Trial Outcomes & Findings for Reach for Health Study: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors (NCT NCT01302379)
NCT ID: NCT01302379
Last Updated: 2020-06-05
Results Overview
Insulin measured as percent change from baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
333 participants
Primary outcome timeframe
change from baseline to 6 months
Results posted on
2020-06-05
Participant Flow
Participant milestones
| Measure |
Metformin + Lifestyle Intervention
Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time
Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.
|
Placebo + Lifestyle Intervention
Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time
Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.
|
Metformin + Standard Dietary Guidelines
Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time
Standard printed dietary guidelines: Set of standard health education materials provided to participants at single time point (immediately after randomization)
|
Placebo + Standard Dietary Guidelines
Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time
Standard printed dietary guidelines: Set of standard health education materials provided to participants at single time point (immediately after randomization)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
83
|
83
|
84
|
83
|
|
Overall Study
COMPLETED
|
76
|
78
|
80
|
79
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reach for Health Study: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors
Baseline characteristics by cohort
| Measure |
Metformin + Lifestyle Intervention
n=83 Participants
Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time
Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.
|
Placebo + Lifestyle Intervention
n=83 Participants
Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time
Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.
|
Metformin + Standard Dietary Guidelines
n=84 Participants
Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time
Standard printed dietary guidelines: Set of standard health education materials provided to participants at single time point (immediately after randomization)
|
Placebo + Standard Dietary Guidelines
n=83 Participants
Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time
Standard printed dietary guidelines: Set of standard health education materials provided to participants at single time point (immediately after randomization)
|
Total
n=333 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
62.9 years
STANDARD_DEVIATION 62.1 • n=7 Participants
|
62.1 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
63.1 years
STANDARD_DEVIATION 7.4 • n=4 Participants
|
62.6 years
STANDARD_DEVIATION 6.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
333 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
294 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
69 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
277 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Mixed Race or Other race
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Time Since Diagnosis
|
2.4 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
3.1 years
STANDARD_DEVIATION 2.4 • n=7 Participants
|
2.6 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
2.5 years
STANDARD_DEVIATION 1.7 • n=4 Participants
|
2.7 years
STANDARD_DEVIATION 2.0 • n=21 Participants
|
|
Body Mass Index
|
31.4 kg/m2
STANDARD_DEVIATION 5.2 • n=5 Participants
|
30.8 kg/m2
STANDARD_DEVIATION 4.6 • n=7 Participants
|
30.8 kg/m2
STANDARD_DEVIATION 4.7 • n=5 Participants
|
31.5 kg/m2
STANDARD_DEVIATION 5.4 • n=4 Participants
|
31.1 kg/m2
STANDARD_DEVIATION 5.0 • n=21 Participants
|
PRIMARY outcome
Timeframe: change from baseline to 6 monthsPopulation: Obese or overweight postmenopausal breast cancer survivors
Insulin measured as percent change from baseline
Outcome measures
| Measure |
Metformin + Lifestyle Intervention
n=83 Participants
Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time
Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.
|
Placebo + Lifestyle Intervention
n=83 Participants
Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time
Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.
|
Metformin + Standard Dietary Guidelines
n=84 Participants
Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time
Standard printed dietary guidelines: Set of standard health education materials provided to participants at single time point (immediately after randomization)
|
Placebo + Standard Dietary Guidelines
n=83 Participants
Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time
Standard printed dietary guidelines: Set of standard health education materials provided to participants at single time point (immediately after randomization)
|
|---|---|---|---|---|
|
Insulin
|
-21.8 percent change from baseline
Interval -29.7 to -13.0
|
-17.7 percent change from baseline
Interval -25.9 to -8.6
|
-13.2 percent change from baseline
Interval -21.7 to -3.7
|
-1.1 percent change from baseline
Interval -10.9 to 9.8
|
PRIMARY outcome
Timeframe: change from baseline to 6 monthsPopulation: Obese or overweight postmenopausal breast cancer survivors
Glucose measured as percent change from baseline
Outcome measures
| Measure |
Metformin + Lifestyle Intervention
n=83 Participants
Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time
Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.
