Trial Outcomes & Findings for Study to Promote Weight Loss in Primary Care Practices (NCT NCT00749606)
NCT ID: NCT00749606
Last Updated: 2018-02-12
Results Overview
Weight (kg)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
257 participants
Primary outcome timeframe
baseline, 1, 2, 3 years
Results posted on
2018-02-12
Participant Flow
Enrollment took place from June 22, 2009 - Oct 2, 2010 from 5 diverse primary care practice sites in upstate NY: Oneida Healthcare Center (small city), Pulaski Health Center (rural), Syracuse Community Healthcare Center and University Health Care Center (urban, poor, medium city), and University Internists (higher income, medium city).
Participant milestones
| Measure |
Individual Calls
Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.
Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.
|
Conference Calls
Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.
Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.
|
|---|---|---|
|
Year 1
STARTED
|
129
|
128
|
|
Year 1
COMPLETED
|
74
|
80
|
|
Year 1
NOT COMPLETED
|
55
|
48
|
|
Year 2
STARTED
|
74
|
80
|
|
Year 2
COMPLETED
|
63
|
72
|
|
Year 2
NOT COMPLETED
|
11
|
8
|
|
Year 3 (Observation)
STARTED
|
63
|
72
|
|
Year 3 (Observation)
COMPLETED
|
63
|
69
|
|
Year 3 (Observation)
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Promote Weight Loss in Primary Care Practices
Baseline characteristics by cohort
| Measure |
Individual Calls
n=129 Participants
Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.
Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.
|
Conference Calls
n=128 Participants
Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.
Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.
|
Total
n=257 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.7 years
STANDARD_DEVIATION 13.1 • n=93 Participants
|
52.7 years
STANDARD_DEVIATION 12.8 • n=4 Participants
|
51.7 years
STANDARD_DEVIATION 12.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
166 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=93 Participants
|
63 Participants
n=4 Participants
|
91 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
128 Participants
n=93 Participants
|
126 Participants
n=4 Participants
|
254 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
110 Participants
n=93 Participants
|
112 Participants
n=4 Participants
|
222 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
129 participants
n=93 Participants
|
128 participants
n=4 Participants
|
257 participants
n=27 Participants
|
|
Weight
|
105.8 kg
STANDARD_DEVIATION 23.6 • n=93 Participants
|
109.4 kg
STANDARD_DEVIATION 26.1 • n=4 Participants
|
107.6 kg
STANDARD_DEVIATION 24.9 • n=27 Participants
|
PRIMARY outcome
Timeframe: baseline, 1, 2, 3 yearsWeight (kg)
Outcome measures
| Measure |
Individual Telephone Intervention
n=129 Participants
Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.
Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.
|
Group Telephone Intervention
n=128 Participants
Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.
Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.
|
|---|---|---|
|
Weight
Baseline
|
105.8 kg
Standard Deviation 23.6
|
109.4 kg
Standard Deviation 26.1
|
|
Weight
Year 1
|
102.07 kg
Standard Deviation 19.73
|
101.23 kg
Standard Deviation 18.97
|
|
Weight
Year 2
|
104.20 kg
Standard Deviation 21.57
|
100.33 kg
Standard Deviation 20.49
|
|
Weight
Year 3
|
104.47 kg
Standard Deviation 21.51
|
100.27 kg
Standard Deviation 20.44
|
SECONDARY outcome
Timeframe: baseline, 1, 2, 3 yearsSystolic blood pressure (mm Hg) / Diastolic blood pressure (mm Hg)
Outcome measures
| Measure |
Individual Telephone Intervention
n=129 Participants
Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.
Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.
|
Group Telephone Intervention
n=128 Participants
Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.
Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.
