Total Lifestyle Coaching Pilot Study (TLC)

Not Applicable

Completed

• Conditions: Obesity; Weight Loss; Telemedicine

• Registration Number: NCT03025217
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-09
• Primary Completion: 2015-08
• Study Completion: 2016-11
• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-01-18
• Study First Posted: 2017-01-19
• Results First Submitted: 2018-07-09
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-19
• Last Update Submitted: 2019-02-19
• Results First Posted: 2019-02-20
• Last Update Posted: 2019-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Weight	26 weeks	Change in weight between baseline (week 0) and post intervention (week 26)

Secondary Outcome Measures

Name	Time	Method
Perceived Stress Scale	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.