Research Aimed at Improving Both Mood and Weight

Completed · Not applicable

Conditions studied: Depression, Obesity

In brief

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 program to help improve mood and weight for obese adults with clinically significant depressive symptoms. The ENGAGE study is a mechanistic investigation added to the main trial with funding through the NIH common fund for the Science of Behavior Change roadmap initiative. Beginning Jan 11, 2016, at least 100 of newly enrolled trial participants will be consented to undergo additional assays evaluating neurobiological mechanisms of self-regulation.

Key facts

Study ID

NCT02246413

Run by

Palo Alto Medical Foundation

People needed

409

Starts

2014-09-30

Expected to finish

2018-12-21

Last updated by the study team

2024-04-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Palo Alto Medical Foundation — Palo Alto, California, United States
• Stanford University — Stanford, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.