Trial Outcomes & Findings for Lifestyle Education for Activity and Nutrition for a Leaner You (NCT NCT00957008)
NCT ID: NCT00957008
Last Updated: 2019-04-19
Results Overview
Waist circumference was measured at the level of the umbilicus with a plastic tape measure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
197 participants
Primary outcome timeframe
Month 9
Results posted on
2019-04-19
Participant Flow
We conducted a total of 787 telephone screening interviews between February 2008 and February 2009 from the greater Columbia, South Carolina area. 197 men and women were eligible. Participants were recruited using a wide variety of techniques, including newspaper, mailers, community events, and worksite and other e-mail distributions.
Exclusion criteria included significant weight loss (\>20 lbs) in the last 6 months, elevated blood pressure (160/95 mm Hg), ailments that limited their physical activity, or serious medical conditions or other issues (e.g. pregnancy or depression) contraindicating or confounding the weight loss intervention.
Participant milestones
| Measure |
Group-based Behavioral Weight Loss Education Group (GWL)
During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
|
Combined GWL and SWA Group (GWL+SWA)
These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
|
Armband Alone Group (SWA-alone)
The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
|
Standard Care (Control Group)
Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual's focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
49
|
49
|
49
|
50
|
|
Overall Study
COMPLETED
|
28
|
37
|
32
|
26
|
|
Overall Study
NOT COMPLETED
|
21
|
12
|
17
|
24
|
Reasons for withdrawal
| Measure |
Group-based Behavioral Weight Loss Education Group (GWL)
During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
|
Combined GWL and SWA Group (GWL+SWA)
These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
|
Armband Alone Group (SWA-alone)
The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
|
Standard Care (Control Group)
Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual's focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
13
|
10
|
12
|
16
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
3
|
4
|
|
Overall Study
Physician Decision
|
1
|
0
|
1
|
1
|
|
Overall Study
Relocated; Family conflict
|
4
|
1
|
1
|
3
|
Baseline Characteristics
Lifestyle Education for Activity and Nutrition for a Leaner You
Baseline characteristics by cohort
| Measure |
Group-based Behavioral Weight Loss Education Group (GWL)
n=49 Participants
During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
|
Combined GWL and SWA Group (GWL+SWA)
n=49 Participants
These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
|
Armband Alone Group (SWA-alone)
n=49 Participants
The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
|
Standard Care (Control Group)
n=50 Participants
Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual's focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
|
Total
n=197 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
50 Participants
n=7 Participants
|
194 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Age, Continuous
|
46.8 years
STANDARD_DEVIATION 12.4 • n=99 Participants
|
45.7 years
STANDARD_DEVIATION 10.4 • n=107 Participants
|
47.7 years
STANDARD_DEVIATION 11.6 • n=206 Participants
|
47.2 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
46.9 years
STANDARD_DEVIATION 10.8 • n=31 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
161 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
36 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=99 Participants
|
49 participants
n=107 Participants
|
49 participants
n=206 Participants
|
50 participants
n=7 Participants
|
197 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Month 9Waist circumference was measured at the level of the umbilicus with a plastic tape measure.
Outcome measures
| Measure |
A - GWL
n=49 Participants
Group Weight Loss Program (GWL) - Participants in this group attended a 14-session group weight loss program administered by trained facilitators plus 6 one-on-one telephone sessions with a facilitator.
Group weight loss program: Participants will be asked to attend 14 one-and-half-hour group sessions at the University of South Carolina's Public Health Research Center (PHRC) over a 16 week period. After the groups end, they will be asked to take part in 6 telephone calls during their remaining 2 months in the program. They will also receive a weight loss manual.
|
B - GWL+SWA
n=49 Participants
Group weight loss program plus use of the Senseware Armband - Participants in this group attended a 14-session group weight loss program administered by trained facilitators plus 6 one-on-one telephone sessions with a facilitator and wore a SenseWear Armband. The SenseWear system includes the Armband, a real-time display device, and a personalized Weight Management Solutions web account. Participants received training in using the Armband and were asked to wear it at least 16 hours per day.
Group weight loss program plus use of the Senseware Armband: Participants will be asked to attend 15 one-and-half-hour group sessions at the University of South Carolina's Public Health Research Center (PHRC) over a 17 week period. After the groups end, they will be asked to take part in 6 telephone calls during their remaining 2 months in the program. They will also receive a SenseWear Armband to wear during their 6 months in the program. One of these group sessions will be devoted to learning
|
C - SWA Alone
n=49 Participants
Use of the senseware armband alone program - The intervention for the SWA Alone group was the SenseWear system includes the Armband, a real-time display device, and a personalized Weight Management Solutions web account. Participants received training in using the Armband and were asked to wear it at least 16 hours per day.
Use of the senseware armband alone program: Participants will be asked to attend a one-hour group session at the University of South Carolina's Public Health Research Center (PHRC) to learn how to use the SenseWear Armband. They will then be asked to take part in a follow-up telephone call one week after they start wearing the armband. For the 6 months they are in the program, they will be asked to wear the Armband regularly, upload data from the Armband to a web-based application, and input nutritional and health information into a personalized web account. They will also receive a weight loss manual in addition to the Armband.
|
D - Standard Care
n=50 Participants
Standard Care - Participants in this group received a self-directed weight loss manual that focused on cognitive and behavior change principles and learning activities based on Active Living Every Day and Healthy Eating Every Day
|
|---|---|---|---|---|
|
Waist Circumference
|
105.87 cm
Standard Error 2.24
|
99.27 cm
Standard Error 2.22
|
102.32 cm
Standard Error 2.23
|
102.77 cm
Standard Error 2.28
|
PRIMARY outcome
Timeframe: nine monthBody weight was assessed using a calibrated balance-beam scale.
Outcome measures
| Measure |
A - GWL
n=49 Participants
Group Weight Loss Program (GWL) - Participants in this group attended a 14-session group weight loss program administered by trained facilitators plus 6 one-on-one telephone sessions with a facilitator.
Group weight loss program: Participants will be asked to attend 14 one-and-half-hour group sessions at the University of South Carolina's Public Health Research Center (PHRC) over a 16 week period. After the groups end, they will be asked to take part in 6 telephone calls during their remaining 2 months in the program. They will also receive a weight loss manual.
|
B - GWL+SWA
n=49 Participants
Group weight loss program plus use of the Senseware Armband - Participants in this group attended a 14-session group weight loss program administered by trained facilitators plus 6 one-on-one telephone sessions with a facilitator and wore a SenseWear Armband. The SenseWear system includes the Armband, a real-time display device, and a personalized Weight Management Solutions web account. Participants received training in using the Armband and were asked to wear it at least 16 hours per day.
Group weight loss program plus use of the Senseware Armband: Participants will be asked to attend 15 one-and-half-hour group sessions at the University of South Carolina's Public Health Research Center (PHRC) over a 17 week period. After the groups end, they will be asked to take part in 6 telephone calls during their remaining 2 months in the program. They will also receive a SenseWear Armband to wear during their 6 months in the program. One of these group sessions will be devoted to learning
|
C - SWA Alone
n=49 Participants
Use of the senseware armband alone program - The intervention for the SWA Alone group was the SenseWear system includes the Armband, a real-time display device, and a personalized Weight Management Solutions web account. Participants received training in using the Armband and were asked to wear it at least 16 hours per day.
Use of the senseware armband alone program: Participants will be asked to attend a one-hour group session at the University of South Carolina's Public Health Research Center (PHRC) to learn how to use the SenseWear Armband. They will then be asked to take part in a follow-up telephone call one week after they start wearing the armband. For the 6 months they are in the program, they will be asked to wear the Armband regularly, upload data from the Armband to a web-based application, and input nutritional and health information into a personalized web account. They will also receive a weight loss manual in addition to the Armband.
|
D - Standard Care
n=50 Participants
Standard Care - Participants in this group received a self-directed weight loss manual that focused on cognitive and behavior change principles and learning activities based on Active Living Every Day and Healthy Eating Every Day
|
|---|---|---|---|---|
|
Body Weight
|
99.98 Kg
Standard Error 3.00
|
93.73 Kg
Standard Error 2.99
|
97.60 Kg
Standard Error 2.99
|
101.32 Kg
Standard Error 3.05
|
PRIMARY outcome
Timeframe: 4 monthOutcome measures
| Measure |
A - GWL
n=49 Participants
Group Weight Loss Program (GWL) - Participants in this group attended a 14-session group weight loss program administered by trained facilitators plus 6 one-on-one telephone sessions with a facilitator.
Group weight loss program: Participants will be asked to attend 14 one-and-half-hour group sessions at the University of South Carolina's Public Health Research Center (PHRC) over a 16 week period. After the groups end, they will be asked to take part in 6 telephone calls during their remaining 2 months in the program. They will also receive a weight loss manual.
|
B - GWL+SWA
n=49 Participants
Group weight loss program plus use of the Senseware Armband - Participants in this group attended a 14-session group weight loss program administered by trained facilitators plus 6 one-on-one telephone sessions with a facilitator and wore a SenseWear Armband. The SenseWear system includes the Armband, a real-time display device, and a personalized Weight Management Solutions web account. Participants received training in using the Armband and were asked to wear it at least 16 hours per day.
Group weight loss program plus use of the Senseware Armband: Participants will be asked to attend 15 one-and-half-hour group sessions at the University of South Carolina's Public Health Research Center (PHRC) over a 17 week period. After the groups end, they will be asked to take part in 6 telephone calls during their remaining 2 months in the program. They will also receive a SenseWear Armband to wear during their 6 months in the program. One of these group sessions will be devoted to learning
|
C - SWA Alone
n=49 Participants
Use of the senseware armband alone program - The intervention for the SWA Alone group was the SenseWear system includes the Armband, a real-time display device, and a personalized Weight Management Solutions web account. Participants received training in using the Armband and were asked to wear it at least 16 hours per day.
Use of the senseware armband alone program: Participants will be asked to attend a one-hour group session at the University of South Carolina's Public Health Research Center (PHRC) to learn how to use the SenseWear Armband. They will then be asked to take part in a follow-up telephone call one week after they start wearing the armband. For the 6 months they are in the program, they will be asked to wear the Armband regularly, upload data from the Armband to a web-based application, and input nutritional and health information into a personalized web account. They will also receive a weight loss manual in addition to the Armband.
|
D - Standard Care
n=50 Participants
Standard Care - Participants in this group received a self-directed weight loss manual that focused on cognitive and behavior change principles and learning activities based on Active Living Every Day and Healthy Eating Every Day
|
|---|---|---|---|---|
|
Body Weight
|
100.74 kg
Standard Error 2.99
|
96.83 kg
Standard Error 2.99
|
98.48 kg
Standard Error 2.97
|
101.23 kg
Standard Error 3.03
|
PRIMARY outcome
Timeframe: 4 monthOutcome measures
| Measure |
A - GWL
n=49 Participants
Group Weight Loss Program (GWL) - Participants in this group attended a 14-session group weight loss program administered by trained facilitators plus 6 one-on-one telephone sessions with a facilitator.
Group weight loss program: Participants will be asked to attend 14 one-and-half-hour group sessions at the University of South Carolina's Public Health Research Center (PHRC) over a 16 week period. After the groups end, they will be asked to take part in 6 telephone calls during their remaining 2 months in the program. They will also receive a weight loss manual.
|
B - GWL+SWA
n=49 Participants
Group weight loss program plus use of the Senseware Armband - Participants in this group attended a 14-session group weight loss program administered by trained facilitators plus 6 one-on-one telephone sessions with a facilitator and wore a SenseWear Armband. The SenseWear system includes the Armband, a real-time display device, and a personalized Weight Management Solutions web account. Participants received training in using the Armband and were asked to wear it at least 16 hours per day.
Group weight loss program plus use of the Senseware Armband: Participants will be asked to attend 15 one-and-half-hour group sessions at the University of South Carolina's Public Health Research Center (PHRC) over a 17 week period. After the groups end, they will be asked to take part in 6 telephone calls during their remaining 2 months in the program. They will also receive a SenseWear Armband to wear during their 6 months in the program. One of these group sessions will be devoted to learning
|
C - SWA Alone
n=49 Participants
Use of the senseware armband alone program - The intervention for the SWA Alone group was the SenseWear system includes the Armband, a real-time display device, and a personalized Weight Management Solutions web account. Participants received training in using the Armband and were asked to wear it at least 16 hours per day.
