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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02159014
Recruitment Status : Completed
First Posted : June 9, 2014
Last Update Posted : October 14, 2015
Sponsor:
Collaborators:
West Essex Clinical Commissioning Group
School for Social Entrepreneurs London and Lloyds TSB
University College, London
Information provided by (Responsible Party):
Dr Thomas Dannhauser, North Essex Partnership NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE June 3, 2014
First Posted Date  ICMJE June 9, 2014
Last Update Posted Date October 14, 2015
Study Start Date  ICMJE August 2014
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2014)
  • Recruitment and retention rates [ Time Frame: 24 weeks ]
  • Activity adherence rates [ Time Frame: 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2014)
  • Level of physical activity participation [ Time Frame: 24 weeks ]
    Assessed using the General Practice Physical Activity Questionnaire (GPPAQ)
  • 10 year risk of cardiac or cerebral ischaemic event [ Time Frame: 24 weeks ]
    Assessed using the QRISK2 for CVD / Stroke
  • 10 year risk of developing diabetes mellitus [ Time Frame: 24 weeks ]
    Assessed using the QDS Diabetes risk tool
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 6, 2014)
  • Depressive and anxiety symptoms [ Time Frame: 24 weeks ]
    Assessed on the Hospital Anxiety and Depression Scale (HADS)
  • Change in cardiovascular fitness. [ Time Frame: 24 weeks ]
    Assessed on the Modified Siconolfi Step Test
  • Change in body composition [ Time Frame: 24 weeks ]
    Assessed by measuring body fat percentage
  • Life quality [ Time Frame: 24 weeks ]
    Assessed on the World Health Organization Quality of Life (WHOQOL-BREF) tool.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE DanceFit Prime: A Dance Based Physical Activity and Nutritional Intervention for Primary Care - A Feasibility Study
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiac Diseases
  • Stroke
  • Diabetes Mellitus
  • Dementia
  • Mild Cognitive Impairment
Intervention  ICMJE
  • Behavioral: Facilitated group-based aerobic dance
    Physical activity facilitated by instructor
  • Behavioral: Online, video prompted, individual aerobic dance
    Supported online activity intervention
  • Behavioral: Facilitated group-based nutritional intervention
    Education, skill training, access and use of NHS Change4Life Eat Well web resource
  • Behavioral: Self-paced online aerobic dance activity
    Self paced physical activity
  • Behavioral: Individual self-paced nutritional intervention
    Individual use of online nutritional advice resources.
Study Arms  ICMJE
  • Experimental: Phase 1
    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).
    Interventions:
    • Behavioral: Facilitated group-based aerobic dance
    • Behavioral: Online, video prompted, individual aerobic dance
    • Behavioral: Facilitated group-based nutritional intervention
  • Active Comparator: Phase 2
    Self-paced online physical activity (video based aerobic dance) intervention and use of NHS Change4Life Eat Well web resource.
    Interventions:
    • Behavioral: Self-paced online aerobic dance activity
    • Behavioral: Individual self-paced nutritional intervention
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2014)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02159014
Other Study ID Numbers  ICMJE DanceFit Prime
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dr Thomas Dannhauser, North Essex Partnership NHS Foundation Trust
Original Responsible Party Same as current
Current Study Sponsor  ICMJE North Essex Partnership NHS Foundation Trust
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • West Essex Clinical Commissioning Group
  • School for Social Entrepreneurs London and Lloyds TSB
  • University College, London
Investigators  ICMJE
Study Director: Thomas M Dannhauser, PhD North Essex Partnership Foundation NHS Trust, University College London
PRS Account North Essex Partnership NHS Foundation Trust
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP