ObesityTODINCT01692574

Treatment for Depressed, Obese Individuals at Risk for Cardiovascular Disease (CVD)

A study testing Behavior Modification for Weight Loss, Alternative Approach to Weight Loss and Cognitive-Behavior Therapy for Depression in people with Obesity and Major Depressive Disorder, run by University of Pennsylvania 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: Obesity, Major Depressive Disorder, Dysthymic Disorder
What is being tested?: Behavior Modification for Weight Loss, Alternative Approach to Weight Loss and Cognitive-Behavior Therapy for Depression
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 1 siteUnited States
Study dates: Aug 2012to Nov 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Female and male participants, with a BMI of 27 kg/m2 to 45 kg/m2
Age 18 - 70 years old
Presence of current major depressive disorder or dysthymic disorder
At least 2 CVD risk factors, as characterized by the metabolic syndrome, including:
Elevated waist circumference (males 40 inches or 102 cm; females 35 inches of 88 cm)
Fasting blood glucose 100 mg/dL

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Blood pressure 130/85 mm Hg
Triglycerides 150 mg/dL
Reduced HDL cholesterol (males 40 mg/dL; females 50 mg/dL)
OR medications for these conditions
Able to comply will all study procedures and schedule
Able to speak and read English

Who cannot join

Cardiovascular event (e.g., myocardial infarction, stroke) within the past 12 months
Use of tricyclic anti-depressants, monoamine oxidase inhibitors or paroxetine, mood stabilizers, or antipsychotic medications. (Note: participants who take SSRI/SNRI may be acceptable, provided they have been on a stable dose of these medications 3 months.)
Use of weight-loss medications or any medications known to significantly affect weight (e.g., oral steroids) in past 3 months
Weight loss of 5% or more in past 6 months
Enrollment in weight reduction program in prior 3 months
Treatment in individual psychotherapy for any psychiatric disorder in prior 3 months (Note: participants in couples or family counseling will be allowed.)

Show all 22Show fewer

Severe depression or severe impairment of functioning as judged by the assessor or PI
Presence of active suicidal ideation
Diabetes
Alcohol/drug abuse/dependence
Renal/hepatic disease
Change in thyroid medications in last 3 months
Pregnant/lactating, within 6-months post-partum
Current diagnoses, or history within the last 5 years, of anorexia or bulimia
Psychotic symptoms or hospitalization for a psychiatric disorder in previous 12 months
Mood disorder NOS, substance-induced mood disorders, mood disorders due to a general medical condition
History of bipolar disorder
History of head trauma
Any changes in smoking behavior in prior 3 months (or plans to change in the next 3 months)
Plans for bariatric surgery
Any other uncontrolled major medical problems
Women who are pregnant

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania: Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Treatment of Obesity in Depressed Individuals: A Randomized Controlled Trial

To determine whether individuals who suffer from depression and obesity are able to lose weight and show improvements in mood and cardiovascular disease risk factors following 20 weeks of a combined treatment of cognitive-behavior therapy for depression and behavior modification for weight loss. Participants will be assigned to one of three treatments: 1) cognitive-behavior therapy for the treatment of depression combined with an alternative approach to weight loss, 2) a weight loss intervention combined with a depression support and education , or 3) cognitive-behavioral therapy for depression combined with a weight loss intervention.

Conditions: Obesity, Major Depressive Disorder, Dysthymic Disorder, Cardiovascular Disease
Being tested: Behavior Modification for Weight Loss, Alternative Approach to Weight Loss, Cognitive-Behavior Therapy for Depression, Depression Support and Education
Keywords: depression and obesity treatment
Medical subject headings: Obesity, Depressive Disorder, Major, Dysthymic Disorder, Cardiovascular Diseases, Depression

What participants receive

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

Behavior Modification for Weight LossBehavioural
Alternative Approach to Weight LossBehavioural
Cognitive-Behavior Therapy for DepressionBehavioural
Depression Support and EducationBehavioural

Study groups in NCT01692574
Study group	Role	What they receive
Combined	Experimental	Group cognitive-behavior therapy for depression combined with behavior modification for weight loss Receives: Behavioral: Behavior Modification for Weight Loss; Behavioral: Cognitive-Behavior Therapy for Depression
GCBT-ND	Active comparator	Group cognitive-behavior therapy for depression combined with an alternative approach to weight loss Receives: Behavioral: Alternative Approach to Weight Loss; Behavioral: Cognitive-Behavior Therapy for Depression
DSE	Active comparator	Behavior modification for weight loss combined with depression support and education. Receives: Behavioral: Behavior Modification for Weight Loss; Behavioral: Depression Support and Education

