Background
Methods
Trial design
Participants
Eligibility criteria of participants
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30 to 55 years-old.
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Having one or more risk factors for metabolic syndrome1 (waist circumference >94.5 cm for men and >89.5 cm for women; blood pressure ≥130/85 mmHg; triglycerides in plasma ≥150 mg/dL; HDLc in plasma <40 mg/dL for men and <50 mg/dL for women; fasting glycaemia ≥100 mg/dL).
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Low active (achieving less than 150 min/week of moderate-to-vigorous physical activity or to have not participated in any supervised exercise programmes for at least the last 24 weeks).
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Accept and sign written informed consent.
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Accept the randomized group assignment.
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Morbid obesity (BMI ≥ 40).
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A past/current history and/or evidence through physical examination or laboratory findings of significant cardiovascular, respiratory, neuromuscular or psychiatric disease/disorder.
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Diseases/disorders that may contraindicate performing physical exercise or a stress test [7].
Enrolment, screening and allocation
Blinding
Sample size
Ethical implications
Trial intervention
Counselling programme
N | Aims of the session | Example of meeting activities/actions (Participant actions unless otherwise specified)
| |
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1st Group Session (week 1) | To explain the programme To connect with the rest of the group and establish the dynamics of the meetings To become aware of the benefits of a healthy lifestyle To establish personal goals limiting the time spent in sedentary behaviours | Before the session | 1. Browse the BELLUGA’T guide promoting a healthy lifestyle. 2. Review the schedule and the programme plan. |
During the session | Leader’s action: 1. Present the programme: structure, dates, goals, strategies, etc. 2. Introduce ice-breaker and rapport-building activities. Participant’s action: 1. Discuss beneficial effects of a healthy lifestyle. 2. Propose actions to reduce time spent in sedentary behaviours. | ||
After the session | 1. Read the guide’s article about encouraging a healthier lifestyle. 2. Establish personal goals to reduce time spent in sedentary behaviors, based on ideas listed during group session. | ||
1st Individual Session (week 2) | To become aware of the effect of his/her cardiovascular risk factors on his/her health status To establish personal goals for controlling his/her risk factors and plan for the actions needed to succeed in achieving those goals | Before the session | Leader’s action: 1. Email results of baseline tests within 48 h of 1st session. Participant’s action: 1. Read reports of basal tests. 2. Read the guide’s article about metabolic risk factors. |
During the session | 1. Discuss reports with the leader. 2. Discuss personal risk factors and establish personal goals for the short (2 weeks), mid (16 weeks), and long term (40 weeks). 3. Select actions to achieve personal goals to reduce metabolic risk factors. | ||
After the session | 1. Place actions needed to achieve risk factor goals in a visible place and start putting them into practice. | ||
2nd Group Session (week 4) | To become aware of the importance of a good workout To establish personal goals to increase physical activity | Before the meeting | 1. Read guide’s article about increasing physical activity. 2. Reassess personal level of physical activity according to the reported accelerometer data (guide). |
During the session | Leader’s action: 1. Provide information about ways to achieve a physically active lifestyle. 2. Present specific information about training, hydration, and stretching. 3. Introduce digital resources to help participants be more active. Participant’s action: 1. Discuss beneficial effects of physical exercise in addition to routine physical activity. 2. Brainstorm examples of physical activities and exercise programmes | ||
After the session | 1. Establish physical activity plan to be more active at work and in spare time in the next week. 2. Record physical activity in the smartphone application (app) or on paper. | ||
3rd Group Session (week 7) | To become aware of the possibilities of exercising at home, at work and in spare time using everyday items To establish personal goals to increase physical exercise | Before the meeting | 1. Read and watch the video from the guide about tips to be more active at home. |
During the session | Leader’s action: 1. Demonstrate aerobic and strength exercises using stretch bands, dumbbells and improvised exercise material. Participant’s action: 1. Work on aerobic and strength exercises with improvised materials. 2. Share ideas and discuss ways of incorporating physical exercise into daily routines. | ||
After the session | 1. Review the video of the aerobic and strength exercises practiced in class. 2. Establish physical exercise goals and record them in the app or on paper. | ||
4 rd Group Session (week 10) | To become aware of the importance of good nutrition To establish personal goals to achieve good nutrition | Before the meeting | 1. Read the guide’s article about healthy food choices. |
During the session | Leader’s action: 1. Provide nformation about healthy benefits of healthy eating. 2. Present the healthy food pyramid and the Mediterranean diet concept. Participant’s action: 1. Discuss the beneficial effects of healthy nutrition. 2. Brainstorm different ways of making healthy food choices. | ||
After the session | 1. Identify unhealthy food choices made and record them in the app or on paper. | ||
2nd Individual Session (week 12) | To assess the current routine of physical activity and exercise and establish new strategies if necessary To become aware of the effect of good nutrition on his/her health status To establish personal nutritional goals and the actions needed to achieve them | Before the meeting | Leader’s action: 1. Email results of baseline dietary habits questionnaire within 48 h of 2nd session. Participant’s action: 1. Carry out a self-assessment of the establishment of physical activity/exercise goals and the progress made. 2. Read report of baseline dietary habits questionnaire. 3. Read the guide’s article about strategies to overcome nutritional barriers. |
