Aussie Fans in Training (Aussie-FIT): Feasibility trial of a health improvement program for men with cardiovascular disease

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2020
INTERVENTION: Aussie‐FIT is a program designed to promote physical activity (PA), weight loss and healthy living among middle‐aged men in Australia, using the context of AFL. Aussie‐FIT is based upon the existing, successful FFIT program (developed in Scotland). Aussie‐FIT is tailored to engage males via delivery in the AFL context by coaches associated with the clubs, taking into account any salient cultural differences in the relationship between masculinity and health. The original FFIT program was developed by a team of experts in obesity, PA, community‐based programs, gender and health, and delivery of men’s weight management programs. Aligned with the original FFIT, Aussie‐FIT will be gender‐sensitive and will aim to support participants to change their eating habits and food consumed (based on estimated weight maintenance requirements according to age, gender and body weight). The targeted strategies will include portion control, reduction of sugary drinks and energy dense foods, reduction in alcohol consumption, and a gradual increase in moderate PA that is initiated in the club setting but readily incorporated into daily lives to maximise sustainability of lifestyle changes (see Gray et al., 2013, for additional detail on intervention features and rationale). The target population for this intervention is designed for men with a history of Cardiovascular disease. Unlike previous Aussie‐Fit and FFIT interventions, the educational process will place greater emphasis on increasing PA as behaviour change over weight loss. Four community coaches will be recruited to take the role of Aussie‐FIT program tutors. The coaches will ideally be coaching personnel who usually deliver the clubs’ community programs and they will be selected on the basis of recommendations from ou CONDITION: Cardiovascular ‐ Coronary heart disease Cardiovascular ‐ Diseases of the vasculature and circulation including the lymphatic system Cardiovascular ‐ Hypertension Cardiovascular ‐ Other cardiovascular diseases Cardiovascular Disease;Overweight;Obesity;Cardiovascular health risks; ; Cardiovascular Disease ; Overweight ; Obesity ; Cardiovascular health risks Diet and Nutrition ‐ Obesity Public Health ‐ Health promotion/education PRIMARY OUTCOME: Assess trial feasibility with regard to participant uptake, adherence, and attrition from the study. Outcomes are assessed through records of expressions of interest, enrolments and completions, and registers of attendance at each session.[Assessed throughout the program] SECONDARY OUTCOME: Biological markers of CVD risk‐ Blood specimen. Urea and electrolytes (UE)[Measured at week 0 (baseline), and 3 and 6 months following baseline] Biological markers of CVD risk‐ Blood specimen; C‐reactive protein (CRP)[Measured at week 0 (baseline), and 3 and 6 months following baseline] Biological markers of CVD risk‐ Blood specimen; Glycated haemoglobin (HbA1c)[Measured at week 0 (baseline), and 3 and 6 months following baseline] Biological markers of CVD risk‐ Blood specimen; High density lipoprotein (HDL)[Measured at week 0 (baseline), and 3 and 6 months following baseline] Biological markers of CVD risk‐ Blood specimen; Liver function tests (LFT)[Measured at week 0 (baseline), and 3 and 6 months following baseline] Biological markers of CVD risk‐ Blood specimen; Low density lipoprotein cholesterol (cLDL)[Measured at week 0 (baseline), and 3 and 6 months following baseline] Biological markers of CVD risk‐ Blood specimen; Total cholesterol (Chol)[Measured at week 0 (baseline), and 3 and 6 months following baseline] Biological markers of CVD risk‐ Blood specimen; Triglycerides (TG)[Measured at week 0 (baseline), and 3 and 6 months following baseline] BMI Calculated as weight in kilograms divided by the square of height in metres (kg/m2).[Measured at week 0 (baseline), and 3 and 6 months following baseline] Goal conflict and goal facilitation‐ Measured using the goal conflict and goal facilitation scale[Measured at week 0 (baseline), and 3 and 6 months following baseline] Motivation to lose weight (Sheldon et al., 2017)[Measured at week 0 (baseline), and 3 and 6 months following baseline] Physical activity measured with valid and reliable physical activity monitor ActiGraph GTX‐9 worn continuously for 1 week at each time‐point, on their waist; setup to gather continuous data at 30Hz epoch.[Measured at week 0 (baseline), and 3 and 6 months following baseline] Positive and Negative Affect: Measured using the short form of the Positive and Negative Affect Scale (PANAS).[Measured at week 0 (baseline), and 3 and 6 months following baseline] Quality of life‐ The health related quality of life measured using the EQ‐5D‐5 L[Measured at week 0 (baseline), and 3 and 6 months following baseline] Questionnaires and interviews adapted from Quested et al., (2018) will be used to evaluate the coach training‐ Coaches will evaluate the training provided to them; and participants will feedback on the trainers' style. Interviews will be semi‐structured with open‐ended questions, audio‐recorded and will last up to one hour[Measured at week 0 (baseline), and 3 and 6 months following baseline] Questionnaires and interviews adapted from Quested et al., (2018) will be used to evaluate the feasibility and acceptability of program‐ Attendance to program sessions and to measurement sessions; fidelity of program delivery; perceptions of effectiveness and acceptability (both coaches' and participants'). Interviews will be semi‐structured with open‐ended questions, audio‐recorded and will last up to one hour[Measured at 3 and 6 months following baseline] Recruitment‐ How participants found out about the program; program uptake (number of people who expressed interest; number of people who fit inclusion criteria)[Measured at week 0 (baseline)] Self‐esteem. Measured using the Rosenberg Self‐Esteem (RSE) Scale (Rosenberg, 1965). [Measured at week 0 (baseline), and 3 and 6 months following baseline] Self‐reported diet measured with valid and reliable adaptation of the Dietary Instrument for Nutrition Education (DINE) calculating a fatty food score, fruit and vegetable score, and sugary food score. High scores indicative of high consumption. Questionnaire items adjusted for Australian population.[Measured at week 0 (baseline), and 3 and 6 months following baseline] Sleep‐ Measured using the Pittsburgh Sleep Questionnaire[Measured at week 0 (baseline), and 3 and 6 months following baseline] Systolic and diastolic blood pressure measured with valid and reliable blood pressure monitor (Omron HEM‐705CP, Milton Keynes, UK)[Measured at week 0 (baseline), and 3 and 6 months following baseline] The total number of alcohol units consumed in previous week measured with a 7 day recall diary.[Measured at week 0 (baseline), and 3 and 6 months following baseline] Waist circumference measured twice with a standard tape measure (three times, if the first two measurements differ by 5 mm or more) and the mean of all recorded measurements calculated[Measured at week 0 (baseline), and 3 and 6 months following baseline] Weight in kilograms measured with valid and reliable body scale (e.g. Tanita); light clothing, no shoes and empty pockets.[Measured at week 0 (baseline), and 3 and 6 months following baseline] INCLUSION CRITERIA: Male participants aged 18 and over (no upper limit), BMI of 28 or over. CVD diagnosis at least 3 months prior to recruitment. No upper limit is placed on length of time since diagnosis. Consent for randomisation
Epistemonikos ID: 627128eb02da8ba655e2c05b5cc02af7f3fea216
First added on: Aug 24, 2024