Osteo Arthritis KneeI-CANNCT03832296
Independent Weight Loss Maintenance for Communities With Arthritis in North Carolina: the I-CAN Clinical Trial
A study testing Weight-Loss Maintenance in people with Osteo Arthritis Knee, run by Wake Forest University Health Sciences at 3 sites in United States.
Trial summary
The study team is currently conducting a pragmatic, community-based assessor-blinded randomized controlled trial (RCT) in overweight and obese adults > 50 years with knee OA in both urban and rural counties in North Carolina. Read more about this study
- Who is it for?
- Ages 51 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Weight-Loss Maintenance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Mar 2018to 30 Jun 2020
- 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 51 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥ 51
- achieved a weight loss ≥ 5% in the D+E intervention arm of the WE-CAN trial
Who cannot join
- Weight loss < 5% of baseline body weight
- Significant co-morbid disease that would threaten safety or impair ability to participate in interventions or testing (Blindness; Type 1 diabetes; Severe coronary artery disease)
- Inability to finish 18-month study or unlikely to be compliant (Planning to leave area > 2 month during the next 18 months)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johnston County - UNC Chapel Hill
Chapel Hill, North Carolina, 27516
Haywood County - Haywood Regional Medical Center
Clyde, North Carolina, 28721
Forsyth County - Wake Forest University/Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27109
About this study
The study team is currently conducting a pragmatic, community-based assessor-blinded randomized controlled trial (RCT) in overweight and obese adults > 50 years with knee OA in both urban and rural counties in North Carolina. As the participants randomized to the 18 month diet and exercise group in the WE-CAN study successfully complete the intervention (≥ 5% weight loss), the study team has the unique opportunity to evaluate the effectiveness of a theoretically-based tapered weight maintenance intervention. Eligible participants will be randomized to either the weight-loss maintenance or health education attention control groups.
Read the detailed description
Results from the Intensive Diet and Exercise for Arthritis (IDEA) trial showed that 10% diet-induced weight loss combined with exercise (D+E) was twice as effective at relieving knee pain and improving function and mobility as previous long-term weight loss and exercise programs in similar cohorts. The treatment effects of D+E on these clinical outcomes were mediated by changes in self-efficacy over the course of the trial. However, most people tend to regain most or all of the lost weight in three to five years. The challenge is maintaining the weight loss and sustaining the efficacy of the intervention.
Our current trial (WE-CAN) is designed to adapt the successful IDEA intervention to real-world clinical and community settings. As WE-CAN participants in the D+E group complete their intervention, the investigators will leverage our organizational infrastructure to maintain weight-loss without supervised intervention by increasing participant confidence to establish and adhere to a routine of good exercise and diet behaviors independently.
Participants will include 212 older adults aged ≥ 51 yrs. with knee osteoarthritis (OA) who achieved a weight loss ≥ 5% in the D+E intervention arm of the WE-CAN trial. All WE-CAN participants meet the ACR clinical criteria for knee OA, which includes knee pain on most days of the week plus at least three of the following six: age ≥ 50 years, stiffness < 30 min/day, crepitus, bony tenderness, bony enlargement, and/or no palpable warmth. Eligible WE-CAN D+E participants will be randomized to either 6-month facilitated weight-loss maintenance or health education control interventions. The primary aim is to compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on maintaining weight loss subsequent to a 12-month unsupervised follow-up period. Secondary aims will compare the two interventions on WOMAC knee pain and function, health-related quality of life (SF-36), 6-minute walk distance, and weight-loss maintenance self-efficacy following the 12-month unsupervised period. The study team will also establish the cost-effectiveness of a 6-month facilitated weight-loss maintenance intervention for older adults with knee OA by conducting cost-effectiveness and budgetary impact analyses using data from the current trial in a validated computer-simulated model of knee OA.
