Trial Outcomes & Findings for Weight Loss in Chronic Disease Patient Population (NCT NCT01155050)

NCT ID: NCT01155050

Last Updated: 2024-01-25

Results Overview

Body weight at five-month follow-up minus baseline body weight. Body weight is measured in pounds

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 202 participants
• Primary outcome timeframe: five-month follow-up compared to baseline
• Results posted on: 2024-01-25

Participant Flow

Subjects were recruited between January 1, 2010 and June 30, 2010. Recruitment was done at primary care clinics at three LSU Health Care Services Division locations in three Louisiana cities.

Potential subjects were screened for eligibility and then randomized within site to the four treatment arms.

Participant milestones

Measure	Tele-health Home Monitoring Participants will use the tele-health monitoring equipment to measure daily weight. Tele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants.	Self-Directed Group Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.	TrestleTree Telephone Coaching Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss. TrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss.	Home Monitoring + Telephone Coach System to track stage of change in weight loss. Tele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.
Overall Study STARTED	50	51	52	49
Overall Study COMPLETED	35	31	33	27
Overall Study NOT COMPLETED	15	20	19	22

Reasons for withdrawal

Measure	Tele-health Home Monitoring Participants will use the tele-health monitoring equipment to measure daily weight. Tele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants.	Self-Directed Group Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.	TrestleTree Telephone Coaching Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss. TrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss.	Home Monitoring + Telephone Coach System to track stage of change in weight loss. Tele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.
Overall Study Lost to Follow-up	15	20	19	22

