Trial Outcomes & Findings for Total Lifestyle Coaching Pilot Study (TLC) (NCT NCT03025217)

NCT ID: NCT03025217

Last Updated: 2019-02-20

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 31 participants
• Primary outcome timeframe: 26 weeks
• Results posted on: 2019-02-20

Participant Flow

Participant milestones

Measure	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. Total Lifestyle Coaching (TLC)
Overall Study STARTED	31
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	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. Total Lifestyle Coaching (TLC)
Overall Study Pregnancy	1
Overall Study Lost to Follow-up	1
Overall Study Not eligible, poor English	2

Baseline Characteristics

Total Lifestyle Coaching Pilot Study (TLC)

Baseline characteristics by cohort

Measure	TLC Program n=27 Participants 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)
Age, Continuous	55 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 26 weeks

Population: Program Completers

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

Outcome measures

Measure	TLC Program n=27 Participants 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)
Change in Weight Baseline	209 pounds Standard Deviation 35.5
Change in Weight 26 weeks	205 pounds Standard Deviation 36.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	TLC Program n=27 Participants 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)
Perceived Stress Scale Baseline	19 score on a scale Standard Deviation 7.1
Perceived Stress Scale 26 weeks	13 score on a scale Standard Deviation 7.5

Adverse Events

TLC Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michelle Dossett

Massachusetts General Hospital

Phone: 617-643-6034

Email: mdossett@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place