|
Placebo + Lifestyle Intervention
n=83 Participants
Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time
Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.
|
Metformin + Standard Dietary Guidelines
n=84 Participants
Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time
Standard printed dietary guidelines: Set of standard health education materials provided to participants at single time point (immediately after randomization)
|
Placebo + Standard Dietary Guidelines
n=83 Participants
Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time
Standard printed dietary guidelines: Set of standard health education materials provided to participants at single time point (immediately after randomization)
|
|---|---|---|---|---|
|
Glucose
|
-1.2 percent change from baseline
Interval -3.9 to 1.5
|
-2.3 percent change from baseline
Interval -4.9 to 0.4
|
-1.6 percent change from baseline
Interval -4.2 to 1.0
|
2.0 percent change from baseline
Interval -0.7 to 4.8
|
PRIMARY outcome
Timeframe: change from baseline to 6 monthsPopulation: Obese or overweight postmenopausal breast cancer survivors
C-reactive protein measured as percent change from baseline
Outcome measures
| Measure |
Metformin + Lifestyle Intervention
n=83 Participants
Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time
Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.
|
Placebo + Lifestyle Intervention
n=83 Participants
Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time
Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.
|
Metformin + Standard Dietary Guidelines
n=84 Participants
Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time
Standard printed dietary guidelines: Set of standard health education materials provided to participants at single time point (immediately after randomization)
|
Placebo + Standard Dietary Guidelines
n=83 Participants
Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time
Standard printed dietary guidelines: Set of standard health education materials provided to participants at single time point (immediately after randomization)
|
|---|---|---|---|---|
|
C-reactive Protein
|
-21.4 percent change from baseline
Interval -38.9 to 1.0
|
-6.7 percent change from baseline
Interval -27.4 to 19.7
|
-9.2 percent change from baseline
Interval -29.0 to 16.1
|
5.9 percent change from baseline
Interval -17.4 to 35.7
|
PRIMARY outcome
Timeframe: change from baseline to 6 monthsPopulation: Obese or overweight postmenopausal breast cancer survivors
Bioavailable testosterone measured as percent change from baseline
Outcome measures
| Measure |
Metformin + Lifestyle Intervention
n=83 Participants
Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time
Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.
|
Placebo + Lifestyle Intervention
n=83 Participants
Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time
Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.
|
Metformin + Standard Dietary Guidelines
n=84 Participants
Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time
Standard printed dietary guidelines: Set of standard health education materials provided to participants at single time point (immediately after randomization)
|
Placebo + Standard Dietary Guidelines
n=83 Participants
Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time
Standard printed dietary guidelines: Set of standard health education materials provided to participants at single time point (immediately after randomization)
|
|---|---|---|---|---|
|
Bioavailable Testosterone
|
-13.7 percent change from baseline
Interval -20.3 to -6.5
|
-4.5 percent change from baseline
Interval -11.7 to 3.4
|
-11.1 percent change from baseline
Interval -17.8 to -3.9
|
-1.3 percent change from baseline
Interval -8.7 to 6.7
|
PRIMARY outcome
Timeframe: change from baseline to 6 monthsPopulation: Obese or overweight postmenopausal breast cancer survivors
Serum hormone binding globulin measured as percent change from baseline
Outcome measures
| Measure |
Metformin + Lifestyle Intervention
n=83 Participants
Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time
Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.
|
Placebo + Lifestyle Intervention
n=83 Participants
Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time
Lifestyle intervention: Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.
