Trial Outcomes & Findings for Survivorship Promotion In Reducing IGF-1 Trial (NCT NCT02431676)
NCT ID: NCT02431676
Last Updated: 2024-08-28
Results Overview
Insulin-like growth factor (IGF)-1 levels (ng/ml) at 6 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
121 participants
Primary outcome timeframe
6 months
Results posted on
2024-08-28
Participant Flow
Participant milestones
| Measure |
Self-Directed
In this group, the study staff will meet with you once at the beginning of the study to give you written information about weight management.
Self-control weight loss
|
Coach Directed Behavioral Weight Loss
The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight
Coach Directed Behavioral Weight Loss: Behavioral-based telephonic coaching with web-based support to promote healthy lifestyle and weight loss in overweight and obese adults.The goal of this intervention is to achieve at least 5% weight loss in the first six months of the intervention and maintain these improvements through month twelve by meeting dietary and exercise goals
|
Metformin
This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals
Metformin: Participants will receive metformin, an oral medication for type 2 diabetes.Participants randomized to the metformin intervention will receive metformin up to 2,000 mg per day.Dosing can be flexible, two or three times per day with meals as tolerated for 12 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
39
|
42
|
|
Overall Study
COMPLETED
|
40
|
38
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Self-Directed
In this group, the study staff will meet with you once at the beginning of the study to give you written information about weight management.
Self-control weight loss
|
Coach Directed Behavioral Weight Loss
The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight
Coach Directed Behavioral Weight Loss: Behavioral-based telephonic coaching with web-based support to promote healthy lifestyle and weight loss in overweight and obese adults.The goal of this intervention is to achieve at least 5% weight loss in the first six months of the intervention and maintain these improvements through month twelve by meeting dietary and exercise goals
|
Metformin
This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals
Metformin: Participants will receive metformin, an oral medication for type 2 diabetes.Participants randomized to the metformin intervention will receive metformin up to 2,000 mg per day.Dosing can be flexible, two or three times per day with meals as tolerated for 12 months.
|
|---|---|---|---|
|
Overall Study
no lab obtained
|
0
|
1
|
2
|
Baseline Characteristics
Survivorship Promotion In Reducing IGF-1 Trial
Baseline characteristics by cohort
| Measure |
Self-Directed
n=40 Participants
In this group, the study staff will meet with you once at the beginning of the study to give you written information about weight management.
Self-control weight loss
|
Coach Directed Behavioral Weight Loss
n=39 Participants
The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight
Coach Directed Behavioral Weight Loss: Behavioral-based telephonic coaching with web-based support to promote healthy lifestyle and weight loss in overweight and obese adults.The goal of this intervention is to achieve at least 5% weight loss in the first six months of the intervention and maintain these improvements through month twelve by meeting dietary and exercise goals
|
Metformin
n=42 Participants
This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals
Metformin: Participants will receive metformin, an oral medication for type 2 diabetes.Participants randomized to the metformin intervention will receive metformin up to 2,000 mg per day.Dosing can be flexible, two or three times per day with meals as tolerated for 12 months.
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
60.9 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
59.5 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 9.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other non-black races
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
BMI
|
34.7 kg/m^2
STANDARD_DEVIATION 4.9 • n=5 Participants
|
35.5 kg/m^2
STANDARD_DEVIATION 5.0 • n=7 Participants
|
35.0 kg/m^2
STANDARD_DEVIATION 6.3 • n=5 Participants
|
35.0 kg/m^2
STANDARD_DEVIATION 5.4 • n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthsInsulin-like growth factor (IGF)-1 levels (ng/ml) at 6 months.
Outcome measures
| Measure |
Self-Directed
n=40 Participants
In this group, the study staff will meet with you once at the beginning of the study to give you written information about weight management.
Self-control weight loss
|
Coach Directed Behavioral Weight Loss
n=38 Participants
The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight
Coach Directed Behavioral Weight Loss: Behavioral-based telephonic coaching with web-based support to promote healthy lifestyle and weight loss in overweight and obese adults.The goal of this intervention is to achieve at least 5% weight loss in the first six months of the intervention and maintain these improvements through month twelve by meeting dietary and exercise goals
|
Metformin
n=40 Participants
This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals
Metformin: Participants will receive metformin, an oral medication for type 2 diabetes.Participants randomized to the metformin intervention will receive metformin up to 2,000 mg per day.Dosing can be flexible, two or three times per day with meals as tolerated for 12 months.
|
|---|---|---|---|
|
IGF-1 Levels
|
73.2 ng/ml
Standard Deviation 19.9
|
73.6 ng/ml
Standard Deviation 20.9
|
71.2 ng/ml
Standard Deviation 21.4
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data was obtained for 39 participants in the self-directed arm, 37 in the coach directed arm and 37 in the metformin arm for this outcome measure.
IGF-1 at 12 months
Outcome measures
| Measure |
Self-Directed
n=39 Participants
In this group, the study staff will meet with you once at the beginning of the study to give you written information about weight management.
Self-control weight loss
|
Coach Directed Behavioral Weight Loss
n=37 Participants
The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight
Coach Directed Behavioral Weight Loss: Behavioral-based telephonic coaching with web-based support to promote healthy lifestyle and weight loss in overweight and obese adults.The goal of this intervention is to achieve at least 5% weight loss in the first six months of the intervention and maintain these improvements through month twelve by meeting dietary and exercise goals
|
Metformin
n=37 Participants
This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals
Metformin: Participants will receive metformin, an oral medication for type 2 diabetes.Participants randomized to the metformin intervention will receive metformin up to 2,000 mg per day.Dosing can be flexible, two or three times per day with meals as tolerated for 12 months.
|
|---|---|---|---|
|
IGF-1 Levels
|
73.4 ng/ml
Standard Deviation 20.7
|
76.6 ng/ml
Standard Deviation 25.7
|
76.2 ng/ml
Standard Deviation 25.7
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data was obtained for 39 participants in the self-directed arm, 37 in the coach directed arm and 36 in the metformin arm for this outcome measure.