There have been numerous attempts to prevent weight regain in adults. This study is significant in that it is designed to encourage older adults with knee OA that have experienced significant weight loss to develop strategies that will build self-efficacy for maintaining weight loss on their own long after the active intervention ends.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Weight-Loss Maintenance, Health Education (Attention Control)
- Keywords
- Arthritis, Knee, weight loss
- Medical subject headings
- Arthritis, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight-Loss MaintenanceBehavioural
Over the course of the first 6-months, participants will build their self-efficacy to maintain weight loss on their own, empowered to do what is needed to achieve personal goals and long-term behavior change (months 7-18). The first 6 months of I-CAN will prepare participants for successful independent weight-loss maintenance in months 7-18. During the 12-month independent weight-loss maintenance phase participants exercise on their own and maintain their weight loss (or increase weight loss if they choose) with the only contact from interventionists being two newsletters at months 9 and 15.
Health Education (Attention Control)Behavioural
Participants in the control group will attend an individual session during month 1, and a monthly face-to-face group meeting during months 2-6. The sessions will provide attention, social interaction, and physician-based health education. Participants will receive a newsletter during months 9 and 15.
| Study group | Role | What they receive |
|---|---|---|
| Weight-Loss Maintenance | Experimental | Weight Loss Maintenance Intervention Receives: Behavioral: Weight-Loss Maintenance |
| Health Education (Attention Control) | Active comparator | Health Education Intervention Receives: Behavioral: Health Education (Attention Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight-Loss Maintenance
Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on maintaining weight loss subsequent to a 12-month unsupervised follow-up period.
Measured: 18 Months
Secondary outcomes (17)
Knee Pain measured by the WOMAC Index
The investigators will measure self-reported pain using the WOMAC (scores will be pulled from the KOOS Questionnaire in which the WOMAC is embedded). The pain index assesses participants' pain on a scale, ranging from 0 (none) to 4 (extreme). The pain subscale consists of 5 items and total scores can range from 0-20, with larger scores indicating greater dysfunction.
Measured: 18 Months
Function measured by the WOMAC Index
The investigators will measure self-reported physical function using the WOMAC (scores will be pulled from the KOOS Questionnaire in which the WOMAC is embedded). The LK version asks participants to indicate on a scale from 0 (none) to 4 (extreme) the degree of difficulty experienced in the last week due to knee OA. Individual scores for the 17 items are totaled to generate a summary score that could range from 0-68, with higher scores indicating poorer function.
Measured: 18 Months
Health Related Quality of Life: SF-36
Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on health-related quality of life (SF-36) subsequent to a 12-month unsupervised follow-up period. Two summary scores are acquired: physical health and mental health. Range=0-100. Higher scores indicate better health.
Measured: 18 Months
Mobility- 6 minute walk test
The primary mobility measure will be 6-minute walk distance. Participants are told to walk as far as possible in 6 minutes on an established course.
Measured: 18 Months
Self-Efficacy - Perceived Stress: questionnaire
Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The perceived stress questionnaire will measure the degree to which people perceive their lives as stressful. Range = 0-40. Higher numbers indicate higher stress.
Measured: 18 Months
Self-Efficacy - Walking Efficacy for Duration: walking efficacy for duration scale
Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The walking efficacy for duration scale measures one's ability to walk/jog at a moderately fast pace for various durations. Range 0-100. A higher score indicates a higher self-efficacy.
Measured: 18 Months
Self-Efficacy - PANAS
Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The Positive and Negative Affect (PANAS) measures both positive and negative affect, leading to more insightful outlooks regarding participants' feeling states. This scale consists of 20 items that reflect the intensity of how the participant "feels" right now. Range=10-50 for each subscale. A higher score for positive affect indicates a higher level of positive affect. A higher score for negative affect indicates a higher level of negative affect.
Measured: 18 Months
Self-Efficacy - Gait Efficacy - gait efficacy/environmental efficacy scale
Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The gait efficacy/environmental efficacy scale will ask the participants' confidence in performing certain activities. Confidence in performing activities. Participants will be asked to indicate their level of confidence being able to complete different tasks. Range=0-100. A higher score indicates higher self-efficacy.
Measured: 18 Months
Self-Efficacy - Satisfaction with Life: Satisfaction with life scale
Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The Satisfaction with life scale is focused to assess global life satisfaction. Range=5 to 35. A higher scale indicates a higher level of life satisfaction.
Measured: 18 Months
Self-Efficacy - Weight Efficacy Scale
Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The Weight Efficacy Lifestyle Questionnaire (WEL) is a 20-item measure employed to assess self-efficacy for weight management. Range=0 to 180. Higher numbers indicate better confidence.
Measured: 18 Months
Self-Efficacy - Adherence Self Efficacy Scale
Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The adherence questionnaire is designed to assess beliefs in one's ability (confidence) to continue exercising at various intensities and frequencies. Range=0-100. A higher score indicates higher self-efficacy.
Measured: 18 Months
Self-Efficacy - Barriers Self-Efficacy to Exercise
Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The Barriers Self-Efficacy to Exercise measures confidence in dealing with barriers to exercise. Range=0-100. Higher numbers indicate higher confidence.
Measured: 18 Months
Self-Efficacy - Multidimensional Outcome Expectations for Exercise Scale (MOEES): questionnaire
Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The MOEES questionnaire consists of three subscales: physical outcome expectations (score range 6-30), social outcome expectations (score range 4-20), and self-evaluative outcome expectations (score range 5-25). Each subscale is scored by summing the numerical ratings for each response. Higher scores are indicative of higher levels of outcome expectations for exercise.
Measured: 18 Months
Self-Efficacy - Perceived Barriers: questionnaire
Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy. The perceived barriers questionnaire measures a person's perceptions to barriers to performing exercise. The questionnaire is scored by finding the mean for each response (range = 1-5). Higher scores indicate higher perception of barriers.
Measured: 18 Months
Self-Efficacy - Weight Loss Maintenance: questionnaire
Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on self-efficacy for maintaining weight loss. Range=0-100. Higher scores indicate more confidence in maintaining weight loss.
Measured: 18 Months
Cost-Effectiveness
Resource utilization will be collected by questionnaire. MD and non-MD office visits will be collected via self-report with domains including visits to clinicians (physicians, nurses, physical therapists, others), tests, medications, injections, surgery, alternative therapies. The number of visits associated with utilization of each of 4 domains, MD visits, non-MD visits, ED visits, and inpatient stays, will be examined.
Measured: 18 Months
Cost-Effectiveness- WPAI
The Work Productivity and Activity Impairment index (WPAI) will be used to assess absenteeism and reduced productivity while at work (presenteeism). Outcome (OC) scores can be derived from the WPAI: OC1, percent work time missed due to health, (percentage of absenteeism); percent impairment while working due to health, (percentage of presenteeism); percent overall work impairment due to health, percent activity impairment due to health. For all 4 outcomes, greater scores (range 0-100%) indicate greater impact of health.
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start29 Mar 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will include 212 older adults aged ≥ 51 yrs. with knee OA who achieved a weight loss ≥ 5% in the D+E intervention arm of the WE-CAN trial. Eligible WE-CAN D+E participants will be randomized to either the weight-loss maintenance or health education attention control groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen P Messier, PhD, Principal investigator, Wake Forest UniversityLeigh Callahan, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832296
- Sponsor's protocol ID
- IRB00033618.I-CAN
- Acronym
- I-CAN
- Status last verified
- Nov 2020
- First submitted
- 4 Feb 2019
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators support data sharing and will comply with all NIH guidelines as outlined in the NIH Data Sharing Policy and Implementation Guidance document. The primary means of data sharing and dissemination will be through scientific publications and presentations. Ensuring patient privacy and confidentiality will be of primary importance in creating the files to be shared. All data files will be de-identified. De-identification procedures will meet HIPAA criteria detailed in the Code of Federal Regulations, Part 46, Section 164.514. The study team will create a link on our website that describes the data files. Documentation will also be provided along with the redacted data files. The documentation will include electronic versions of the protocol, data collection forms (with instructions for scoring, if needed), data dictionary, data code book, labels, and formats. Requests for data will be answered via completion of an online request form and data-sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Independent Weight Loss Maintenance for Communities With Arthritis in North Carolina: the I-CAN Clinical Trial
- ClinicalTrials.gov ID
- NCT03832296
- Acronym / sponsor ID
- I-CAN / IRB00033618.I-CAN
- Conditions
- Osteo Arthritis Knee
- Keywords
- Arthritis, Knee, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 6 Feb 2019 (actual)
- 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 study team is currently conducting a pragmatic, community-based assessor-blinded randomized controlled trial (RCT) in overweight and obese adults > 50 years with knee OA in both urban and rural counties in North Carolina. As the participants randomized to the 18 month diet and exercise group in the WE-CAN study successfully complete the intervention (≥ 5% weight loss), the study team has the unique opportunity to evaluate the effectiveness of a theoretically-based tapered weight maintenance intervention. Eligible participants will be randomized to either the weight-loss maintenance or health education attention control groups.
Detailed description
Results from the Intensive Diet and Exercise for Arthritis (IDEA) trial showed that 10% diet-induced weight loss combined with exercise (D+E) was twice as effective at relieving knee pain and improving function and mobility as previous long-term weight loss and exercise programs in similar cohorts. The treatment effects of D+E on these clinical outcomes were mediated by changes in self-efficacy over the course of the trial. However, most people tend to regain most or all of the lost weight in three to five years. The challenge is maintaining the weight loss and sustaining the efficacy of the intervention.
Our current trial (WE-CAN) is designed to adapt the successful IDEA intervention to real-world clinical and community settings. As WE-CAN participants in the D+E group complete their intervention, the investigators will leverage our organizational infrastructure to maintain weight-loss without supervised intervention by increasing participant confidence to establish and adhere to a routine of good exercise and diet behaviors independently.
Participants will include 212 older adults aged ≥ 51 yrs. with knee osteoarthritis (OA) who achieved a weight loss ≥ 5% in the D+E intervention arm of the WE-CAN trial. All WE-CAN participants meet the ACR clinical criteria for knee OA, which includes knee pain on most days of the week plus at least three of the following six: age ≥ 50 years, stiffness < 30 min/day, crepitus, bony tenderness, bony enlargement, and/or no palpable warmth. Eligible WE-CAN D+E participants will be randomized to either 6-month facilitated weight-loss maintenance or health education control interventions. The primary aim is to compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on maintaining weight loss subsequent to a 12-month unsupervised follow-up period. Secondary aims will compare the two interventions on WOMAC knee pain and function, health-related quality of life (SF-36), 6-minute walk distance, and weight-loss maintenance self-efficacy following the 12-month unsupervised period. The study team will also establish the cost-effectiveness of a 6-month facilitated weight-loss maintenance intervention for older adults with knee OA by conducting cost-effectiveness and budgetary impact analyses using data from the current trial in a validated computer-simulated model of knee OA.
There have been numerous attempts to prevent weight regain in adults. This study is significant in that it is designed to encourage older adults with knee OA that have experienced significant weight loss to develop strategies that will build self-efficacy for maintaining weight loss on their own long after the active intervention ends.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will include 212 older adults aged ≥ 51 yrs. with knee OA who achieved a weight loss ≥ 5% in the D+E intervention arm of the WE-CAN trial. Eligible WE-CAN D+E participants will be randomized to either the weight-loss maintenance or health education attention control groups.
| Arm | Type | Receives |
|---|---|---|
| Weight-Loss Maintenance | Experimental | Behavioral: Weight-Loss MaintenanceWeight Loss Maintenance Intervention |
| Health Education (Attention Control) | Active comparator | Behavioral: Health Education (Attention Control)Health Education Intervention |
Who may qualify
- Ages
- 51 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age ≥ 51
- achieved a weight loss ≥ 5% in the D+E intervention arm of the WE-CAN trial
Key exclusion criteria (3 listed)
- Weight loss < 5% of baseline body weight
- Significant co-morbid disease that would threaten safety or impair ability to participate in interventions or testing (Blindness; Type 1 diabetes; Severe coronary artery disease)
- Inability to finish 18-month study or unlikely to be compliant (Planning to leave area > 2 month during the next 18 months)
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 |
|---|---|---|
| Weight-Loss MaintenanceOver the course of the first 6-months, participants will build their self-efficacy to maintain weight loss on their own, empowered to do what is needed to achieve personal goals and long-term behavior change (months 7-18). The first 6 months of I-CAN will prepare participants for successful independent weight-loss maintenance in months 7-18. During the 12-month independent weight-loss maintenance phase participants exercise on their own and maintain their weight loss (or increase weight loss if they choose) with the only contact from interventionists being two newsletters at months 9 and 15. | Behavioural | Weight-Loss Maintenance |
| Health Education (Attention Control)Participants in the control group will attend an individual session during month 1, and a monthly face-to-face group meeting during months 2-6. The sessions will provide attention, social interaction, and physician-based health education. Participants will receive a newsletter during months 9 and 15. | Behavioural | Health Education (Attention Control) |
Primary outcome
Weight-Loss Maintenance
Time frame: 18 Months
Compare the effects of a 6-month weight-loss maintenance intervention grounded in social cognitive theory to a health education intervention on maintaining weight loss subsequent to a 12-month unsupervised follow-up period.
17 secondary outcomes
Knee Pain measured by the WOMAC Index
Time frame: 18 Months
Function measured by the WOMAC Index
Time frame: 18 Months
Health Related Quality of Life: SF-36
Time frame: 18 Months
Mobility- 6 minute walk test
Time frame: 18 Months
Self-Efficacy - Perceived Stress: questionnaire
Time frame: 18 Months
Self-Efficacy - Walking Efficacy for Duration: walking efficacy for duration scale
Time frame: 18 Months
Self-Efficacy - PANAS
Time frame: 18 Months
Self-Efficacy - Gait Efficacy - gait efficacy/environmental efficacy scale
Time frame: 18 Months
Self-Efficacy - Satisfaction with Life: Satisfaction with life scale
Time frame: 18 Months
Self-Efficacy - Weight Efficacy Scale
Time frame: 18 Months
Self-Efficacy - Adherence Self Efficacy Scale
Time frame: 18 Months
Self-Efficacy - Barriers Self-Efficacy to Exercise
Time frame: 18 Months
Self-Efficacy - Multidimensional Outcome Expectations for Exercise Scale (MOEES): questionnaire
Time frame: 18 Months
Self-Efficacy - Perceived Barriers: questionnaire
Time frame: 18 Months
Self-Efficacy - Weight Loss Maintenance: questionnaire
Time frame: 18 Months
Cost-Effectiveness
Time frame: 18 Months
Cost-Effectiveness- WPAI
Time frame: 18 Months
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 26 Feb 2021.
- Individual participant dataSharing planned: Yes. The investigators support data sharing and will comply with all NIH guidelines as outlined in the NIH Data Sharing Policy and Implementation Guidance document. The primary means of data sharing and dissemination will be through scientific publications and presentations. Ensuring patient privacy and confidentiality will be of primary importance in creating the files to be shared. All data files will be de-identified. De-identification procedures will meet HIPAA criteria detailed in the Code of Federal Regulations, Part 46, Section 164.514. The study team will create a link on our website that describes the data files. Documentation will also be provided along with the redacted data files. The documentation will include electronic versions of the protocol, data collection forms (with instructions for scoring, if needed), data dictionary, data code book, labels, and formats. Requests for data will be answered via completion of an online request form and data-sharing agreement.
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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.
Stephen P Messier, PhD principal investigator
Wake Forest University
Leigh Callahan, PhD principal investigator
University of North Carolina, Chapel Hill
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight-Loss Maintenance in people with Osteo Arthritis Knee, run by Wake Forest University Health Sciences at 3 sites 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 2 inclusion and 3 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 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Maintenance (time frame: 18 Months). 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 26 Feb 2021.