Baseline Characteristics

Weight Loss in Chronic Disease Patient Population

Baseline characteristics by cohort

Measure	Tele-health Home Monitoring n=50 Participants Participants will use the tele-health monitoring equipment to measure daily weight. Tele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants.	Self-Directed Group n=51 Participants Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.	TrestleTree Telephone Coaching n=52 Participants Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss. TrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss.	Home Monitoring + Telephone Coach n=49 Participants System to track stage of change in weight loss. Tele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.	Total n=202 Participants Total of all reporting groups
Age, Continuous	51.04 years STANDARD_DEVIATION 9.74 • n=5 Participants	51.94 years STANDARD_DEVIATION 11.73 • n=7 Participants	50.62 years STANDARD_DEVIATION 9.87 • n=5 Participants	49.55 years STANDARD_DEVIATION 10.37 • n=4 Participants	50.80 years STANDARD_DEVIATION 10.41 • n=21 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	49 Participants n=7 Participants	48 Participants n=5 Participants	43 Participants n=4 Participants	186 Participants n=21 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	16 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	9 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	32 Participants n=5 Participants	26 Participants n=7 Participants	28 Participants n=5 Participants	25 Participants n=4 Participants	111 Participants n=21 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	23 Participants n=7 Participants	23 Participants n=5 Participants	21 Participants n=4 Participants	82 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	50 participants n=5 Participants	51 participants n=7 Participants	52 participants n=5 Participants	49 participants n=4 Participants	202 participants n=21 Participants
Diagnosis of diabetes	26 Participants n=5 Participants	25 Participants n=7 Participants	23 Participants n=5 Participants	21 Participants n=4 Participants	95 Participants n=21 Participants
Diagnosis of hypertension	49 Participants n=5 Participants	47 Participants n=7 Participants	50 Participants n=5 Participants	47 Participants n=4 Participants	193 Participants n=21 Participants
Use diabetes medication	24 Participants n=5 Participants	18 Participants n=7 Participants	19 Participants n=5 Participants	21 Participants n=4 Participants	82 Participants n=21 Participants
Use cholesterol medication	20 Participants n=5 Participants	30 Participants n=7 Participants	22 Participants n=5 Participants	15 Participants n=4 Participants	87 Participants n=21 Participants
Use blood pressure medication	47 Participants n=5 Participants	44 Participants n=7 Participants	47 Participants n=5 Participants	41 Participants n=4 Participants	179 Participants n=21 Participants
Use anti-depression medication	12 Participants n=5 Participants	14 Participants n=7 Participants	19 Participants n=5 Participants	15 Participants n=4 Participants	60 Participants n=21 Participants
Low-density lipoprotein	118 mg/dL STANDARD_DEVIATION 32 • n=5 Participants	120 mg/dL STANDARD_DEVIATION 33 • n=7 Participants	117 mg/dL STANDARD_DEVIATION 41 • n=5 Participants	117 mg/dL STANDARD_DEVIATION 36 • n=4 Participants	118 mg/dL STANDARD_DEVIATION 35 • n=21 Participants
High-density lipoprotein	41 mg/dL STANDARD_DEVIATION 12 • n=5 Participants	43 mg/dL STANDARD_DEVIATION 10 • n=7 Participants	48 mg/dL STANDARD_DEVIATION 18 • n=5 Participants	44 mg/dL STANDARD_DEVIATION 22 • n=4 Participants	44 mg/dL STANDARD_DEVIATION 16 • n=21 Participants
Triglycerides	121 mg/dL STANDARD_DEVIATION 74 • n=5 Participants	111 mg/dL STANDARD_DEVIATION 57 • n=7 Participants	112 mg/dL STANDARD_DEVIATION 51 • n=5 Participants	153 mg/dL STANDARD_DEVIATION 145 • n=4 Participants	123 mg/dL STANDARD_DEVIATION 88 • n=21 Participants
systolic blood pressure	136 mm Hg STANDARD_DEVIATION 22 • n=5 Participants	140 mm Hg STANDARD_DEVIATION 16 • n=7 Participants	135 mm Hg STANDARD_DEVIATION 20 • n=5 Participants	142 mm Hg STANDARD_DEVIATION 21 • n=4 Participants	138 mm Hg STANDARD_DEVIATION 20 • n=21 Participants
diastolic blood pressure	80 mm Hg STANDARD_DEVIATION 16 • n=5 Participants	81 mm Hg STANDARD_DEVIATION 12 • n=7 Participants	78 mm Hg STANDARD_DEVIATION 11 • n=5 Participants	83 mm Hg STANDARD_DEVIATION 13 • n=4 Participants	80 mm Hg STANDARD_DEVIATION 13 • n=21 Participants
Weight	111 kg STANDARD_DEVIATION 25 • n=5 Participants	106 kg STANDARD_DEVIATION 26 • n=7 Participants	112 kg STANDARD_DEVIATION 21 • n=5 Participants	113 kg STANDARD_DEVIATION 25 • n=4 Participants	110 kg STANDARD_DEVIATION 24 • n=21 Participants
Body Mass Index	41 kg/m^2 STANDARD_DEVIATION 9 • n=5 Participants	41 kg/m^2 STANDARD_DEVIATION 9 • n=7 Participants	42 kg/m^2 STANDARD_DEVIATION 7 • n=5 Participants	42 kg/m^2 STANDARD_DEVIATION 10 • n=4 Participants	41 kg/m^2 STANDARD_DEVIATION 9 • n=21 Participants
Waist circumference	119 cm STANDARD_DEVIATION 16 • n=5 Participants	118 cm STANDARD_DEVIATION 16 • n=7 Participants	120 cm STANDARD_DEVIATION 14 • n=5 Participants	115 cm STANDARD_DEVIATION 21 • n=4 Participants	118 cm STANDARD_DEVIATION 17 • n=21 Participants

PRIMARY outcome

Timeframe: five-month follow-up compared to baseline

Population: Analysis was based on those completing the five-month program and not lost to follow-up after five months.

Body weight at five-month follow-up minus baseline body weight. Body weight is measured in pounds

Outcome measures

Measure	Tele-health Home Monitoring n=35 Participants Participants will use the tele-health monitoring equipment to measure daily weight. Tele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants.	Self-Directed Group n=31 Participants Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.	TrestleTree Telephone Coaching n=33 Participants Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss. TrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss.	Home Monitoring + Telephone Coach n=27 Participants System to track stage of change in weight loss. Tele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.
Change in Body Weight	-1.7 pounds Standard Error 1.1	-.2 pounds Standard Error 1.9	-4.3 pounds Standard Error 1.4	-3.0 pounds Standard Error 1.9

PRIMARY outcome

Timeframe: five-month follow-up compared to baseline

Population: Analysis was done using those who completed the five-month programs and were not lost to follow-up at five months.

Waist circumference at five-month follow-up minus waist circumference at baseline. Waist circumference is measured in centimeters.

