OverweightFitMeFitNCT01868763
TeleLifestyleCoaching for Weight Loss
A study testing telemedical devices (weighing machine and step counter) and care calls once per week for 12 weeks in people with Overweight, run by West German Center of Diabetes and Health at 1 site in Germany.
Trial summary
Lifestyle changes often fail due to loss of motivation. Telemedicine and personal coaching have the potential to support lifestyle change and weight loss. Therefore, the aim of our randomized controlled trial was to examine the effect of telemedicine with and without coaching in comparison to a control group on weight… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- telemedical devices (weighing machine and step counter) and care calls once per week for 12 weeks
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≥27 kg/m2
Who cannot join
- Hypoglycemia inducing medication
- severe disease with hospital stay during the last 3 months
- smoking cessation for less then 3 months
- planned smoking cessation during study phase
- acute infects
- chronic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TeleLifestyleCoaching Use of Telemedicine for Weight Loss and Care of Weight Associated Illnesses
Lifestyle changes often fail due to loss of motivation. Telemedicine and personal coaching have the potential to support lifestyle change and weight loss. Therefore, the aim of our randomized controlled trial was to examine the effect of telemedicine with and without coaching in comparison to a control group on weight loss in overweight participants.
Read the detailed description
In an occupational health care setting overweight employees were randomized into a three arm 12-week trial. Participants in the telemedical (TM) and telemedical coaching (TMC) group got a weighing machine and a step counter, with automatic transfer into a personalized online portal, which could be monitored from both, the participant and the study centre. The TMC group weekly got care calls from the study centre aiming to discuss measured data and to fix target agreements. The control group remained in routine care. Wilcoxon signed rank test was used to determine if differences (baseline vs. after 12 weeks) were significantly different from 0 and ANOVA test for determination of inter group differences.
- Conditions
- Overweight
- Being tested
- telemedical devices (weighing machine and step counter), care calls once per week for 12 weeks
- Keywords
- telemedicine, coaching, lifestyle change, weight loss
- Medical subject headings
- Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telemedical devices (weighing machine and step counter)Device
care calls once per week for 12 weeksBehavioural
| Study group | Role | What they receive |
|---|---|---|
| control (C) group | No intervention | The control group will remain in routine care for 12 weeks. |
| telemedical (TM) group | Experimental | Participants in the telemedical (TM) group will get a weighing machine and a step counter, with automatic transfer into a personalized online portal, which can be monitored from both, the participant and the study centre. Receives: Device: telemedical devices (weighing machine and step counter) |
| telemedical coaching (TMC) group | Experimental | Participants in the telemedical coaching (TMC) group will get a weighing machine and a step counter, with automatic transfer into a personalized online portal, which can be monitored from both, the participant and the study centre. Additionally, they will be called once per week for 12 weeks from the study centre aiming to discuss measured data and to fix target agreements. Receives: Device: telemedical devices (weighing machine and step counter); Behavioral: care calls once per week for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Weight will be measured at baseline and after 12 weeks
Measured: 12 weeks
Secondary outcomes (1)
cardiometabolic risk factors
Body mass index [kg/m2], waist circumference [cm], blood pressure [mmHg], triglycerides [mg/dl], HbA1c [%], total, HDL and LDL cholesterol [mg/dl]
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startAug 2012
- Primary completionDec 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- West German Center of Diabetes and Health
- Sponsor type
- University, hospital or other
- Collaborators
- HMM Holding AG
- Responsible party
- Principal investigator, Stephan Martin, West German Center of Diabetes and Health
- Investigators
- Stephan Martin, MD, Principal investigator, West-German Centre of Diabetes and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868763
- Sponsor's protocol ID
- FitMeFit
- Acronym
- FitMeFit
- Status last verified
- Jun 2013
- First submitted
- 30 May 2013
- Last updated
- 6 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kempf K, Rohling M, Stichert M, Fischer G, Boschem E, Konner J, Martin S. Telemedical Coaching Improves Long-Term Weight Loss in Overweight Persons: A Randomized Controlled Trial. Int J Telemed Appl. 2018 Sep 9;2018:7530602. doi: 10.1155/2018/7530602. eCollection 2018.
PubMed 30271433
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TeleLifestyleCoaching Use of Telemedicine for Weight Loss and Care of Weight Associated Illnesses
- ClinicalTrials.gov ID
- NCT01868763
- Acronym / sponsor ID
- FitMeFit / FitMeFit
- Conditions
- Overweight
- Keywords
- telemedicine, coaching, lifestyle change, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- West German Center of Diabetes and HealthUniversity, hospital or other
- Collaborators
- HMM Holding AG
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lifestyle changes often fail due to loss of motivation. Telemedicine and personal coaching have the potential to support lifestyle change and weight loss. Therefore, the aim of our randomized controlled trial was to examine the effect of telemedicine with and without coaching in comparison to a control group on weight loss in overweight participants.
Detailed description
In an occupational health care setting overweight employees were randomized into a three arm 12-week trial. Participants in the telemedical (TM) and telemedical coaching (TMC) group got a weighing machine and a step counter, with automatic transfer into a personalized online portal, which could be monitored from both, the participant and the study centre. The TMC group weekly got care calls from the study centre aiming to discuss measured data and to fix target agreements. The control group remained in routine care. Wilcoxon signed rank test was used to determine if differences (baseline vs. after 12 weeks) were significantly different from 0 and ANOVA test for determination of inter group differences.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control (C) group | No intervention | –The control group will remain in routine care for 12 weeks. |
| telemedical (TM) group | Experimental | Device: telemedical devices (weighing machine and step counter)Participants in the telemedical (TM) group will get a weighing machine and a step counter, with automatic transfer into a personalized online portal, which can be monitored from both, the participant and the study centre. |
| telemedical coaching (TMC) group | Experimental | Device: telemedical devices (weighing machine and step counter), Behavioral: care calls once per week for 12 weeksParticipants in the telemedical coaching (TMC) group will get a weighing machine and a step counter, with automatic transfer into a personalized online portal, which can be monitored from both, the participant and the study centre. Additionally, they will be called once per week for 12 weeks from the study centre aiming to discuss measured data and to fix target agreements. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI ≥27 kg/m2
Key exclusion criteria (6 listed)
- Hypoglycemia inducing medication
- severe disease with hospital stay during the last 3 months
- smoking cessation for less then 3 months
- planned smoking cessation during study phase
- acute infects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telemedical devices (weighing machine and step counter) | Device | telemedical (TM) group, telemedical coaching (TMC) group |
| care calls once per week for 12 weeks | Behavioural | telemedical coaching (TMC) group |
Primary outcome
weight loss
Time frame: 12 weeks
Weight will be measured at baseline and after 12 weeks
1 secondary outcome
cardiometabolic risk factors
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2013.
- Derived from this study: PubMed 30271433Kempf K, Rohling M, Stichert M, Fischer G, Boschem E, Konner J, Martin S. Telemedical Coaching Improves Long-Term Weight Loss in Overweight Persons: A Randomized Controlled Trial. Int J Telemed Appl. 2018 Sep 9;2018:7530602. doi: 10.1155/2018/7530602. eCollection 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Martin, MD principal investigator
West-German Centre of Diabetes and Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telemedical devices (weighing machine and step counter) and care calls once per week for 12 weeks in people with Overweight, run by West German Center of Diabetes and Health at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight loss (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01868763, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2013.