During the session | 1. Review progress and resolve problems or setbacks in active lifestyle goal-setting and action planning. 2. Highlight positive changes and define potential ways forward, building on successes. 3. Discuss the dietary habits report with the leader and agree on personal goals. 4. Identify possible barriers to healthy eating and select actions/strategies to overcome them. | ||
After the session | 1. Develop physical activity and exercise plan for the upcoming weeks. 2. Place actions needed to achieve active lifestyle goals in a visible place and start putting them into practice. | ||
6rd Group Session (week 16) | To become aware of barriers to new activity and nutritional behaviors and devise strategies to overcome them To establish new strategies to overcome barriers and maintain a new healthy lifestyle | Before the meeting | 1. Read guide’s article about other healthy habits such as sleep and rest, reduce stress, no smoking, etc. 2. Review goals and think about new actions to overcome barriers. |
During the session | Leader’s action: 1. Provide information about maintaining a healthy lifestyle. 2. Resolve doubts and facilitate access to additional resources that may be needed. Participant’s action: 1. Share strategies to overcome barriers to new active lifestyle and dietary habits. 2. Brainstorm ideas to use the physical and social environment to become healthier. | ||
After the session | 1. Review materials, acquired knowledge and strategies. 2. Think about how to apply them in oneself current situation. | ||
3rd Individual Session (weeks 18–19) | To become aware of the effects of oneself new lifestyle on reducing cardiovascular risk factors To establish new weekly personal goals for the next 6 months | Before the meeting | Leader’s action: 1. Email results of post-intervention tests within 48 h of 1st session. Participant’s action: 1. Read the email reports of post-intervention results. 2. Review initial metabolic risk factors results emailed after 1st group session. |
During the session | 1. Analyse progress based on 16-week follow-up report after 16 weeks) and resolve problems or setbacks. 2. Highlight positive changes and discuss potential ways forward. 3. Agree on relapse prevention plans (active lifestyle and healthy eating) for the next 6 months. | ||
After the session | 1. Maintain a new healthy lifestyle. 2. Keep a log of physical activity/exercise and eating habits, supported by the BELLUGA’T app. 3. Consult the programme guide, other educational material provided, and physical activity or primary healthcare professionals, as needed. |
Supervised physical exercise
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AIT group: Four series of 4 min of cycling at a heart rate of 80% of the VO2peak registered previously during the stress test, with active pauses of 2 min at 60% of the VO2peak between them (Table 2).Table 2Weekly schedule for the main part of the AIT program sessionsWeek numberSupervised/self-administered lessons (n/n)Content of the main part of the AIT sessionsWork volume(Rep x time)Work Intensity(% VO2peak)Active rest(time)Total accumulated time12/116 × 1’8030”24’22/18 × 2’801’24’32/15 × 3’802’25’42/14 × 4’802’24’51/24 × 4’802’24’61/24 × 4’802’24’70/34 × 4’802’24’81/24 × 4’802’24’91/24 × 4’802’24’100/34 × 4’802’24’111/24 × 4’802’24’121/24 × 4’802’24’130/34 × 4’802’24’141/24 × 4’802’24’150/34 × 4’802’24’161/24 × 4’802’24’
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Given that maintaining the anticipated exercise intensity might, at the beginning of the programme, excessively burden participants allocated to this group, the length of the series will be shorter during the initial sessions. Thus, intensity will be established at 80% of the VO2peak but series will last for 1 min during the first week, after which they will be increased by 1 min each successive week until reaching a duration of four minutes. At the same time, active pauses will be shortened so as to accumulate an exercise time of 24 min in that part of the session.
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TCT group: Participants allocated to this group will perform activities such as walking, cycling, team activities and toning exercises, always at an intensity of 60% of their VO2peak. The number of training sessions per week and the ratio of supervised to self-administered sessions will be the same as that shown in Table 2 for the AIT group.
Outcome measures
Time point | Enrolment | Baseline assessment | Allocation | +16 weeks assessment | +24 weeks assessment |
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t-1 | t0 | t1 | t2 | ||
Preliminary data: | |||||
Eligibility screen | ✔ | ||||
Informed consent | ✔ | ||||
Allocation | ✔ | ||||
Anthropometric measurements
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Body mass | ✔ | ✔ | ✔ | ||
Height | ✔ | ✔ | ✔ | ||
Body mass index | ✔ | ✔ | ✔ | ||
Waist circumference | ✔ | ✔ | ✔ | ||
Hip circumference | ✔ | ✔ | ✔ | ||
Blood sampling and biochemical measurements
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Lipid profile (TG, TC, HDLc, LDLc) | ✔ | ✔ | ✔ | ||
Plasma glucose | ✔ | ✔ | ✔ | ||
Plasma glycated haemoglobin | ✔ | ✔ | ✔ | ||
Plasma adiponectin | ✔ | ✔ | ✔ | ||
Plasma Interleucin-6 | ✔ | ✔ | ✔ | ||
Plasma metabolome-lipidome | ✔ | ✔ | ✔ | ||
Plasma MicroRNA | ✔ | ✔ | ✔ | ||
Medical procedures
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Resting blood pressure | ✔ | ✔ | ✔ | ||
Cardiorespiratory fitness (VO2peak) | ✔ | ✔ | ✔ | ||
Physical activity and sedentary behaviour
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Physical activity (LPA and MVPA) | ✔ | ✔ | ✔ | ||
Sedentary time | ✔ | ✔ | ✔ | ||
Self-reported Questionnaires
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Food frequency questionnaire | ✔ | ✔ | ✔ | ||
Healthy eating index | ✔ | ✔ | ✔ | ||
Empowerment related to health | ✔ | ✔ | ✔ | ||
Physical activity and dietary habits self-efficacy | ✔ | ✔ | ✔ | ||
Health related quality of life (EQ-5D) | ✔ | ✔ | ✔ | ||
Direct costs | ✔ | ||||
Indirect costs | ✔ | ||||
Demographic variables | ✔ | ||||
Enjoyment with the programme | ✔ | ||||
Reasons for abandoning | ✔ | ✔ | ✔ |