Trial Outcomes & Findings for Improving Weight Management at the VA (NCT NCT02626819)

Last Updated: 2018-12-21

Results Overview

Weight Change from baseline to 3 months. Two weight measurements were taken using a Medline MDR500PHY Physician Digital Scale equipped with height rod. The two weight measurements were averaged. Weight was measured in kilograms and height taken at the baseline, using these two measures Body Mass Index was calculated.

Recruitment status

COMPLETED

Study phase

Target enrollment

45 participants

Primary outcome timeframe

3 Months

Results posted on

2018-12-21

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1: Receiving MOVE! Toward Your Goals Receiving MOVE! Toward Your Goals intervention (MTG tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) MOVE! Toward Your Goals: Patients will take an online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals to help them in their weight loss journey. The goals may be supported by the patients' PACT members	Arm 2: Receiving Enhanced Usual Care Receiving Enhanced Usual Care (standard VA Health Living Messages handouts, potential support of weight management efforts from primary care provider) Enhanced Usual Care: Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.
Overall Study STARTED	22	23
Overall Study COMPLETED	18	20
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: Receiving MOVE! Toward Your Goals Receiving MOVE! Toward Your Goals intervention (MTG tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) MOVE! Toward Your Goals: Patients will take an online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals to help them in their weight loss journey. The goals may be supported by the patients' PACT members	Arm 2: Receiving Enhanced Usual Care Receiving Enhanced Usual Care (standard VA Health Living Messages handouts, potential support of weight management efforts from primary care provider) Enhanced Usual Care: Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.
Overall Study Lost to Follow-up	3	2
Overall Study Withdrawal by Subject	1	0
Overall Study Diagnosed w/ catastrophic illness	0	1

Baseline Characteristics

One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 3 Months

Population: Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputations to adjust for missing data.

Outcome measures

Outcome measures
Measure	Arm 1: Receiving MOVE! Toward Your Goals n=21 Participants Receiving MOVE! Toward Your Goals intervention (MTG tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) MOVE! Toward Your Goals: Patients will take an online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals to help them in their weight loss journey. The goals may be supported by the patients' PACT members	Arm 2: Receiving Enhanced Usual Care n=22 Participants Receiving Enhanced Usual Care (standard VA Health Living Messages handouts, potential support of weight management efforts from primary care provider) Enhanced Usual Care: Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.
Weight Change (kg)	-1.06 kilograms Standard Deviation 1.72	0.07 kilograms Standard Deviation 2.40

PRIMARY outcome

Timeframe: 6 Months

Population: Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputation to adjust for missing data

Change in weight from baseline to 6-months. Two weight measurements were taken using a Medline MDR500PHY Physician Digital Scale equipped with height rod. The two weight measurements were averaged. Weight was measured in kilograms and height taken at the baseline, using these two measures Body Mass Index was calculated.

Outcome measures

Outcome measures
Measure	Arm 1: Receiving MOVE! Toward Your Goals n=21 Participants Receiving MOVE! Toward Your Goals intervention (MTG tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) MOVE! Toward Your Goals: Patients will take an online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals to help them in their weight loss journey. The goals may be supported by the patients' PACT members	Arm 2: Receiving Enhanced Usual Care n=22 Participants Receiving Enhanced Usual Care (standard VA Health Living Messages handouts, potential support of weight management efforts from primary care provider) Enhanced Usual Care: Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.
Weight Change (kg)	-1.52 kilograms Standard Deviation 3.06	0.23 kilograms Standard Deviation 3.64

PRIMARY outcome

Timeframe: 12 months

Population: Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputations to adjust for missing data

Change in weight from baseline to the 12-months. Two weight measurements were taken using a Medline MDR500PHY Physician Digital Scale equipped with height rod. The two weight measurements were averaged. Weight was measured in kilograms and height taken at the baseline, using these two measures Body Mass Index was calculated.