Outcome measures

Measure	Tele-health Home Monitoring n=35 Participants Participants will use the tele-health monitoring equipment to measure daily weight. Tele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants.	Self-Directed Group n=31 Participants Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.	TrestleTree Telephone Coaching n=33 Participants Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss. TrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss.	Home Monitoring + Telephone Coach n=27 Participants System to track stage of change in weight loss. Tele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.
Change in Waist Circumference	-.1 centimeters Standard Error .7	-.5 centimeters Standard Error .8	-1.5 centimeters Standard Error .9	-.6 centimeters Standard Error 1.6

SECONDARY outcome

Timeframe: Systolic blood pressure (mmHg) at five months minus systolic blood pressure at baseline.

Population: Outcome results are for those who completed the study through five-months and were not lost to follow-up.

Change is systolic blood pressure (mmHg) from baseline to five-month follow-up.

Outcome measures

Measure	Tele-health Home Monitoring n=35 Participants Participants will use the tele-health monitoring equipment to measure daily weight. Tele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants.	Self-Directed Group n=31 Participants Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.	TrestleTree Telephone Coaching n=33 Participants Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss. TrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss.	Home Monitoring + Telephone Coach n=27 Participants System to track stage of change in weight loss. Tele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.
Change in Systolic Blood Pressure	-4.7 mm Hg Standard Error 2.9	-1.6 mm Hg Standard Error 2.5	-3.4 mm Hg Standard Error 3.2	-9.6 mm Hg Standard Error 3.6

SECONDARY outcome

Timeframe: Diastolic blood pressure (mmHg) at five months minus diastolic blood pressure at baseline.

Population: Analysis is based on those who completed the study through five months and were not lost to follow-up.

Change in diastolic blood pressure (mmHg) from baseline to follow-up.

Outcome measures

Measure	Tele-health Home Monitoring n=35 Participants Participants will use the tele-health monitoring equipment to measure daily weight. Tele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants.	Self-Directed Group n=31 Participants Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.	TrestleTree Telephone Coaching n=33 Participants Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss. TrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss.	Home Monitoring + Telephone Coach n=27 Participants System to track stage of change in weight loss. Tele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.
Change in Diastolic Blood Pressure	-2.5 mm Hg Standard Error 1.9	-1.3 mm Hg Standard Error 1.6	-1.6 mm Hg Standard Error 2.0	-5.3 mm Hg Standard Error 2.2

SECONDARY outcome

Timeframe: five months

Population: The analysis was based on those who completed the study through five months and who had both baseline and follow-up lab results available from the electronic medical record.

Change in HbA1c value from baseline to five-month follow-up among those completing the study through five months.

Outcome measures

Measure	Tele-health Home Monitoring n=18 Participants Participants will use the tele-health monitoring equipment to measure daily weight. Tele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants.	Self-Directed Group n=14 Participants Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.	TrestleTree Telephone Coaching n=14 Participants Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss. TrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss.	Home Monitoring + Telephone Coach n=7 Participants System to track stage of change in weight loss. Tele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.
Change in HbA1c	-.01 change in HbA1c percentage Standard Error .21	.19 change in HbA1c percentage Standard Error .13	.11 change in HbA1c percentage Standard Error .19	-.01 change in HbA1c percentage Standard Error .08

SECONDARY outcome

Timeframe: five months

Population: The analysis was based on those subjects completing the study through five months and for whom triglyceride levels were available in the study sites' electronic medical records.

Change from baseline to five month follow-up in triglyceride level.

Outcome measures

Measure	Tele-health Home Monitoring n=16 Participants Participants will use the tele-health monitoring equipment to measure daily weight. Tele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants.	Self-Directed Group n=14 Participants Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.	TrestleTree Telephone Coaching n=8 Participants Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss. TrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss.	Home Monitoring + Telephone Coach n=11 Participants System to track stage of change in weight loss. Tele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.
Change in Triglycerides	-5.3 mg/dL Standard Error 8.9	3.8 mg/dL Standard Error 7.2	12 mg/dL Standard Error 9.2	2 mg/dL Standard Error 10.1

SECONDARY outcome

Timeframe: five months

Population: The analysis is based on subjects completing the study through five months and who had total cholesterol lab values available in the study sites' electronic medical records.

