Study Assessing the Contribution of Telemedicine Monitoring in Addition to Standard Follow-up of an Obesity Program

ConditionObesity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorElsan

About this trial

STROBERRY Study is a Prospective, monocentric, randomized, open-label study assessing the contribution of telemedicine, in addition to standard follow-up, strengthening an Obesity program in Berry (France). The principal objective is to study the effectiveness of a follow-up reinforced with telemedicine in addition to the standard multidisciplinary annual follow-up on the rate of patients lost to follow-up after initial or second line management in a multidisciplinary bariatric medical program

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Woman or Male aged from 18 to 60 years old included

Patient in obesity (BMI> or = 30)

Patient who has completed a multidisciplinary medical program for obesity management, as a first- or second-line intention (after initial obesity management) at the investigating center

Affiliation to a social security scheme

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Quarterly remote motivational interviews

    Other intervention

    Remote motivational interview will be in the form of quarterly telephone call (at 3, 6 and 9 months after the start of annual follow up; the patient is seen again at 12 months as part of the annual follow-up) and this for 4 years. It will be performed by medical staff trained in motivational interviewing and who have completed at least 40 hours training in therapeutic education

Treatment groups

116 Participants
are divided into 2 treatment groups
Group A: Standard multidisciplinary follow-up reinforced with telemedicineExperimental treatment 1 intervention
Group B: Standard multidisciplinary follow upNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Rates of patients lost to follow up

Rates of patients lost to follow up measured in both arms and compared 4 years after randomization

Time frame
4 years

Secondary outcomes

1

The evolution of quality of life, self-esteem and perceived health compared to baseline

The evolution of quality of life, self-esteem and perceived health will be measured using the Duke questionnaire, and will be assessed at standard annual visits at 1, 2, 3 and 4 years after randomization

Time frame
1,2,3 and 4 years
2

Rate of patients lost to follow-up will be assessed at standard annual visits at 1, 2 and 3 years after randomization

Rate of patients lost to follow-up will be assessed at standard annual visits at 1, 2 and 3 years after randomization

Time frame
1,2 and 3 years
3

Change in waist circumference (cm) compared with the baseline measurement will be assessed at standard annual visits at 1, 2, 3 and 4 years after randomization.

Change in waist circumference (cm) compared with the baseline measurement will be assessed at standard annual visits at 1, 2, 3 and 4 years after randomization.

Time frame
1,2,3 and 4 years

Other outcomes

Sponsors and contacts

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