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Clinical Trials/NCT03025217
NCT03025217
Completed
Not Applicable

Total Lifestyle Coaching Pilot Study (TLC)

Massachusetts General Hospital0 sites31 target enrollmentSeptember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Massachusetts General Hospital
Enrollment
31
Primary Endpoint
Change in Weight
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
November 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michelle Dossett, MD, PhD, MPH

Assistant Physician

Massachusetts General Hospital

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)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Weight

Time Frame: 26 weeks

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

Secondary Outcomes

  • Perceived Stress Scale(26 weeks)

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