Change in total cholesterol level from baseline to five-month follow-up.

Outcome measures

Measure	Tele-health Home Monitoring n=16 Participants Participants will use the tele-health monitoring equipment to measure daily weight. Tele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants.	Self-Directed Group n=14 Participants Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.	TrestleTree Telephone Coaching n=8 Participants Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss. TrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss.	Home Monitoring + Telephone Coach n=11 Participants System to track stage of change in weight loss. Tele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.
Change in Total Cholesterol	-10.1 mg/dL Standard Error 9.1	-6.1 mg/dL Standard Error 4.8	-.8 mg/dL Standard Error 11.0	-6.9 mg/dL Standard Error 4.7

SECONDARY outcome

Timeframe: five months

Population: The analysis is based on those subjects who completed the study through five months and who had fast plasma glucose lab values available in the study sites' electronic medical record.

Change from baseline to five-month follow-up in fasting plasma glucose level.

Outcome measures

Measure	Tele-health Home Monitoring n=19 Participants Participants will use the tele-health monitoring equipment to measure daily weight. Tele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants.	Self-Directed Group n=16 Participants Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.	TrestleTree Telephone Coaching n=14 Participants Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss. TrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss.	Home Monitoring + Telephone Coach n=14 Participants System to track stage of change in weight loss. Tele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.
Change in Fasting Plasma Glucose	13.6 mg/dL Standard Error 9.8	4.1 mg/dL Standard Error 5.9	5.9 mg/dL Standard Error 20.1	10.9 mg/dL Standard Error 9.4

Adverse Events

Tele-health Home Monitoring

Serious events: 14 serious events

Other events: 1 other events

Deaths: 0 deaths

Self-Directed Group

Serious events: 20 serious events

Other events: 3 other events

Deaths: 0 deaths

TrestleTree Telephone Coaching

Serious events: 22 serious events

Other events: 6 other events

Deaths: 0 deaths

Home Monitoring + Telephone Coach

Serious events: 19 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tele-health Home Monitoring n=50 participants at risk Participants will use the tele-health monitoring equipment to measure daily weight. Tele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants.	Self-Directed Group n=51 participants at risk Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.	TrestleTree Telephone Coaching n=52 participants at risk Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss. TrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss.	Home Monitoring + Telephone Coach n=49 participants at risk System to track stage of change in weight loss. Tele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.
General disorders unexpected outpatient clinic visit	0.00% 0/50 • Five months from baseline (randomization) through five-month follow-up The adverse event data summary includes all adverse events identified for the initially randomized 202 subjects, not just for the 126 subjects who completed the study. That is because adverse events identified over the course of the five-month study include identified adverse events for those who subsequently did not complete the study. For example, a subject may have had an adverse event in the second month but have been lost to follow-up by the end of month five when the study ended.	3.9% 2/51 • Number of events 2 • Five months from baseline (randomization) through five-month follow-up The adverse event data summary includes all adverse events identified for the initially randomized 202 subjects, not just for the 126 subjects who completed the study. That is because adverse events identified over the course of the five-month study include identified adverse events for those who subsequently did not complete the study. For example, a subject may have had an adverse event in the second month but have been lost to follow-up by the end of month five when the study ended.	5.8% 3/52 • Number of events 3 • Five months from baseline (randomization) through five-month follow-up The adverse event data summary includes all adverse events identified for the initially randomized 202 subjects, not just for the 126 subjects who completed the study. That is because adverse events identified over the course of the five-month study include identified adverse events for those who subsequently did not complete the study. For example, a subject may have had an adverse event in the second month but have been lost to follow-up by the end of month five when the study ended.	2.0% 1/49 • Number of events 1 • Five months from baseline (randomization) through five-month follow-up The adverse event data summary includes all adverse events identified for the initially randomized 202 subjects, not just for the 126 subjects who completed the study. That is because adverse events identified over the course of the five-month study include identified adverse events for those who subsequently did not complete the study. For example, a subject may have had an adverse event in the second month but have been lost to follow-up by the end of month five when the study ended.
Surgical and medical procedures Hospitalization and/or emergency department visit	28.0% 14/50 • Number of events 20 • Five months from baseline (randomization) through five-month follow-up The adverse event data summary includes all adverse events identified for the initially randomized 202 subjects, not just for the 126 subjects who completed the study. That is because adverse events identified over the course of the five-month study include identified adverse events for those who subsequently did not complete the study. For example, a subject may have had an adverse event in the second month but have been lost to follow-up by the end of month five when the study ended.	35.3% 18/51 • Number of events 29 • Five months from baseline (randomization) through five-month follow-up The adverse event data summary includes all adverse events identified for the initially randomized 202 subjects, not just for the 126 subjects who completed the study. That is because adverse events identified over the course of the five-month study include identified adverse events for those who subsequently did not complete the study. For example, a subject may have had an adverse event in the second month but have been lost to follow-up by the end of month five when the study ended.	36.5% 19/52 • Number of events 31 • Five months from baseline (randomization) through five-month follow-up The adverse event data summary includes all adverse events identified for the initially randomized 202 subjects, not just for the 126 subjects who completed the study. That is because adverse events identified over the course of the five-month study include identified adverse events for those who subsequently did not complete the study. For example, a subject may have had an adverse event in the second month but have been lost to follow-up by the end of month five when the study ended.	38.8% 19/49 • Number of events 27 • Five months from baseline (randomization) through five-month follow-up The adverse event data summary includes all adverse events identified for the initially randomized 202 subjects, not just for the 126 subjects who completed the study. That is because adverse events identified over the course of the five-month study include identified adverse events for those who subsequently did not complete the study. For example, a subject may have had an adverse event in the second month but have been lost to follow-up by the end of month five when the study ended.

