ObesityPOWERNCT00783315
Evaluating Weight Loss Programs for Obese People at Risk for Heart Disease (The POWER Study)
A study testing Call-Center Directed (CCD) Weight Loss Program, In-Person Directed (IPD) Weight Loss Program and Self-Directed Weight Loss Program in people with Obesity, run by Johns Hopkins University at 1 site in United States.
Trial summary
Many people who are obese also have high blood pressure, high cholesterol, or diabetes-all conditions that can increase the risk of heart disease. This study will evaluate two programs that aim to encourage weight loss among obese people who are at risk for developing heart disease. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Call-Center Directed (CCD) Weight Loss Program, In-Person Directed (IPD) Weight Loss Program and Self-Directed Weight Loss Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 415 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2008to 28 Feb 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertension, hypercholesterolemia, and/or diabetes mellitus, all of which are treated with medication, measured in the clinic, or confirmed by primary care provider (systolic blood pressure greater than or equal to 140 mm Hg, diastolic blood pressure greater than or equal to 90 mm Hg, low density lipoprotein cholesterol [LDL-C] greater than or equal to 130 mg/dL, or fasting blood sugar greater than 125 mg/dL)
- BMI of at least 30 to 50 kg/m2 and weight less than or equal to 400 lbs
- Willing to change diet, physical activity, and weight
- Willing to be randomly assigned to any of the study groups
- Patient of a participating doctor
- Patient self-reports two doctor visits in the 12 months before study entry
Show all 13Show fewer
- Demonstrated use of Web and e-mail
- Access to Internet at least 4 days per week
- People with the following conditions are eligible to enroll in the study with primary care provider approval:
- Diabetes mellitus
- Prior cardiovascular disease event more than 6 months before study entry
- Known stable cardiovascular disease or peripheral vascular disease
- Screen positive on Rose Questionnaire
Who cannot join
- Heart attack, stroke, or atherosclerotic cardiovascular disease (ASCVD) procedure in the 6 months before study entry
- Serious medical condition that is likely to hinder accurate measurement of weight, for which weight loss is not advisable, or that would cause weight loss [e.g., end-stage renal disease (ESRD) on dialysis, cancer diagnosis or treatment in the 2 years before study entry]
- Prior or planned bariatric surgery
- Use of prescription weight loss medication, including off-label drugs (e.g., topiramate, bupropion, byetta) or over-the-counter orlistat in the 6 months before study entry
- Long-term use (in the 6 months before study entry) of medications likely to cause weight gain or prevent weight loss (e.g., corticosteroids, lithium, olanzapine, risperidone, clozapine)
- Unintentional weight loss in the 6 months before study entry (greater than or equal to 5% of body weight)
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- Intentional weight loss in the 6 months before study entry (greater than or equal to 5% of body weight)
- Pregnant or breastfeeding in the 6 months before study entry
- Planning to become pregnant in the 2 years after study entry
- Planning to relocate from area in the 2 years after study entry
- Another member of the household is a study participant or study staff member
- Self-reported average consumption of more than 14 alcoholic drinks each week
- Psychiatric hospitalization in the 1 year before study entry
- Unstable angina
- Blood pressure greater than 160/100 mm Hg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Practice-Based Opportunities for Weight Reduction Trial at Johns Hopkins
Many people who are obese also have high blood pressure, high cholesterol, or diabetes-all conditions that can increase the risk of heart disease. This study will evaluate two programs that aim to encourage weight loss among obese people who are at risk for developing heart disease.
Read the detailed description
High blood pressure, high cholesterol, and diabetes are all conditions that increase a person's risk of developing heart disease. Many people with these conditions are also overweight, and it is recommended that such people lose weight to reduce their risk of heart disease. Previous weight loss studies have mainly examined in-person weight loss programs and not Web- or e-mail-based weight loss programs. In addition, the primary care providers of participants in these previous studies typically had no direct involvement in the programs. This study will compare two weight loss programs-an In-Person Directed (IPD) program, which is primarily comprised of in-person visits with health counselors, and a Call-Center Directed (CCD) program, which uses only telephone, Web sites, and e-mail to contact and counsel participants. These two programs will also be compared against a self-directed weight loss program, which will act as a control group. The ultimate purpose of this study is to evaluate the effectiveness of the IPD, CCD, and self-directed programs at increasing weight loss and reducing risk factors in obese people at risk of developing heart disease.
