Exercise Snacks Enabled by an mHealth Intervention Delivered in General Practice to Promote a Sustainable Active Lifestyle in Adults With Obesity

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCharles University, Czech Republic

About this trial

Adults with obesity gain as much from regular physical activity as anyone else, but structured exercise programmes are hard to sustain once the programme ends. This trial tests a different approach, built around exercise snacks, that is short bouts of activity of a few minutes at a time, spread through an ordinary day.

Physically inactive adults aged 18 to 65 with obesity are invited by their own general practitioner. Everyone who takes part receives a wrist-worn activity tracker and keeps it at the end of the study.

Participants are allocated at random in two steps. At the start, two out of every three take part in a six-month programme of supervised group exercise sessions and individual counselling based on motivational interviewing. The remaining third receives the tracker together with brief standardised advice on physical activity. After six months, everyone who took part in the programme is allocated at random a second time, half and half: one half receives an automated conversational agent that supports them by message for the following twelve months, and the other half receives no further support.

The trial asks two questions. First, whether the six-month programme increases physical activity compared with the tracker and brief advice alone. Second, whether the automated conversational agent helps participants sustain their activity over the following year. Physical activity is measured with a research-grade accelerometer worn on the wrist for one week at the start, at six months and at eighteen months. Aerobic fitness, cardiometabolic blood markers, physical function and wellbeing are measured at the same three visits.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 to 65 years

Body mass index 30.0 to 39.9 kg/m2, that is obesity class I or II

Registered with a participating general practice

Physically inactive, defined as meeting neither of the following: at least 150 minutes per week of physical activity, counting moderate-intensity activity once and vigorous-intensity activity twice; or at least two sessions per week of organised exercise

Disqualifiers

Insufficient command of Czech to take part in counselling and complete questionnaires

Pregnancy

Another member of the same household already enrolled in the study

Significant comorbidity limiting safe participation or adherence, including serious mental illness, advanced cardiac disease, marked mobility limitation and neurological disorders

Trial design

Design model

Sequential

Treatments tested in this trial

  • Exercise snacks programme

    Behavioral

    Six-month lifestyle physical activity programme centred on exercise snacks, that is brief structured bouts of activity distributed across the day. Two supervised group sessions and six individual counselling sessions delivered remotely by video call, based on motivational interviewing and delivered by trained counsellors. The target given to participants is at least 150 intensity minutes per week, based on individual heart-rate thresholds derived from their own cardiopulmonary exercise test.

  • Conversational agent

    Behavioral

    Automated conversational agent based on a large language model, grounded in motivational interviewing and the Health Action Process Approach, delivered from six to eighteen months through a widely used messaging application and drawing on the participant's own activity data.

  • Wrist-worn activity tracker

    Device

    Wrist-worn activity tracker showing daily intensity minutes, calibrated to the participant's individual heart-rate thresholds derived from their own cardiopulmonary exercise test. Participants keep the tracker at the end of the study.

  • Standardised physical activity advice

    Behavioral

    A short standardised leaflet on physical activity recommendations and on using the activity tracker, given at baseline. No supervised sessions and no counselling are provided.

Treatment groups

306 Participants
are divided into 3 treatment groups
Group A: Programme, then conversational agentExperimental treatment 3 interventions
Group B: Programme, then no maintenance supportExperimental treatment 2 interventions
Group C: Active controlActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in device-measured physical activity, programme versus active control

Minutes per day of moderate to vigorous physical activity, measured by a wrist-worn accelerometer worn for seven consecutive days.

Time frame
Baseline to 6 months
2

Change in device-measured physical activity, conversational agent versus no further support

Minutes per day of moderate to vigorous physical activity, measured by a wrist-worn accelerometer worn for seven consecutive days.

Time frame
6 months to 18 months

Secondary outcomes

1

Change in peak oxygen uptake (L/min), programme versus active control

Peak oxygen uptake in litres per minute during a maximal walking cardiopulmonary exercise test on a treadmill. Tested only if Primary Outcome 1 is significant.

Time frame
Baseline to 6 months
2

Change in peak oxygen uptake (L/min), conversational agent versus no further support

Peak oxygen uptake in litres per minute during a maximal walking cardiopulmonary exercise test on a treadmill. Tested only if Primary Outcome 2 is significant.

Time frame
6 months to 18 months

Other outcomes

1

Fasting plasma glucose

Fasting plasma glucose concentration in millimoles per litre, measured in a venous blood sample taken at the general practice after an overnight fast.

Time frame
Baseline, 6 months, 18 months
2

Glycated haemoglobin (HbA1c)

Glycated haemoglobin (HbA1c) concentration in millimoles per mole, measured in a venous blood sample taken at the general practice.

Time frame
Baseline, 6 months, 18 months
3

Total cholesterol

Total cholesterol concentration in millimoles per litre, measured in a venous blood sample taken at the general practice after an overnight fast.

Time frame
Baseline, 6 months, 18 months
4

Low-density lipoprotein cholesterol

Low-density lipoprotein (LDL) cholesterol concentration in millimoles per litre, measured in a venous blood sample taken at the general practice after an overnight fast.

Time frame
Baseline, 6 months, 18 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Charles University, Czech Republic

Lead sponsor

University of Hradec Kralove

Collaborator

University of Ostrava

Collaborator

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