Obesity
Conditions
Keywords
Obesity, Metabolic syndrome, Weight loss, Diabetes prevention
Brief summary
The purpose of this study is to determine if primary care based, telephone-delivered weight loss interventions are effective.
Detailed description
Obesity is related to the rising incidence of type 2 diabetes. Cost-effective interventions leading to sustained weight loss are needed to improve the public health and reverse the alarming rise in diabetes, its cardiovascular complications and other obesity-related illnesses. The Diabetes Prevention Program is identified as a model for a successful weight loss intervention. The proposed study is a randomized controlled trial of 2 active telephone-based interventions based on the Diabetes Prevention Model that will be delivered at primary care sites.
Interventions
BEHAVIORALIndividual 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.
BEHAVIORALGroup 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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
State University of New York - Upstate Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Obese * Metabolic syndrome * Read and write English * Planning to stay in treatment with their PCP for the next 3 years * On stable doses of medications for chronic diseases such as hypothyroidism for 3 years
Exclusion criteria
* Unstable health * Diabetes mellitus * Severe medical comorbidities that might interfere with their ability to participate in intervention such as severe psychiatric disease or significant heart disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | baseline, 1, 2, 3 years | Weight (kg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Lipid Panel | baseline, 1, 2, 3 years | LDL-cholesterol (mg/dL) |
| Fasting Glucose Level | baseline, 1, 2, 3 years | Fasting glucose (mg/dL) |
| Blood Pressure | baseline, 1, 2, 3 years | Systolic blood pressure (mm Hg) / Diastolic blood pressure (mm Hg) |
| SF-12 Physical Summary Score | baseline, 6 months, 1 and 2 years | The 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). |
| International Physical Activity Questionnaire | baseline, 6 months, 1 and 2 years | Measure of physical activity is calculated as in mets/week |
| Health Behaviors (Diet, Physical Activity) | baseline, 6 months, 1 and 2 years | National Cancer Institute Fat screener |
Participant flow
Recruitment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 129 |
| 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. | 128 |
| Total | 257 |
Baseline characteristics
| Characteristic | Individual Calls | Total | Conference Calls |
|---|---|---|---|
| Age, Continuous | 50.7 years STANDARD_DEVIATION 13.1 | 51.7 years STANDARD_DEVIATION 12.9 | 52.7 years STANDARD_DEVIATION 12.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 128 Participants | 254 Participants | 126 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 33 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 110 Participants | 222 Participants | 112 Participants |
| Region of Enrollment United States | 129 participants | 257 participants | 128 participants |
| Sex: Female, Male Female | 101 Participants | 166 Participants | 65 Participants |
| Sex: Female, Male Male | 28 Participants | 91 Participants | 63 Participants |
| Weight | 105.8 kg STANDARD_DEVIATION 23.6 | 107.6 kg STANDARD_DEVIATION 24.9 | 109.4 kg STANDARD_DEVIATION 26.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 129 | 0 / 128 |
| serious Total, serious adverse events | 19 / 129 | 16 / 128 |
Outcome results
Primary
Weight
Weight (kg)
Time frame: baseline, 1, 2, 3 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Individual Calls | Weight | Baseline | 105.8 kg | Standard Deviation 23.6 |
| Individual Calls | Weight | Year 1 | 102.07 kg | Standard Deviation 19.73 |
| Individual Calls | Weight | Year 2 | 104.20 kg | Standard Deviation 21.57 |
| Individual Calls | Weight | Year 3 | 104.47 kg | Standard Deviation 21.51 |
| Conference Calls | Weight | Year 1 | 101.23 kg | Standard Deviation 18.97 |
| Conference Calls | Weight | Year 3 | 100.27 kg | Standard Deviation 20.44 |
| Conference Calls | Weight | Baseline | 109.4 kg | Standard Deviation 26.1 |
| Conference Calls | Weight | Year 2 | 100.33 kg | Standard Deviation 20.49 |
p-value: <0.01Mixed Models Analysis
Secondary
Blood Pressure
Systolic blood pressure (mm Hg) / Diastolic blood pressure (mm Hg)
Time frame: baseline, 1, 2, 3 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Individual Calls | Blood Pressure | Systolic blood pressure baseline | 128.75 mmHg | Standard Deviation 31.13 |
| Individual Calls | Blood Pressure | Diastolic blood pressure Baseline | 75.24 mmHg | Standard Deviation 15.93 |
| Individual Calls | Blood Pressure | Diastolic blood pressure Year 1 | 76.23 mmHg | Standard Deviation 21.33 |
| Individual Calls | Blood Pressure | Systolic blood pressure Year 2 | 132.05 mmHg | Standard Deviation 45.59 |
| Individual Calls | Blood Pressure | Diastolic blood pressure Year 2 | 77.85 mmHg | Standard Deviation 23.24 |
| Individual Calls | Blood Pressure | Systolic blood pressure Year 1 | 129.94 mmHg | Standard Deviation 41.83 |
| Individual Calls | Blood Pressure | Diastolic blood pressure Year 3 | 78.16 mmHg | Standard Deviation 23 |
| Individual Calls | Blood Pressure | Systolic blood pressure Year 3 | 134.43 mmHg | Standard Deviation 45.06 |
| Conference Calls | Blood Pressure | Diastolic blood pressure Year 3 | 75.74 mmHg | Standard Deviation 21.95 |
| Conference Calls | Blood Pressure | Systolic blood pressure baseline | 129.54 mmHg | Standard Deviation 31.24 |
| Conference Calls | Blood Pressure | Systolic blood pressure Year 1 | 129.90 mmHg | Standard Deviation 40.48 |
| Conference Calls | Blood Pressure | Systolic blood pressure Year 2 | 132.60 mmHg | Standard Deviation 43.5 |
| Conference Calls | Blood Pressure | Systolic blood pressure Year 3 | 131.17 mmHg | Standard Deviation 43.04 |
| Conference Calls | Blood Pressure | Diastolic blood pressure Year 1 | 74.83 mmHg | Standard Deviation 20.63 |
| Conference Calls | Blood Pressure | Diastolic blood pressure Year 2 | 76.73 mmHg | Standard Deviation 22.18 |
| Conference Calls | Blood Pressure | Diastolic blood pressure Baseline | 75.61 mmHg | Standard Deviation 16 |
Secondary
Fasting Glucose Level
Fasting glucose (mg/dL)
Time frame: baseline, 1, 2, 3 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Individual Calls | Fasting Glucose Level | Baseline | 99.70 mg/dL | Standard Deviation 30.05 |
| Individual Calls | Fasting Glucose Level | Year 1 | 100.43 mg/dL | Standard Deviation 40.21 |
| Individual Calls | Fasting Glucose Level | Year 2 | 101.12 mg/dL | Standard Deviation 43.83 |
| Individual Calls | Fasting Glucose Level | Year 3 | 101.39 mg/dL | Standard Deviation 43.42 |
| Conference Calls | Fasting Glucose Level | Year 3 | 100.61 mg/dL | Standard Deviation 41.46 |
| Conference Calls | Fasting Glucose Level | Baseline | 99.44 mg/dL | Standard Deviation 30.19 |
| Conference Calls | Fasting Glucose Level | Year 2 | 101.37 mg/dL | Standard Deviation 41.84 |
| Conference Calls | Fasting Glucose Level | Year 1 | 100.72 mg/dL | Standard Deviation 39.15 |
Secondary
Fasting Lipid Panel
LDL-cholesterol (mg/dL)
Time frame: baseline, 1, 2, 3 years
Population: Note: LDL-cholesterol measurements were not available for 13 participants in the Individual Call arm and 6 participants in the Conference Call arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Individual Calls | Fasting Lipid Panel | Baseline | 107.32 mg/dL | Standard Deviation 51.17 |
| Individual Calls | Fasting Lipid Panel | Year 1 | 113.21 mg/dL | Standard Deviation 68.81 |