Use of the senseware armband alone program: Participants will be asked to attend a one-hour group session at the University of South Carolina's Public Health Research Center (PHRC) to learn how to use the SenseWear Armband. They will then be asked to take part in a follow-up telephone call one week after they start wearing the armband. For the 6 months they are in the program, they will be asked to wear the Armband regularly, upload data from the Armband to a web-based application, and input nutritional and health information into a personalized web account. They will also receive a weight loss manual in addition to the Armband.
|
D - Standard Care
n=50 Participants
Standard Care - Participants in this group received a self-directed weight loss manual that focused on cognitive and behavior change principles and learning activities based on Active Living Every Day and Healthy Eating Every Day
|
|---|---|---|---|---|
|
Waist Circumference
|
107.10 cm
Standard Error 2.23
|
102.12 cm
Standard Error 2.21
|
102.99 cm
Standard Error 2.21
|
104.69 cm
Standard Error 2.26
|
SECONDARY outcome
Timeframe: Month 9Population: Last observation carried forward
Outcome measures
| Measure |
A - GWL
n=44 Participants
Group Weight Loss Program (GWL) - Participants in this group attended a 14-session group weight loss program administered by trained facilitators plus 6 one-on-one telephone sessions with a facilitator.
Group weight loss program: Participants will be asked to attend 14 one-and-half-hour group sessions at the University of South Carolina's Public Health Research Center (PHRC) over a 16 week period. After the groups end, they will be asked to take part in 6 telephone calls during their remaining 2 months in the program. They will also receive a weight loss manual.
|
B - GWL+SWA
n=39 Participants
Group weight loss program plus use of the Senseware Armband - Participants in this group attended a 14-session group weight loss program administered by trained facilitators plus 6 one-on-one telephone sessions with a facilitator and wore a SenseWear Armband. The SenseWear system includes the Armband, a real-time display device, and a personalized Weight Management Solutions web account. Participants received training in using the Armband and were asked to wear it at least 16 hours per day.
Group weight loss program plus use of the Senseware Armband: Participants will be asked to attend 15 one-and-half-hour group sessions at the University of South Carolina's Public Health Research Center (PHRC) over a 17 week period. After the groups end, they will be asked to take part in 6 telephone calls during their remaining 2 months in the program. They will also receive a SenseWear Armband to wear during their 6 months in the program. One of these group sessions will be devoted to learning
|
C - SWA Alone
n=41 Participants
Use of the senseware armband alone program - The intervention for the SWA Alone group was the SenseWear system includes the Armband, a real-time display device, and a personalized Weight Management Solutions web account. Participants received training in using the Armband and were asked to wear it at least 16 hours per day.
Use of the senseware armband alone program: Participants will be asked to attend a one-hour group session at the University of South Carolina's Public Health Research Center (PHRC) to learn how to use the SenseWear Armband. They will then be asked to take part in a follow-up telephone call one week after they start wearing the armband. For the 6 months they are in the program, they will be asked to wear the Armband regularly, upload data from the Armband to a web-based application, and input nutritional and health information into a personalized web account. They will also receive a weight loss manual in addition to the Armband.
|
D - Standard Care
n=40 Participants
Standard Care - Participants in this group received a self-directed weight loss manual that focused on cognitive and behavior change principles and learning activities based on Active Living Every Day and Healthy Eating Every Day
|
|---|---|---|---|---|
|
Blood Fasting Glucose
|
-5.42 mg/dl
Interval -10.21 to -0.62
|
-12.59 mg/dl
Interval -17.6 to -7.57
|
-8.88 mg/dl
Interval -13.76 to -4.01
|
1.99 mg/dl
Interval -2.79 to 6.76
|
Adverse Events
Group-based Behavioral Weight Loss Education Group (GWL)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Combined GWL and SWA Group (GWL+SWA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Armband Alone Group (SWA-alone)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care (Control Group)
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