Outcome measures

Outcome measures
Measure	Arm 1: Receiving MOVE! Toward Your Goals n=21 Participants Receiving MOVE! Toward Your Goals intervention (MTG tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) MOVE! Toward Your Goals: Patients will take an online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals to help them in their weight loss journey. The goals may be supported by the patients' PACT members	Arm 2: Receiving Enhanced Usual Care n=22 Participants Receiving Enhanced Usual Care (standard VA Health Living Messages handouts, potential support of weight management efforts from primary care provider) Enhanced Usual Care: Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.
Weight Change (kg)	-1.02 kilograms Standard Deviation 4.16	0.74 kilograms Standard Deviation 4.90

PRIMARY outcome

Timeframe: 3 months

Population: At the 3-months, 6 participants in Arm 1 did not complete the study visits and thus were not included in analysis.

The percentage of patients who achieve 5-10% weight loss at 3- month study visit.

Outcome measures

Outcome measures
Measure	Arm 1: Receiving MOVE! Toward Your Goals n=15 Participants Receiving MOVE! Toward Your Goals intervention (MTG tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) MOVE! Toward Your Goals: Patients will take an online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals to help them in their weight loss journey. The goals may be supported by the patients' PACT members	Arm 2: Receiving Enhanced Usual Care n=22 Participants Receiving Enhanced Usual Care (standard VA Health Living Messages handouts, potential support of weight management efforts from primary care provider) Enhanced Usual Care: Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.
Percent of Patients With Clinically Significant Weight Loss	1 Participants	2 Participants

PRIMARY outcome

Timeframe: 6 months

Population: At the 6-months, 2 participants in Arm 1 and 1 participant in Arm 2 did not complete the study visit and thus were not included in analysis.

Percentage of patients who achieved 2.5% weight loss at 6 months. Weight measured in kg.

Outcome measures

Outcome measures
Measure	Arm 1: Receiving MOVE! Toward Your Goals n=19 Participants Receiving MOVE! Toward Your Goals intervention (MTG tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) MOVE! Toward Your Goals: Patients will take an online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals to help them in their weight loss journey. The goals may be supported by the patients' PACT members	Arm 2: Receiving Enhanced Usual Care n=21 Participants Receiving Enhanced Usual Care (standard VA Health Living Messages handouts, potential support of weight management efforts from primary care provider) Enhanced Usual Care: Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.
Percent of Patients With 2.5% Weight Loss at 6 Months.	7 Participants	5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: At the 6-months, 2 participants in Arm 1 and 1 participant in Arm 2 did not complete the study visit and thus were not included in analysis.

The percentage of patients who achieve 5-10% weight loss at 6- month study visit.

Outcome measures

Outcome measures
Measure	Arm 1: Receiving MOVE! Toward Your Goals n=19 Participants Receiving MOVE! Toward Your Goals intervention (MTG tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) MOVE! Toward Your Goals: Patients will take an online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals to help them in their weight loss journey. The goals may be supported by the patients' PACT members	Arm 2: Receiving Enhanced Usual Care n=21 Participants Receiving Enhanced Usual Care (standard VA Health Living Messages handouts, potential support of weight management efforts from primary care provider) Enhanced Usual Care: Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.
Percent of Patients With Clinically Significant Weight Loss	2 Participants	1 Participants

PRIMARY outcome

Timeframe: 12 months

Population: At the 12-months, 3 participants in Arm 1 and 2 participants in Arm 2 did not complete the study visit and thus were not included in analysis.

Percentage of patients who achieved 2.5% weight loss at 12 months. Weight measured in kg.

Outcome measures

Outcome measures
Measure	Arm 1: Receiving MOVE! Toward Your Goals n=18 Participants Receiving MOVE! Toward Your Goals intervention (MTG tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) MOVE! Toward Your Goals: Patients will take an online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals to help them in their weight loss journey. The goals may be supported by the patients' PACT members	Arm 2: Receiving Enhanced Usual Care n=20 Participants Receiving Enhanced Usual Care (standard VA Health Living Messages handouts, potential support of weight management efforts from primary care provider) Enhanced Usual Care: Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.
Percent of Patients Who Achieved 2.5% Weight Loss	5 Participants	4 Participants

PRIMARY outcome

Timeframe: 12 months

Population: At the 12-months, 3 participants in Arm 1 and 2 participants in Arm 2 did not complete the study visit and thus were not included in analysis.

