DanceFit Prime: A Dance Based Physical Activity and Nutritional Intervention for Primary Care - A Feasibility Study (DanceFit)
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|ClinicalTrials.gov Identifier: NCT02159014|
Recruitment Status : Completed
First Posted : June 9, 2014
Last Update Posted : October 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Diseases Stroke Diabetes Mellitus Dementia Mild Cognitive Impairment||Behavioral: Facilitated group-based aerobic dance Behavioral: Online, video prompted, individual aerobic dance Behavioral: Facilitated group-based nutritional intervention Behavioral: Self-paced online aerobic dance activity Behavioral: Individual self-paced nutritional intervention||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||August 2014|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
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
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
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.
- Recruitment and retention rates [ Time Frame: 24 weeks ]
- Activity adherence rates [ Time Frame: 24 weeks ]
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02159014
|Chigwell Medical Centre|
|Chigwell, Essex, United Kingdom, IG6 2TA|
|Study Director:||Thomas M Dannhauser, PhD||North Essex Partnership Foundation NHS Trust, University College London|