IGF-1 level to IGFBP3 level ratio (molar ratio) at 6 months.
Outcome measures
| Measure |
Self-Directed
n=39 Participants
In this group, the study staff will meet with you once at the beginning of the study to give you written information about weight management.
Self-control weight loss
|
Coach Directed Behavioral Weight Loss
n=37 Participants
The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight
Coach Directed Behavioral Weight Loss: Behavioral-based telephonic coaching with web-based support to promote healthy lifestyle and weight loss in overweight and obese adults.The goal of this intervention is to achieve at least 5% weight loss in the first six months of the intervention and maintain these improvements through month twelve by meeting dietary and exercise goals
|
Metformin
n=36 Participants
This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals
Metformin: Participants will receive metformin, an oral medication for type 2 diabetes.Participants randomized to the metformin intervention will receive metformin up to 2,000 mg per day.Dosing can be flexible, two or three times per day with meals as tolerated for 12 months.
|
|---|---|---|---|
|
IGF-1 to IGFBP3 Level Ratio (Molar Ratio)
|
0.18 ratio
Standard Deviation 0.047
|
0.18 ratio
Standard Deviation 0.065
|
0.17 ratio
Standard Deviation 0.046
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 and 12 monthsChanges in weight among Metformin group, or coach-directed Groups versus the self-directed arm at 6 and 12 months
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 and 12 monthsChanges in BMI among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 and 12 monthsChanges in EuroQol score among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 and 12 monthsChanges in dietary intake among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 and 12 monthsChanges in physical activity amount among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 and 12 monthsChanges in fasting glucose among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 and 12 monthsChanges in insulin among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 and 12 monthsChanges in Hb-A1C among Metformin arm, or Coach-directed behavioral weight loss arm versus the Self-control weight loss arm at 6 and 12 months.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 and 12 monthsChanges in IL-6 among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 and 12 monthsChanges in IL-8 among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 and 12 monthsChanges in CRP among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 and 12 monthsassessing side effect among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.
Outcome measures
Outcome data not reported
Adverse Events
Self-Directed
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
Coach Directed Behavioral Weight Loss
Serious events: 5 serious events
Other events: 3 other events
Deaths: 0 deaths
Metformin
Serious events: 12 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Self-Directed
n=40 participants at risk
In this group, the study staff will meet with you once at the beginning of the study to give you written information about weight management.
Self-control weight loss
|
Coach Directed Behavioral Weight Loss
n=39 participants at risk
The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight
Coach Directed Behavioral Weight Loss: Behavioral-based telephonic coaching with web-based support to promote healthy lifestyle and weight loss in overweight and obese adults.The goal of this intervention is to achieve at least 5% weight loss in the first six months of the intervention and maintain these improvements through month twelve by meeting dietary and exercise goals
|
Metformin
n=42 participants at risk
This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals
Metformin: Participants will receive metformin, an oral medication for type 2 diabetes.Participants randomized to the metformin intervention will receive metformin up to 2,000 mg per day.Dosing can be flexible, two or three times per day with meals as tolerated for 12 months.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
7.5%
3/40 • 12 month
|
5.1%
2/39 • 12 month
|
2.4%
1/42 • 12 month
|
|
Cardiac disorders
CVD
|
0.00%
0/40 • 12 month
|
0.00%
0/39 • 12 month
|
7.1%
3/42 • 12 month
|
|
General disorders
Other
|
7.5%
3/40 • 12 month
|
7.7%
3/39 • 12 month
|
19.0%
8/42 • 12 month
|
Other adverse events
| Measure |
Self-Directed
n=40 participants at risk
In this group, the study staff will meet with you once at the beginning of the study to give you written information about weight management.
Self-control weight loss
|
Coach Directed Behavioral Weight Loss
n=39 participants at risk
The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight
Coach Directed Behavioral Weight Loss: Behavioral-based telephonic coaching with web-based support to promote healthy lifestyle and weight loss in overweight and obese adults.The goal of this intervention is to achieve at least 5% weight loss in the first six months of the intervention and maintain these improvements through month twelve by meeting dietary and exercise goals
|
Metformin
n=42 participants at risk
This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals
Metformin: Participants will receive metformin, an oral medication for type 2 diabetes.Participants randomized to the metformin intervention will receive metformin up to 2,000 mg per day.Dosing can be flexible, two or three times per day with meals as tolerated for 12 months.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.00%
0/40 • 12 month
|
5.1%
2/39 • 12 month
|
4.8%
2/42 • 12 month
|
|
Cardiac disorders
Heart Disease
|
0.00%
0/40 • 12 month
|
0.00%
0/39 • 12 month
|
4.8%
2/42 • 12 month
|
|
Musculoskeletal and connective tissue disorders
Injury
|
12.5%
5/40 • 12 month
|
2.6%
1/39 • 12 month
|
4.8%
2/42 • 12 month
|
|
Gastrointestinal disorders
Gallstone
|
5.0%
2/40 • 12 month
|
0.00%
0/39 • 12 month
|
0.00%
0/42 • 12 month
|
|
Surgical and medical procedures
Gallstone removal
|
5.0%
2/40 • 12 month
|
0.00%
0/39 • 12 month
|
0.00%
0/42 • 12 month
|
|
Surgical and medical procedures
bariatric surgery
|
2.5%
1/40 • 12 month
|
0.00%
0/39 • 12 month
|
0.00%
0/42 • 12 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place