DiabetesMAMAONCT00344500

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

A study testing Behavioral Weight Loss Program in people with Diabetes 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

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Diabetes, Obesity, Weight Gain
What is being tested?: Behavioral Weight Loss Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 122 participants
Where: 1 siteUnited States
Study dates: Oct 2005to Sep 2009
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 the West Los Angeles 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

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: Management of Antipsychotic Medication Associated Obesity

This program aims to help Veterans who take antipsychotic medications lose weight. The investigators use a program based on the American Diabetes Association's "Diabetes Prevention Program," and the investigators 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 West Los Angeles VA hospital.

Read the detailed description

Rationale: The focus of this project is to develop a strategy to combat medication associated weight gain, the most problematic side effect of the newer antipsychotic medications. Improvements in long-term health outcomes might then be expected to change quality of life, promote treatment adherence, rehabilitative potential, and decrease resource utilization.

Procedures:

Half of the patients will randomized to the behavioral weight loss program (Lifestyle Balance Program) and do the following: Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient Given a 7% weight loss goal Assisted in obtaining a 500 calorie reduction per day Asked to 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

The other half of the patients will be randomized to "Usual Care" and will:

Receive pamphlets about Lifestyle Balance, starting exercise, and general nutritional information regarding food pyramids and the amount of calories in fast foods.

Be encouraged to exercise and eat a healthy diet Not receive classes on nutrition or exercise Be seen on the same schedule as the experimental group, in order to equalize contact time.

After six months, if patients in the "usual care group" wish to participate in the more rigorous behavioral weight loss program they will be given that opportunity.

Visits:

Time Line:

Each subject will be followed for one year. Healthy Lifestyles courses will take eight weeks to complete. Visits will be monthly for the remaining 12 months Enrollment: 120 patients Course of study: October 2005-October 2008

At Beginning and Termination:

Informed Consent (at start of study only) Psychiatric interviews and assessments Physical Examination Framingham risk assessment for cardiovascular disease Electrocardiogram Lipid Profile, fasting glucose, Hemoglobin A1C

At Each Visit:

Vitals, weight, waist circumference, BMI, and % Fat Food and exercise diaries will be reviewed

At Month One and Month Six:

Lipid Profile, fasting glucose, Hemoglobin A1C Electrocardiogram Psychiatric assessments

At Month Nine:

Lipid Profile, fasting glucose, Hemoglobin A1C Electrocardiogram

Clinical Care:

All patients will continue their clinical care with their current psychiatrist and general physician. Medications will not be manipulated for the purpose of this study.

Incentives:

The group participating in the behavioral intervention program will receive rewards for achieving weight loss goals and be given incentives such as a pedometer and Slimfast meal replacements.

Conditions: Diabetes, Obesity, Weight Gain
Being tested: Behavioral Weight Loss Program
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.

Behavioral Weight Loss ProgramBehavioural
Also called Lifestyle Balance Program
Patients randomized 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 NCT00344500
Study group	Role	What they receive
Usual Care	No intervention	Usual Care
Lifestyle Balance	Active comparator	Behavioral Weight Loss Program Receives: Behavioral: Behavioral Weight Loss Program

What is being measured

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

Mean Weight
Average weight of subjects attending each of the first 8 weekly visits and the 10 monthly visits which followed, per study group.
Measured: Weekly/Monthly, up to 1 year
Change in Predicted Trajectory of Mean BMI Per GLMM Analysis
General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random. The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates. Using a likelihood ratio test, we compared different options to model these trajectories and found a linear model, which assumes that the same rate of change is maintained over the whole study, provided a good fit to the data. We used a linear model of the average rate of change over time (slope) for all comparisons. To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics.
Measured: 12 months
Change in Predicted Trajectory of Mean Body Fat Percentage Per GLMM Analysis
Computed as % body fat at 12 month - % body fat at baseline. General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random. The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates. Using a likelihood ratio test, we found a linear model, assuming the same rate of change throughout the study, provided a good fit to the data compared to other models. We used a linear model of the average rate of change over time (slope) for all comparisons. To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics.
Measured: 12 months