This study will enroll overweight adults who have high blood pressure, high cholesterol, or diabetes. Participants will attend a baseline study visit for weight and blood pressure measurements. They will then be randomly assigned to participate in one of the following three programs for 2 years.
- IPD Program: This program will be directed by health counselors from Johns Hopkins University. For Months 1 to 3, participants will attend a group or individual meeting with a counselor each week. For Months 4 to 6, meetings will be held three times a month; after Month 6, meetings will occur twice a month. Some of these meetings may be held over the phone or by e-mail. Participants will keep a food and exercise diary and they will enter their weight and calorie consumption on the study Web site. Study researchers will provide participants' doctors with relevant information on participants' weight loss.
- CCD Program: This program will be directed by counselors from Healthways, Inc., a company that assists individuals in managing their medical problems. All contacts will occur by phone, e-mail, or the Web; there will be no in-person visits. Participants will be able to review weight loss information on the study Web site. For Months 1 to 3, participants will contact their counselors each week. For Months 4 to 6, contact with study counselors will occur at least once a month; after Month 6, contact with study counselors will occur every other month. Participants will keep a food and exercise diary and they will enter their weight and calorie consumption on the study Web site. Study researchers will provide participants' doctors with relevant information on participants' weight loss.
- Self-Directed Program: In this program, study staff will meet with participants once at the beginning of the study, at which time participants will receive written information about losing weight. Participants will also receive access to a study Web site that has information about weight loss.
All participants will attend study visits at Months 6, 12, and 24 and at the end of the study, which is anticipated to be in February 2011. Study researchers will also collect information by phone at Month 18. At each study visit, participants will complete questionnaires; provide blood samples; and undergo measurements of weight, waist, and blood pressure. A portion of blood may be stored for future studies; this will be optional.
- Conditions
- Obesity
- Being tested
- Call-Center Directed (CCD) Weight Loss Program, In-Person Directed (IPD) Weight Loss Program, Self-Directed Weight Loss Program
- Keywords
- Hypertension, Diabetes, Hypercholesterolemia
- Medical subject headings
- Obesity, Hypertension, Diabetes Mellitus, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Call-Center Directed (CCD) Weight Loss ProgramBehavioural
This program will be implemented by trained counselors of Healthways, Inc., and will use telephone, Web, and e-mail contacts to engage participants. There will be no in-person visits.
In-Person Directed (IPD) Weight Loss ProgramBehavioural
This program will be primarily implemented through in-person visits (including group sessions) with health counselors at Johns Hopkins University. Telephone, Web, and e-mail contacts will occasionally be used.
Self-Directed Weight Loss ProgramBehavioural
Participants will meet with study staff at the beginning of the study and will receive written information about weight loss.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Self-Directed Weight Loss Program (Control Group) Receives: Behavioral: Self-Directed Weight Loss Program |
| 2 | Experimental | Call-Center Directed (CCD) Weight Loss Program Receives: Behavioral: Call-Center Directed (CCD) Weight Loss Program |
| 3 | Experimental | In-Person Directed (IPD) Weight Loss Program Receives: Behavioral: In-Person Directed (IPD) Weight Loss Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured: Measured at Month 24
Secondary outcomes (7)
Blood pressure
Measured: Measured at Month 24
Hypertension control
Measured: Measured at Month 24
Homeostasis model assessment of insulin resistance (HOMA-IR)
Measured: Measured at Month 24
Framingham risk
Measured: Measured at Month 24
Metabolic syndrome
Measured: Measured at Month 24
Body mass index (BMI)
Measured: Measured at Month 24
Lipid levels
Measured: Measured at Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study start1 Feb 2008
- Primary completion28 Feb 2011
- Study completion28 Feb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three Group: 1. advice only comparison group 2. remotely delivered behavioral weight loss group 3. in-person behavioral weight loss group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Healthways, Inc.
