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Trial record 1 of 2 for:    22735431 [PUBMED-IDS]
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Evaluating the Effectiveness of a Stepped-Care Approach to Long-Term Weight Loss (The Step-Up Study) (Step-Up)

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ClinicalTrials.gov Identifier: NCT00714168
Recruitment Status : Completed
First Posted : July 14, 2008
Results First Posted : February 1, 2016
Last Update Posted : February 1, 2016
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
John M. Jakicic, PhD, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Obesity
Interventions Behavioral: Standard Behavioral Weight Loss Program
Behavioral: Stepped-Care Weight Loss Program
Enrollment 363
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Standard Behavioral Weight Loss Program Stepped-Care Weight Loss Program
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 165 198
Completed 121 139
Not Completed 44 59
Reason Not Completed
Pregnancy             5             4
Lost to Follow-up             32             50
Relocation             4             3
Non-study medical condition             3             2
Arm/Group Title Standard Behavioral Weight Loss Program Stepped-Care Weight Loss Program Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 165 198 363
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 165 participants 198 participants 363 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
165
 100.0%
198
 100.0%
363
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 165 participants 198 participants 363 participants
42.39  (9.22) 42.04  (8.89) 42.20  (9.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 165 participants 198 participants 363 participants
Female
136
  82.4%
164
  82.8%
300
  82.6%
Male
29
  17.6%
34
  17.2%
63
  17.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 165 participants 198 participants 363 participants
165 198 363
1.Primary Outcome
Title Weight Loss
Hide Description Change in Weight from Baseline
Time Frame Measured at Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
We used an intention-to-treat analysis with all randomized subjects included in the analysis.
Arm/Group Title Standard Behavioral Weight Loss Program Stepped-Care Weight Loss Program
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 165 198
Least Squares Mean (95% Confidence Interval)
Unit of Measure: kg
-8.1
(-9.4 to -6.9)
-6.9
(-8.0 to -5.8)
2.Secondary Outcome
Title Physical Activity
Hide Description Change in Physical Activity from Baseline
Time Frame Measured at Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat with all randomized subjects included in the analysis.
Arm/Group Title Standard Behavioral Weight Loss Program Stepped-Care Weight Loss Program
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 165 198
Least Squares Mean (95% Confidence Interval)
Unit of Measure: kcal/week
700
(474 to 926)
841
(627 to 1054)
3.Secondary Outcome
Title Energy Intake
Hide Description Change in Energy Intake from Baseline
Time Frame Measured at Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat with all randomized subjects analyzed.
Arm/Group Title Standard Behavioral Weight Loss Program Stepped-Care Weight Loss Program
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 165 198
Least Squares Mean (95% Confidence Interval)
Unit of Measure: kcal/day
-511
(-602 to -420)
-537
(-611 to -463)
4.Secondary Outcome
Title Cardiovascular Fitness
Hide Description Change in Minutes to achieve 85% of age-predicted maximal heart rate from Baseline
Time Frame Measured at Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat with all randomized subjects included in the analysis.
Arm/Group Title Standard Behavioral Weight Loss Program Stepped-Care Weight Loss Program
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 165 198
Least Squares Mean (95% Confidence Interval)
Unit of Measure: minutes
2.7
(2.2 to 3.2)
2.7
(2.3 to 3.1)
5.Secondary Outcome
Title Body Composition
Hide Description Change in Percent Body Fat from Baseline
Time Frame Measured at Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat with all randomized subjects included in the analysis
Arm/Group Title Standard Behavioral Weight Loss Program Stepped-Care Weight Loss Program
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 165 198
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent body fat
-5.6
(-6.4 to -4.8)
-5.0
(-5.7 to -4.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Behavioral Weight Loss Program Stepped-Care Weight Loss Program
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Standard Behavioral Weight Loss Program Stepped-Care Weight Loss Program
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Behavioral Weight Loss Program Stepped-Care Weight Loss Program
Affected / at Risk (%) Affected / at Risk (%)
Total   0/165 (0.00%)   0/198 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Standard Behavioral Weight Loss Program Stepped-Care Weight Loss Program
Affected / at Risk (%) Affected / at Risk (%)
Total   0/165 (0.00%)   0/198 (0.00%) 
This study was not designed to test for weight loss equivalency between conditions. This study is unable to determined if an alternative intensity or frequency of intervention steps would be more or less effective for weight loss.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: John M. Jakicic, PhD
Organization: University of Pittsburgh
Phone: 412-383-4001
Responsible Party: John M. Jakicic, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00714168     History of Changes
Other Study ID Numbers: 584
R01HL084400-04 ( U.S. NIH Grant/Contract )
HL 084400
First Submitted: July 10, 2008
First Posted: July 14, 2008
Results First Submitted: January 6, 2013
Results First Posted: February 1, 2016
Last Update Posted: February 1, 2016