Status:
COMPLETED
Research Aimed at Improving Both Mood and Weight
Lead Sponsor:
Palo Alto Medical Foundation
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
University of Washington
Conditions:
Depression
Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The RAINBOW study is an NIH R01-funded randomized controlled trial to evaluate the clinical and cost effectiveness and implementation potential of a primary care integrated multicondition intervention...
Detailed Description
The large numbers of primary care patients affected by coexisting obesity and depression and common risk factors for diabetes and heart disease underscore the urgency of developing effective, accessib...
Eligibility Criteria
Inclusion
- RAINBOW
- Inclusion criteria:
- Ethnicity and race: Any;
- Obesity: BMI≥30 kg/m2 for non-Asians; BMI≥27 kg/m2 for Asians;
- Clinically significant depressive symptoms: PHQ-9≥10;
- A PAMF patient for ≥1 year
- Seen in primary care at least once in the preceding 24 months;
- Able and willing to enroll and meet the requirements of the study
- Exclusion criteria:
- Inability to speak, read or understand English;
- Having no reliable telephone service, no device to use to watch a DVD, or no regular Internet access via a computer and/or mobile device;
- Had bariatric surgery within the past 12 months or plans to undergo bariatric surgery during the 24-month study period;
- Ongoing psychiatric care outside of the PAMF network.
- Active suicidal ideation that includes active plan and/or intent;
- Any Axis I disorder other than Minor or Major Depressive Disorder and/or Dysthymia, with the exception of any comorbid Anxiety Disorder;
- Active Bulimia Nervosa within the past 12 months (however Binge Eating Disorder without purging is not an exclusionary condition);
- Active alcohol or substance use disorder (including prescription drugs).
- Pre-existing diabetes (other than during pregnancy) or diabetes diagnosed as a result of fasting blood glucose or hemoglobin A1c levels obtained through study screening;
- Pre-existing cardiovascular disease.
- Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past 12 months;
- Severe medical comorbidities that require aggressive treatment, e.g., stage 4 or greater renal disease, liver failure;
- Diagnosis of a terminal illness and/or in hospice care;
- Residence in long-term care facility;
- Cognitive impairment based on the Callahan 6-item scale
- Plan to move out of the area or transfer care outside PAMF during the study period;
- Investigator discretion for reasons of clinical safety or protocol adherence.
- ENGAGE
- Inclusion criteria:
- • RAINBOW participant
- Exclusion criteria:
- Weight over 350 pounds
- MRI is contraindicated
- Traumatic brain injury
Exclusion
Key Trial Info
Start Date :
September 30 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2018
Estimated Enrollment :
409 Patients enrolled
Trial Details
Trial ID
NCT02246413
Start Date
September 30 2014
End Date
December 21 2018
Last Update
April 26 2024
Active Locations (2)
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1
Palo Alto Medical Foundation
Palo Alto, California, United States, 94301
2
Stanford University
Stanford, California, United States, 94305