An interventional study of Total Lifestyle Coaching (TLC) in Obesity, Weight Loss and Telemedicine, sponsored by Massachusetts General Hospital. Completed. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-20.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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.
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.
1,766 studies on the registry are indexed under Weight Loss; 278 are open to participants now.
This study's enrollment of 31 is below the median of 73 across 1,496 interventional studies indexed under Weight Loss.
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Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
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Inclusion Criteria:
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)
Change in Weight
Change in weight between baseline (week 0) and post intervention (week 26)
Time frame: 26 weeks
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.
Time frame: 26 weeks
| Milestone | TLC Program |
|---|---|
| Started | 31 |
| Completed | 27 |
| Not completed | 4 |
| Withdrew: Pregnancy | 1 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Not eligible, poor english | 2 |
Change in weight between baseline (week 0) and post intervention (week 26)
| pounds | TLC Program |
|---|---|
| Baseline | 209 ± 35.5 |
| 26 weeks | 205 ± 36.7 |
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.
| score on a scale | TLC Program |
|---|---|
| Baseline | 19 ± 7.1 |
| 26 weeks | 13 ± 7.5 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TLC Program | — | 0/27 (0%) | 0/27 (0%) |
| Age, Continuous(years) | TLC Program |
|---|---|
| Mean | 55 ± 12 |
| Sex: Female, Male(Participants) | TLC Program |
|---|---|
| Female | 23 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | TLC Program |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 23 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | TLC Program |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 23 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
No study locations are listed for this record.
Plan to share: Undecided
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital