Psychotic DisordersWeb-MOVE!NCT00983476

Web-Based Delivery of MOVE! to Veterans With Serious Mental Illness (SMI)

A study testing in-person MOVE! SMI and web-based MOVE! SMI in people with Psychotic Disorders and Obesity, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Psychotic Disorders, Obesity, Health Behaviors
What is being tested?: in-person MOVE! SMI and web-based MOVE! SMI
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 276 participants
Where: 1 siteUnited States
Study dates: Mar 2012to Jun 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnostic and Statistical Manual (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, recurrent major depressive disorder with psychosis, or PTSD;
age 18 and over;
no psychiatric hospitalization during the month prior to enrollment;
receipt of an antipsychotic medication for at least 3 months prior to enrollment;
BMI of 30 or higher, or BMI of 28 or higher if 10 pounds of recent weight gain;
medical clearance to participate from a VA physician;
control over diet.

Who cannot join

any medical condition for which a weight program is contraindicated;
history of bariatric surgery;
pregnant and nursing mothers;
a diagnosis of dementia;
not able to provide informed consent by self or legally appointed representative.

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073

Other trials in United States

About this study

Official title: Web-Based Delivery of MOVE! to Veterans With Serious Mental Illness

Obesity and physical inactivity have reached epidemic proportions, resulting in increased rates of a variety of chronic diseases, increased risk of death, and substantial health care costs. Individuals with serious mental illness are even more likely to be overweight or obese, which contributes to the high rate of co-morbid medical disease and early mortality found among this population. Specific individual and group-based psychoeducational interventions have repeatedly and consistently been shown to help adults with serious mental illness improve their weight. However, these require substantial time from mental health clinicians, and frequent visits by patients to mental health clinics. This creates challenges for patients who may need to travel to a medical center that provides these services, and who often have limited transportation options. It is likely that these barriers can be addressed with a computerized, web-based intervention focused on diet and exercise education, and tailored for veterans with serious mental illness. Web-based systems can deliver content that is intensive, engaging, and tailored to the needs and preferences of specific patients. Web-based systems can be delivered using computers at community-based outpatient Clinics or other settings in the community. The objective of this project is to develop and evaluate the effectiveness of a web-based intervention to help patients with serious mental illness lose weight.

Read the detailed description

Background: Obesity has reached epidemic proportions, and often has serious adverse health consequences. The VA has deployed a "MOVE! Weight Management Program" nationally in the general patient population. Since individuals with serious mental illness (SMI) often have cognitive deficits, specialized psychoeducational interventions are needed in this population. Specialized psychoeducational interventions for weight have been developed and studied in populations with SMI. This evidence-based practice has been adapted for use in VA, resulting in a "MOVE! SMI" intervention. However, it has proven to be quite difficult to disseminate this intervention. Patients with SMI often have limited transportation options, and may not want to participate in groups. Also, in-person MOVE! SMI requires substantial time from mental health clinicians. This clinician time has been difficult to deploy or is not available at many clinic locations. It is likely that these barriers can be addressed with a computerized, web-based version of MOVE! . Specialized web-based approaches have been studied and found to be successful in people with SMI, and can deliver content that is intensive and engaging with minimal requirements for staff time.

Objectives: The VA Network 5 and 22 Mental Illness Research, Education, and Clinical Centers (MIRECCs) developed a web-based system that provides computerized counseling regarding diet to individuals with SMI. The proposed project expanded this system. This project's objectives are to: 1) develop a comprehensive web-based system that delivers MOVE! using design features that meet the needs of individuals with mental illness; 2) evaluate the effectiveness, in patients with serious mental illness, of web-based MOVE! compared with in-person MOVE! and a control group; and, 3) characterize, from the patient's perspective, the strengths, weaknesses, and barriers to the use of in-person and web-based MOVE!.

Methods: This is a prospective, randomized, controlled trial in patients with SMI who are obese and receiving treatment with medications that often have weight gain as a major side-effect. Participants are assigned to in-person MOVE! SMI, web-based MOVE! SMI with support from peer coaches, or a comparison group. Research assessments occur at 0, 3, 6, 9 and 12 months. Changes in outcomes are compared over time between the three groups. Comparative effectiveness is evaluated at 6 months. A secondary objective is to evaluate the extent to which gains are maintained at 9 and 12 months.

Status: The project team developed the needed materials, methods, and informatics systems. Patients were enrolled, and study enrollment and interventions are complete. Follow up interviews are complete and the interventions have been evaluated.

Conditions: Psychotic Disorders, Obesity, Health Behaviors
Being tested: in-person MOVE! SMI, web-based MOVE! SMI
Keywords: Randomized controlled trial, Obesity, Comparative Effectiveness, Clinical practice guidelines, Medical Informatics Computing, Services, Mental Health, Self-care, Psychotic disorders, Mental Health Care, Veterans
Medical subject headings: Psychotic Disorders, Obesity, Health Behavior, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

in-person MOVE! SMIBehavioural
Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
web-based MOVE! SMIBehavioural
online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))

Study groups in NCT00983476
Study group	Role	What they receive
Arm 1	Experimental	in-person MOVE! SMI Receives: Behavioral: in-person MOVE! SMI
Arm 2	Experimental	web-based MOVE! SMI Receives: Behavioral: web-based MOVE! SMI
Arm 3	No intervention	usual care + educational handouts regarding weight loss

What is being measured

The primary outcome is the main question the study is designed to answer.

Body Mass Index (BMI)
BMI = (weight in pounds * 703)/ (height in inches²) at 6 month follow-up as predicted by the mixed model described in Statistical Analysis 1
Measured: 6 months
Body Mass Index (BMI) Within Obese Sample
BMI = (weight in pounds * 703)/ (height in inches²); obese defined as BMI > 30
Measured: 6 months
Dietary Habits: Reducing Calories (Self-efficacy, Motivation, Readiness to Change)
Self-Efficacy and Eating Habits Survey (Sallis et al., 1988): Reducing Calories Factor.
The Reducing Calories factor includes survey items 6-10, which are each scored on a scale from 1-5. The factor score is an average of the scores on those items. Higher scores indicate more confidence in making the change in reducing calories. Range in the factor scores can be from 1 (min) to 5 (max).
Measured: 6 months
Dietary Habits: Reducing Fat (Self-efficacy, Motivation, Readiness to Change)
Self-Efficacy and Eating Habits Survey (Sallis et al., 1988): Reducing Fat Factor.
The Reducing Fat factor includes survey items 16-20, which are each scored on a scale from 1-5. The factor score is an average of the scores on those items. Higher scores indicate more confidence in making the change in reducing fat in the diet. Range in the factor scores can be from 1 (min) to 5 (max).
Measured: 6 months

Secondary outcomes (5)

Quality of Life: Physical Functioning
Impact of Weight on Quality of Life (IWQOL; Kolotkin et al., 2008): Physical Functioning subscale.
The Physical Functioning subscale includes survey items 1-11, which are each scored on a scale from 1-5. The subscale score is an average of the scores on those items. Lower scores indicate greater impairment. Range in the subscale scores can be from 1 (min) to 5 (max).
Measured: 6 months
Quality of Life: Self-Esteem
Impact of Weight on Quality of Life (IWQOL; Kolotkin et al. 2008): Self-Esteem subscale.
The Self-Esteem subscale includes survey items 12-18, which are each scored on a scale from 1-5. The subscale score is an average of the scores on those items. Lower scores indicate greater impairment. Range in the subscale scores can be from 1 (min) to 5 (max).
Measured: 6 months
Quality of Life: Sexual Life
Impact of Weight on Quality of Life (IWQOL; Kolotkin et al 2008): Sexual Life subscale.
The Sexual Life subscale includes survey items 19-22, which are each scored on a scale from 1-5. The subscale score is an average of the scores on those items. Lower scores indicate greater impairment. Range in the subscale scores can be from 1 (min) to 5 (max).
Measured: 6 months
BMI
BMI = (weight in pounds * 703)/ height in inches²
Measured: 9 months
BMI
BMI = (weight in pounds * 703)/ height in inches²
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012Jun 2015

First posted24 Sep 2009 (estimated)
Study startMar 2012
Primary completionJun 2015
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Psychotic DisordersStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe 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
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 276 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00983476
Sponsor's protocol ID: IIR 09-083
Acronym: Web-MOVE!
Status last verified: Mar 2017
First submitted: 22 Sep 2009
Last updated: 13 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Cohen AN, Golden JF, Young AS. Peer wellness coaches for adults with mental illness. Psychiatr Serv. 2014 Jan 1;65(1):129-30. doi: 10.1176/appi.ps.650101. No abstract available.
PubMed 24382767
Muralidharan A, Brown CH, Zhang Y, Niv N, Cohen AN, Kreyenbuhl J, Oberman RS, Goldberg RW, Young AS. Quality of life outcomes of web-based and in-person weight management for adults with serious mental illness. J Behav Med. 2020 Oct;43(5):865-872. doi: 10.1007/s10865-019-00117-1. Epub 2019 Nov 18.
PubMed 31741204

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
RecruitingPhase 2/3
ACP-204 in Adults With Alzheimer's Disease Psychosis
Alzheimer's Disease Psychosis

All Psychotic Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Web-Based Delivery of MOVE! to Veterans With Serious Mental Illness
ClinicalTrials.gov ID: NCT00983476
Acronym / sponsor ID: Web-MOVE! / IIR 09-083
Conditions: Psychotic Disorders, Obesity, Health Behaviors
Keywords: Randomized controlled trial, Obesity, Comparative Effectiveness, Clinical practice guidelines, Medical Informatics Computing, Services, Mental Health, Self-care, Psychotic disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 276 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: Mar 2012
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 24 Sep 2009 (estimated)
Results: Posted 13 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Arm 1	Experimental	Behavioral: in-person MOVE! SMIin-person MOVE! SMI
Arm 2	Experimental	Behavioral: web-based MOVE! SMIweb-based MOVE! SMI
Arm 3	No intervention	–usual care + educational handouts regarding weight loss

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Diagnostic and Statistical Manual (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, recurrent major depressive disorder with psychosis, or PTSD;
age 18 and over;
no psychiatric hospitalization during the month prior to enrollment;
receipt of an antipsychotic medication for at least 3 months prior to enrollment;
BMI of 30 or higher, or BMI of 28 or higher if 10 pounds of recent weight gain;

Key exclusion criteria (5 listed)

any medical condition for which a weight program is contraindicated;
history of bariatric surgery;
pregnant and nursing mothers;
a diagnosis of dementia;
not able to provide informed consent by self or legally appointed representative.

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
in-person MOVE! SMIIndividual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))	Behavioural	Arm 1
web-based MOVE! SMIonline sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))	Behavioural	Arm 2

Primary outcome

Body Mass Index (BMI)
Time frame: 6 months
BMI = (weight in pounds * 703)/ (height in inches²) at 6 month follow-up as predicted by the mixed model described in Statistical Analysis 1
Body Mass Index (BMI) Within Obese Sample
Time frame: 6 months
BMI = (weight in pounds * 703)/ (height in inches²); obese defined as BMI > 30
Dietary Habits: Reducing Calories (Self-efficacy, Motivation, Readiness to Change)
Time frame: 6 months
Self-Efficacy and Eating Habits Survey (Sallis et al., 1988): Reducing Calories Factor. The Reducing Calories factor includes survey items 6-10, which are each scored on a scale from 1-5. The factor score is an average of the scores on those items. Higher scores indicate more confidence in making the change in reducing calories. Range in the factor scores can be from 1 (min) to 5 (max).
Dietary Habits: Reducing Fat (Self-efficacy, Motivation, Readiness to Change)
Time frame: 6 months
Self-Efficacy and Eating Habits Survey (Sallis et al., 1988): Reducing Fat Factor. The Reducing Fat factor includes survey items 16-20, which are each scored on a scale from 1-5. The factor score is an average of the scores on those items. Higher scores indicate more confidence in making the change in reducing fat in the diet. Range in the factor scores can be from 1 (min) to 5 (max).

5 secondary outcomes

Quality of Life: Physical Functioning
Time frame: 6 months
Quality of Life: Self-Esteem
Time frame: 6 months
Quality of Life: Sexual Life
Time frame: 6 months
BMI
Time frame: 9 months
BMI
Time frame: 12 months

Results and safety

Results posted to the registry on 13 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: In-person MOVE! SMI	95	78
Arm 2: Web-based MOVE! SMI	93	71
Arm 3: Usual Care + Handouts	88	88

Primary outcome: Body Mass Index (BMI)

Time frame: 6 months. Mean (Standard Error). Unit: kg/(meters squared)

Measure	Arm 1: In-person MOVE! SMI n = 78	Arm 2: Web-based MOVE! SMI n = 71	Arm 3: Usual Care + Handouts n = 88
Value	34.9 (0.4)	33.4 (0.4)	34.4 (0.4)

Arm 1: In-person MOVE! SMI vs Arm 2: Web-based MOVE! SMI vs Arm 3: Usual Care + Handouts: Slope: 2.2, p = 0.11, Mixed Models Analysis

Population analysed: All randomized participants who received any intervention as randomized were included in the primary analyses, regardless of the number of assessments completed. Receiving intervention as randomized was defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).

Primary outcome: Body Mass Index (BMI) Within Obese Sample

Time frame: 6 months. Mean (Standard Error). Unit: kilogram/(meters squared)

Measure	Arm 1: In-person MOVE! SMI n = 68	Arm 2: Web-based MOVE! SMI n = 59	Arm 3: Usual Care + Handouts n = 73
Value	35.9 (0.4)	34.2 (0.4)	35.6 (0.4)

Arm 1: In-person MOVE! SMI vs Arm 2: Web-based MOVE! SMI vs Arm 3: Usual Care + Handouts: Slope: 4.02, p = 0.02, Mixed Models Analysis

Population analysed: Analyses excluded participants with BMI of 28-29.9 (overweight) at baseline, leaving only those with BMI \>= 30 at baseline who received the intervention as randomized.

Primary outcome: Dietary Habits: Reducing Calories (Self-efficacy, Motivation, Readiness to Change)

Time frame: 6 months. Mean (Standard Error). Unit: units on a scale

Measure	Arm 1: In-person MOVE! SMI n = 68	Arm 2: Web-based MOVE! SMI n = 61	Arm 3: Usual Care + Handouts n = 74
Value	4.1 (0.11)	3.9 (0.11)	4.0 (0.10)

Arm 1: In-person MOVE! SMI vs Arm 2: Web-based MOVE! SMI vs Arm 3: Usual Care + Handouts: Mean Difference (Final Values): 1.14, p = 0.32, ANOVA

Population analysed: All randomized participants who received the intervention as randomized and completed this measure at 6 months were included in the analysis. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).

Primary outcome: Dietary Habits: Reducing Fat (Self-efficacy, Motivation, Readiness to Change)

Time frame: 6 months. Mean (Standard Error). Unit: units on a scale

Measure	Arm 1: In-person MOVE! SMI n = 68	Arm 2: Web-based MOVE! SMI n = 61	Arm 3: Usual Care + Handouts n = 74
Value	4.1 (0.11)	3.9 (0.11)	3.8 (0.11)

Arm 1: In-person MOVE! SMI vs Arm 2: Web-based MOVE! SMI vs Arm 3: Usual Care + Handouts: Mean Difference (Final Values): 2.23, p = 0.11, ANOVA

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected for a period of 3 years, from the start of recruitment in 2012 through the completion of all data collection in 2015.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: In-person MOVE! SMI	1 of 95 (1.1%)	0 of 95 (0%)	Not reported
Arm 2: Web-based MOVE! SMI	2 of 93 (2.2%)	0 of 93 (0%)	Not reported
Arm 3: Usual Care + Handouts	2 of 88 (2.3%)	0 of 88 (0%)	Not reported

Limitations and caveats (from the sponsor): This study was conducted at one VA medical center in an urban, metropolitan area. Sites can vary markedly in contextual factors; There was a large proportion of overweight patients with SMI who declined to participate.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24382767Cohen AN, Golden JF, Young AS. Peer wellness coaches for adults with mental illness. Psychiatr Serv. 2014 Jan 1;65(1):129-30. doi: 10.1176/appi.ps.650101. No abstract available.
Derived from this study: PubMed 31741204Muralidharan A, Brown CH, Zhang Y, Niv N, Cohen AN, Kreyenbuhl J, Oberman RS, Goldberg RW, Young AS. Quality of life outcomes of web-based and in-person weight management for adults with serious mental illness. J Behav Med. 2020 Oct;43(5):865-872. doi: 10.1007/s10865-019-00117-1. Epub 2019 Nov 18.
VA MOVE! ProgramLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Psychotic Disorders

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
RecruitingPhase 2/3
ACP-204 in Adults With Alzheimer's Disease Psychosis
Alzheimer's Disease Psychosis

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.

Alexander S Young, MD MSHS principal investigator

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing in-person MOVE! SMI and web-based MOVE! SMI in people with Psychotic Disorders and Obesity, run by VA Office of Research and Development 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 7 inclusion and 5 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 13 Apr 2017. 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?

Yes. Results are posted in the registry (first posted 13 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Body Mass Index (BMI) (time frame: 6 months). The study lists 4 primary outcomes in all. 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 NCT00983476, which also lists 2 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 13 Apr 2017.