What is being measured

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

Weight loss
To determine whether depressed, obese individuals who receive the combined treatment of cognitive-behavior therapy for depression and behavior modification for weight loss are able to lose 5% of their initial weight at the end of 20 weeks of treatment.
Measured: Baseline to 20 weeks of treatment, follow-up at week 46

Secondary outcomes (1)

Changes in metabolic cardiovascular disease risk factors and inflammatory markers
Measured: Baseline to 20 weeks of treatment, follow up at week 46

Timeline

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

Aug 2012Nov 2015

First posted25 Sep 2012 (estimated)
Study startAug 2012
Primary completionNov 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe 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: Factorial
Masking: None (open label)
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01692574
Sponsor's protocol ID: 813829
Acronym: TODI
Status last verified: Aug 2016
First submitted: 20 Sep 2012
Last updated: 22 Aug 2016
Results posted: No
Data monitoring committee: Yes

Publications

Faulconbridge LF, Driscoll CFB, Hopkins CM, Bailer Benforado B, Bishop-Gilyard C, Carvajal R, Berkowitz RI, DeRubeis R, Wadden TA. Combined Treatment for Obesity and Depression: A Pilot Study. Obesity (Silver Spring). 2018 Jul;26(7):1144-1152. doi: 10.1002/oby.22209.
PubMed 29932516

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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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Obesity in Depressed Individuals: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT01692574
Acronym / sponsor ID: TODI / 813829
Conditions: Obesity, Major Depressive Disorder, Dysthymic Disorder, Cardiovascular Disease
Keywords: depression and obesity treatment
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: Aug 2012
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 25 Sep 2012 (estimated)
Results: Not posted in the source record

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Combined	Experimental	Behavioral: Behavior Modification for Weight Loss, Behavioral: Cognitive-Behavior Therapy for DepressionGroup cognitive-behavior therapy for depression combined with behavior modification for weight loss
GCBT-ND	Active comparator	Behavioral: Alternative Approach to Weight Loss, Behavioral: Cognitive-Behavior Therapy for DepressionGroup cognitive-behavior therapy for depression combined with an alternative approach to weight loss
DSE	Active comparator	Behavioral: Behavior Modification for Weight Loss, Behavioral: Depression Support and EducationBehavior modification for weight loss combined with depression support and education.

Who may qualify

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

Key inclusion criteria (12 listed)

Female and male participants, with a BMI of 27 kg/m2 to 45 kg/m2
Age 18 - 70 years old
Presence of current major depressive disorder or dysthymic disorder
At least 2 CVD risk factors, as characterized by the metabolic syndrome, including:
Able to comply will all study procedures and schedule

Key exclusion criteria (22 listed)

Cardiovascular event (e.g., myocardial infarction, stroke) within the past 12 months
Use of tricyclic anti-depressants, monoamine oxidase inhibitors or paroxetine, mood stabilizers, or antipsychotic medications. (Note: participants who take SSRI/SNRI may be acceptable, provided they have been on a stable dose of these medications 3 months.)
Use of weight-loss medications or any medications known to significantly affect weight (e.g., oral steroids) in past 3 months
Weight loss of 5% or more in past 6 months
Enrollment in weight reduction program in prior 3 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
Behavior Modification for Weight Loss	Behavioural	Combined, DSE
Alternative Approach to Weight Loss	Behavioural	GCBT-ND
Cognitive-Behavior Therapy for Depression	Behavioural	Combined, GCBT-ND
Depression Support and Education	Behavioural	DSE

Primary outcome

Weight loss
Time frame: Baseline to 20 weeks of treatment, follow-up at week 46
To determine whether depressed, obese individuals who receive the combined treatment of cognitive-behavior therapy for depression and behavior modification for weight loss are able to lose 5% of their initial weight at the end of 20 weeks of treatment.

1 secondary outcome

Changes in metabolic cardiovascular disease risk factors and inflammatory markers
Time frame: Baseline to 20 weeks of treatment, follow up at week 46

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 22 Aug 2016.
Derived from this study: PubMed 29932516Faulconbridge LF, Driscoll CFB, Hopkins CM, Bailer Benforado B, Bishop-Gilyard C, Carvajal R, Berkowitz RI, DeRubeis R, Wadden TA. Combined Treatment for Obesity and Depression: A Pilot Study. Obesity (Silver Spring). 2018 Jul;26(7):1144-1152. doi: 10.1002/oby.22209.

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

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.

Lucy F Hemsley-Faulconbridge, PhD principal investigator

University of Pennsylvania Center for Weight and Eating Disorders

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

Questions about this trial

What is this clinical trial studying?

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 12 inclusion and 22 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 22 Aug 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight loss (time frame: Baseline to 20 weeks of treatment, follow-up at week 46). 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 NCT01692574, which also lists 1 linked publication.

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 22 Aug 2016.