NCT07867665

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
306

participants targeted

Target at P75+ for not_applicable obesity

Timeline
29mo left

Started Oct 2026

Typical duration for not_applicable obesity

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Mar 2029

First Submitted

Initial submission to the registry

September 25, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

2.4 years

First QC Date

September 25, 2026

Last Update Submit

October 7, 2026

Conditions

Keywords

exercise snacksphysical activityprimary caregeneral practicewearableconversational agentlarge language modelmotivational interviewingbehaviour maintenanceaccelerometry

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline to 6 months

  • 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.

    6 months to 18 months

Secondary Outcomes (2)

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

    Baseline to 6 months

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

    6 months to 18 months

Other Outcomes (35)

  • Fasting plasma glucose

    Baseline, 6 months, 18 months

  • Glycated haemoglobin (HbA1c)

    Baseline, 6 months, 18 months

  • Total cholesterol

    Baseline, 6 months, 18 months

  • +32 more other outcomes

Study Arms (3)

Programme, then conversational agent

EXPERIMENTAL

Months 0 to 6: two supervised group sessions, six individual motivational interviewing counselling sessions delivered remotely, and a wrist-worn activity tracker. Months 6 to 18: an automated conversational agent based on a large language model, delivering maintenance support by message.

Behavioral: Exercise snacks programmeBehavioral: Conversational agentDevice: Wrist-worn activity tracker

Programme, then no maintenance support

EXPERIMENTAL

Months 0 to 6: identical to Arm 1. Months 6 to 18: no further programme contact; participants keep the tracker.

Behavioral: Exercise snacks programmeDevice: Wrist-worn activity tracker

Active control

ACTIVE COMPARATOR

A wrist-worn activity tracker and a short standardised leaflet on physical activity recommendations and tracker use, from baseline to 18 months.

Device: Wrist-worn activity trackerBehavioral: Standardised physical activity advice

Interventions

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.

Programme, then conversational agentProgramme, then no maintenance support

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.

Programme, then conversational agent

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.

Active controlProgramme, then conversational agentProgramme, then no maintenance support

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.

Active control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Willing to wear the study-provided activity tracker for the whole study
  • Judged by the general practitioner to be medically fit for a maximal walking treadmill exercise test and for a physical activity programme of moderate to vigorous intensity

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Ostrava, Faculty of Education

Ostrava, 701 03, Czechia

Location

Institute of General Practice, First Faculty of Medicine, Charles University

Prague, 128 00, Czechia

Location

Faculty of Physical Education and Sport, Charles University

Prague, 162 52, Czechia

Location

MeSH Terms

Conditions

ObesitySedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Tomáš Větrovský, MD, PhD

    Charles University, Czech Republic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomáš Větrovský, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Participants are randomised twice. At baseline, participants are randomised 2:1 to the six-month programme or to an active control condition. At six months, after the six-month assessment has been completed, all participants allocated to the programme are randomised 1:1 to receive a conversational agent for maintenance support or to receive no further support. The second randomisation is unconditional and does not depend on response to the first phase. Participants in the active control condition are not re-randomised and continue unchanged to eighteen months.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 25, 2026

First Posted

October 9, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in each publication, together with a data dictionary. The exact set of variables will be agreed for each request. Data that could identify a participant will not be shared.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning 12 months after publication of the primary results, with no end date.
Access Criteria
Requests should be directed to the principal investigator. Data will be shared with researchers who provide a methodologically sound proposal, after approval of that proposal and signature of a data sharing agreement.

Locations