Total Lifestyle Coaching Pilot Study (TLC)

Obesity Clinical Trial

— TLC  

Official title:

Total Lifestyle Coaching Pilot Study (TLC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03025217
• Other study ID #: 2014P001549
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: November 2016

Study information

• Verified date: February 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Obesity
• Telemedicine
• Weight Loss

Intervention

Behavioral:
• Total Lifestyle Coaching (TLC)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight	Change in weight between baseline (week 0) and post intervention (week 26)	26 weeks
Secondary	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.	26 weeks