ClinicalTrials.gov

History of Changes for Study: NCT02159014
DanceFit Prime: A Dance Based Physical Activity and Nutritional Intervention for Primary Care - A Feasibility Study (DanceFit Prime)
Latest version (submitted October 13, 2015) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 June 6, 2014 None (earliest Version on record)
2 June 2, 2015 Recruitment Status, Study Status, Contacts/Locations, Arms and Interventions and Study Identification
3 October 13, 2015 Recruitment Status, Study Status and Study Design
Comparison Format:

Scroll up to access the controls

Study NCT02159014
Submitted Date:  June 6, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: DanceFit Prime
Brief Title: DanceFit Prime: A Dance Based Physical Activity and Nutritional Intervention for Primary Care - A Feasibility Study (DanceFit Prime)
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
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2014
Overall Status: Not yet recruiting
Study Start: August 2014
Primary Completion: August 2015 [Anticipated]
Study Completion: October 2015 [Anticipated]
First Submitted: June 3, 2014
First Submitted that
Met QC Criteria:
June 6, 2014
First Posted: June 9, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 6, 2014
Last Update Posted: June 9, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: North Essex Partnership NHS Foundation Trust
Responsible Party: Principal Investigator
Investigator: Dr Thomas Dannhauser
Official Title: Chief Investigator
Affiliation: North Essex Partnership NHS Foundation Trust
Collaborators: West Essex Clinical Commissioning Group
School for Social Entrepreneurs London and Lloyds TSB
University College, London
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module 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.

Open or close this module Conditions
Conditions: 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
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 40 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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).
Behavioral: Facilitated group-based aerobic dance-based physical activity
Physical activity facilitated by instructor
Behavioral: Online, video prompted, individual aerobic dance based activity
Supported online activity intervention
Behavioral: Facilitated group-based nutritional intervention
Education, skill training, access and use of NHS Change4Life Eat Well web resource
Active Comparator: Phase 2
Self-paced online physical activity (video based aerobic dance) intervention 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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Recruitment and retention rates
[ Time Frame: 24 weeks ]

2. Activity adherence rates
[ Time Frame: 24 weeks ]

Secondary Outcome Measures:
1. Level of physical activity participation
[ Time Frame: 24 weeks ]

Assessed using the General Practice Physical Activity Questionnaire (GPPAQ)
2. 10 year risk of cardiac or cerebral ischaemic event
[ Time Frame: 24 weeks ]

Assessed using the QRISK2 for CVD / Stroke
3. 10 year risk of developing diabetes mellitus
[ Time Frame: 24 weeks ]

Assessed using the QDS Diabetes risk tool
Other Outcome Measures:
1. Depressive and anxiety symptoms
[ Time Frame: 24 weeks ]

Assessed on the Hospital Anxiety and Depression Scale (HADS)
2. Change in cardiovascular fitness.
[ Time Frame: 24 weeks ]

Assessed on the Modified Siconolfi Step Test
3. Change in body composition
[ Time Frame: 24 weeks ]

Assessed by measuring body fat percentage
4. Life quality
[ Time Frame: 24 weeks ]

Assessed on the World Health Organization Quality of Life (WHOQOL-BREF) tool.
Open or close this module Eligibility
Minimum Age: 17 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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.
Open or close this module Contacts/Locations
Central Contact Person: Thomas M Dannhauser, PhD
Email: t.dannhauser@ucl.ac.uk
Study Officials: Thomas M Dannhauser, PhD
Study Director
North Essex Partnership Foundation NHS Trust, University College London
Locations: United Kingdom, Essex
Chigwell Medical Centre
Chigwell, Essex, United Kingdom, IG6 2TA
Contact:Contact: Renier Van Zyl renier@nhs.net
Contact:Principal Investigator: Faye C Dannhauser, MBBS, MRCGP
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: 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. PubMed 24886353
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services