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Total Lifestyle Coaching Pilot Study (TLC) (TLC)

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ClinicalTrials.gov Identifier: NCT03025217
Recruitment Status : Completed
First Posted : January 19, 2017
Results First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Michelle Dossett, MD, PhD, MPH, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Obesity
Weight Loss
Telemedicine
Intervention Behavioral: Total Lifestyle Coaching (TLC)
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TLC Program
Hide Arm/Group 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.

Total Lifestyle Coaching (TLC)

Period Title: Overall Study
Started 31
Completed 27
Not Completed 4
Reason Not Completed
Pregnancy             1
Lost to Follow-up             1
Not eligible, poor English             2
Arm/Group Title TLC Program
Hide Arm/Group 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.

Total Lifestyle Coaching (TLC)

Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants
55  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
23
  85.2%
Male
4
  14.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Hispanic or Latino
4
  14.8%
Not Hispanic or Latino
23
  85.2%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   7.4%
White
23
  85.2%
More than one race
0
   0.0%
Unknown or Not Reported
2
   7.4%
1.Primary Outcome
Title Change in Weight
Hide Description Change in weight between baseline (week 0) and post intervention (week 26)
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Program Completers
Arm/Group Title TLC Program
Hide Arm/Group 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.

Total Lifestyle Coaching (TLC)

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: pounds
Baseline 209  (35.5)
26 weeks 205  (36.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TLC Program
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .095
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Cohen's d
Estimated Value 0.33
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Perceived Stress Scale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TLC Program
Hide Arm/Group 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.

Total Lifestyle Coaching (TLC)

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 19  (7.1)
26 weeks 13  (7.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TLC Program
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Cohen's d
Estimated Value 0.75
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TLC Program
Hide Arm/Group 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.

Total Lifestyle Coaching (TLC)

All-Cause Mortality
TLC Program
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
TLC Program
Affected / at Risk (%)
Total   0/27 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TLC Program
Affected / at Risk (%)
Total   0/27 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Michelle Dossett
Organization: Massachusetts General Hospital
Phone: 617-643-6034
EMail: mdossett@mgh.harvard.edu
Layout table for additonal information
Responsible Party: Michelle Dossett, MD, PhD, MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03025217    
Other Study ID Numbers: 2014P001549
First Submitted: January 17, 2017
First Posted: January 19, 2017
Results First Submitted: July 9, 2018
Results First Posted: February 20, 2019
Last Update Posted: February 20, 2019