Trial Outcomes & Findings for Evaluating the Effectiveness of a Stepped-Care Approach to Long-Term Weight Loss (The Step-Up Study) (NCT NCT00714168)
NCT ID: NCT00714168
Last Updated: 2016-02-01
Results Overview
Change in Weight from Baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
363 participants
Primary outcome timeframe
Measured at Month 18
Results posted on
2016-02-01
Participant Flow
Recruitment included television and newspaper advertisements. Participants were enrolled between May 2008 and February 2010 at 2 clinical sites: 1) University of Pittsburgh, 2) University of North Carolina - Chapel Hill.
433 individuals attended an orientation and provided written informed consent. Of these, 70 did not schedule a baseline assessment, failed to show for a baseline assessment, or were found to be ineligible after written consent was obtain. Thus, 363 were randomized to participate in this study.
Participant milestones
| Measure |
Standard Behavioral Weight Loss Program
Participants will take part in a standard behavioral weight loss program.
Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss.
|
Stepped-Care Weight Loss Program
Participants will take part in a stepped-care weight loss program.
Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level.
|
|---|---|---|
|
Overall Study
STARTED
|
165
|
198
|
|
Overall Study
COMPLETED
|
121
|
139
|
|
Overall Study
NOT COMPLETED
|
44
|
59
|
Reasons for withdrawal
| Measure |
Standard Behavioral Weight Loss Program
Participants will take part in a standard behavioral weight loss program.
Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss.
|
Stepped-Care Weight Loss Program
Participants will take part in a stepped-care weight loss program.
Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level.
|
|---|---|---|
|
Overall Study
Pregnancy
|
5
|
4
|
|
Overall Study
Lost to Follow-up
|
32
|
50
|
|
Overall Study
Relocation
|
4
|
3
|
|
Overall Study
Non-study medical condition
|
3
|
2
|
Baseline Characteristics
Evaluating the Effectiveness of a Stepped-Care Approach to Long-Term Weight Loss (The Step-Up Study)
Baseline characteristics by cohort
| Measure |
Standard Behavioral Weight Loss Program
n=165 Participants
Participants will take part in a standard behavioral weight loss program.
Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss.
|
Stepped-Care Weight Loss Program
n=198 Participants
Participants will take part in a stepped-care weight loss program.
Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level.
|
Total
n=363 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
165 Participants
n=5 Participants
|
198 Participants
n=7 Participants
|
363 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42.39 years
STANDARD_DEVIATION 9.22 • n=5 Participants
|
42.04 years
STANDARD_DEVIATION 8.89 • n=7 Participants
|
42.20 years
STANDARD_DEVIATION 9.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
300 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
165 participants
n=5 Participants
|
198 participants
n=7 Participants
|
363 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 18Population: We used an intention-to-treat analysis with all randomized subjects included in the analysis.
Change in Weight from Baseline
Outcome measures
| Measure |
Standard Behavioral Weight Loss Program
n=165 Participants
Participants will take part in a standard behavioral weight loss program.
Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss.
|
Stepped-Care Weight Loss Program
n=198 Participants
Participants will take part in a stepped-care weight loss program.
Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level.
|
|---|---|---|
|
Weight Loss
|
-8.1 kg
Interval -9.4 to -6.9
|
-6.9 kg
Interval -8.0 to -5.8
|
SECONDARY outcome
Timeframe: Measured at Month 18Population: Intention-to-treat with all randomized subjects included in the analysis.
Change in Physical Activity from Baseline
Outcome measures
| Measure |
Standard Behavioral Weight Loss Program
n=165 Participants
Participants will take part in a standard behavioral weight loss program.
Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss.
|
Stepped-Care Weight Loss Program
n=198 Participants
Participants will take part in a stepped-care weight loss program.
Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level.
|
|---|---|---|
|
Physical Activity
|
700 kcal/week
Interval 474.0 to 926.0
|
841 kcal/week
Interval 627.0 to 1054.0
|
SECONDARY outcome
Timeframe: Measured at Month 18Population: Intention-to-treat with all randomized subjects analyzed.
Change in Energy Intake from Baseline
Outcome measures
| Measure |
Standard Behavioral Weight Loss Program
n=165 Participants
Participants will take part in a standard behavioral weight loss program.
Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss.
|
Stepped-Care Weight Loss Program
n=198 Participants
Participants will take part in a stepped-care weight loss program.
Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level.
|
|---|---|---|
|
Energy Intake
|
-511 kcal/day
Interval -602.0 to -420.0
|
-537 kcal/day
Interval -611.0 to -463.0
|
SECONDARY outcome
Timeframe: Measured at Month 18Population: Intention-to-treat with all randomized subjects included in the analysis.
Change in Minutes to achieve 85% of age-predicted maximal heart rate from Baseline
Outcome measures
| Measure |
Standard Behavioral Weight Loss Program
n=165 Participants
Participants will take part in a standard behavioral weight loss program.
Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss.
|
Stepped-Care Weight Loss Program
n=198 Participants
Participants will take part in a stepped-care weight loss program.
Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level.
|
|---|---|---|
|
Cardiovascular Fitness
|
2.7 minutes
Interval 2.2 to 3.2
|
2.7 minutes
Interval 2.3 to 3.1
|
SECONDARY outcome
Timeframe: Measured at Month 18Population: Intention-to-treat with all randomized subjects included in the analysis
Change in Percent Body Fat from Baseline
Outcome measures
| Measure |
Standard Behavioral Weight Loss Program
n=165 Participants
Participants will take part in a standard behavioral weight loss program.
Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss.
|
Stepped-Care Weight Loss Program
n=198 Participants
Participants will take part in a stepped-care weight loss program.
Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level.
|
|---|---|---|
|
Body Composition
|
-5.6 percent body fat
Interval -6.4 to -4.8
|
-5.0 percent body fat
Interval -5.7 to -4.3
|
Adverse Events
Standard Behavioral Weight Loss Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stepped-Care Weight Loss Program
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