The percentage of patients who achieve 5-10% weight loss at 12- month study visit.

Outcome measures

Outcome measures
Measure	Arm 1: Receiving MOVE! Toward Your Goals n=18 Participants Receiving MOVE! Toward Your Goals intervention (MTG tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) MOVE! Toward Your Goals: Patients will take an online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals to help them in their weight loss journey. The goals may be supported by the patients' PACT members	Arm 2: Receiving Enhanced Usual Care n=20 Participants Receiving Enhanced Usual Care (standard VA Health Living Messages handouts, potential support of weight management efforts from primary care provider) Enhanced Usual Care: Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.
Percent of Patients With Clinically Significant Weight Loss	2 Participants	3 Participants

Adverse Events

Arm 1: Receiving MOVE! Toward Your Goals

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2: Receiving Enhanced Usual Care

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

Melanie Jay, MD MS

Manhattan Campus of the VA NY Harbor Healthcare System

Phone: 212-686-7500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm 1: Receiving MOVE! Toward Your Goals n=22 Participants Receiving MOVE! Toward Your Goals intervention (MTG tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) MOVE! Toward Your Goals: Patients will take an online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals to help them in their weight loss journey. The goals may be supported by the patients' PACT members	Arm 2: Receiving Enhanced Usual Care n=23 Participants Receiving Enhanced Usual Care (standard VA Health Living Messages handouts, potential support of weight management efforts from primary care provider) Enhanced Usual Care: Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=21 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	0 Participants n=22 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	0 Participants n=43 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.
Age, Categorical Between 18 and 65 years	18 Participants n=21 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	19 Participants n=22 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	37 Participants n=43 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.
Age, Categorical >=65 years	3 Participants n=21 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	3 Participants n=22 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	6 Participants n=43 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.
Age, Continuous	53.29 years STANDARD_DEVIATION 10.37 • n=21 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	56.14 years STANDARD_DEVIATION 10.73 • n=22 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	54.74 years STANDARD_DEVIATION 10.53 • n=43 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.
Sex: Female, Male Female	5 Participants n=21 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	9 Participants n=22 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	14 Participants n=43 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.
Sex: Female, Male Male	16 Participants n=21 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	13 Participants n=22 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	29 Participants n=43 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=21 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	6 Participants n=22 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	9 Participants n=43 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=21 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	15 Participants n=22 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	33 Participants n=43 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=21 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	1 Participants n=22 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	1 Participants n=43 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=21 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	0 Participants n=22 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	1 Participants n=43 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.
Race (NIH/OMB) Asian	2 Participants n=21 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	0 Participants n=22 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	2 Participants n=43 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=21 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	0 Participants n=22 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	0 Participants n=43 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.
Race (NIH/OMB) Black or African American	11 Participants n=21 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	11 Participants n=22 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	22 Participants n=43 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.
Race (NIH/OMB) White	4 Participants n=21 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	4 Participants n=22 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	8 Participants n=43 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.
Race (NIH/OMB) More than one race	3 Participants n=21 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	6 Participants n=22 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	9 Participants n=43 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=21 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	1 Participants n=22 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	1 Participants n=43 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.
Body Mass Index (BMI)	30.7 kg/m2 STANDARD_DEVIATION 3.4 • n=21 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	33.0 kg/m2 STANDARD_DEVIATION 5.8 • n=22 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.	31.8 kg/m2 STANDARD_DEVIATION 4.9 • n=43 Participants • One participant from Arm 2 was removed from the study due to a catastrophic illness, and one participant from Arm 1 officially withdrew from study and did not want data to be used. For these reasons only 43 participants were analyzed.