Timeline

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

Oct 2005Sep 2009

First posted26 Jun 2006 (estimated)
Study startOct 2005
Primary completionSep 2009
Study completionSep 2009

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 (3)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: None (open label)
Enrolment: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00344500
Sponsor's protocol ID: D3925-R
Acronym: MAMAO
Status last verified: Mar 2016
First submitted: 22 Jun 2006
Last updated: 6 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Guzik LH, Wirshing DA. Behavioral weight loss classes for patients with severe mental illness. Psychiatr Serv. 2007 Nov;58(11):1498. doi: 10.1176/ps.2007.58.11.1498. No abstract available.
PubMed 17978266
Erickson ZD, Mena SJ, Pierre JM, Blum LH, Martin E, Hellemann GS, Aragaki DR, Firestone L, Lee C, Lee P, Kunkel CF, Ames D. Behavioral interventions for antipsychotic medication-associated obesity: a randomized, controlled clinical trial. J Clin Psychiatry. 2016 Feb;77(2):e183-9. doi: 10.4088/JCP.14m09552.
PubMed 26930534
Tully A, Smyth S, Conway Y, Geddes J, Devane D, Kelly JP, Jordan F. Interventions for the management of obesity in people with bipolar disorder. Cochrane Database Syst Rev. 2020 Jul 20;7(7):CD013006. doi: 10.1002/14651858.CD013006.pub2.
PubMed 32687629

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?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Management of Antipsychotic Medication Associated Obesity
ClinicalTrials.gov ID: NCT00344500
Acronym / sponsor ID: MAMAO / D3925-R
Conditions: Diabetes, Obesity, Weight Gain
Keywords: Antipsychotic, Bipolar, Diabetes, Mental Illness, Nutrition, Obesity, Schizoaffective, Schizophrenia
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: Oct 2005
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 26 Jun 2006 (estimated)
Results: Posted 18 May 2015

Clinical summary

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

Detailed description

Procedures:

The other half of the patients will be randomized to "Usual Care" and will:

Receive pamphlets about Lifestyle Balance, starting exercise, and general nutritional information regarding food pyramids and the amount of calories in fast foods.

Be encouraged to exercise and eat a healthy diet Not receive classes on nutrition or exercise Be seen on the same schedule as the experimental group, in order to equalize contact time.

After six months, if patients in the "usual care group" wish to participate in the more rigorous behavioral weight loss program they will be given that opportunity.

Visits:

Time Line:

At Beginning and Termination:

At Each Visit:

Vitals, weight, waist circumference, BMI, and % Fat Food and exercise diaries will be reviewed

At Month One and Month Six:

Lipid Profile, fasting glucose, Hemoglobin A1C Electrocardiogram Psychiatric assessments

At Month Nine:

Lipid Profile, fasting glucose, Hemoglobin A1C Electrocardiogram

Clinical Care:

All patients will continue their clinical care with their current psychiatrist and general physician. Medications will not be manipulated for the purpose of this study.

Incentives:

The group participating in the behavioral intervention program will receive rewards for achieving weight loss goals and be given incentives such as a pedometer and Slimfast meal replacements.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Usual Care	No intervention	–Usual Care
Lifestyle Balance	Active comparator	Behavioral: Behavioral Weight Loss ProgramBehavioral Weight Loss Program

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
Behavioral Weight Loss ProgramAlso: Lifestyle Balance ProgramPatients randomized 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

Primary outcome

Mean Weight
Time frame: Weekly/Monthly, up to 1 year
Average weight of subjects attending each of the first 8 weekly visits and the 10 monthly visits which followed, per study group.
Change in Predicted Trajectory of Mean BMI Per GLMM Analysis
Time frame: 12 months
General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random. The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates. Using a likelihood ratio test, we compared different options to model these trajectories and found a linear model, which assumes that the same rate of change is maintained over the whole study, provided a good fit to the data. We used a linear model of the average rate of change over time (slope) for all comparisons. To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics.
Change in Predicted Trajectory of Mean Body Fat Percentage Per GLMM Analysis
Time frame: 12 months
Computed as % body fat at 12 month - % body fat at baseline. General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random. The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates. Using a likelihood ratio test, we found a linear model, assuming the same rate of change throughout the study, provided a good fit to the data compared to other models. We used a linear model of the average rate of change over time (slope) for all comparisons. To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics.

Results and safety

Results posted to the registry on 18 May 2015, 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	48	25
Lifestyle Balance	60	25
Changeover	14	12

Primary outcome: Mean Weight

Time frame: Weekly/Monthly, up to 1 year. Mean (Standard Deviation). Unit: Pounds

Measure	Usual Care (UC) n = 48	Lifestyle Balance (LB) n = 60
Week 0 (n=47, 60)	235.22 (34.51)	232.1 (46.3)
Week 1 (n=44, 56)	235.95 (35.33)	233.41 (46.1)
Week 2 (n=42, 50)	232.3 (33.56)	233.34 (47.78)
Week 3 (n=38, 45)	235.98 (35.88)	233.54 (42.91)
Week 4 (n=41, 47)	236.89 (36.03)	237.84 (51.64)
Week 5 (n=34, 43)	235.99 (37.94)	234.79 (45.95)
Week 6 (n=38, 41)	237.88 (37.84)	237.38 (52.9)
Week 7 (n=36, 42)	235.3 (36.54)	235.5 (52.73)

Usual Care (UC) vs Lifestyle Balance (LB): p <0.01, Mixed Models Analysis

Population analysed: All subjects who enrolled in this research program. Subjects were assessed weekly, when able. Since some were not able to do every weekly assessment, N varies weekly, and the weekly assessments below are the means of the number of subjects out of the total in the group who were assessed at that point.

Primary outcome: Change in Predicted Trajectory of Mean BMI Per GLMM Analysis

Time frame: 12 months. Number. Unit: kg/m^2

Measure	Usual Care (UC) n = 48	Lifestyle Balance (LB) n = 60
Value	0.6	-1.7

Primary outcome: Change in Predicted Trajectory of Mean Body Fat Percentage Per GLMM Analysis

Time frame: 12 months. Number. Unit: Body Fat Percentage Change

Measure	Usual Care (UC) n = 48	Lifestyle Balance (LB) n = 60
Value	1.5	-2

Adverse events

Time frame: Four (4) years, between November 2005 and October 2009.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	8 of 48 (16.7%)	1 of 48 (2.1%)	Not reported
Lifestyle Balance	9 of 60 (15%)	0 of 60 (0%)	Not reported
Changeover	1 of 14 (7.1%)	1 of 14 (7.1%)	Not reported

Limitations and caveats (from the sponsor): Limitations to our study were its single-site recruitment yielding subjects mostly male and all veterans, limiting of statistical power by control subjects allowed to join treatment group resulting in exclusion from data, and a high dropout rate.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17978266Guzik LH, Wirshing DA. Behavioral weight loss classes for patients with severe mental illness. Psychiatr Serv. 2007 Nov;58(11):1498. doi: 10.1176/ps.2007.58.11.1498. No abstract available.
Results publication: PubMed 26930534Erickson ZD, Mena SJ, Pierre JM, Blum LH, Martin E, Hellemann GS, Aragaki DR, Firestone L, Lee C, Lee P, Kunkel CF, Ames D. Behavioral interventions for antipsychotic medication-associated obesity: a randomized, controlled clinical trial. J Clin Psychiatry. 2016 Feb;77(2):e183-9. doi: 10.4088/JCP.14m09552.
Derived from this study: PubMed 32687629Tully A, Smyth S, Conway Y, Geddes J, Devane D, Kelly JP, Jordan F. Interventions for the management of obesity in people with bipolar disorder. Cochrane Database Syst Rev. 2020 Jul 20;7(7):CD013006. doi: 10.1002/14651858.CD013006.pub2.

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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

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

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral Weight Loss Program in people with Diabetes 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 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 6 Apr 2016. 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 18 May 2015). 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 (time frame: Weekly/Monthly, up to 1 year). The study lists 3 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 NCT00344500, which also lists 3 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 6 Apr 2016.