Total Lifestyle Coaching Pilot Study (TLC) (TLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03025217
Recruitment Status : Completed
First Posted : January 19, 2017
Results First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Information provided by (Responsible Party):
Michelle Dossett, MD, PhD, MPH, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Obesity Weight Loss Telemedicine Behavioral: Total Lifestyle Coaching (TLC) Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Total Lifestyle Coaching Pilot Study (TLC)
Study Start Date : September 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: TLC Program
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.
Behavioral: Total Lifestyle Coaching (TLC)

Primary Outcome Measures :
  1. Change in Weight [ Time Frame: 26 weeks ]
    Change in weight between baseline (week 0) and post intervention (week 26)

Secondary Outcome Measures :
  1. Perceived Stress Scale [ Time Frame: 26 weeks ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Michelle Dossett, MD, PhD, MPH, Assistant Physician, Massachusetts General Hospital Identifier: NCT03025217     History of Changes
Other Study ID Numbers: 2014P001549
First Posted: January 19, 2017    Key Record Dates
Results First Posted: February 20, 2019
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms