ObesityNCT01222858
Innovative Technology To Improve Patient Adherence To Weight Loss Recommendations
A study testing Diet and Activity Education and Self-monitoring with Feedback in people with Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
The proposed project addresses the significant problem of obesity and uses innovative technology to improve adherence to a behavioral weight loss strategies. If the program is effective, it would provide an outstanding resource for physicians to use with their patients and thus would have tremendous clinical impact. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- Diet and Activity Education and Self-monitoring with Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to May 2013
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI between 25 and 45 kg/m2
- Referred by their physician because of an obesity-related co-morbidity, such as diabetes, hypertension or metabolic syndrome
- All ethnic groups will be recruited
- No health problems that make weight loss or unsupervised exercise unsafe
- English speaking
- Have access to a computer and the Internet
Who cannot join
- report a heart condition, chest pain during periods of activity or rest, or loss of consciousness
- are currently pregnant or intend to become pregnant in the next 12 months
- are planning to move outside of the state within the next 12 months
- have participated in a study conducted by the Weight Control \& Diabetes Research Center in the past 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Innovative Technology to Improve Patient Adherence to Weight Loss Recommendations
The proposed project addresses the significant problem of obesity and uses innovative technology to improve adherence to a behavioral weight loss strategies. If the program is effective, it would provide an outstanding resource for physicians to use with their patients and thus would have tremendous clinical impact.
Read the detailed description
Overweight/obesity is a major health problem that affects over two-thirds of Americans, increases morbidity and mortality and has annual medical costs exceeding $75 billion. Although many Americans indicate that they are trying to lose weight, adherence to weight loss regimens is often poor. Programs are needed that can improve adherence and weight loss for overweight/obese individuals. Physicians play an important role in motivating patients to improve health behaviors and recent reviews suggest that having physicians advise patients to lose weight and then referring patients to an effective program produces the best behavior change and maintenance. The problem, however, is that physicians currently have limited options for such referrals. The challenge for the field is to develop a program to which physicians can refer their overweight/obese patients. The program must be low cost, easily accessible, and must promote adherence to the weight loss regimen and consequently improve weight loss outcomes.
The goal of this Challenge Grant application is to develop and test an innovative web-based program that would provide an accessible and effective approach to enhancing adherence to clinical recommendations for weight loss. If effective, the program would provide an outstanding resource for physicians and their patients and could consequently have important clinical and public health impact.
We propose to develop a program based on our prior research that uses innovative Internet technology to provide a low cost, easily disseminated program that captures two critical elements of effective behavioral weight loss programs-namely, training in key behavioral weight control strategies and increased participant accountability. Patients, referred by their physician for weight loss, will be offered a 12 week program that they can view at their convenience on their computer. The program will use Web-based interactive multi-media approaches for presentation of the behavioral skills and provide a Web-based form for submission of self-monitoring and weight data; to maximize patient accountability, the program will include a system of automated feedback for participants, which comments on their weight loss to date and their performance within several behavioral weight-loss domains, with suggestions tailored to the characteristics and performance of the individual. Periodic reports on the patients' progress will also be sent to the referring physician. We will test this program in a randomized trial with 250 patients referred by their physicians who will be randomly assigned to either Internet Education (Control) (N=125) or to the Innovative Technology program (N=125). Participants in both groups will receive a 12 week Internet program of either basic weight loss education or the Innovative Technology program and will be weighed at the start and end of the 3 month program and at 3 month follow-up. The primary hypothesis is that patients who are assigned to the Innovative Technology program will achieve larger average weight losses than those in the control group over the 12-week program. Secondary hypotheses are that the Innovative technology group will adhere better over the 12-weeks (assessed by log-ins to the web site and self-reported changes in diet and activity) and achieve better weight losses at 6 months than the control group.
The proposed project addresses the significant problem of obesity and uses innovative technology to improve adherence to a behavioral weight loss strategies. If the program is effective, it would provide an outstanding resource for physicians to use with their patients and thus would have tremendous clinical impact.
- Conditions
- Obesity
- Being tested
- Diet and Activity Education, Self-monitoring with Feedback
- Keywords
- Obesity, Primary Care, Internet, Technology, Behavior Modification
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet and Activity EducationBehavioural
Education about behavioral modification of eating and activity habits for weight loss.
Self-monitoring with FeedbackBehavioural
Participants self-monitor diet and activity behaviors, which are submitted via a website. Automated feedback on the self-monitoring record is provided to participants.
| Study group | Role | What they receive |
|---|---|---|
| Internet Education Program | Active comparator | Participants receive 12 weekly Internet-based weight loss lessons containing information for modification of diet and activity behaviors. Receives: Behavioral: Diet and Activity Education |
| Innovative Technology Intervention | Experimental | Participants receive a 12-week Internet-based eating and activity intervention including multimedia lessons and enhanced self-monitoring of weight loss behaviors with automated feedback. Receives: Behavioral: Diet and Activity Education; Behavioral: Self-monitoring with Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Amount of weight lost (kg) from initial body weight at study entry.
Measured: Baseline, 3-mos, 6-mos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rena R. Wing, The Miriam Hospital
- Investigators
- Rena R. Wing, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222858
- Sponsor's protocol ID
- 5RC1HL100002-02
- Status last verified
- Jul 2014
- First submitted
- 15 Oct 2010
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Technology to Improve Patient Adherence to Weight Loss Recommendations
- ClinicalTrials.gov ID
- NCT01222858
- Acronym / sponsor ID
- 5RC1HL100002-02
- Conditions
- Obesity
- Keywords
- Obesity, Primary Care, Internet, Technology, Behavior Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 18 Oct 2010 (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.
The proposed project addresses the significant problem of obesity and uses innovative technology to improve adherence to a behavioral weight loss strategies. If the program is effective, it would provide an outstanding resource for physicians to use with their patients and thus would have tremendous clinical impact.
Detailed description
Overweight/obesity is a major health problem that affects over two-thirds of Americans, increases morbidity and mortality and has annual medical costs exceeding $75 billion. Although many Americans indicate that they are trying to lose weight, adherence to weight loss regimens is often poor. Programs are needed that can improve adherence and weight loss for overweight/obese individuals. Physicians play an important role in motivating patients to improve health behaviors and recent reviews suggest that having physicians advise patients to lose weight and then referring patients to an effective program produces the best behavior change and maintenance. The problem, however, is that physicians currently have limited options for such referrals. The challenge for the field is to develop a program to which physicians can refer their overweight/obese patients. The program must be low cost, easily accessible, and must promote adherence to the weight loss regimen and consequently improve weight loss outcomes.
The goal of this Challenge Grant application is to develop and test an innovative web-based program that would provide an accessible and effective approach to enhancing adherence to clinical recommendations for weight loss. If effective, the program would provide an outstanding resource for physicians and their patients and could consequently have important clinical and public health impact.
We propose to develop a program based on our prior research that uses innovative Internet technology to provide a low cost, easily disseminated program that captures two critical elements of effective behavioral weight loss programs-namely, training in key behavioral weight control strategies and increased participant accountability. Patients, referred by their physician for weight loss, will be offered a 12 week program that they can view at their convenience on their computer. The program will use Web-based interactive multi-media approaches for presentation of the behavioral skills and provide a Web-based form for submission of self-monitoring and weight data; to maximize patient accountability, the program will include a system of automated feedback for participants, which comments on their weight loss to date and their performance within several behavioral weight-loss domains, with suggestions tailored to the characteristics and performance of the individual. Periodic reports on the patients' progress will also be sent to the referring physician. We will test this program in a randomized trial with 250 patients referred by their physicians who will be randomly assigned to either Internet Education (Control) (N=125) or to the Innovative Technology program (N=125). Participants in both groups will receive a 12 week Internet program of either basic weight loss education or the Innovative Technology program and will be weighed at the start and end of the 3 month program and at 3 month follow-up. The primary hypothesis is that patients who are assigned to the Innovative Technology program will achieve larger average weight losses than those in the control group over the 12-week program. Secondary hypotheses are that the Innovative technology group will adhere better over the 12-weeks (assessed by log-ins to the web site and self-reported changes in diet and activity) and achieve better weight losses at 6 months than the control group.
The proposed project addresses the significant problem of obesity and uses innovative technology to improve adherence to a behavioral weight loss strategies. If the program is effective, it would provide an outstanding resource for physicians to use with their patients and thus would have tremendous clinical impact.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet Education Program | Active comparator | Behavioral: Diet and Activity EducationParticipants receive 12 weekly Internet-based weight loss lessons containing information for modification of diet and activity behaviors. |
| Innovative Technology Intervention | Experimental | Behavioral: Diet and Activity Education, Behavioral: Self-monitoring with FeedbackParticipants receive a 12-week Internet-based eating and activity intervention including multimedia lessons and enhanced self-monitoring of weight loss behaviors with automated feedback. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- BMI between 25 and 45 kg/m2
- Referred by their physician because of an obesity-related co-morbidity, such as diabetes, hypertension or metabolic syndrome
- All ethnic groups will be recruited
- No health problems that make weight loss or unsupervised exercise unsafe
- English speaking
Key exclusion criteria (4 listed)
- report a heart condition, chest pain during periods of activity or rest, or loss of consciousness
- are currently pregnant or intend to become pregnant in the next 12 months
- are planning to move outside of the state within the next 12 months
- have participated in a study conducted by the Weight Control \& Diabetes Research Center in the past 2 years
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 |
|---|---|---|
| Diet and Activity EducationEducation about behavioral modification of eating and activity habits for weight loss. | Behavioural | Innovative Technology Intervention, Internet Education Program |
| Self-monitoring with FeedbackParticipants self-monitor diet and activity behaviors, which are submitted via a website. Automated feedback on the self-monitoring record is provided to participants. | Behavioural | Innovative Technology Intervention |
Primary outcome
Weight Loss
Time frame: Baseline, 3-mos, 6-mos
Amount of weight lost (kg) from initial body weight at study entry.
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 8 Jul 2014.
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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.
Rena R. Wing, PhD principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet and Activity Education and Self-monitoring with Feedback in people with Obesity, run by The Miriam Hospital 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 6 inclusion and 4 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 8 Jul 2014. 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 Loss (time frame: Baseline, 3-mos, 6-mos). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2014.