity participation. The investigators propose a feasibility study of a multimodal dance-based physical activity and nutrition intervention aimed at patients at high risk of stroke, heart disease, diabetes and dementia, in primary care settings.
Detailed Description
Regular physical activity improves physical and mental health and reduces the risk of heart disease, stroke, cancer, diabetes, dementia, obesity and premature death from any cause (Department of Health & Prevention., 2004). Unfortunately the majority of adults are not active enough to reap these benefits (Chaudhury & Roth, 2006). Specific psychological techniques can be used to overcome the known barriers to increased activity. People who are inactive can be identified in primary care through the use of standard risk tools. Similarly, standard risk tools can identify people at high risk of stroke, heart disease and diabetes, and people at risk from dementia are identified by a diagnosis of mild cognitive impairment. Combining these clinical indicators can identify people who are inactive and at highest risk who may therefore benefit most from activity interventions. These high risk patients can be offered physical activity programmes that are designed to increase longterm adherence. Aerobic dance is an activity that combines physical, social and cognitive stimulation and allows easily adjusted intensity levels to meet individual needs. Engagement in an activity program also provides opportunities to offer advice on healthy nutrition and associated meal preparation skills. Information technology can be used to increase activity participation. Video materials can be produced to guide activity participation at home, thereby increasing overall activity participation. TRIAL DESIGN The investigators plan a longitudinal study where participants will be followed up for a total of 24 weeks. Outcome measures will be collected at three time points that separates two phases. Phase 1 consists of the group based weekly intervention plus access to online material and Phase 2 consists of only access to the online material. The time points are: baseline (Time 0), 12 weeks post intervention (Time 1) and 24 weeks post intervention (Time 2). Outcomes measured at time 1 will be used to determine the effects of Phase 1 immediately following participation, and measure at 24 weeks (Time 2) to determine the outcomes 12 weeks after the end of the group based intervention intervention and therefore the longer term effects with support from online material only. Participants will therefore serve as their own controls during Phase 2 for comparison with Phase 1. In other words the investigators will compare the results for each participant following Phase 1 with their results following Phase 2 to determine the effects of removing the group facilitation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Diseases, Stroke, Diabetes Mellitus, Dementia, Mild Cognitive Impairment
Keywords
Physical activity intervention, Aerobic dance, Nutritional intervention, Online participation, Primary Care settings, General Practice Physical Activity Questionnaire GPPAQ, Qrisk2, QDS Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1
Arm Type
Experimental
Arm Description
Facilitated group-based physical activity (aerobic dance), online physical activity (video based aerobic dance) and nutritional intervention (nutritional education, cooking skill training, access and use of NHS Change4Life Eat Well web resource).
Arm Title
Phase 2
Arm Type
Active Comparator
Arm Description
Self-paced online physical activity (video based aerobic dance) intervention and use of NHS Change4Life Eat Well web resource.
Intervention Type
Behavioral
Intervention Name(s)
Facilitated group-based aerobic dance
Intervention Description
Physical activity facilitated by instructor
Intervention Type
Behavioral
Intervention Name(s)
Online, video prompted, individual aerobic dance
Intervention Description
Supported online activity intervention
Intervention Type
Behavioral
Intervention Name(s)
Facilitated group-based nutritional intervention
Intervention Description
Education, skill training, access and use of NHS Change4Life Eat Well web resource
Intervention Type
Behavioral
Intervention Name(s)
Self-paced online aerobic dance activity
Intervention Description
Self paced physical activity
Intervention Type
Behavioral
Intervention Name(s)
Individual self-paced nutritional intervention
Intervention Description
Individual use of online nutritional advice resources.
Primary Outcome Measure Information:
Title
Recruitment and retention rates
Time Frame
24 weeks
Title
Activity adherence rates
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Level of physical activity participation
Description
Assessed using the General Practice Physical Activity Questionnaire (GPPAQ)
Time Frame
24 weeks
Title
10 year risk of cardiac or cerebral ischaemic event
Description
Assessed using the QRISK2 for CVD / Stroke
Time Frame
24 weeks
Title
10 year risk of developing diabetes mellitus
Description
Assessed using the QDS Diabetes risk tool
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Depressive and anxiety symptoms
Description
Assessed on the Hospital Anxiety and Depression Scale (HADS)
Time Frame
24 weeks
Title
Change in cardiovascular fitness.
Description
Assessed on the Modified Siconolfi Step Test
Time Frame
24 weeks
Title
Change in body composition
Description
Assessed by measuring body fat percentage
Time Frame
24 weeks
Title
Life quality
Description
Assessed on the World Health Organization Quality of Life (WHOQOL-BREF) tool.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients identified as Inactive/Moderately Inactive on the GPPAQ and at high risk due the presence of one or more of the following additional risk factors: 20% or higher 10 year risk of stroke or heart attack by using QRISK2 for stroke (Hippisley-Cox, Coupland, Vinogradova, et al, 2008). 20% or higher 10-year risk of type 2 diabetes on the QDS measure (Hippisley-Cox, Coupland, Robson, et al, 2009). Diagnosis of mild cognitive impairment from a memory clinic. Diagnosed transient ischaemic cardiac or cerebral event (stable ischaemic heart disease, transient ischaemic attack). Aged 17 years or older. At low risk from serious adverse effects from increased physical activity as indicated by performance on the revised Physical Activity Readiness Questionnaire (PAR-Q)(Thomas, Reading & Shephard, 1992). Participants should have a suitable exercise space available at home for safe participation in the online component. Participants with access to the internet at home, and where it has been determined following a home visit by the research team that they can access the online material and safely participate. Exclusion Criteria: Blood pressure above 160/100 mmHg. Body mass index over 40 kg/m2. Musculoskeletal or other medical problems preventing safe participation in regular moderate intensity exercise (65-77% of predicted maximum heart rate). This will include a resting tachycardia (heart rate above 100 bpm) and history of myocardial infarction, unstable angina or transient cerebral ischemia within the last month, severe osteoporosis, uncontrolled diabetes, febrile illness and destabilising arrythmias. Participants with modifiable exclusion criteria will be reconsidered after successful management. Patients will be referred for medical /cardiological review and management prior to commencing exercise if indicated by the PAR-Q and the intervention will be guided by the PARmed-X (Chisholm, Stewart & Crooks, 1987). Participants taking medications affecting heart rate will need to be on a stable dosing regimen for 3 months prior to commencing in order to control for potential spurious results on fitness measures caused by these treatments. Participants who do not have the necessary space, internet connection or computer equipment to allow them to participate safely using the online material.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas M Dannhauser, PhD
Organizational Affiliation
North Essex Partnership Foundation NHS Trust, University College London
Official's Role
Study Director
Facility Information:
Facility Name
Chigwell Medical Centre
City
Chigwell
State/Province
Essex
ZIP/Postal Code
IG6 2TA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24886353
Citation
Dannhauser TM, Cleverley M, Whitfield TJ, Fletcher BC, Stevens T, Walker Z. A complex multimodal activity intervention to reduce the risk of dementia in mild cognitive impairment--ThinkingFit: pilot and feasibility study for a randomized controlled trial. BMC Psychiatry. 2014 May 5;14:129. doi: 10.1186/1471-244X-14-129.
Results Reference
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DanceFit Prime: A Dance Based Physical Activity and Nutritional Intervention for Primary Care - A Feasibility Study

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