|
|---|---|---|
|
Blood Pressure
Systolic blood pressure baseline
|
128.75 mmHg
Standard Deviation 31.13
|
129.54 mmHg
Standard Deviation 31.24
|
|
Blood Pressure
Systolic blood pressure Year 1
|
129.94 mmHg
Standard Deviation 41.83
|
129.90 mmHg
Standard Deviation 40.48
|
|
Blood Pressure
Systolic blood pressure Year 2
|
132.05 mmHg
Standard Deviation 45.59
|
132.60 mmHg
Standard Deviation 43.50
|
|
Blood Pressure
Systolic blood pressure Year 3
|
134.43 mmHg
Standard Deviation 45.06
|
131.17 mmHg
Standard Deviation 43.04
|
|
Blood Pressure
Diastolic blood pressure Baseline
|
75.24 mmHg
Standard Deviation 15.93
|
75.61 mmHg
Standard Deviation 16.00
|
|
Blood Pressure
Diastolic blood pressure Year 1
|
76.23 mmHg
Standard Deviation 21.33
|
74.83 mmHg
Standard Deviation 20.63
|
|
Blood Pressure
Diastolic blood pressure Year 2
|
77.85 mmHg
Standard Deviation 23.24
|
76.73 mmHg
Standard Deviation 22.18
|
|
Blood Pressure
Diastolic blood pressure Year 3
|
78.16 mmHg
Standard Deviation 23.00
|
75.74 mmHg
Standard Deviation 21.95
|
SECONDARY outcome
Timeframe: baseline, 1, 2, 3 yearsPopulation: Note: LDL-cholesterol measurements were not available for 13 participants in the Individual Call arm and 6 participants in the Conference Call arm
LDL-cholesterol (mg/dL)
Outcome measures
| Measure |
Individual Telephone Intervention
n=116 Participants
Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.
Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.
|
Group Telephone Intervention
n=122 Participants
Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.
Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.
|
|---|---|---|
|
Fasting Lipid Panel
Baseline
|
107.32 mg/dL
Standard Deviation 51.17
|
108.01 mg/dL
Standard Deviation 49.91
|
|
Fasting Lipid Panel
Year 1
|
113.21 mg/dL
Standard Deviation 68.81
|
109.11 mg/dL
Standard Deviation 66.94
|
|
Fasting Lipid Panel
Year 2
|
113.80 mg/dL
Standard Deviation 75.97
|
107.91 mg/dL
Standard Deviation 72.13
|
|
Fasting Lipid Panel
Year 3
|
109.74 mg/dL
Standard Deviation 75.21
|
107.02 mg/dL
Standard Deviation 72.10
|
SECONDARY outcome
Timeframe: baseline, 1, 2, 3 yearsFasting glucose (mg/dL)
Outcome measures
| Measure |
Individual Telephone Intervention
n=129 Participants
Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.
Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.
|
Group Telephone Intervention
n=128 Participants
Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.
Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.
|
|---|---|---|
|
Fasting Glucose Level
Baseline
|
99.70 mg/dL
Standard Deviation 30.05
|
99.44 mg/dL
Standard Deviation 30.19
|
|
Fasting Glucose Level
Year 1
|
100.43 mg/dL
Standard Deviation 40.21
|
100.72 mg/dL
Standard Deviation 39.15
|
|
Fasting Glucose Level
Year 2
|
101.12 mg/dL
Standard Deviation 43.83
|
101.37 mg/dL
Standard Deviation 41.84
|
|
Fasting Glucose Level
Year 3
|
101.39 mg/dL
Standard Deviation 43.42
|
100.61 mg/dL
Standard Deviation 41.46
|
SECONDARY outcome
Timeframe: baseline, 6 months, 1 and 2 yearsNational Cancer Institute Fat screener
Outcome measures
| Measure |
Individual Telephone Intervention
n=129 Participants
Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.
Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.
|
Group Telephone Intervention
n=128 Participants
Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.
Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.
|
|---|---|---|
|
Health Behaviors (Diet, Physical Activity)
Change from baseline at 6 months
|
2.644 percentage of daily calories from fat
Standard Error 0.622
|
1.392 percentage of daily calories from fat
Standard Error 0.617
|
|
Health Behaviors (Diet, Physical Activity)
Change from baseline at 1 year
|
2.910 percentage of daily calories from fat
Standard Error 0.599
|
1.402 percentage of daily calories from fat
Standard Error 0.605
|
|
Health Behaviors (Diet, Physical Activity)
Change from baseline at 2 years
|
1.173 percentage of daily calories from fat
Standard Error 0.643
|
1.395 percentage of daily calories from fat
Standard Error 0.632
|
SECONDARY outcome
Timeframe: baseline, 6 months, 1 and 2 yearsThe impact of physical health on overall quality of life; higher score reflects better quality of life. Range 0-100 (0 indicates the lowest level and 100 the highest level of health).
Outcome measures
| Measure |
Individual Telephone Intervention
n=129 Participants
Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.
Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.
|
Group Telephone Intervention
n=128 Participants
Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.
Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.
|
|---|---|---|
|
SF-12 Physical Summary Score
Change from baseline at 6 months
|
2.543 units on a scale
Standard Error 1.056
|
1.274 units on a scale
Standard Error 1.028
|
|
SF-12 Physical Summary Score
Change from baseline at 1 year
|
1.064 units on a scale
Standard Error 1.200
|
1.082 units on a scale
Standard Error 1.102
|
|
SF-12 Physical Summary Score
Change from baseline at 2 years
|
1.506 units on a scale
Standard Error 1.358
|
0.932 units on a scale
Standard Error 1.297
|
SECONDARY outcome
Timeframe: baseline, 6 months, 1 and 2 yearsMeasure of physical activity is calculated as in mets/week
Outcome measures
| Measure |
Individual Telephone Intervention
n=129 Participants
Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.
Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.
|
Group Telephone Intervention
n=128 Participants
Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.
Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.
|
|---|---|---|
|
International Physical Activity Questionnaire
Change from baseline at 6 months
|
-0.611 mets per week
Standard Error 3.781
|
8.427 mets per week
Standard Error 3.717
|
|
International Physical Activity Questionnaire
Change from baseline at 1 year
|
7.229 mets per week
Standard Error 3.978
|
11.812 mets per week
Standard Error 3.735
|
|
International Physical Activity Questionnaire
Change from baseline at 2 years
|
10.099 mets per week
Standard Error 4.976
|
15.968 mets per week
Standard Error 4.646
|
Adverse Events
Individual Calls
Serious events: 19 serious events
Other events: 0 other events
Deaths: 0 deaths
Conference Calls
Serious events: 16 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Individual Calls
n=129 participants at risk
Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.
Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.
|
Conference Calls
n=128 participants at risk
Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.
Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.
|
|---|---|---|
|
Cardiac disorders
Hospitalization
|
1.6%
2/129 • Number of events 2 • 3 years
|
3.1%
4/128 • Number of events 5 • 3 years
|
|
Psychiatric disorders
Hospitalization
|
0.78%
1/129 • Number of events 1 • 3 years
|
0.78%
1/128 • Number of events 2 • 3 years
|
|
Endocrine disorders
Hospitalization
|
0.78%
1/129 • Number of events 1 • 3 years
|
0.00%
0/128 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hospitalization
|
0.78%
1/129 • Number of events 1 • 3 years
|
0.00%
0/128 • 3 years
|
|
Gastrointestinal disorders
Hospitalization
|
0.00%
0/129 • 3 years
|
1.6%
2/128 • Number of events 2 • 3 years
|
|
Hepatobiliary disorders
Hospitalization
|
1.6%
2/129 • Number of events 2 • 3 years
|
0.00%
0/128 • 3 years
|
|
General disorders
Hospitalization
|
2.3%
3/129 • Number of events 3 • 3 years
|
0.00%
0/128 • 3 years
|
|
General disorders
Death
|
0.78%
1/129 • Number of events 1 • 3 years
|
0.00%
0/128 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
0.00%
0/129 • 3 years
|
1.6%
2/128 • Number of events 3 • 3 years
|
|
Vascular disorders
Hospitalization
|
0.78%
1/129 • Number of events 1 • 3 years
|
1.6%
2/128 • Number of events 2 • 3 years
|
|
Immune system disorders
Hospitalization
|
0.00%
0/129 • 3 years
|
0.78%
1/128 • Number of events 1 • 3 years
|
|
Infections and infestations
Hospitalization
|
1.6%
2/129 • Number of events 2 • 3 years
|
3.1%
4/128 • Number of events 4 • 3 years
|
|
Injury, poisoning and procedural complications
Hospitalizations
|
1.6%
2/129 • Number of events 2 • 3 years
|
0.00%
0/128 • 3 years
|
|
Surgical and medical procedures
Hospitalization
|
5.4%
7/129 • Number of events 7 • 3 years
|
3.9%
5/128 • Number of events 6 • 3 years
|
|
Nervous system disorders
Hospitalization
|
2.3%
3/129 • Number of events 4 • 3 years
|
0.78%
1/128 • Number of events 1 • 3 years
|
Other adverse events
Adverse event data not reported
Additional Information
Ruth S. Weinstock MD PhD
SUNY Upstate Medical University
Phone: 315-464-5740
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place