Trial Outcomes & Findings for HealthyMe Online Weight Management Education/HealthyMe at Home (NCT NCT02057952)
NCT ID: NCT02057952
Last Updated: 2018-09-05
Results Overview
Change in weight from baseline to 12 months reported in pounds.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
Baseline to 12 Months
Results posted on
2018-09-05
Participant Flow
Participant milestones
| Measure |
Usual Care Control
No intervention.
|
In Person Weight Management
Education and exercise in a community health center environment.
Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance.
|
Video Conference Weight Management
Education and exercise delivered through video conference.
Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance.
|
|---|---|---|---|
|
Overall Study
STARTED
|
51
|
49
|
50
|
|
Overall Study
COMPLETED
|
43
|
39
|
28
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HealthyMe Online Weight Management Education/HealthyMe at Home
Baseline characteristics by cohort
| Measure |
Usual Care Control
n=51 Participants
No intervention.
|
In Person Weight Management
n=49 Participants
Education and exercise in a community health center environment.
Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance.
|
Video Conference Weight Management
n=50 Participants
Education and exercise delivered through video conference.
Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.9 YEAR OF AGE
STANDARD_DEVIATION 6.1 • n=39 Participants
|
53.2 YEAR OF AGE
STANDARD_DEVIATION 8.1 • n=41 Participants
|
53.2 YEAR OF AGE
STANDARD_DEVIATION 6.1 • n=35 Participants
|
53.4 YEAR OF AGE
STANDARD_DEVIATION 6.8 • n=31 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=39 Participants
|
38 Participants
n=41 Participants
|
46 Participants
n=35 Participants
|
123 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
27 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
49 Participants
n=39 Participants
|
49 Participants
n=41 Participants
|
50 Participants
n=35 Participants
|
148 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=39 Participants
|
49 participants
n=41 Participants
|
50 participants
n=35 Participants
|
150 participants
n=31 Participants
|
|
Years of Education, continuous
|
13.2 Years
STANDARD_DEVIATION 2.4 • n=39 Participants
|
13.6 Years
STANDARD_DEVIATION 2.4 • n=41 Participants
|
12.6 Years
STANDARD_DEVIATION 1.7 • n=35 Participants
|
13.1 Years
STANDARD_DEVIATION 2.2 • n=31 Participants
|
|
weight, continuous
|
236.4 pounds
STANDARD_DEVIATION 43.6 • n=39 Participants
|
234.1 pounds
STANDARD_DEVIATION 46.7 • n=41 Participants
|
227.6 pounds
STANDARD_DEVIATION 35.5 • n=35 Participants
|
232.7 pounds
STANDARD_DEVIATION 42.0 • n=31 Participants
|
|
body mass index, continuous
|
39.4 kilograms divided by meters squared
STANDARD_DEVIATION 6.2 • n=39 Participants
|
38.9 kilograms divided by meters squared
STANDARD_DEVIATION 5.8 • n=41 Participants
|
38.5 kilograms divided by meters squared
STANDARD_DEVIATION 5.5 • n=35 Participants
|
38.9 kilograms divided by meters squared
STANDARD_DEVIATION 5.8 • n=31 Participants
|
|
Short Form 36 (RANGE 0 [Worst] -100 [Best]), continuous
|
52.8 standardized score
STANDARD_DEVIATION 19.0 • n=39 Participants
|
59.2 standardized score
STANDARD_DEVIATION 18.4 • n=41 Participants
|
56.5 standardized score
STANDARD_DEVIATION 21.8 • n=35 Participants
|
56.1 standardized score
STANDARD_DEVIATION 19.8 • n=31 Participants
|
|
Patient Health Questionnaire (range 0 [best] -27[worst]), continuous
|
7.6 standardized score
STANDARD_DEVIATION 6.0 • n=39 Participants
|
6.9 standardized score
STANDARD_DEVIATION 5.5 • n=41 Participants
|
7.3 standardized score
STANDARD_DEVIATION 5.3 • n=35 Participants
|
7.3 standardized score
STANDARD_DEVIATION 5.6 • n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 MonthsPopulation: The number of participants analyzed is based on the number of participants who completed weight data at baseline and 12 months.
Change in weight from baseline to 12 months reported in pounds.
Outcome measures
| Measure |
Usual Care Control
n=43 Participants
No intervention.
|
In Person Weight Management
n=39 Participants
Education and exercise in a community health center environment.
Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance.
|
Video Conference Weight Management
n=28 Participants
Education and exercise delivered through video conference.
Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance.
|
|---|---|---|---|
|
Body Weight
|
-0.8 pounds
Standard Deviation 10.9
|
-1.5 pounds
Standard Deviation 14.6
|
-7.3 pounds
Standard Deviation 11.5
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: Usual care participants didn't have access to the experimental treatments. In person and video conference arm participants were all eligible for participation.
Minutes of participation in study sessions.
Outcome measures
| Measure |
Usual Care Control
No intervention.
|
In Person Weight Management
n=49 Participants
Education and exercise in a community health center environment.
Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance.
|
Video Conference Weight Management
n=50 Participants
Education and exercise delivered through video conference.
Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance.
|
|---|---|---|---|
|
Attendance Reported in Minutes
|
—
|
0 minutes
Interval 0.0 to 2880.0
|
90 minutes
Interval 0.0 to 2640.0
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Analysis are based on number of participants with complete weight data at baseline and 6 months.
Change in body weight from baseline to 6 months.
Outcome measures
| Measure |
Usual Care Control
n=49 Participants
No intervention.
|
In Person Weight Management
n=42 Participants
Education and exercise in a community health center environment.
Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance.
|
Video Conference Weight Management
n=33 Participants
Education and exercise delivered through video conference.
Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance.
|
|---|---|---|---|
|
Change in Body Weight From Baseline to 6 Months.
|
1.3 pounds
Standard Deviation 9.8
|
-0.9 pounds
Standard Deviation 10.7
|
3.1 pounds
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: Baseline to 12 MonthsPopulation: The analysis of change based on participants with complete Short Form 36 (SF36) scores at baseline and 12 months.
The Short Form 36 survey or Short-Form 36 is a patient report survey. Scores range from 0 (worst) to 100 (best) and represent overall health-related quality of life.
Outcome measures
| Measure |
Usual Care Control
n=43 Participants
No intervention.
|
In Person Weight Management
n=39 Participants
Education and exercise in a community health center environment.
Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance.
|
Video Conference Weight Management
n=28 Participants
Education and exercise delivered through video conference.
Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance.
|
|---|---|---|---|
|
Change in Short Form 36 Survey Score
|
6.5 score on scale
Standard Deviation 8.7
|
-3.1 score on scale
Standard Deviation 18.3
|
7.1 score on scale
Standard Deviation 19.6
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Participants who completed 12 month follow-up
Systolic blood pressure. Measured using blood pressure cuff and sphygmomanometer. Units in Milometers of Mercury (mmHg). Scale range is based on participants' actual blood pressure (change baseline to 12 months). Negative value indicates decrease in blood pressure.
Outcome measures
| Measure |
Usual Care Control
n=40 Participants
No intervention.
|
In Person Weight Management
n=36 Participants
Education and exercise in a community health center environment.
Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance.
|
Video Conference Weight Management
n=26 Participants
Education and exercise delivered through video conference.
Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance.
|
|---|---|---|---|
|
Change in Systolic Blood Pressure
|
-3.8 mmHg
Standard Deviation 14.6
|
-1.1 mmHg
Standard Deviation 17.2
|
-7.4 mmHg
Standard Deviation 19.8
|
SECONDARY outcome
Timeframe: 12 monthsThe cost effectiveness ratios were calculated by dividing the difference in total cost per arm by the difference in percent of subjects with 2+ kg weight loss
Outcome measures
| Measure |
Usual Care Control
n=51 Participants
No intervention.
|
In Person Weight Management
n=49 Participants
Education and exercise in a community health center environment.
Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance.
|
Video Conference Weight Management
n=50 Participants
Education and exercise delivered through video conference.
Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance.
|
|---|---|---|---|
|
Cost-effectiveness
|
0 Total Cost / 100 participants
|
5564 Total Cost / 100 participants
|
3744 Total Cost / 100 participants
|
SECONDARY outcome
Timeframe: 6 MonthsThe Short Form 36 survey or Short-Form 36 is a patient report survey. Scores range from 0 (worst) to 100 (best) and represent overall health-related quality of life.
Outcome measures
| Measure |
Usual Care Control
n=49 Participants
No intervention.
|
In Person Weight Management
n=42 Participants
Education and exercise in a community health center environment.
Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance.
|
Video Conference Weight Management
n=32 Participants
Education and exercise delivered through video conference.
Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance.
|
|---|---|---|---|
|
Change in SF 36 From Baseline to 6 Months
|
3.5 units on a scale
Standard Deviation 15.6
|
-1.1 units on a scale
Standard Deviation 13.5
|
6.1 units on a scale
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: 6 MonthsChange in pressure from baseline to 6 months
Outcome measures
| Measure |
Usual Care Control
n=43 Participants
No intervention.
|
In Person Weight Management
n=38 Participants
Education and exercise in a community health center environment.
Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance.
|
Video Conference Weight Management
n=32 Participants
Education and exercise delivered through video conference.
Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance.
|
|---|---|---|---|
|
Change in Systolic Blood Pressure
|
2.5 mmHg
Standard Deviation 15.1
|
-0.8 mmHg
Standard Deviation 18.9
|
7.4 mmHg
Standard Deviation 20.5
|
SECONDARY outcome
Timeframe: 6 MonthsChange in pressure from baseline to 6 months
Outcome measures
| Measure |
Usual Care Control
n=43 Participants
No intervention.
|
In Person Weight Management
n=38 Participants
Education and exercise in a community health center environment.
Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance.
|
Video Conference Weight Management
n=32 Participants
Education and exercise delivered through video conference.
Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance.
|
|---|---|---|---|
|
Change in Diastolic Blood Pressure at 6 Months
|
1.8 mmHg
Standard Deviation 10.4
|
0 mmHg
Standard Deviation 12.5
|
6.0 mmHg
Standard Deviation 19.7
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Participants who completed 12 month follow-up
Diastolic blood pressure change from baseline to 12 months. Measured using blood pressure cuff and sphygmomanometer. Units in Milometers of Mercury (mmHg). Scale range is based on participants' actual blood pressure (change baseline to 12 months; negative value indicates decrease in blood pressure).
Outcome measures
| Measure |
Usual Care Control
n=40 Participants
No intervention.
|
In Person Weight Management
n=36 Participants
Education and exercise in a community health center environment.
Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance.
|
Video Conference Weight Management
n=26 Participants
Education and exercise delivered through video conference.
Education and exercise: The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance.
|
|---|---|---|---|
|
Change in Diastolic Blood Pressure Baseline to 12 Months
|
-5.8 mmHg
Standard Deviation 11.4
|
-2.6 mmHg
Standard Deviation 11.8
|
-8.1 mmHg
Standard Deviation 20.2
|
Adverse Events
Usual Care Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
In Person Weight Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Video Conference Weight Management
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place