Evaluating Weight Loss Programs for Obese People at Risk for Heart Disease (The POWER Study)
POWER
Practice-Based Opportunities for Weight Reduction Trial at Johns Hopkins
2 other identifiers
interventional
415
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Feb 2008
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 30, 2008
CompletedFirst Posted
Study publicly available on registry
October 31, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2011
CompletedSeptember 5, 2018
August 1, 2018
3.1 years
October 30, 2008
August 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight
Measured at Month 24
Secondary Outcomes (7)
Blood pressure
Measured at Month 24
Hypertension control
Measured at Month 24
Homeostasis model assessment of insulin resistance (HOMA-IR)
Measured at Month 24
Framingham risk
Measured at Month 24
Metabolic syndrome
Measured at Month 24
- +2 more secondary outcomes
Study Arms (3)
1
ACTIVE COMPARATORSelf-Directed Weight Loss Program (Control Group)
2
EXPERIMENTALCall-Center Directed (CCD) Weight Loss Program
3
EXPERIMENTALIn-Person Directed (IPD) Weight Loss Program
Interventions
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.
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.
Participants will meet with study staff at the beginning of the study and will receive written information about weight loss.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Healthways, Inc.collaborator
Study Sites (1)
ProHealth
Baltimore, Maryland, 21207, United States
Related Publications (5)
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.
PMID: 26026649DERIVEDJerome 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.
PMID: 25042773DERIVEDBennett 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.
PMID: 24002616DERIVEDAppel 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.
PMID: 22085317DERIVEDYeh 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.
PMID: 20573639DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lawrence J. Appel, MD
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Persons who measured weight and other outcomes were masked to randomized assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2008
First Posted
October 31, 2008
Study Start
February 1, 2008
Primary Completion
February 28, 2011
Study Completion
February 28, 2011
Last Updated
September 5, 2018
Record last verified: 2018-08