ObesityTLCNCT03025217
Total Lifestyle Coaching Pilot Study (TLC)
A study testing Total Lifestyle Coaching (TLC) in people with Obesity and Weight Loss, run by Massachusetts General Hospital.
Trial summary
The investigators aim to develop, pilot and evaluate a new "Total Lifestyle Coaching" (TLC) program, that will address both information and behavior-change aspects of nutrition education for patients whose body mass index (BMI) exceeds 25. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Loss, Telemedicine
- What is being tested?
- Total Lifestyle Coaching (TLC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 21 and older
- body mass index (BMI) exceeds 25
- speaks English
- has access to a telephone
- able to come into MGH-Revere health center for at least four face-to-face meetings over a six month period.
- overweight (BMI exceeds 25)
Who cannot join
None listed.
About this study
The investigators aim to develop, pilot and evaluate a new "Total Lifestyle Coaching" (TLC) program, that will address both information and behavior-change aspects of nutrition education for patients whose body mass index (BMI) exceeds 25.
Read the detailed description
This is a single-arm pilot study of patients at the Revere Healthcare Center with a BMI greater than 25. The intervention consists of a single in-person assessment with a dietician followed by telephone coaching sessions addressing nutrition, sleep, stress-reduction skills, and physical activity over the course of 6 months. Study team assessed anthropomorphic, demographic, and behavioral measures prior to the initial dietician assessment and at study completion (6 months following enrollment). Semi-structured exit interviews assessing participants' experiences in the program were also conducted following program completion.
- Conditions
- Obesity, Weight Loss, Telemedicine
- Being tested
- Total Lifestyle Coaching (TLC)
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Lifestyle Coaching (TLC)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| TLC Program | Experimental | The TLC Program consists of one in-person visit with a licensed dietician and biweekly phone coaching sessions. During the program, the dietician will 1) identify specific nutrition goals, 2) review and tailor the education materials to the patient's needs, and 3) set up regular telephone coaching sessions of up to two sessions per month for six months for each patient. Motivational interviewing and nutrition/health coaching will be provided. Receives: Behavioral: Total Lifestyle Coaching (TLC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Change in weight between baseline (week 0) and post intervention (week 26)
Measured: 26 weeks
Secondary outcomes (1)
Perceived Stress Scale
Change in perceived stress as measured by the PSS-10 questionnaire administered at baseline (week 0) and post intervention (week 26). Score range is 0 - 40 with higher scores indicating higher perceived stress.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study startSep 2014
- Primary completionAug 2015
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Dossett, MD, PhD, MPH, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025217
- Sponsor's protocol ID
- 2014P001549
- Acronym
- TLC
- Status last verified
- Feb 2019
- First submitted
- 17 Jan 2017
- Last updated
- 20 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Chad-Friedman E, Pearsall M, Miller KM, Wheeler AE, Denninger JW, Mehta DH, Dossett ML. Total Lifestyle Coaching: A Pilot Study Evaluating the Effectiveness of a Mind-Body and Nutrition Telephone Coaching Program for Obese Adults at a Community Health Center. Glob Adv Health Med. 2018 Jul 4;7:2164956118784902. doi: 10.1177/2164956118784902. eCollection 2018.
PubMed 30013821
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Lifestyle Coaching Pilot Study (TLC)
- ClinicalTrials.gov ID
- NCT03025217
- Acronym / sponsor ID
- TLC / 2014P001549
- Conditions
- Obesity, Weight Loss, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 19 Jan 2017 (estimated)
- Results
- Posted 20 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to develop, pilot and evaluate a new "Total Lifestyle Coaching" (TLC) program, that will address both information and behavior-change aspects of nutrition education for patients whose body mass index (BMI) exceeds 25.
Detailed description
This is a single-arm pilot study of patients at the Revere Healthcare Center with a BMI greater than 25. The intervention consists of a single in-person assessment with a dietician followed by telephone coaching sessions addressing nutrition, sleep, stress-reduction skills, and physical activity over the course of 6 months. Study team assessed anthropomorphic, demographic, and behavioral measures prior to the initial dietician assessment and at study completion (6 months following enrollment). Semi-structured exit interviews assessing participants' experiences in the program were also conducted following program completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TLC Program | Experimental | Behavioral: Total Lifestyle Coaching (TLC)The TLC Program consists of one in-person visit with a licensed dietician and biweekly phone coaching sessions. During the program, the dietician will 1) identify specific nutrition goals, 2) review and tailor the education materials to the patient's needs, and 3) set up regular telephone coaching sessions of up to two sessions per month for six months for each patient. Motivational interviewing and nutrition/health coaching will be provided. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 21 and older
- body mass index (BMI) exceeds 25
- speaks English
- has access to a telephone
- able to come into MGH-Revere health center for at least four face-to-face meetings over a six month period.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Total Lifestyle Coaching (TLC) | Behavioural | TLC Program |
Primary outcome
Change in Weight
Time frame: 26 weeks
Change in weight between baseline (week 0) and post intervention (week 26)
1 secondary outcome
Perceived Stress Scale
Time frame: 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30013821Chad-Friedman E, Pearsall M, Miller KM, Wheeler AE, Denninger JW, Mehta DH, Dossett ML. Total Lifestyle Coaching: A Pilot Study Evaluating the Effectiveness of a Mind-Body and Nutrition Telephone Coaching Program for Obese Adults at a Community Health Center. Glob Adv Health Med. 2018 Jul 4;7:2164956118784902. doi: 10.1177/2164956118784902. eCollection 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Total Lifestyle Coaching (TLC) in people with Obesity and Weight Loss, run by Massachusetts General Hospital.
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 6 inclusion and 0 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 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 20 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Weight (time frame: 26 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 NCT03025217, 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 20 Feb 2019; AzTrials last refreshed its copy on 29 Oct 2026.