| Individual Calls | Fasting Lipid Panel | Year 2 | 113.80 mg/dL | Standard Deviation 75.97 |
| Individual Calls | Fasting Lipid Panel | Year 3 | 109.74 mg/dL | Standard Deviation 75.21 |
| Conference Calls | Fasting Lipid Panel | Year 3 | 107.02 mg/dL | Standard Deviation 72.1 |
| Conference Calls | Fasting Lipid Panel | Baseline | 108.01 mg/dL | Standard Deviation 49.91 |
| Conference Calls | Fasting Lipid Panel | Year 2 | 107.91 mg/dL | Standard Deviation 72.13 |
| Conference Calls | Fasting Lipid Panel | Year 1 | 109.11 mg/dL | Standard Deviation 66.94 |
Secondary
Health Behaviors (Diet, Physical Activity)
National Cancer Institute Fat screener
Time frame: baseline, 6 months, 1 and 2 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Individual Calls | Health Behaviors (Diet, Physical Activity) | Change from baseline at 6 months | 2.644 percentage of daily calories from fat | Standard Error 0.622 |
| Individual Calls | Health Behaviors (Diet, Physical Activity) | Change from baseline at 1 year | 2.910 percentage of daily calories from fat | Standard Error 0.599 |
| Individual Calls | Health Behaviors (Diet, Physical Activity) | Change from baseline at 2 years | 1.173 percentage of daily calories from fat | Standard Error 0.643 |
| Conference Calls | Health Behaviors (Diet, Physical Activity) | Change from baseline at 6 months | 1.392 percentage of daily calories from fat | Standard Error 0.617 |
| Conference Calls | Health Behaviors (Diet, Physical Activity) | Change from baseline at 1 year | 1.402 percentage of daily calories from fat | Standard Error 0.605 |
| Conference Calls | Health Behaviors (Diet, Physical Activity) | Change from baseline at 2 years | 1.395 percentage of daily calories from fat | Standard Error 0.632 |
Secondary
International Physical Activity Questionnaire
Measure of physical activity is calculated as in mets/week
Time frame: baseline, 6 months, 1 and 2 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Individual Calls | International Physical Activity Questionnaire | Change from baseline at 6 months | -0.611 mets per week | Standard Error 3.781 |
| Individual Calls | International Physical Activity Questionnaire | Change from baseline at 1 year | 7.229 mets per week | Standard Error 3.978 |
| Individual Calls | International Physical Activity Questionnaire | Change from baseline at 2 years | 10.099 mets per week | Standard Error 4.976 |
| Conference Calls | International Physical Activity Questionnaire | Change from baseline at 6 months | 8.427 mets per week | Standard Error 3.717 |
| Conference Calls | International Physical Activity Questionnaire | Change from baseline at 1 year | 11.812 mets per week | Standard Error 3.735 |
| Conference Calls | International Physical Activity Questionnaire | Change from baseline at 2 years | 15.968 mets per week | Standard Error 4.646 |
Secondary
SF-12 Physical Summary Score
The 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).
Time frame: baseline, 6 months, 1 and 2 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Individual Calls | SF-12 Physical Summary Score | Change from baseline at 6 months | 2.543 units on a scale | Standard Error 1.056 |
| Individual Calls | SF-12 Physical Summary Score | Change from baseline at 1 year | 1.064 units on a scale | Standard Error 1.2 |
| Individual Calls | SF-12 Physical Summary Score | Change from baseline at 2 years | 1.506 units on a scale | Standard Error 1.358 |
| Conference Calls | SF-12 Physical Summary Score | Change from baseline at 6 months | 1.274 units on a scale | Standard Error 1.028 |
| Conference Calls | SF-12 Physical Summary Score | Change from baseline at 1 year | 1.082 units on a scale | Standard Error 1.102 |
| Conference Calls | SF-12 Physical Summary Score | Change from baseline at 2 years | 0.932 units on a scale | Standard Error 1.297 |