Obesity, Telemedicine, Weight Loss
Conditions
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.
Interventions
BEHAVIORALTotal Lifestyle Coaching (TLC)
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight | 26 weeks | Change in weight between baseline (week 0) and post intervention (week 26) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Not eligible, poor English | 2 |
| Overall Study | Pregnancy | 1 |
Baseline characteristics
| Characteristic | TLC Program |
|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
Primary
Change in Weight
Change in weight between baseline (week 0) and post intervention (week 26)
Time frame: 26 weeks
Population: Program Completers
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TLC Program | Change in Weight | Baseline | 209 pounds | Standard Deviation 35.5 |
| TLC Program | Change in Weight | 26 weeks | 205 pounds | Standard Deviation 36.7 |
p-value: 0.095t-test, 2 sided
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.
Time frame: 26 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TLC Program | Perceived Stress Scale | Baseline | 19 score on a scale | Standard Deviation 7.1 |
| TLC Program | Perceived Stress Scale | 26 weeks | 13 score on a scale | Standard Deviation 7.5 |
p-value: 0.001t-test, 2 sided