|
Metformin + Standard Dietary Guidelines
n=84 Participants
Metformin: Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time
Standard printed dietary guidelines: Set of standard health education materials provided to participants at single time point (immediately after randomization)
|
Placebo + Standard Dietary Guidelines
n=83 Participants
Placebo: Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time
Standard printed dietary guidelines: Set of standard health education materials provided to participants at single time point (immediately after randomization)
|
|---|---|---|---|---|
|
Serum Hormone Binding Globulin
|
12.5 percent change from baseline
Interval 5.9 to 19.6
|
7.6 percent change from baseline
Interval 1.4 to 14.3
|
9.8 percent change from baseline
Interval 3.5 to 16.5
|
-0.1 percent change from baseline
Interval -5.9 to 6.1
|
Adverse Events
Metformin vs Placebo
Serious events: 5 serious events
Other events: 1 other events
Deaths: 0 deaths
Lifestyle vs. Control
Serious events: 5 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Metformin vs Placebo
n=333 participants at risk
Main effect for Metformin vs Placebo
|
Lifestyle vs. Control
n=333 participants at risk
Main effect for the lifestyle intervention vs control intervention
|
|---|---|---|
|
General disorders
Injury due to fall
|
0.30%
1/333 • Number of events 1 • Across the 6 month intervention
The study was designed and powered for a main effects analysis and therefore the results are presented as per the original statistical plan: Metformin vs. Placebo and Lifestyle intervention vs. Control.
|
0.30%
1/333 • Number of events 1 • Across the 6 month intervention
The study was designed and powered for a main effects analysis and therefore the results are presented as per the original statistical plan: Metformin vs. Placebo and Lifestyle intervention vs. Control.
|
|
General disorders
Abdominal pain
|
0.30%
1/333 • Number of events 1 • Across the 6 month intervention
The study was designed and powered for a main effects analysis and therefore the results are presented as per the original statistical plan: Metformin vs. Placebo and Lifestyle intervention vs. Control.
|
0.30%
1/333 • Number of events 1 • Across the 6 month intervention
The study was designed and powered for a main effects analysis and therefore the results are presented as per the original statistical plan: Metformin vs. Placebo and Lifestyle intervention vs. Control.
|
|
General disorders
slurred speach
|
0.30%
1/333 • Number of events 1 • Across the 6 month intervention
The study was designed and powered for a main effects analysis and therefore the results are presented as per the original statistical plan: Metformin vs. Placebo and Lifestyle intervention vs. Control.
|
0.30%
1/333 • Number of events 1 • Across the 6 month intervention
The study was designed and powered for a main effects analysis and therefore the results are presented as per the original statistical plan: Metformin vs. Placebo and Lifestyle intervention vs. Control.
|
|
General disorders
transient neurological defect
|
0.30%
1/333 • Number of events 1 • Across the 6 month intervention
The study was designed and powered for a main effects analysis and therefore the results are presented as per the original statistical plan: Metformin vs. Placebo and Lifestyle intervention vs. Control.
|
0.30%
1/333 • Number of events 1 • Across the 6 month intervention
The study was designed and powered for a main effects analysis and therefore the results are presented as per the original statistical plan: Metformin vs. Placebo and Lifestyle intervention vs. Control.
|
|
Cardiac disorders
transient ischemic attack
|
0.30%
1/333 • Number of events 1 • Across the 6 month intervention
The study was designed and powered for a main effects analysis and therefore the results are presented as per the original statistical plan: Metformin vs. Placebo and Lifestyle intervention vs. Control.
|
0.30%
1/333 • Number of events 1 • Across the 6 month intervention
The study was designed and powered for a main effects analysis and therefore the results are presented as per the original statistical plan: Metformin vs. Placebo and Lifestyle intervention vs. Control.
|
Other adverse events
| Measure |
Metformin vs Placebo
n=333 participants at risk
Main effect for Metformin vs Placebo
|
Lifestyle vs. Control
n=333 participants at risk
Main effect for the lifestyle intervention vs control intervention
|
|---|---|---|
|
General disorders
Itching
|
0.30%
1/333 • Number of events 1 • Across the 6 month intervention
The study was designed and powered for a main effects analysis and therefore the results are presented as per the original statistical plan: Metformin vs. Placebo and Lifestyle intervention vs. Control.
|
0.30%
1/333 • Number of events 1 • Across the 6 month intervention
The study was designed and powered for a main effects analysis and therefore the results are presented as per the original statistical plan: Metformin vs. Placebo and Lifestyle intervention vs. Control.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place