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
About this trial
This is an interventional treatment trial for Obesity
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)
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
NCT ID
NCT03025217
First Posted
January 17, 2017
Last Updated
February 19, 2019
Sponsor
Massachusetts General Hospital
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
Learn more about this trial
Total Lifestyle Coaching Pilot Study (TLC)
We'll reach out to this number within 24 hrs