- Responsible party
- Sponsor
- Investigators
- Lawrence J. Appel, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783315
- Sponsor's protocol ID
- NA_00012877
- Other IDs
- U01HL087085
- Acronym
- POWER
- Status last verified
- Aug 2018
- First submitted
- 30 Oct 2008
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bennett WL, Wang NY, Gudzune KA, Dalcin AT, Bleich SN, Appel LJ, Clark JM. Satisfaction with primary care provider involvement is associated with greater weight loss: Results from the practice-based POWER trial. Patient Educ Couns. 2015 Sep;98(9):1099-105. doi: 10.1016/j.pec.2015.05.006. Epub 2015 May 27.
PubMed 26026649Jerome GJ, Dalcin A, Coughlin JW, Fitzpatrick S, Wang NY, Durkin N, Yeh HC, Charleston J, Pozefsky T, Daumit GL, Clark JM, Louis TA, Appel LJ. Longitudinal accuracy of web-based self-reported weights: results from the Hopkins POWER Trial. J Med Internet Res. 2014 Jul 15;16(7):e173. doi: 10.2196/jmir.3332.
PubMed 25042773Bennett WL, Gudzune KA, Appel LJ, Clark JM. Insights from the POWER practice-based weight loss trial: a focus group study on the PCP's role in weight management. J Gen Intern Med. 2014 Jan;29(1):50-8. doi: 10.1007/s11606-013-2562-6. Epub 2013 Sep 4.
PubMed 24002616Appel LJ, Clark JM, Yeh HC, Wang NY, Coughlin JW, Daumit G, Miller ER 3rd, Dalcin A, Jerome GJ, Geller S, Noronha G, Pozefsky T, Charleston J, Reynolds JB, Durkin N, Rubin RR, Louis TA, Brancati FL. Comparative effectiveness of weight-loss interventions in clinical practice. N Engl J Med. 2011 Nov 24;365(21):1959-68. doi: 10.1056/NEJMoa1108660. Epub 2011 Nov 15.
PubMed 22085317Yeh HC, Clark JM, Emmons KE, Moore RH, Bennett GG, Warner ET, Sarwer DB, Jerome GJ, Miller ER, Volger S, Louis TA, Wells B, Wadden TA, Colditz GA, Appel LJ. Independent but coordinated trials: insights from the practice-based Opportunities for Weight Reduction Trials Collaborative Research Group. Clin Trials. 2010 Aug;7(4):322-32. doi: 10.1177/1740774510374213. Epub 2010 Jun 23.
PubMed 20573639
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practice-Based Opportunities for Weight Reduction Trial at Johns Hopkins
- ClinicalTrials.gov ID
- NCT00783315
- Acronym / sponsor ID
- POWER / NA_00012877
- Conditions
- Obesity
- Keywords
- Hypertension, Diabetes, Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Healthways, Inc.
- Study start
- 1 Feb 2008 (actual)
- Primary completion
- 28 Feb 2011 (actual)
- Study completion
- 28 Feb 2011 (actual)
- First posted
- 31 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many people who are obese also have high blood pressure, high cholesterol, or diabetes-all conditions that can increase the risk of heart disease. This study will evaluate two programs that aim to encourage weight loss among obese people who are at risk for developing heart disease.
Detailed description
High blood pressure, high cholesterol, and diabetes are all conditions that increase a person's risk of developing heart disease. Many people with these conditions are also overweight, and it is recommended that such people lose weight to reduce their risk of heart disease. Previous weight loss studies have mainly examined in-person weight loss programs and not Web- or e-mail-based weight loss programs. In addition, the primary care providers of participants in these previous studies typically had no direct involvement in the programs. This study will compare two weight loss programs-an In-Person Directed (IPD) program, which is primarily comprised of in-person visits with health counselors, and a Call-Center Directed (CCD) program, which uses only telephone, Web sites, and e-mail to contact and counsel participants. These two programs will also be compared against a self-directed weight loss program, which will act as a control group. The ultimate purpose of this study is to evaluate the effectiveness of the IPD, CCD, and self-directed programs at increasing weight loss and reducing risk factors in obese people at risk of developing heart disease.
This study will enroll overweight adults who have high blood pressure, high cholesterol, or diabetes. Participants will attend a baseline study visit for weight and blood pressure measurements. They will then be randomly assigned to participate in one of the following three programs for 2 years.
- IPD Program: This program will be directed by health counselors from Johns Hopkins University. For Months 1 to 3, participants will attend a group or individual meeting with a counselor each week. For Months 4 to 6, meetings will be held three times a month; after Month 6, meetings will occur twice a month. Some of these meetings may be held over the phone or by e-mail. Participants will keep a food and exercise diary and they will enter their weight and calorie consumption on the study Web site. Study researchers will provide participants' doctors with relevant information on participants' weight loss.
- CCD Program: This program will be directed by counselors from Healthways, Inc., a company that assists individuals in managing their medical problems. All contacts will occur by phone, e-mail, or the Web; there will be no in-person visits. Participants will be able to review weight loss information on the study Web site. For Months 1 to 3, participants will contact their counselors each week. For Months 4 to 6, contact with study counselors will occur at least once a month; after Month 6, contact with study counselors will occur every other month. Participants will keep a food and exercise diary and they will enter their weight and calorie consumption on the study Web site. Study researchers will provide participants' doctors with relevant information on participants' weight loss.
- Self-Directed Program: In this program, study staff will meet with participants once at the beginning of the study, at which time participants will receive written information about losing weight. Participants will also receive access to a study Web site that has information about weight loss.
All participants will attend study visits at Months 6, 12, and 24 and at the end of the study, which is anticipated to be in February 2011. Study researchers will also collect information by phone at Month 18. At each study visit, participants will complete questionnaires; provide blood samples; and undergo measurements of weight, waist, and blood pressure. A portion of blood may be stored for future studies; this will be optional.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three Group: 1. advice only comparison group 2. remotely delivered behavioral weight loss group 3. in-person behavioral weight loss group
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Self-Directed Weight Loss ProgramSelf-Directed Weight Loss Program (Control Group) |
| 2 | Experimental | Behavioral: Call-Center Directed (CCD) Weight Loss ProgramCall-Center Directed (CCD) Weight Loss Program |
| 3 | Experimental | Behavioral: In-Person Directed (IPD) Weight Loss ProgramIn-Person Directed (IPD) Weight Loss Program |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Hypertension, hypercholesterolemia, and/or diabetes mellitus, all of which are treated with medication, measured in the clinic, or confirmed by primary care provider (systolic blood pressure greater than or equal to 140 mm Hg, diastolic blood pressure greater than or equal to 90 mm Hg, low density lipoprotein cholesterol [LDL-C] greater than or equal to 130 mg/dL, or fasting blood sugar greater than 125 mg/dL)
