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
Massachusetts General Hospital
Information provided by (Responsible Party):
Michelle Dossett, MD, PhD, MPH, Massachusetts General Hospital
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|
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)|
|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|
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 :
- Change in Weight [ Time Frame: 26 weeks ]Change in weight between baseline (week 0) and post intervention (week 26)
Secondary Outcome Measures :
- 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.
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