Other adverse events

Measure	Tele-health Home Monitoring n=50 participants at risk Participants will use the tele-health monitoring equipment to measure daily weight. Tele-health Home Monitoring: Daily tele-health monitoring data will be collected from randomized participants.	Self-Directed Group n=51 participants at risk Participants will receive information on physical activity recommendations and guidelines on nutrition aimed at promoting weight loss.	TrestleTree Telephone Coaching n=52 participants at risk Participants will speak to Trestletree health coaches for 15 to 60 minutes each session. During these sessions, the coaches will identify the participant's stage of change and intervene accordingly. The telephone calls will be centered on weight loss. TrestleTree Telephone Coaching: Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss.	Home Monitoring + Telephone Coach n=49 participants at risk System to track stage of change in weight loss. Tele-health Home Monitoring Plus Trestle Telephone Coaching: Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.
General disorders mild or moderate unanticipated health events	2.0% 1/50 • Number of events 1 • Five months from baseline (randomization) through five-month follow-up The adverse event data summary includes all adverse events identified for the initially randomized 202 subjects, not just for the 126 subjects who completed the study. That is because adverse events identified over the course of the five-month study include identified adverse events for those who subsequently did not complete the study. For example, a subject may have had an adverse event in the second month but have been lost to follow-up by the end of month five when the study ended.	5.9% 3/51 • Number of events 3 • Five months from baseline (randomization) through five-month follow-up The adverse event data summary includes all adverse events identified for the initially randomized 202 subjects, not just for the 126 subjects who completed the study. That is because adverse events identified over the course of the five-month study include identified adverse events for those who subsequently did not complete the study. For example, a subject may have had an adverse event in the second month but have been lost to follow-up by the end of month five when the study ended.	11.5% 6/52 • Number of events 6 • Five months from baseline (randomization) through five-month follow-up The adverse event data summary includes all adverse events identified for the initially randomized 202 subjects, not just for the 126 subjects who completed the study. That is because adverse events identified over the course of the five-month study include identified adverse events for those who subsequently did not complete the study. For example, a subject may have had an adverse event in the second month but have been lost to follow-up by the end of month five when the study ended.	6.1% 3/49 • Number of events 3 • Five months from baseline (randomization) through five-month follow-up The adverse event data summary includes all adverse events identified for the initially randomized 202 subjects, not just for the 126 subjects who completed the study. That is because adverse events identified over the course of the five-month study include identified adverse events for those who subsequently did not complete the study. For example, a subject may have had an adverse event in the second month but have been lost to follow-up by the end of month five when the study ended.

Additional Information

Ronald Horswell

PenningtonBRC

Phone: 225-763-2931

Email: Ronald.Horswell@pbrc.edu

Results disclosure agreements

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