- BMI of at least 30 to 50 kg/m2 and weight less than or equal to 400 lbs
- Willing to change diet, physical activity, and weight
- Willing to be randomly assigned to any of the study groups
- Patient of a participating doctor
Key exclusion criteria (15 listed)
- Heart attack, stroke, or atherosclerotic cardiovascular disease (ASCVD) procedure in the 6 months before study entry
- Serious medical condition that is likely to hinder accurate measurement of weight, for which weight loss is not advisable, or that would cause weight loss [e.g., end-stage renal disease (ESRD) on dialysis, cancer diagnosis or treatment in the 2 years before study entry]
- Prior or planned bariatric surgery
- Use of prescription weight loss medication, including off-label drugs (e.g., topiramate, bupropion, byetta) or over-the-counter orlistat in the 6 months before study entry
- Long-term use (in the 6 months before study entry) of medications likely to cause weight gain or prevent weight loss (e.g., corticosteroids, lithium, olanzapine, risperidone, clozapine)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Call-Center Directed (CCD) Weight Loss ProgramThis program will be implemented by trained counselors of Healthways, Inc., and will use telephone, Web, and e-mail contacts to engage participants. There will be no in-person visits. | Behavioural | 2 |
| In-Person Directed (IPD) Weight Loss ProgramThis program will be primarily implemented through in-person visits (including group sessions) with health counselors at Johns Hopkins University. Telephone, Web, and e-mail contacts will occasionally be used. | Behavioural | 3 |
| Self-Directed Weight Loss ProgramParticipants will meet with study staff at the beginning of the study and will receive written information about weight loss. | Behavioural | 1 |
Primary outcome
Weight
Time frame: Measured at Month 24
7 secondary outcomes
Blood pressure
Time frame: Measured at Month 24
Hypertension control
Time frame: Measured at Month 24
Homeostasis model assessment of insulin resistance (HOMA-IR)
Time frame: Measured at Month 24
Framingham risk
Time frame: Measured at Month 24
Metabolic syndrome
Time frame: Measured at Month 24
Body mass index (BMI)
Time frame: Measured at Month 24
Lipid levels
Time frame: Measured at Month 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Derived from this study: PubMed 26026649Bennett WL, Wang NY, Gudzune KA, Dalcin AT, Bleich SN, Appel LJ, Clark JM. Satisfaction with primary care provider involvement is associated with greater weight loss: Results from the practice-based POWER trial. Patient Educ Couns. 2015 Sep;98(9):1099-105. doi: 10.1016/j.pec.2015.05.006. Epub 2015 May 27.
- Derived from this study: PubMed 25042773Jerome GJ, Dalcin A, Coughlin JW, Fitzpatrick S, Wang NY, Durkin N, Yeh HC, Charleston J, Pozefsky T, Daumit GL, Clark JM, Louis TA, Appel LJ. Longitudinal accuracy of web-based self-reported weights: results from the Hopkins POWER Trial. J Med Internet Res. 2014 Jul 15;16(7):e173. doi: 10.2196/jmir.3332.
- Derived from this study: PubMed 24002616Bennett WL, Gudzune KA, Appel LJ, Clark JM. Insights from the POWER practice-based weight loss trial: a focus group study on the PCP's role in weight management. J Gen Intern Med. 2014 Jan;29(1):50-8. doi: 10.1007/s11606-013-2562-6. Epub 2013 Sep 4.
- Derived from this study: PubMed 22085317Appel LJ, Clark JM, Yeh HC, Wang NY, Coughlin JW, Daumit G, Miller ER 3rd, Dalcin A, Jerome GJ, Geller S, Noronha G, Pozefsky T, Charleston J, Reynolds JB, Durkin N, Rubin RR, Louis TA, Brancati FL. Comparative effectiveness of weight-loss interventions in clinical practice. N Engl J Med. 2011 Nov 24;365(21):1959-68. doi: 10.1056/NEJMoa1108660. Epub 2011 Nov 15.
- Derived from this study: PubMed 20573639Yeh HC, Clark JM, Emmons KE, Moore RH, Bennett GG, Warner ET, Sarwer DB, Jerome GJ, Miller ER, Volger S, Louis TA, Wells B, Wadden TA, Colditz GA, Appel LJ. Independent but coordinated trials: insights from the practice-based Opportunities for Weight Reduction Trials Collaborative Research Group. Clin Trials. 2010 Aug;7(4):322-32. doi: 10.1177/1740774510374213. Epub 2010 Jun 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence J. Appel, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Call-Center Directed (CCD) Weight Loss Program, In-Person Directed (IPD) Weight Loss Program and Self-Directed Weight Loss Program in people with Obesity, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: Measured at Month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00783315, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.