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Total Lifestyle Coaching Pilot Study (TLC) (TLC)

Primary Purpose

Obesity, Weight Loss, Telemedicine

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Total Lifestyle Coaching (TLC)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. age 21 and older
  2. body mass index (BMI) exceeds 25
  3. speaks English
  4. has access to a telephone
  5. able to come into MGH-Revere health center for at least four face-to-face meetings over a six month period.
  6. overweight (BMI exceeds 25)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    TLC Program

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Change in Weight
    Change in weight between baseline (week 0) and post intervention (week 26)

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    January 17, 2017
    Last Updated
    February 19, 2019
    Sponsor
    Massachusetts General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03025217
    Brief Title
    Total Lifestyle Coaching Pilot Study (TLC)
    Acronym
    TLC
    Official Title
    Total Lifestyle Coaching Pilot Study (TLC)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    August 2015 (Actual)
    Study Completion Date
    November 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Weight Loss, Telemedicine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    31 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TLC Program
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Total Lifestyle Coaching (TLC)
    Primary Outcome Measure Information:
    Title
    Change in Weight
    Description
    Change in weight between baseline (week 0) and post intervention (week 26)
    Time Frame
    26 weeks
    Secondary Outcome Measure Information:
    Title
    Perceived Stress Scale
    Description
    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.
    Time Frame
    26 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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)

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    30013821
    Citation
    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.
    Results Reference
    derived

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    Total Lifestyle Coaching Pilot Study (TLC)

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