DiabetesMAMAO2NCT01052714

Healthy Lifestyles for Mentally Ill People Who Have Experienced Weight Gain From Their Antipsychotic Medications - 2

A study testing Lifestyle Balance in people with Diabetes and Obesity, run by VA Office of Research and Development at 3 sites 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 to 70 years
Conditions the study is for: Diabetes, Obesity, Weight Gain
What is being tested?: Lifestyle Balance
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 121 participants
Where: 3 sitesUnited States
Study dates: 1 Sep 2010to 28 May 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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Must be a Veteran
Diagnosis of psychotic disorders, schizophrenia, schizoaffective disorder and bipolar illness
Age 18-70
Clinically determined to require ongoing treatment with Second Generation Antipsychotics (SGA) such as olanzapine, risperidone, quetiapine, ziprasidone, aripiprazole, clozapine
Experienced weight gain since treatment with SGA's
Inpatient or outpatient at Long Beach, West Los Angeles, Sepulveda, or Downtown VA
Competent to sign informed consent

Who cannot join

Have recently been diagnosed with schizophrenia (less than 1 year)
Are pregnant or breast feeding a baby
Have a medically unstable condition

Trial locations and contacts

3 sites in 1 country.

United States3 sites

VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, 91343
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: Management of Antipsychotic Medication Associated Obesity - 2

This program aims to help Veterans who take antipsychotic medications lose weight. We use a program based on the American Diabetes Association's "Diabetes Prevention Program," and we have modified it to fit the lifestyles of people with mental illness. All participants are educated about nutrition and cutting down fat intake, how and when to exercise, and the causes of diabetes and how to prevent it. Participants must be Veterans who live within one hour of the Long Beach, West Los Angeles, Sepulveda, or West Los Angeles VA hospitals.

Conditions: Diabetes, Obesity, Weight Gain
Being tested: Lifestyle Balance
Keywords: Antipsychotic, Bipolar, Diabetes, Mental Illness, Nutrition, Obesity, Schizoaffective, Schizophrenia, Weight Gain, Weight Loss
Medical subject headings: Diabetes Mellitus, Obesity, Weight Gain, Mental Disorders, Schizophrenia, Weight Loss

What participants receive

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

Lifestyle BalanceBehavioural
Also called Lifestyle Balance Program
Patients assigned to the behavioral weight loss program (Lifestyle Balance Program) will do the following: -Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient - Be given a 7% weight loss goal - Be assisted in obtaining a 500 calorie reduction per day -Exercise for at least 30 min/day, at least 5 days a week - Maintain weekly food and exercise diaries -Be quizzed on their knowledge of healthy eating habits and nutrition

Study groups in NCT01052714
Study group	Role	What they receive
Usual Care	No intervention	Control group with time-matched study visits
Lifestyle Balance	Active comparator	Weight management group education and individual counseling Receives: Behavioral: Lifestyle Balance
Usual Care then Lifestyle Balance	Other	Participants originally randomized to Usual Care, allowed to change over to Lifestyle Balance at month 6 per their request. Receives: Behavioral: Lifestyle Balance

What is being measured

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

Mean Weight Change Per Week From Baseline to Termination
Participants' weight was measured at each visit by study personnel using hospital scales, and the study groups' average weight changes per week were compared.
Measured: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Mean Waist Circumference Change Per Week From Baseline to Termination
Participants' waist circumference was measured at each visit by study personnel using a measuring tape, and the study groups' average waist circumference changes per week were compared.
Measured: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Mean Body Mass Index (BMI) Change Per Week From Baseline to Termination
Study personnel calculated each participant's BMI at each visit using their weight measurement taken at that visit and their height measurement taken at baseline. The study groups' average BMI changes per week were then compared.
Measured: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Mean Serum Insulin Level Change Per Week From Baseline to Termination
Results obtained through VA facility's Outpatient Lab. The study groups' average serum level changes per week were then compared.
Measured: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
Mean Triglycerides Level Change Per Week From Baseline to Termination
Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared.
Measured: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
Mean Low-Density Lipoprotein (LDL) Cholesterol Level Change Per Week From Baseline to Termination
Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared.
Measured: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
Mean High-Density Lipoprotein (HDL) Cholesterol Level Change Per Week From Baseline to Termination
Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared.
Measured: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
Health Knowledge Quiz Mean Total Score Change Per Week From Baseline to Termination
Quiz of information covered during Lifestyle Balance classes, score range 0 - 30, worst to best. The study groups' average score changes per week were then compared.
Measured: Up to 4 observations per person,at baseline, 2 months, 6 months, and 12 months.
Change in Mean Total Calories Consumed Per Week From Baseline to Termination
Caloric intake assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in total calories consumed per week were then compared.
Measured: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Change in Mean Empty Calories Consumed Per Week From Baseline to Termination
Caloric intake assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in empty calories consumed per week were then compared.
Measured: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Change in Mean Total Exercise Time Per Week From Baseline to Termination
Minutes exercised assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in total minutes exercised per week were then compared.
Measured: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Mean University Rhode Island Change Assessment Scale (URICA) Total Score Change Per Week From Baseline to Termination
Self-reported survey of respondents' feelings about changing their weight problem. Total score is also called the Readiness Score, ranging from -2 to +14 (worse to better), calculated by subtracting the mean from the precontemplation responses from the summation of the means of responses to contemplation, action, and the struggling to maintain items.
Measured: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 1 Score Change Per Week From Baseline to Termination
Self-reported survey of quality of life as related to respondents' physical health, score range 7-35, worst to best. The study groups' average subscore changes per week were then compared.
Measured: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 2 Score Change Per Week From Baseline to Termination
Self-reported survey of quality of life as related to respondents' psychological health, score range 6-30, worst to best. The study groups' average subscore changes per week were then compared.
Measured: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 3 Score Change Per Week From Baseline to Termination
Self-reported survey of quality of life as related to respondents' social relationships, score range 3-15, worst to best. The study groups' average subscore changes per week were then compared.
Measured: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 4 Score Change Per Week From Baseline to Termination
Self-reported survey of quality of life as related to respondents' environment, score range 8-40, worst to best. The study groups' average subscore changes per week were then compared.
Measured: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Brief Psychiatric Rating Scale (BPRS) Mean Total Score Change Per Week From Baseline to Termination
Clinician-assessed symptom survey, score range 18 - 126, best to worst. The study groups' average score changes per week were then compared.
Measured: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Beck Anxiety Inventory (BAI) Mean Total Score Change Per Week From Baseline to Termination
Self-reported symptom survey, score range 0 - 63, best to worst. The study groups' average score changes per week were then compared.
Measured: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.

Timeline

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

1 Sep 201028 May 2015

First posted20 Jan 2010 (estimated)
Study start1 Sep 2010
Primary completion28 May 2015
Study completion28 May 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 (4)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies 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: Crossover
Masking: Single blind
Who is masked: Investigator
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01052714
Sponsor's protocol ID: D7358-R
Acronym: MAMAO2
Status last verified: Jul 2018
First submitted: 15 Jan 2010
Last updated: 9 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kwan CL, Gelberg HAL, Rosen JA, Chamberlin V, Shah C, Nguyen C, Pierre JM, Erickson ZD, Mena SJ, King M Jr, Arnold I, Baker MR, Meyer HB, Ames D. Nutritional counseling for adults with severe mental illness: key lessons learned. J Acad Nutr Diet. 2014 Mar;114(3):369-374. doi: 10.1016/j.jand.2013.12.005. No abstract available.
PubMed 24534370
Gelberg HA, Kwan CL, Mena SJ, Erickson ZD, Baker MR, Chamberlin V, Nguyen C, Rosen JA, Shah C, Ames D. Meal replacements as a weight loss tool in a population with severe mental illness. Eat Behav. 2015 Dec;19:61-4. doi: 10.1016/j.eatbeh.2015.06.009. Epub 2015 Jul 2.
PubMed 26172565
Erickson ZD, Kwan CL, Gelberg HA, Arnold IY, Chamberlin V, Rosen JA, Shah C, Nguyen CT, Hellemann G, Aragaki DR, Kunkel CF, Lewis MM, Sachinvala N, Sonza PA, Pierre JM, Ames D. A Randomized, Controlled Multisite Study of Behavioral Interventions for Veterans with Mental Illness and Antipsychotic Medication-Associated Obesity. J Gen Intern Med. 2017 Apr;32(Suppl 1):32-39. doi: 10.1007/s11606-016-3960-3.
PubMed 28271424
Tessier JM, Erickson ZD, Meyer HB, Baker MR, Gelberg HA, Arnold IY, Kwan C, Chamberlin V, Rosen JA, Shah C, Hellemann G, Lewis MM, Nguyen C, Sachinvala N, Amrami B, Pierre JM, Ames D. Therapeutic Lifestyle Changes: Impact on Weight, Quality of Life, and Psychiatric Symptoms in Veterans With Mental Illness. Mil Med. 2017 Sep;182(9):e1738-e1744. doi: 10.7205/MILMED-D-16-00405.
PubMed 28885930

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

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Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Management of Antipsychotic Medication Associated Obesity - 2
ClinicalTrials.gov ID: NCT01052714
Acronym / sponsor ID: MAMAO2 / D7358-R
Conditions: Diabetes, Obesity, Weight Gain
Keywords: Antipsychotic, Bipolar, Diabetes, Mental Illness, Nutrition, Obesity, Schizoaffective, Schizophrenia
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 1 Sep 2010 (actual)
Primary completion: 28 May 2015 (actual)
Study completion: 28 May 2015 (actual)
First posted: 20 Jan 2010 (estimated)
Results: Posted 6 Oct 2017

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
Usual Care	No intervention	–Control group with time-matched study visits
Lifestyle Balance	Active comparator	Behavioral: Lifestyle BalanceWeight management group education and individual counseling
Usual Care then Lifestyle Balance	Other	Behavioral: Lifestyle BalanceParticipants originally randomized to Usual Care, allowed to change over to Lifestyle Balance at month 6 per their request.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Must be a Veteran
Diagnosis of psychotic disorders, schizophrenia, schizoaffective disorder and bipolar illness
Age 18-70
Clinically determined to require ongoing treatment with Second Generation Antipsychotics (SGA) such as olanzapine, risperidone, quetiapine, ziprasidone, aripiprazole, clozapine
Experienced weight gain since treatment with SGA's

Key exclusion criteria (3 listed)

Have recently been diagnosed with schizophrenia (less than 1 year)
Are pregnant or breast feeding a baby
Have a medically unstable condition

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
Lifestyle BalanceAlso: Lifestyle Balance ProgramPatients assigned to the behavioral weight loss program (Lifestyle Balance Program) will do the following: -Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient - Be given a 7% weight loss goal - Be assisted in obtaining a 500 calorie reduction per day -Exercise for at least 30 min/day, at least 5 days a week - Maintain weekly food and exercise diaries -Be quizzed on their knowledge of healthy eating habits and nutrition	Behavioural	Lifestyle Balance, Usual Care then Lifestyle Balance

Primary outcome

Mean Weight Change Per Week From Baseline to Termination
Time frame: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Participants' weight was measured at each visit by study personnel using hospital scales, and the study groups' average weight changes per week were compared.
Mean Waist Circumference Change Per Week From Baseline to Termination
Time frame: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Participants' waist circumference was measured at each visit by study personnel using a measuring tape, and the study groups' average waist circumference changes per week were compared.
Mean Body Mass Index (BMI) Change Per Week From Baseline to Termination
Time frame: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Study personnel calculated each participant's BMI at each visit using their weight measurement taken at that visit and their height measurement taken at baseline. The study groups' average BMI changes per week were then compared.
Mean Serum Insulin Level Change Per Week From Baseline to Termination
Time frame: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
Results obtained through VA facility's Outpatient Lab. The study groups' average serum level changes per week were then compared.
Mean Triglycerides Level Change Per Week From Baseline to Termination
Time frame: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared.
Mean Low-Density Lipoprotein (LDL) Cholesterol Level Change Per Week From Baseline to Termination
Time frame: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared.
Mean High-Density Lipoprotein (HDL) Cholesterol Level Change Per Week From Baseline to Termination
Time frame: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared.
Health Knowledge Quiz Mean Total Score Change Per Week From Baseline to Termination
Time frame: Up to 4 observations per person,at baseline, 2 months, 6 months, and 12 months.
Quiz of information covered during Lifestyle Balance classes, score range 0 - 30, worst to best. The study groups' average score changes per week were then compared.
Change in Mean Total Calories Consumed Per Week From Baseline to Termination
Time frame: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Caloric intake assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in total calories consumed per week were then compared.
Change in Mean Empty Calories Consumed Per Week From Baseline to Termination
Time frame: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Caloric intake assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in empty calories consumed per week were then compared.
Change in Mean Total Exercise Time Per Week From Baseline to Termination
Time frame: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Minutes exercised assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in total minutes exercised per week were then compared.
Mean University Rhode Island Change Assessment Scale (URICA) Total Score Change Per Week From Baseline to Termination
Time frame: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Self-reported survey of respondents' feelings about changing their weight problem. Total score is also called the Readiness Score, ranging from -2 to +14 (worse to better), calculated by subtracting the mean from the precontemplation responses from the summation of the means of responses to contemplation, action, and the struggling to maintain items.
WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 1 Score Change Per Week From Baseline to Termination
Time frame: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Self-reported survey of quality of life as related to respondents' physical health, score range 7-35, worst to best. The study groups' average subscore changes per week were then compared.
WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 2 Score Change Per Week From Baseline to Termination
Time frame: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Self-reported survey of quality of life as related to respondents' psychological health, score range 6-30, worst to best. The study groups' average subscore changes per week were then compared.
WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 3 Score Change Per Week From Baseline to Termination
Time frame: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Self-reported survey of quality of life as related to respondents' social relationships, score range 3-15, worst to best. The study groups' average subscore changes per week were then compared.
WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 4 Score Change Per Week From Baseline to Termination
Time frame: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Self-reported survey of quality of life as related to respondents' environment, score range 8-40, worst to best. The study groups' average subscore changes per week were then compared.
Brief Psychiatric Rating Scale (BPRS) Mean Total Score Change Per Week From Baseline to Termination
Time frame: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Clinician-assessed symptom survey, score range 18 - 126, best to worst. The study groups' average score changes per week were then compared.
Beck Anxiety Inventory (BAI) Mean Total Score Change Per Week From Baseline to Termination
Time frame: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Self-reported symptom survey, score range 0 - 63, best to worst. The study groups' average score changes per week were then compared.

Results and safety

Results posted to the registry on 6 Oct 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
Usual Care	42	17
Lifestyle Balance	62	33
Usual Care Then Lifestyle Balance	17	15

Primary outcome: Mean Weight Change Per Week From Baseline to Termination

Time frame: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.. Mean (Standard Error). Unit: Pounds per week

Measure	Usual Care n = 42	Lifestyle Balance n = 62
Value	0.133 (0.057)	-0.0756 (0.0135)

Usual Care vs Lifestyle Balance: p <.001, Mixed Models Analysis

Population analysed: Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join "Usual Care then Lifestyle Balance" group to receive the Lifestyle Balance intervention.

Primary outcome: Mean Waist Circumference Change Per Week From Baseline to Termination

Time frame: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.. Mean (Standard Error). Unit: Inches per week

Measure	Usual Care n = 42	Lifestyle Balance n = 62
Value	-0.011 (0.0136)	-0.016 (0.003)

Usual Care vs Lifestyle Balance: p = 0.718, Mixed Models Analysis

Primary outcome: Mean Body Mass Index (BMI) Change Per Week From Baseline to Termination

Time frame: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.. Mean (Standard Error). Unit: Units on a scale per week

Measure	Usual Care n = 42	Lifestyle Balance n = 62
Value	0.035 (0.011)	-0.009 (0.002)

Usual Care vs Lifestyle Balance: p <.001, Mixed Models Analysis

Primary outcome: Mean Serum Insulin Level Change Per Week From Baseline to Termination

Time frame: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.. Mean (Standard Error). Unit: Pmol/L per week

Measure	Usual Care n = 42	Lifestyle Balance n = 62
Value	-0.018 (1.23)	-0.44 (0.28)

Usual Care vs Lifestyle Balance: p = 0.676, Mixed Models Analysis

Adverse events

Time frame: During 52-week period from participant randomization to termination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	8 of 59 (13.6%)	0 of 59 (0%)	1 of 59
Lifestyle Balance	7 of 79 (8.9%)	0 of 79 (0%)	2 of 79

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24534370Kwan CL, Gelberg HAL, Rosen JA, Chamberlin V, Shah C, Nguyen C, Pierre JM, Erickson ZD, Mena SJ, King M Jr, Arnold I, Baker MR, Meyer HB, Ames D. Nutritional counseling for adults with severe mental illness: key lessons learned. J Acad Nutr Diet. 2014 Mar;114(3):369-374. doi: 10.1016/j.jand.2013.12.005. No abstract available.
Background: PubMed 26172565Gelberg HA, Kwan CL, Mena SJ, Erickson ZD, Baker MR, Chamberlin V, Nguyen C, Rosen JA, Shah C, Ames D. Meal replacements as a weight loss tool in a population with severe mental illness. Eat Behav. 2015 Dec;19:61-4. doi: 10.1016/j.eatbeh.2015.06.009. Epub 2015 Jul 2.
Results publication: PubMed 28271424Erickson ZD, Kwan CL, Gelberg HA, Arnold IY, Chamberlin V, Rosen JA, Shah C, Nguyen CT, Hellemann G, Aragaki DR, Kunkel CF, Lewis MM, Sachinvala N, Sonza PA, Pierre JM, Ames D. A Randomized, Controlled Multisite Study of Behavioral Interventions for Veterans with Mental Illness and Antipsychotic Medication-Associated Obesity. J Gen Intern Med. 2017 Apr;32(Suppl 1):32-39. doi: 10.1007/s11606-016-3960-3.
Derived from this study: PubMed 28885930Tessier JM, Erickson ZD, Meyer HB, Baker MR, Gelberg HA, Arnold IY, Kwan C, Chamberlin V, Rosen JA, Shah C, Hellemann G, Lewis MM, Nguyen C, Sachinvala N, Amrami B, Pierre JM, Ames D. Therapeutic Lifestyle Changes: Impact on Weight, Quality of Life, and Psychiatric Symptoms in Veterans With Mental Illness. Mil Med. 2017 Sep;182(9):e1738-e1744. doi: 10.7205/MILMED-D-16-00405.
Individual participant dataSharing planned: No

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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.

Donna Ames, MD principal investigator

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

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

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle Balance in people with Diabetes and Obesity, run by VA Office of Research and Development 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 7 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 9 Aug 2018. 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?

Yes. Results are posted in the registry (first posted 6 Oct 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?

Mean Weight Change Per Week From Baseline to Termination (time frame: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.). The study lists 18 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 NCT01052714, which also lists 4 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 9 Aug 2018.